ISO 17025 Lead Auditor - Delegate Pack

ISO/IEC 17025:2017
Lead Implementor / Lead Auditor

Version 1.1
The world’s largest global training provider

info@theknowledgeacademy.com
theknowledgeacademy.com
ISO/IEC 17025:2017
Lead Implementor / Lead Auditor
© 2020 The Knowledge Academy Ltd 1
About The Knowledge Academy
• World Class Training Solutions
• Subject Matter Experts
• Highest Quality Training Material
• Accelerated Learning Techniques
• Project, Programme, and Change
Management, ITIL® Consultancy
• Bespoke Tailor Made Training Solutions
• PRINCE2®, MSP®, ITIL®, Soft Skills, and More
1
Administration
• Trainer
• Fire Procedures
• Facilities
• Days/Times
• Breaks
• Special Needs
• Delegate ID check
• Phones and Mobile devices
Outlines
• Module 1: Introduction to ISO 17025
• Module 2: Requirements of ISO
17025
• Module 3: ISO 19011 relationship to
ISO 17025
• Module 4: Scope
• Module 5: Normative references
2
Outlines
• Module 6: Terms and definitions • Module 11: Management system
requirements
• Module 7: General requirements
• Module 12: Management system
• Module 8: Structural documentation
requirements
• Module 13: Control management
• Module 9: Resource requirements system documents
• Module 10: Process requirements • Module 14: Control of records
Outlines
• Module 15: Address risks and • Module 20: Fundamental audit
opportunities concepts and principles
• Module 16: Improvement • Module 21: Auditing requirements
and assessment: ISO 17011:2017,
• Module 17: Corrective actions ISO 19011:2018
• Module 18: Management reviews • Module 22 Recognition and
oversight of ILAC, IAAC, APAC etc.
• Module 19: Terminology – ISO
9000, VIM etc.
3
Outlines
• Module 23: Test Reports, AB • Module 27: GUM (Uncertainty),
symbols, equipment stickers, PT/ILC, Traceability
certificates
• Module 28 Opening and closing
• Module 24: Clauses 4, 5, and 6 meeting activities
review
• Module 29: ISO 19011 relationship
• Module 25: Clauses 7 and 8 review to ISO 17025
• Module 26: Guidelines for auditing: • Module 30: Auditing technical
ISO 19011 methods
Outlines
• Module 31: Reporting audit results • Module 35: Planning LMS
implementation
• Module 32: Audit checklists and
audit reports • Module 36: Implementing LMS
• Module 33: Review of standards and • Module 37: Laboratory
internal auditing issues Management System Monitoring,
Measurement, and Continuous
• Module 34: Introduction to Lab Improvement
Management System (LMS)
4
Outlines
• Module 38: Planning ISO 17025
Audit
• Module 39: Conducting the ISO
17025 Audit
• Module 40: Concluding and
ensuring follow‐up of ISO 17025
Audit
Module 1: Introduction to ISO 17025
5
ISO 17025
• ISO 17025 is the international standard which sets out the general needs for the
competent, impartial, as well as regular operation of laboratories
• It defines the works that should be involved in laboratory operations to develop
confidence in its capability to produce valid as well as consistently strong testing,
sampling outcomes, as well as calibration
• ISO/IEC 17025:2017 is the current updated standard. This standard was issued with
participation among the International Organisation for Standardisation (ISO) and
International Electro technical Commission (IEC)
ISO 17025
(Continued)
• According to ISO 9001 or ISO 14001, certification is the recognition which is an effective
management system is in place, and ISO/IEC 17025 involves recognition of the technical
capacity of laboratories
• Accreditation is a legal declaration by an Accreditation Body, after confirmation and
evaluation, a laboratory is useful in meeting the needs of ISO 17025 to perform
experiments according to its accredited scope
• The accreditation and standard are utilised by independently owned and operated
laboratories, and those who are part of bigger companies, irrespective of the industry as
well as size, which is included in measurement or sampling works
6
Module 2: Requirements of ISO 17025
Requirements of ISO 17025
• The ISO 17025 laboratory testing, as well as
compliance standard, involves a series of various
needs, can divided into eight categories
• These categories involve Scope, Normative
references, terms and definitions, general
requirements, structural requirements, resource
requirements, process requirements, management
system requirements
• These categories laid out a variety of rules as well as
standards for testing as well as calibration
laboratories, involving testing and calibration
standards, staff capacity, standards of equipment,
quality management, etc.
7
Module 3: ISO 19011 Relationship to ISO
17025
ISO 19011
• ISO 19011:2018 (Guidelines for auditing management systems), was published in July
2018 in response to demand for guidance on combined management system audits
• It provides comprehensive guidelines for auditing quality and/or environmental
management systems
• The goal is to encourage organisations to save money, energy, effort and expense by
eliminating uncertainty about the goals of the environmental or quality audit
programme
• Ensure the audit reports are in the best format and include all relevant information
• Securing alignment of goals within an audit system for individual audits
8
ISO 19011
(Continued)
• Assessing the competence of audit team members against appropriate standards and
minimising duplication of effort in the conduct of hybrid environmental / quality audits
• Significant updates to the new High‐Level Architecture of ISO 19011:2018 are as follows:
A risk‐based approach
Extension of audit program management
Detailed instructions on how to perform an audit
ISO 19011
(Continued)
Extension on auditors' competency criteria
Removal of "Auditor's Guidance and Examples of Discipline‐
Specific Knowledge and Skills" Annex A in ISO 19011:2011
Expansion on "Planning and performing audit guidelines for
auditors“
• Four essential decisions / support tools for efficient preparation, implementing and
reviewing quality and environmental audits are now available within a single standard
9
ISO 17025
(Continued)
• ISO 17025 is the main international standard for general test and calibration laboratory
competency specifications
• In major countries, ISO/IEC 17025 is the standard that most laboratories need to be
certified to be deemed technically competent
• There are many commonalities with the ISO 9001 standard, but ISO/IEC 17025 is more
stringent in competency criteria and refers specifically to those entities that generate
testing and calibration results and are focused on more scientific standards that give
laboratories many benefits
ISO 17025
(Continued)
• The universal ISO 17025 standard applies to all or any laboratory irrespective of the size
or complexity of research and calibration practices
• Generally, laboratories use ISO / IEC 17025 to incorporate a Quality Management
System (QMS) to improve their ability to comply with relevant tests. It is also the basis
for an accreditation body
• Since the standard is about skills, accreditation is simply the formal recognition of a
presentation of that ability
• The common quality manual content follows the ISO / IEC 17025 standard outline
10
ISO 17025
Major Changes in ISO/IEC 17025:2017 Include
• It reduced the prescriptive guidelines of the standard and resulted in additional
guidelines based on performance
• An additional chapter on risk‐based thought
• Greater flexibility in systems, policies, recorded knowledge, and organisational
obligations
• Technology updates. For example, the standard now recognised and incorporates the
use of computers, electronic records, and production of electronic records and reports
Module 4: Scope
11
Scope
• Scope of accreditation is the complete and official
statement of works for which the laboratory is
accredited
• In substance, this is a series of experiments which
your laboratory is accredited to perform
• Several laboratories forget regarding the value of
determining their scope when receiving accredited
or re‐accredited
Scope
(Continued)
• Companies always instantly put their scope together rather than consideration carefully
and present it to the accreditation body without completely considering which they
have to be accredited to perform
• In substance, the scope of accreditation follows two objectives:
• To determine the particular areas the activities of the laboratory which are to be
included the accreditation
• To give the user of an accredited laboratory with a clear view of the particular
calibrations included by the accreditation
12
Module 5: Normative References
Normative References
• The Normative references clause lists that
documents for information which are mentioned in
the text in a way that their content constitutes of the
document
• The references which are applied is discovered in the
place where they are mentioned in the document,
and not in the Normative references clause
• This series of references are provided for the
comfort of the user, who may consult the place
where they are mentioned in the document in order
to understand as well as evaluate to how they apply
13
Module 6: Terms and Definitions
Terms and Definitions
• Some explanations of the terms have been
presented in the updated version of ISO
17025 that are inter as well as intra
laboratory comparison, proficiency testing,
impartiality, verification, decision rule,
complaint as well as validation
• In the definition of the laboratory, there are
definitions of some other terms known as
equipment calibration, sampling works, as
well as sample testing
14
Terms and Definitions
(Continued)
• An administration structure needs to be established, and the structure needs to be
experienced, equipment required to be joined as well as looked after correctly with the
help of strategies for maintenance, methods of testing needs to be accepted, and the
examine nature should be insured
• The utilisation of our accreditation to standard may confirm the ability of an
organisation providing inspecting administrations that are a new idea in an up‐to‐date
version of ISO 17025
Module 7: General Requirements
15
General Requirements
• ISO/IEC 17025 signifies the general requirements
for the impartiality, competence and consistent
operation of laboratories
• ISO/IEC is relevant to every company doing
laboratory works, regardless of the number of
employees
• Regulatory authorities, laboratory customers,
companies as well as schemes utilising peer‐
assessment, accreditation bodies and others utilise
ISO/IEC 17025 in recognising or confirming the
competence of laboratories
Impartiality
• Impartiality is an essential fragment in ISO/IEC 17025. This fragment directs the risks
linked with creating biased outcomes
• There is no permission to the lab to let conflict of interest affect its outcomes under any
circumstance, and the lab should be dedicated to risk‐based when addressing
impartiality
• In substance, there should not be any conflict of interest about the following:
Commercial Relationship
Financial interest
interest interest
16
Impartiality
(Continued)
• As well as the laboratory should recognise risks to impartiality from:
Personal
Activities Relationships
relationships
• The lab needs to recognise any risk to impartiality on a continuous basis.
• If impartiality or risk is detected, the lab requires to take remedial action as well as
demonstrate how it has reduced or eliminated the risk
Confidentiality
• ISO/IEC 17025 addresses the needs including
confidentially
• The lab is liable for the management of all knowledge
collected or created during laboratory works as well
as is held liable by legal actuation
• The standard needs that the lab should notify
information to its clients in advance what it plans to
share with the society
• Moreover, it directs steps it will take if confidential
information is issued among the public
17
Confidentiality
(Continued)
• Confidentially need also includes laboratory employees
• Usually, the laboratory and its employees are liable for the information created or
collected during the performance of the laboratory works, as well as all information is
regarded as possessive information and shall be considered as confidential, with
exception to what is needed by law
Module 8: Structural Requirements
18
Structural Requirements
• The laboratory should determine as well as document the following regarding the
laboratory operations:
The organizational structure
The management with responsibility
The responsibility of the laboratory personnel
The activities of the laboratory
(Continued)
• The laboratory must have authorised employees to assure that regular contact takes
place concerning:
Improvement and implementation and of the
management system
The effectiveness of the management system
The value of meeting customer and regulatory
requirements
• The laboratory is must to document its processes to produce consistency of its works as
well as to assure that the outcomes are correct
19
(Continued)
• Usually, the procedures of laboratory are documented with a quality manual, activities
instructions as well as standard operating processes
• The new standard has identified the need in which the lab should claim conformity with
ISO 17025 standard for this series of laboratory works
• It means the lab is intended to be accredited and should involve in its scope of
accreditation for just to calibration, testing or sampling works which are using its
resources
Module 9: Resource Requirements
20
Resource Requirements
• Calibration and testing utilise the resource
needs of ISO/IEC 17025 to improve their
management system for quality, technical
operations as well as administrative
• Moreover, ISO 17025 accreditation is crucial in
enhancing the reputation of the laboratory
• Part of the procedure of accreditation is
recognising the resource needs of standard
General
• Resource requirements include employees,
facilities, equipment, systems as well as
support services
• The 17025 standard needs all internal as well
as external employees of the laboratory to be
capable and have an impartial attitude
• This involves employees who are included in
calibration, testing, sampling works, and
employees who are involved indirectly, like
technical employees
21
Personnel
• To become an ISO/IEC 17025 accredited lab, all personnel of the laboratory, all internal
as well as external personnel should be capable and work inside the structure of the
management system of the laboratory
• For each and every job purpose of the laboratory, an accurate documentation is needed
• It involves detail capacity as well as job descriptions, supervision, training, as well as
authorisation of personnel of the laboratory
• Laboratory management will communicate the responsibilities as well as authorities to
laboratory personnel by regular meetings or reviews of personnel performance
Personnel
(Continued)
• Management should to communicate to personnel for their responsibilities, duties and
work for what they are allowed to perform
• Besides, the lab should have processes as well as maintain records for the following:
o Determining the competence requirements
o Choosing personnel
o Training personnel
22
Personnel
(Continued)
o Supervision of personnel
o Authorisation of personnel
o Competence of personnel
• The personnel must perform these tasks
for which they are allowed:
o Development, modification,
verification, and validation of methods
Personnel
(Continued)
o Analysis of results
o Reports, reviews and authorisation of results
23
Facilities and Environmental Conditions
• About the facilities and environmental situations of ISO 17025, the laboratory must be
relevant to perform all works and not impact the validity of the outcomes. As a
laboratory, the situations should be:
Documented
Controlled
Monitored
Recorded
(Continued}
• Environmental situations that could affect your lab involve:
Dust
Humidity
Electrical supply
Temperature
Vibration
24
(Continued}
• Laboratory work areas should be:
o Defined
o Controlled
o Isolated from areas with inconsistent activities of laboratory to stop interference or
contamination of the activities
• If any actions are performed outside, the laboratory should assure that all of the
environmental conditions are met which is determined in this standard
Equipment
• The laboratory will have a way to the accurate
equipment needed for the performance of
activities of the laboratory
• A recorded calibration program will require to set
that involves the following:
o Records for every equipment that may impact
activities of the laboratory, involving the
handling, storage, transport, usage as well as
maintenance of equipment
25
Equipment
(Continued}
o Recognition of status of calibration, involving out of service as well as non‐calibrated
equipment
o Tamper counteraction program in order to protect unauthorised adjustments that
would invalidate the calibration status of the equipment
Metrological Traceability
• ISO 17025 laboratories have to manage and set
traceability of their measurements outcomes
utilising a recorded continuous chain of calibrations,
every contributing to measurement uncertainty as
well as connecting them to an accurate reference
• Laboratories should give objective proof
• The measurements outcomes should be traceable
to the International System of Units (SI) in one of
these steps:
o A capable laboratory gave calibration
26
Metrological Traceability
(Continued)
o Certified values of certified reference materials given through a capable producer
with stated metrological traceability to the SI
o The demonstrable realisation of the SI assured by comparison, directly as well as
indirectly, with standards which are national as well as international
• If the measurement may not be traceable to the SI, the laboratory should direct
metrological traceability to an accurate reference
Externally Provided Products and Services
• ISO/IEC 17025 laboratories should assure that only satisfactory externally products
which are provided as well as services that can affect the activities of the laboratory
which are utilised when products and services are:
o expected for inclusion inside the activities of the laboratory
o are given directly to the clients through the laboratory, as earned from the external
provider
o are utilised to support the laboratory's operation
27
(Continued)
• As determined in ISO/IEC 17025, the laboratory should have a procedure as well as
retain records for the following:
o Reviewing, defining, as well as approving needs for externally given products as well
as services
o Defining the basis for selection, evaluation, monitoring of performance as well as
re‐evaluation of the providers which are external
o Assuring that the services as well as products which provided externally, meet the
needs of the lab
(Continued)
o Activities originating from monitoring, evaluations or performance of providers
which is external
• The laboratory should communicate needs to external providers involving:
o Acceptance criteria
o Capacity, involving any needed eligibility of employees
o Works that the lab or its customer plans to perform at the premises of the external
provider
28
Module 10: Process Requirements
Process Requirements
• Process requirements are related to the Technical Requirements of ISO 17025 standard
• Determining the Decision Rule for customer need for conformity report is most
important in this clause
• A laboratory must have a determined method for the receipt, transportation, taking
care of, maintenance, stockpiling, as well as calibration and testing items
• The lab should have a different entry for each and every new thing to be tested or
calibrated in the lab facility under standard prescribed situations
• Divergence from indicated lab conditions are needed to be recorded at every situation
29
Review ‐ Requests, Tenders, and Contracts
• ISO 17025, requirements says that your laboratory should
have a process for the review of requests, tenders, as well
as contracts, this process needs to assure the following:
o The requirements are determined, recorded as well as
understanding
o The lab has the ability as well as resources to match
the requirements
o The lab needs to match the requirements of products
as well as services which are provided externally if the
external providers are utilised
Review ‐ Requests, Tenders, and Contracts
(Continued)
o The relevant techniques or processes are chosen as well as able to meet the needs
of the customers
• The laboratory should have excellent communication with the client
• The lab also should assure that the requirements of customers met, but also notify the
client if the techniques of the lab are improper or expired, or if the request of the lab
may not be made because it would compromise the lab’s honesty
30
Selection, Verification, and Validation of
Methods
Selection and verification of methods
• The laboratory is needed to utilise accurate techniques as well as processes for works,
and while necessary, for evaluation of the measurement uncertainty and mathematical
methods for data analysis
• Techniques, processes as well as supporting documentation required to be updated as
well as available to all employees
• Besides, ISO 17025 mandates that the lab remain updated with the accurate way and
while the clients did not specify a method, the lab selects the best as well as an
updated version
Methods
(Continued)
• The lab needs to tell the customer what way they are utilising
• While selecting a way, the lab must confirm that the method they are using has been
issued either nationally as well as internationally, regionally, or through other reputable
technical company. Scientific journal, as well as texts, are also valid issues
• The lab needs to verify that it may perform the ways which they choose
31
Methods
Validation of Methods
• ISO/IEC 17025 needs laboratories to validate methods which they utilize
• It involves non‐standard ways, laboratory‐improved methods as well as standard ways
• The methods validation should be as long as important to match the requirements of
the provided application
• The impact of the changes should be understood when the changes are performed to a
validated method
Methods
(Continued)
• The laboratory maintains the records of validation which are the following:
The validation of the procedure used
Specification of the requirements
Determination of the performance characteristics of the method
Results obtained
A statement on the validity of the method
32
Sampling
• ISO/IEC needs every laboratory to have a sampling plan as well as method when
carrying out a sampling of materials, substances or products for subsequence
calibration or testing
• The laboratory needs to determine if the sampling methods state the factors to be
controlled to assure the validity of subsequent testing, as well as assure that the
sampling plan or method is available at the site where sampling is undertaken
• Sampling is required to utilise accurate methods of statistical
Sampling
(Continued)
• Sampling methods must describe:
o The selection of samples or sites
o The sampling plan
o The preparation and treatment of
samples
33
Sampling
(Continued)
• While the laboratory is sampling, they needs to maintain accurate records of samples.
These records should involve, when necessary:
o References to the sampling method
o Date and time of sampling
o Data to identify and describe the sample
Sampling
(Continued)
o Personnel performing the sample
o Environmental or transportation conditions
o Diagrams or other equivalent means to identify the sampling location
o Deviations, additions or exclusions from the sampling method and sampling plan
34
Handling Test or Calibration Items
• The laboratory needs to have a process for transportation, receipt, handling, storage,
retention, protection, as well as disposal or return of test or calibration items
• It involves all provisions important to protect the honesty of the test or calibration item
as well as to protect the honesty of the calibration or test item, and the interest of the
customer as well as lab
• The lab needs to take precautions to avoid contamination, deterioration, damage or
loss to the item during handling, storing, transporting as well as preparing for
calibration or test
Handling Test or Calibration Items
• The laboratory also needs the following:
Establish handling instructions
Have a method for the apparent identification of calibration or test
items
Maintain identification when the lab is liable for the item
Assure that the items did not get confused
Accommodate a sub‐division of an item or groups of items and the
transfer of items
Record any deviations
35
Technical Records
• A lab must assure that technical records for
every activity of the lab include results, a
report, as well as information to facilitate, if
feasible, components identification
influencing the measurement outcomes and
its connected measurement uncertainty, as
well as allow to repetition of the activities of
the lab below situations as soon as possible to
the original
• You have to involve the date as well as identify
the employees who are responsible for the
activities of the lab while you are maintaining
records
Technical Records
(Continued)
• Records can involve the data, observations as well as evaluations, and have to be
recorded at the time when they are made
• If there are any changes made, these revisions should be followed to old versions or to
the real observations
• Maintain all the records, containing the original and revisions, involving altered aspects,
date of the alteration as well as employees responsible for any changes
36
Evaluation of Measurement Uncertainty
• As an ISO/IEC 17025 accredited laboratory, it is necessary to understand, from where
measurement uncertainty is coming
• The laboratory should identify the contributions to the uncertainties
• While you are calculating for uncertainty, you should think about all significant
contributions, even arising from sampling
• The lab requires to evaluate its equipment for uncertainty if you are doing calibrations
• While performing testing, you must evaluate measurement uncertainty
Ensure Results Validity
• The laboratory will have a process for controlling the validity of results
• As an ISO/IEC 17025 accredited lab, assuring the validity of outcomes to be the priority
• Be capable of identifying trends utilising statistical methods is one of the primary goals
of validity
• The laboratory needs to develop a process for controlling the validity of their outcomes,
to match the needs
• The main aim is to understand if the procedure or system can be ineffective so you may
take defensive steps
37
Reporting of Results
• This clause may be divided into these sub clauses:
General
Common Requirements for Reports
Specific Requirements for Test Reports
Specific Requirements for Calibration Certificates
Reporting Sampling‐ Specific Requirements
Reporting Statements of Conformity
Reporting Opinions and Interpretations
Amendments to Reports
Complaints
• Managing complaints of the customers is essential,
and you should have a recorded procedure to
evaluate, receive as well as make decisions to
handle ISO 17025 complaints if your lab wants to
be accredited
• The procedure requires to be easily available to any
party which is interested
• If the issued complaint is suitable to the works
performed by the laboratory, the laboratory should
confirm that it is liable for the complaint, and the
lab must be liable for every decision made around
to handling this complaint
38
Nonconforming Work
• This clause indicates that labs need to have a process that should be executed while
results or activities did not conform to their processes or the agreed requirements
which are made by the customer
• The laboratory needs to maintain records of nonconforming work, as well as if the lab
believes nonconformities can retake place, the lab should to take steps which are
remedial
• For non‐conformance, the process required to involve the following:
o Who is authorised as well as liable for the management of nonconforming activity
o Establish steps based on the risk level
Nonconforming Work
(Continued)
o An assessment of the significance of the nonconforming activity involving an
influenced analysis
o The decision to be taken for the nonconformity
o Assurance that the customer is notified
o Who is responsible for authorising the resumption of work
39
Control of Data and Information
Management
• Control of data, as well as information, is an essential factor for laboratories to do works
• Labs must confirm that they have the essential reach to input data as well as
information required to perform its all activities
• The labs must assure that the information management system which is utilised for
processing, collection, reporting, recording, storing as well as retrieving data is validated
for functionality
• It involves the accurate function of interfaces inside the laboratory information
management system
Module 11: Management System
Requirements
40
Management System Requirements
Options
• The laboratories need to implement a management system under Option A or B
General
• According to the ISO 17025, the laboratory needs to establish, document, retain as well
as implement management which is able of supporting and demonstrating the
commitment to the needs
Option A
• Option A has the various clauses which required to be followed. Overall at the bare
least, the management system should address the following given below:
o Management System Documentation
o Control of Management System Documents
o Control of Records
o Actions to address risks and opportunities
41
(Continued)
o Improvement
o Corrective Actions
o Internal Audits
o Management Reviews
(Continued)
Option B
• Option B says that your laboratory complies if:
o The laboratory has established as well as managed a management system under
the needs of ISO 9001
o You are able of supporting as well as demonstrating the compatible fulfilment of
the needs from clauses of ISO 17025
42
(Continued)
o You have satisfied management system documentation as well as management
review requirements of ISO 17025
• If your laboratory is accredited to ISO 9001:2015, you may select Option B. It permits
for more elasticity as you implement 17025:2017
Module 12: Management System
Documentation
43
Management System Documentation
• While laboratories are moving for accreditation, particular ISO/IEC 17025
documentation requirements should be satisfied
• These documents are utilised to develop as well as design testing and calibration
laboratories
• There are many categories of requirements for better understanding as well as defining
quality systems in the laboratory according to the ISO/IEC 17025 standard
• These document categories were defined as following:
Policies
Documents
Procedures
Records
Processes
Review
44
Module 13: Control Management System
Documents
Control Management System Documents
• The ISO 17025 document management requirements relevant to both paper as well as
electronic files and call in laboratories in order to set processes for the control and
security of those documents
• ISO 17025 does not highlight the types of documents which needs to be controlled in a
lab setting
• ISO laboratory control standard also specifies an apparent procedure for document
access, accessibility, review, revision, approval, storage as well as deletion
45
Control Management System Documents
(Continued)
• The primary document control requirements in the ISO 17025 standard given below:
Review
Revision
Organization
Accessibility
Document deletion or storage
Module 14: Control of Records
46
Control of Records
• The laboratory will set as well as retain processes for identification, indexing, collection,
filing, access, storage as well as maintenance as well as disposal of quality and technical
records
• Quality records will involve reports from internal audits as well as management reviews
and records of corrective and preventive actions
• All records will be clear as well as be stored and maintained in such a method which
they are easily retrievable in facilities which gives a relevant environment to stop
damage or deterioration as well as to stop loss
• The laboratory will have processes to back‐up as well as protect stored electronically
and to stop unauthorised access to or amendment of these records
Module 15: Address Risks and
Opportunities
47
Address Risks and Opportunities
• The concept in this requirement is regarding action on risks and opportunity arises from
ISO 9001:2015, that has a strong customer focus
• ISO 17025 and ISO 15189 are standards written by the people of the laboratory who are
experienced in what may go wrong
• They are intended to assure that testing‐related risks are maintained, containing
business risks such as damage which is reputational
• You are addressing all the areas of risk as well as the opportunity for testing service, by
complying these international standards and by having accreditation
Module 16: Improvement
48
Improvement
• The laboratory will constantly enhance the effectiveness of its management system by
the use of the quality policy, quality objectives, data analysis, corrective as well as
preventive actions and management reviews
• For improvement, we have to do the following:
Corrective Actions
Root Cause Analysis
Preventive Actions
Management Review
Non Conformance
Improvement
(Continued)
Internal Audits
Peer Review
QC Data Review
Lower Detection Limits
New Equipment/Instruments
More Employees
Complaints and Customer Surveys
49
Module 17: Corrective Actions
Corrective Actions
• These are the following steps to take corrective actions:
General
Cause analysis
Selection and implementation of corrective actions
Monitoring of corrective actions
Additional audits
50
Module 18: Internal Audit and
Management Reviews
Internal Audit
• Internal audit assures that quality system fulfils
the ISO /IEC 17025 requirements, accreditation
suitable particular criteria document and
regulatory bodies
• The audit also assures whether the requirements
of the laboratory quality manual and associated
documents are applied at all work levels or not
• The non‐conformities discovered during the
internal audit provide valuable information for the
improvements of the technical competence and
laboratory’s quality system, which is to be utilised
as an input to management reviews
51
Management Reviews
• Management reviews are critical procedures in multiple quality‐management systems,
involving laboratory‐management systems, under ISO/IEC 17025 and ISO 15189
• These reviews are exceptional opportunities to understand as well as manage the
inputs as well as outputs of a quality management system
• Usually, laboratory meet some problems that exploit the process of the management
review entirely as they do not understand the importance of this process or they do not
have the experience to run this process in the way of giving expected results
• This activity presents a management review checklist that assists laboratories in
carrying out a useful management review running by the all essential aspects of the
quality management system
Module 19: Terminology – ISO 9000, VIM
etc.
52
ISO 9000 Terminology in English
What is ISO 9000?
• ISO 9000 is a set of standards, developed and published by International Organisation
for Standardisation, which describes, establishes and maintains an efficient quality
assurance framework for the manufacturing and service industries
Some of the common ISO definitions are as follows:
1. Accreditation
• The act of giving an organisation formal approval to operate an audit and registration
program
2. Auditor
• ISO auditors carry out evaluations and monitoring
• They are considered as the "front line" during an audit
• An internal auditor is generally an employee who is trained in auditing and he also
performs annual or bi‐annual audits depending upon the needs of an organisation
• External audits are conducted by a firm that is not in any way affiliated with the audited
organisation
53
3. Concession
• This is the formal act of waiving, surrendering or yielding a privilege or a right
• It is usually made in writing by a customer when it has been determined that a in a
practical or cost efficient manner a contractual requirement cannot be met, and the
desired outcomes will not be affected materially by dropping the requirements
4. Corrective action request (CAR)
• A CAR is one of the most commonly used terms for corrective action in ISO
• The essence of a CAR is to identify a problem that has already occurred and needs root
cause analysis and resolution in order to avoid recurrence
5. Discrepancy
• It can be defined as a failure of meeting the requirement that are specified, supported
by evidence and is also known as “deficiency or “nonconformance”
6. Document Management System
• This is the software that is used to track and store electronic documents
• It is capable of keeping track of the several versions modified by several users
7. Fault Tree Analysis(FTA)
• FTA is the process of finding out possible design weaknesses by using a logic diagram
that defines basic faults and events which can cause system failures and/or safety
hazards
54
8. Observation
• An “observation” is a statement of fact that is made in an report of audit team
• It indicates an audit finding that does not rise to the level of a nonconformity
9. Policy
• It is a definite course or method of action to guide present and future decisions. ISO
makes it mandatory to develop and use a Quality Policy as a basis for your quality
objectives
10. Preventive Action
• It is an action which is taken to reduce the causes of a potential nonconformity
11. Procedure
• It is a particular method of achieving something, and an established way of doing things.
• A series of steps followed in a specific regular order
• It assures a consistent and repetitive approach to actions
55
12. Quality Audit
• It is an examination of an organisation’s quality management system to ensure
conformance to a specific quality standard, like ISO 9001
13. Quality Manual
• It is a document in which your quality standards are defined and where your Quality
Policy is stated
14. Quality Management System
• It is a collection of business processes concentrating on obtaining your Quality Policy
and quality objectives
15. Registrars
• These are organisations that issue ISO certification
56
Module 20: Fundamental Audit Concepts
and Principles
Fundamental Audit Concepts and Principles
• The essential principle of internal audit can be
described by a participant who involves in the
program actively
• These make the audit a reliable and an effective tool
in support of management policies and controls
57
Module 21: Auditing Requirements and
Assessment: ISO 17011:2017, ISO
19011:2018
Auditing : ISO 17011:2017
Internal Audits
• The accreditation body shall develop internal audit procedures to check compliance
with the requirements of this International Standard and the implementation and
maintenance of the management system
• Internal audits are performed generally at least once a year
• Internal audit frequency may be decreased if the accreditation body can demonstrate
that its management system has been successfully applied in compliance with this
International Standard and has proven stability
58
(Continued)
• The audit programme needs to be planned by taking into consideration the significance
of the processes and areas to be audited and the results of previous audits
• The accreditation body must ensure that:
o Internal audits are managed by qualified staff who is knowledgeable with auditing,
accreditation and the requirements of this International Standard
o Internal audits are managed by personnel who are different from those who are
performing the activity to be audited
(Continued)
o Personnel responsible for the audited area are informed regarding the outcome of
the audit
o Actions are taken in a timely and suitable manner
o Any development opportunities are identified
59
Introduction
• Several new management system standards have been published since the first version
of this International Standard was published in 2002
• As a result, there is now a requirement to consider a broader scope of management
system auditing, as well as providing more generic guidance
• In 2006, the ISO Conformity Assessment Committee (CASCO) developed ISO/IEC 17021,
that sets out needs for third‐party management system certification and that was based
on the guidelines contained in the first version of this International Standard
(Continued)
• The second version of ISO / IEC 17021, published in 2011, has been extended to
transform the guidance offered in this International Standard into needs for certification
audits of management systems
• The second edition of this International Standard provides guidance for all users,
including small and medium‐sized organisations
• It focuses on what is commonly referred to as "internal audits" (first‐party) and
"customer audits on their suppliers" (second party)
60
Module 22: Recognition and Oversight of
ILAC, IAAC, APAC etc.
Description of ILAC
What is ILAC?
• The full form of ILAC is International Laboratory Accreditation Cooperation
• It was established in 1977 to facilitate communication between the world's laboratory
accreditation bodies
• In 1996, the Memorandum of Understanding (MOU) was formalised as a cooperation
with 44 bodies
61
Description of ILAC
(Continued)
• A Mutual Recognition Agreement (MRA) was signed on 2 November 2000 among those
participants who successfully completed a peer evaluation
• In October 2012, the MRA was extended to include the accreditation of the inspection
body and 85 signatories (full members) to the Arrangement representing 70 economies
• On 20 January 2003, ILAC was founded in the Netherlands
ILAC’s Global Role
Principle International Forum for:
• Recognition through its Mutual Recognition Arrangement (MRA) of competent testing
and calibration laboratories and inspection bodies worldwide
• Development and appropriate harmonisation of accreditation practice for laboratory
and inspection bodies
• As a trade facilitation tool promotion of laboratory and inspection accreditation
• Assisting with the laboratory development and inspection accreditation systems
62
Abbreviations
The Full Forms are as Follows
EA (France) European Cooperation for Accreditation
APAC (Australia) Asia Pacific Accreditation Cooperation Incorporated
IAAC (Mexico) Inter American Accreditation Cooperation
SADCA (South Southern African Development Community Cooperation in Accreditation
Africa)
AFRAC (South African Accreditation Cooperation
Africa)
ARAC (Morocco) Arab Accreditation Cooperation
Abbreviations
ILAC Resolutions
• GA 8.11 The General Assembly acknowledges that evaluating the technical competence
of bodies producing reference materials with specified values is the accreditation of a
conformity assessment activity
• GA 9.28 ISO Guide 34 accreditation. Be included in the current ILAC arrangement when
ILAC develops and agrees with appropriate procedures for this activity
63
ILAC Documents
RM(Records Management) Regional & ILAC Documents
• Guidance and requirements on the Accreditation of a Reference Material Producer
• APLAC TC 012: Guidelines for the Acceptability of Chemical Reference Materials and
Commercial Chemicals for Equipment Calibration Used in Chemical Testing
• IAAC MD 028/13: Compulsory And Non‐Compulsory Application for the Assessment and
Accreditation of Reference Material Producers
ILAC Documents
(Continued)
• ILAC G9: Guidelines for the Selection and Use of Reference Materials (ILAC G‐9 is now
replaced by ISO Guide 33‐2015)
• ILAC G12: Guidelines for the Requirements for the Competence of RMPs
• ILAC P10: Policy on Traceability of Measurements
64
ILAC P10 Traceability Policy
It is provided by CRMs(Certified Reference Material):
• RMs may not be traceable
• CRMs by definition are traceable
• Values assigned to CRMs by NMIs in the BIPM KCDB or developed under the scope of
accreditation by an accredited RMP are considered traceable
• CRM values in JCTLM DB are considered traceable and the majority of other RMs &
CRMs produced by other RMPs can be regarded as critical consumables that the
laboratory must demonstrate are appropriate
Module 23: Test Reports, AB Symbols,
Equipment Stickers, Certificates
65
AB symbols
• Particular guidance on requirements for placing their accreditation symbols on the
calibration certificate for a specific instrument is provided by Accreditation Bodies (AB)
• From country to country, these can vary a little, while the requirements that are critical
do not vary. These are:
o In the lab scope‐of‐accreditation, all results of measurements need to be included,
and if not, it is important to denote them clearly in the report as non‐accredited
measurements
o It is must to include the measurement uncertainty per the ISO GUM3 in the
measurement report with all measurement
Certificates
Introduction
• We need to maintain standardised calibration certificates as
an ISO/IEC 17025 accredited calibration laboratory
• This standardisation provides our customers with the ultimate
level of trust in our services, as they can ensure that all their
data are not only accurately represented, but are fully
traceable
66
Certificates
Certificate Naming Convention
• One of the significant needs of our ISO 17025 accreditation is creating a certificate
naming convention
• ISO/IEC 17025:2017 Section 7.8.2.1.d requires:
o “Unique identification of the test report or calibration certificate“
o You may have observed a unique convention used to name the documents in the
daily operations of Fox Valley Metrology
o Because of a large number of documents created by Fox Valley Metrology on a daily
basis, it is important that we create a unique name for each document that removes
duplication, but is simple to understand and use
Certificates
(Continued)
• The documents which utilise convention of naming include:
Calibration Certificates
Quotations
On‐Site Job Numbers
Internal Reference Number
Purchase Orders
67
Module 24: Clauses 4, 5, and 6 Review
Clause 4:General Requirements
Clause 4 is broken down in the following two parts:
• 4.1 impartiality
o In ISO 17025, impartiality is a major clause
o The risk associated with creating biased results are addressed in this clause, and
when addressing impartiality, the lab needs to be committed to risk‐based thinking
o In summary, regarding the following, there must not be any conflict of interest:
commercial relationship
financial interest
interest interest
68
(Continued)
o The laboratory must identify risks to impartiality from the following aspects :
Personal
Activities Relationships
relationships
• 4.2 Confidentiality
o All requirements involving confidentiality are discussed in clause 4.2 of ISO
17025:2017
o Managing all the information is the responsibility of the lab, that is created or
obtained during laboratory activities and held is responsible by legal enforcement
(Continued)
o The standard requires that the lab ought to inform in advance to its customer about
the information that is intended by it to share with the public
o Moreover, it addresses the action it will take if in public the confidential information
is released
69
Clause 5: Structural Requirements
• The following are the laboratory operations that the laboratory needs to define and
document in order to get ISO 17025:2017 accredited:
The responsibility
The organisational The activities of The management
of the laboratory
structure the laboratory with responsibility
personnel
• The laboratory needs to have personnel authorised to make sure that regular
communication occurs regarding:
The importance of
Implementation and The effectiveness of
meeting customer as
improvement of the the management
well as regulatory
management system system
requirements
Clause 6: Resource Requirements
Clause 6 is broken down in the following six sub‐clauses:
• 6.1 General
• 6.2 Personnel
• 6.3 Facilities and Environmental Conditions
• 6.4 Equipment
• 6.5 Metrological Traceability
• 6.6 Externally Provided Products and Services
70
Module 25: Clauses 7 and 8 Review
Clause 7: Process Requirements
Process requirements are classified into 11 Sub‐clauses
• 7.1 Review of Requests, Tenders and Contracts
• 7.2 Selection, Verification and Validation of Methods
• 7.3 Sampling
• 7.4 Handling of Test and Calibration Items
• 7.5 Technical Records
• 7.6 Evaluation of Measurement Uncertainty
71
Clause 7: Process Requirements
• 7.7 Ensuring the Validity of Results
• 7.8 Reporting of Results
• 7.9 Complaints
• 7.10 Nonconforming Work
• 7.11 Control of Data and Information Management
Clause 8: Option
• Clause 8 Option‐ ISO 17025 requires the laboratory to establish, document, implement
and maintain a management system capable of supporting and demonstrating
commitment to the requirements
• Laboratories must implement a management system in accordance with Option A or B
in addition to the requirements of Clauses 4‐7
Option A
• Option A has many clauses that need to be followed. Overall, at the bare minimum, the
management system needs to address the following:
Control of Management System Documents
72
Clause 8: Option
(Continued)
Control of Records
Actions to address risks and opportunities
Improvement
Corrective Actions
Internal Audits
Management Reviews
Option B
• Option B takes care that your laboratory meets the requirements of ISO 9001:2015 if
the laboratory has developed and maintained a management system
Clause 8: Option
(Continued)
• You are able to support and demonstrate consistent compliance with the requirements
of clause 4‐7 of ISO 17025:2017
• And have complied with the requirements for documentation and management review
of the management system (clauses 8.2 and 8.9 of ISO17025:2017)
• If your laboratory is ISO 9001:2015 certified, choice B can be chosen. It provides more
flexibility when implementing 17025:2017
73
Module 26: Guidelines for Auditing: ISO
19011
ISO 19011 Auditing Guidelines
What is ISO 19011?
• ISO 19011 is defined as the standard that sets audit management systems guidelines
• This norm provides guidelines on the management of an audit program, auditing
standards, and assessment of individuals responsible for the management of audit
programs
• The audit program consists of the arrangements made to complete all the audits
necessary for a specific purpose
• ISO 19011:2018 provides valuable guidance on how to consistently improve an audit
program, just the way other organisational divisions are expected to improve
74
(Continued)
• One component of such change is to ensure that the goals of the audit program are
compatible with the policies and priorities of the management system
• Organisations should consider the needs of customers and other interested parties in
pushing for reforms in auditing
• In general, the definition of risk is a field of increasing importance in management
systems for auditing and business
• Risk has been incorporated as of the 2011 version throughout the ISO 19011:2018 audit
program management component
Standard Facts of ISO 19011
• When the US adopts a standard version, it is referred to as an American National
Standard (ANS) and is similar to an international standard
• The edition of ANSI may or may not change the standard's international i.e. ISO version
• ASQ/ANSI/ISO 19011:2018 is available in both print and digital (PDF) formats
75
Who ISO 19011:2018 Should Be Used ?
• If your company performs internal or external management system audits or if you
operate an audit program, then ISO 19011 and the ANSI version will be applied
• ISO 19011 can be used by anyone interested in audits or audit programs
• In particular, ISO 19011 is designed for people responsible for managing an audit system
and assessing individuals involved in audit systems and audits
• Anyone who has been commissioned to develop an audit system would probably find
the importance of ISO 19011:2018
What Does ISO 19011:2018 Accomplish?
• ISO 19011 provides guidance on all audit phases of a management system such as:
Defining Program Completing the Audits
Objectives Needed
Reviewing the Results
and Process
76
Module 27: GUM (Uncertainty), PT/ILC,
Traceability
GUM (Uncertainty)
• The GUM stands for the Guide to the Expression of Uncertainty in Measurement (GUM)
• Calibration and testing laboratories are the most common methods of estimating
uncertainty for ISO/IEC 17025
Most Common Mistakes while Calculating Uncertainty
Not Calculating Uncertainty or Missing Uncertainty Budgets
Not Following the GUM Method to Calculate Uncertainty
Measurement Traceability
Not Including ‘Type A’ Uncertainty Data
77
GUM (Uncertainty)
(Continued)
Not Considering all Influences to Measurement Uncertainty
Combining Incompatible Units of Measure
Not Updating Your Uncertainty Budgets
Using Manufacture’s Uncertainty Specifications
Not Reporting Uncertainty to Two Significant Figures
Reporting Uncertainty Smaller Than Your CMC Uncertainty
PT/ILC
• In the Test and Measurement Industry, PT (Proficiency Testing) and ILC (Inter‐Laboratory
Comparisons) are the terms that are used synonymously. They both are similar but
different slightly
• According to ISO guide 43, PT is an exercise that is formal and is managed by a
coordinating body that involves a reference or standard laboratory
• In the formal report, the results are issued that provides the Z and En score clearly
• According to ISO 17025, ILC is the organisation, performance, and evaluation of tests or
measurement on the same item by two or more than two inspection or laboratories
that are as per predetermined conditions
78
PT/ILC
(Continued)
• Further, it is described in ISO Guide 43 an inter‐laboratory comparison as an exercise
which is done by agreement between two or more laboratories taking part, where the
results are given in the formal report
• So, in an ILC, the difference is a proficiency test that an independent third party
organises and manages. Also, the participation of a reference laboratory is included in a
PT and to determine participant performance utilise their results
• The use of a coordinating body or a reference laboratory is not required by an ILC. Thus,
in participant laboratories, the only comparison of performance among the group of
participating members is made
Traceability
• For meeting the requirements of ISO 17025 accreditation, measurement traceability is a
crucial factor for laboratory
• Measurement traceability is essential as assurance and confidence provided by it
enables you to make sure that results of your measurement agrees with the
international or national standard in the statement of uncertainty in measurement
• In calibration or test report, a laboratory may claim anything they desire without
traceability
• The risk of falling victim to fraudulent activities and information, can be minimised with
the traceability and the independent analysis of an inspection body
79
Module 28: Opening and Closing Meeting
Activities
Opening Meeting
What Happens in an Opening Meeting?
• An audit opening meeting's primary purpose is to confirm the audit plan and previous
arrangements
• It is also an opportunity to introduce members of the audit team and explain your audit
approach
• The first meeting will be led by the Lead Auditor and will be held with the organisation's
management and audit areas.
• The meeting should be held in a friendly manner, and the auditee should be confident
and put the auditee at ease
80
Opening Meeting
(Continued)
• If you are assigned guides or accompanied by observers, you can use the opening
meeting to explain their roles carefully to avoid possible interruptions during the audit
• For the auditee, Remember to allocate time in the opening meeting to ask the questions
• The opening meeting can also provide insights into the level of commitment and
support from the management
• The details covered in the opening meeting should be consistent with the auditee's
familiarity with the audit process
Opening Meeting
(Continued)
• The opening meeting may consist of communication which an audit is being conducted
and explaining the audit's nature for internal audits in a small company
• The opening meeting may be very formal and even capture attendance records for other
audit circumstances, especially third‐party audits
81
Closing Meeting
What Happens in a Closing Meeting?
• The closing or exit meeting is the last opportunity for internal audit to show its
professionalism and presentation skills. It is also an opportunity to establish a positive
relationship with the customer
• At the conclusion of the fieldwork, auditors usually hold the exit meeting and treat it as
a "nonevent." So, there should be no surprises during the exit meeting and all problems
should be addressed before the meeting starts
• Auditors may need to schedule a series of pre‐exit meetings to ensure that the final
meeting runs smoothly
Closing Meeting
(Continued)
• The "real" exit meeting is often attended by senior managers who did not participate
directly in the audit
• It can then be confined to a presentation and discussion of the audit process and
results, rather than serving as a working meeting
82
Module 29: ISO 19011 Relationship to ISO
17025
ISO 19011
• ISO 19011:2018 (Guidelines for auditing management systems), was published in July
2018 in response to demand for guidance on combined management system audits
• It provides comprehensive guidelines for auditing quality and/or environmental
management systems
• The goal is to encourage organisations to save money, energy, effort and expense by
eliminating uncertainty about the goals of the environmental or quality audit
programme
• It ensures that the audit reports are in the best format and include all relevant
information
83
ISO 19011
(Continued)
• It secures alignment of goals within an audit system for individual audits
• It assess the competence of audit team members against appropriate standards and
minimising duplication of effort in the conduct of hybrid environmental / quality audits
ISO 17025
• ISO 17025 is the international standard for general test and calibration laboratory
competency specifications
• In major countries, ISO/IEC 17025 is the standard that most laboratories need to be
certified in in order to become technically competent
• There are many commonalities with the ISO 9001 standard, but ISO/IEC 17025 is more
stringent in competency criteria and refers specifically to those entities that generate
testing and calibration results and are focused on more scientific standards that give
laboratories many benefits
• The universal ISO 17025 standard applies to all or any laboratory irrespective of the size
or complexity of research and calibration practices
84
ISO 17025
(Continued)
• It is used by laboratories to improve their quality, body, and technical management
system
• Generally, laboratories use ISO / IEC 17025 to incorporate a Quality Management
System (QMS) to improve their ability to comply with relevant tests
Module 30: Auditing Technical Methods
85
Auditing Technical Methods
• For an auditor, the evidence is required to form an opinion with regard to financial
statements
• The reliability of the audit report will reduce if the proper evidence is not collected by the
auditor
• The methods by which the evidences are collected is called audit techniques
• The following are the few essential audit techniques:
Vouching
Confirmation
Reconciliation
Auditing Technical Methods
(Continued)
Testing
Physical Examination
Analysis
Scanning
Inquiry
Verification of Posting
Flow Chart
Observations
86
Module 31: Reporting Audit Results
Reporting Audit Results
Internal Audit report
• A document is an internal audit report which contains formal results of an audit.
Internal Auditor utilises it for showing what is examined, highlighting negative, positive,
and conclusions
• Thus the management of the company can get to know what needs improvement and
what is going well
• It is crucial for the report to be prepared carefully. The text must be clear, impartial, and
objective for making sure that the results of an audit are useful and the organisation can
utilise them as a guide in order to set the direction of action
87
Module 32: Audit Checklists
Audit Checklist
ISO 17025:2017 Audit Checklist for Laboratory Accreditation System
Requirements
• Accreditation ISO/IEC 17025 is used worldwide in laboratories for calibration and
research
• The audit checklist ISO 17025:2017 is a document needed to validate the laboratory
accreditation program when certifying ISO/IEC 17025:2017 in the laboratory testing and
calibration
• In order to simply achieve ISO 17025:2017 certification, every company must comply
with the ISO 17025 examination carried out by the ISO certification body. ISO 17025
checklist for rapid ISO/IEC 17025 accreditation, is globally verified as ISO documents
88
Audit Checklist
Content of ISO/IEC 17025:2017 Audit Checklists
• ISO 17025:2017 audit checklist deals with audit questions based on the specifications of
ISO/IEC 17025:2017 for each testing and calibration laboratory department as set out
below
o ISO 17025 checklists are considered to be a very good tool for auditors to send an
audit questionnaire while ISO 17025 tests the efficacy of the laboratory
management system implemented
o Based on the ISO 17025:2017 standard, more than 200 internal audit questions are
planned
Module 33: Review of Standards and
Internal Auditing Issues
89
Review of Standards
• The standards, the Institute of Internal Auditors (IIA) declared, are the primary
mechanism to guarantee the internal auditors of an organisation consistently and
accurately provide essential services in a cost‐effective and timely method
• The standard also:
o Provide a framework to perform a broad range of value‐added internal audit
o Describe the fundamental principle that represents the internal auditing practice
o For the evaluation of internal audit performance, establish the basis
o Foster improved process and operations of an organisation
Review of Standards
(Continued)
• The Institute of Internal Auditors (IIA) declared that the standards are the primary
mechanism to make sure that the internal auditors of an organisation consistently and
accurately provide essential services in a cost‐effective and timely method
• For internal auditors throughout the world, the standards are recognised as the
benchmark and are available in more than three dozen translations that are officially
authorised
• The standards need an organisation to have an external quality assessment that is
independent for once every five years, that contains a conformance review with the
standards
90
• Internal auditing is a complex task which includes:
o The identification of risks that can prevent an organisation from achieving its goals
o Helping to ensure the leaders of an organisation know about these risks
o Proactively recommending improvements to diminish the risk to a satisfactory level
• False assurance is the biggest issue, when in an audit, something is missed by auditors,
and they conclude that the processes are well‐controlled, but they are not
• The standards help to guarantee that the duties are performed effectively by the
internal auditor
(Continued)
• Important risks can be overlooked easily if internal auditing is not performed as per to
the standards
• Therefore, business opportunities can be missed, and the stated objectives would not
be met by the organisation
91
Module 34: Introduction to Lab
Management System (LMS)
Standard and Regulatory Framework
• ISO 17025 is an international Scope
standard to test and standardise
laboratories
Normative References
• These sets of requirements are

used by laboratories to show that Terms and Definitions
they work as a quality management

system and they are technically Management Requirements
expert to do the work
Technical Requirements
• The standard is written in five
clauses:
92
1. Scope
• The scope refer to a clear statement of everything that lab works for which it wants to
be accredited
• Specific methods for conducting its tests is set out by a testing lab
• A calibration lab will record the specific measurements and related uncertainty it might
have in its calibration work
• Describing the scope denotes that the lab can classify skilled staff appropriately and give
clients a confidence for its tests and measurements
2. Normative References
• The Normative references clause mention information, those documents that are
quoted in the text in a form that some or all of their content, set up requirements of the
document
• This clause shall be numbered as Clause 2 and shall not be subdivided
• Referenced documents which are listed are not numbered
93
3. Terms and Definitions
Impartiality
Complaint
Inter‐laboratory Comparison
Proficiency Testing
Laboratory
Decision Rule
Verification
Validation
• The following requirements are included in the 2017 version of the ISO/IEC 17025
standard:
1. General Requirements
• This clause highlights two main components: confidentiality and impartiality. This clause
makes sure that the laboratory is committed to impartiality and that the risks associated
with impartiality are identified on a constant basis
• Meantime, confidentiality assures that before releasing the information into a public
domain, clients are informed
• Confidentiality also involves not releasing the information received from a source other
than the client, and the information's source to the client unless it has been authorised
by the source
94
(Continued)
• Additionally, this clause emphasises the release of confidential information when
needed by law or authorised by contractual arrangements
• The laboratory must commit to assure information confidentiality throughout all
treatments, processes and interactions
2. Structural Requirements
• This clause emphasises the laboratory's legal status and structure, the identification of
the management and personnel, and the personnel's availability accountable for
executing and maintaining the integrity of the management system
• It also emphasises the documentation of procedures to the extent required to assure
consistency in applying laboratory activities and the validity of the outcomes
3. Resource Requirements
• This clause sets the requirement for laboratories to assure the availability of facilities,
personnel, systems, equipment and support services necessary for the smooth
operations/performance and management of all its activities
• Equipment's calibration should be done when measurement uncertainty or
measurement accuracy influences the validity of reported outcomes, and this will
further help to establish the metrological traceability of the reported outcomes
• The laboratory shall also assure that it communicates to its clients on all externally given
products and services, i.e. purchasing services, subcontracting activities and supplies
with needs and controls in place
95
4. Process Requirements
• This clause describes the procedures and other methods for the review of tenders,
requests, and contracts
• The clause includes the client's requests, the decision rule and the distinctions among
requests and tenders that must be applicable to clients prior to any other laboratory
activity takes place
• It also includes the selection, validation and verification of methods. It assures that the
laboratory will utilise relevant procedures and methods for its activities
• Moreover, the laboratory will assure that it is utilising the most current methods which
include the latest technological developments
5. Management System Requirements:
• For establishing a management system, this clause now provides two different options
(Option A and Option B)
a. Option A
• The least requirements for the execution of a management system, as per option A, are
as follows:
o Clause 8.2 Management system documentation
o Clause 8.3 Control of management system documents
96
(Continued)
o Clause 8.4 Control of records
o Clause 8.5 Actions to address risks and opportunities
o Clause 8.6 Improvement
o Clause 8.7 Corrective actions
o Clause 8.8 Internal audits
o Clause 8.9 Management review
b. Option B
• Option B provides a provision of establishing and maintaining a management system
according to the requirements of ISO 9001
• This option points out that a laboratory which has already established and maintained a
management system in compliance with the requirements of ISO 9001, with satisfactory
proof of compliance to clauses 4 to 7 of the ISO/IEC 17025 standard can be considered
to fulfil, at least the intention of the management system requirements set out in
clauses 8.2 to 8.9 of the ISO/IEC 17025 standard
97
(Continued)
• This option makes it simpler and practicable for laboratories to manage the
implementation of ISO 9001 and ISO/IEC 17025 at the same time
• In summary, if a laboratory has already implemented ISO 9001, Option B may enable for
higher flexibility in implementing ISO/IEC 17025:2017
Laboratory Management System
ISO/IEC 17025: 2017 Sub‐clause Matrix at a glance
4. General 5. Structural 6. Resource 7. Process Requirements 8. Management System Requirements
Requirements Requirements requirements
7.1 Review of requests, tenders 8.1 Options (A or B)
4.1 5.1 Legal entity 6.1 General & contract
Impartiality 5.2 Identify management 6.2 Personnel 7.2 Selection, verification & Option‐A:
4.2 5.3 Define activities 6.3 Facilities & validation of methods 8.2 Management system documentation
Confidentiality 5.4 Requirements to Environmental 7.3 Sampling 8.3 Control of management system
meet conditions 7.4 Handling of test & documents
5.5. Organisation 6.4 Equipment calibration items 8.4 Control of records
structure, Responsibility, 6.5 Metrological 7.5 Technical records 8.5 Actions to address risk and
authority, inter‐ Traceability 7.6 Evaluation of measurement opportunities
relationship, 6.6 Externally uncertainty 8.6 Improvement
Documented procedures provided products 7.7 Assuring validity of results 8.7 Corrective action
5.6 Controlling authority & services 7.8 Reporting of results 8.8 Internal Audit
5.7 Communication & 7.9 Complaints 8.9 Management review
Integrity of management 7.10 Non‐conforming work
system 7.11 Control of data – Option‐B:
information management ISO 9001: 2015 & Clause 4 to 7 of ISO
17025: 2017.
98
Continued)
Merits of ISO/IEC 17025 Laboratory Management System
• Increase your status
• Increase competitive advantage
• Increase laboratory effectiveness
• Make new business connections
• Improve accessibility to more contracts for testing and calibration
(Continued)
• Offer efficiency in improving processes
of work
• Attain customer trustworthiness
• Offer more reliable and proficient lab
testing and results
99
Laboratories and Accreditation Principles
• The following are the principles of ISO 17025 Laboratories and Accreditation:
Capacity
Exercise of Responsibility
Scientific Method
Objectivity of Results
Impartiality of Conduct
Traceability of Measurement
Repeatability of Test
Transparency of Process
Testing and Calibration Concepts
• Any testing /calibration laboratory that desires to display their capacity to provide
reliable and defined laboratory testing/calibration results requires ISO 17025
• 18 associated organisations like International Laboratory Accreditation Cooperation
(ILAC) and other laboratories established the recognised standard of ISO IEC 17025
• It is a standard value for those laboratories whether possessed by the government or
private sector industry performing:
Equipment
Laboratory Testing Laboratory Sampling
Calibration
100
Identifying the Objective and Scope
• 11 vital steps that can help your thoughts as you prepare for implementation of ISO
17025
Define Scope,
Management,
Obtain Determine Address Risk Define
Commitment
Support of Context of and Processes an
and
Management Organisation Opportunities Procedures
Responsibilitie
s
Engage with Perform Implement

Conduct the Training and Procedures,
Operate LMS
Internal Audits Accreditation Awareness Processes and
Body Program Control
Management
Reviews
Understanding Organisation
Everything regarding organisation, is mentioned in
clause 4.1
An organisation must be :
• Legally identifiable
• Meet the needs of the clients
• Regulatory Authorities
Scope
• Facilities of permanent nature and mobile both
101
(Continued)
• Sites away from permanent or temporary
facility
Defined Authority and Responsibility
• Part of large organisation
• Nominated mangers for technical and
quality function
• Nominated deputies
(Continued)
• Free from commercial and financial
pressure
• Confidential information of clients and
proprietary rights
• Competence, judgement, impartiality
• Inter personnel relationship
102
Analysing Existing System
• Companies are now conscious about the merits of executing quality management
systems and obtaining accreditation
• But the processes of maintenance and implementation processes comprise major
investment
• Organisations recognise that customer satisfaction is vital to their business
• Also, government bodies seek the services of an accredited laboratory understanding
decision is based on reliable and accurate data
• The existence of quality assurance, by appropriate use of processes and guarantees
clients that errors, management methods in test results, are minimised
Module 35: Planning LMS
Implementation
103
Leadership and LMS Project Approval
Leadership in ISO/IEC 17025:2017
5.2 The laboratory shall identify management that has overall responsibility for the
laboratory.
5.3 The laboratory shall define and document the SCOPE of accreditation. Externally
provided laboratory activities (sub‐contracting of entire test or calibration activity) on an
ongoing basis is not allowed.
5.4 Requirements of the standard and that of customers and accreditation agency to be
covered in activities.
5.5 Organization structure, responsibility & authority to be assigned following the norms of
accreditation agency.
5.6 Competent person shall be made responsible for overseeing the effectiveness of quality
management system of laboratory. Such post is usually designated as Quality Manager.
5.7 Effective communication system to be established within laboratory needed for QMS
and meeting customers’ requirements. Integrity of management system to be ensured.
Laboratory Policies
(Continued)
• Policies involve the quality policy statement that required to be documented in the
Quality Manual
• Senior management must record a quality policy statement, that must express the
commitment of the laboratory’s quality
• The quality manual outlines the quality system and documents of the laboratory’s
objectives and the entire concept regarding conforming the ISO/IEC 17025
• It should also explain how the excess of the quality system documentation will be
ordered
• It must be done by working groups denoting distinct departments
104
Document Management Process
• Records to prove conformity with ISO/IEC 17025 and as requisite by customers shall be
maintained for a particular period of time
o Examples are: Test results, original laboratory observations ,supporting documents
like Training certificates, chromatograms, and equipment calibration protocols
o Templates, Checklists, forms etc., help to execute quality work consistently and very
well
o These includes worksheets and checklists for handling nonconforming test results
vendor assessment, and also for the internal audits
(Continued)
• Maintenance and development of
documentation must be controlled by
the procedure of document control
and management that forms a part of
the management system
• Documents cover both internal, like
SOPs, training plans, quality manuals,
and external reports, like instrument
operating manuals, test methods,
regulations, standards
105
(Continued)
• The document control procedure must ensure :
o Official documents are produced or obtained, reviewed, and approved before use
o Documents are uniquely identified with the document and date of the change,
revision number, and issuing authority
o QA controls a quality list with all controlled documents
o The list involves document and revision number, locations, title, date of issue, date
of the last review
(Continued)
o Internal documents cover page
numbers and total in the number of
each page
o Users of the documents should be
adequately trained before they are
released
o Prevailing authorised versions of
documents are easily obtainable at
the workspace of the user
106
Module 36: Implementing LMS
Design of Controls
• Management needs are mainly allied to organisation, analysis of contracts, apprise
documents control, and analysing optimisation regarding quality management system
Control of Documents and Records
• This section integrates the design to control the system of amendment of documents
and confirm access to up‐to‐date documents, averting use of outdated versions
• It also includes a system to record control
107
Design of Controls
(Continued)
Control of Accommodations and Environmental Conditions
• Covers sufficiency of accommodations, comprising its organisation, to the activities
undertaken at the laboratory
• On the basis of this simple policy, laboratories and documents control centre can,
together improve procedures to make sure the correct access, inform and use of
documents
Drafting of Specific Policies and Procedures
• No format has been set in ISO 17025 on writing a quality manual
• Though, laboratories must develop a quality manual as it describes their Quality
Management System along with procedures to implement it
The Fundamentals of Writing a Quality Manual
• It should define the system as it is functioned
• It must be a working document
• It should not be a portrayal of an ideal world
108
(Continued)
Points to Avoid
• Writing a difficult documentation structure, is challenging to maintain
• Redundancy of information in various documents as it is hard to ensure that it is hard to
maintain versions and consistent all together in different documents along with
maintenance
• Even if you will to go beyond the standard, do not commit to anything beyond the
standard
(Continued)
Uncertainty of Measurement
• As per ISO/IEC 17025, this segment explains procedure and policies of your laboratory in
shaping method for performance validation and measuring the uncertainty of
measurement
• It shall contain:
o A depiction of procedures to be used at the earlier justification of methods
109
(Continued)
Procedure During Data Suspicion
• It must certify that the laboratory follows a procedure if there is a suspicion of faulty
data
• It generally involves your quality manager to conduct an enquiry, an audit which may
also call for corrective action
• Your laboratory’s policy must notify clients as early as possible regarding suspicion of
data
(Continued)
Handling of samples and administration of work
• While writing a quality manual with ISO/IEC 17025 standards, your laboratory should
offer a complete depiction of the following:
o Measures for getting, and recording samples
o Sample orders and labelling
o Distribution of work
110
(Continued)
o Quality inspection of results
o Reports preparation
o Hand out reports
o Recording of outcomes
(Continued)
Disposal of Samples and Other Waste
• Your laboratory must classify:
o The policy on the time duration when samples are kept
o The policy on discarding
o The assurance to the accountable discarding of toxic materials
111
(Continued)
Appointment of Staff, Training and Review
• It must define the following:
o The process for choosing staff for training, and conducting training
o The machinery for measuring competency
o The mechanism for delivering authorisations to conduct tests, calibrations,and other
procedures
(Continued)
• The method for an annual review of staff skills and the ways of results recording
Procedures for Audit and Evaluation of the Quality System
• This part must refer to the procedures for the audit and review of the quality system to
write a detailed quality manual
• Though, your laboratory should contain the records that are to be kept and the policy on
the regularity of audits and reviews
112
Communication Planning
• Information must be shared among internal and external departments
• It also have to be shared among the vendors, regulators and clients of laboratories
• When the information flow is upgraded, the laboratory is developed
• The information must be bi‐directional and it’s responsibility lies to the laboratory
management
• It shall not only involve the sending information, policies, memos etc. but it should also
have the mechanism to receive the feedback from the clients as well
(Continued)
• The communication planning must first analyse the purpose for communication
• The appropriate utilisation of laboratory services include
Orders
Specimen Collection
Occurrence of Test Orders
Report Formats and Additional report
comments etc.
113
(Continued)
• The most noteworthy changes make a
big emphasis on the accountabilities
of senior management, and
unambiguous requirements for
regular improvements of the
management system itself, chiefly,
communication with the customer
Training and Awareness Planning
• The efficiency of the training should be assessed
• If the training is associated to a particular test method, the trainee can show adequate
qualification by successfully managing proficiency test sample or a quality control
• Vendor also require installation, acquaintance, and training services
• A training program must be developed and applied for each employee on the basis of
mandatory skills and existing qualifications
• Till a well‐planned training for ISO 17025 is not prepared, the execution will not be
operative and the laboratory cannot get the desired benefits from the laboratory QMS
114
Resource Management
• The resource management requirements are mentioned in clause 6
6.1 General
6.2 Personnel
• Considering competence of supervision and technical staff
• Personnel should be stable or contract
• Procedures and policies to understand training needs are needed
• Job description is to be given in at least minimum contents
Resource Management
(Continued)
• Particular personnel assigned for specific tests such as authorised personnel
6.3 Facilities and Environmental Conditions
• Facility and environmental conditions must be satisfactory to confirm correct
calibrations/performance of tests
• If conditions sacrifices results, Tests / calibrations is to be clogged
• Unsuitable activities are to be separated
• Right to use the facilities is to be controlled
115
Resource Management
(Continued)
6.4 Equipment
• Equipment must be obtainable, capable to achieve requisite accuracy, defined by an
established calibration program, functioned by authorised personnel and exclusively
identifiable
• Records are to be maintained and consist location, maintenance schedule, model
number etc., and check that it meets terms
• Indication of calibration status
Resource Management
(Continued)
• Equipment which are out of service are to be recognised clearly
• If equipment needs to be validated before use if they goes outside the lab
•
Safeguard against unplanned adjustments, such as use passwords to control computers
6.5 Metrological Traceability
• Confirm a satisfactory program for the calibration of equipment
• Make sure calibration is traceable to SI units, consensus standards or, Certified
Reference Materials (CRM) or inter‐lab validated agreed methods
116
Resource Management
(Continued)
6.6 Externally Provided Products and Services
• Authorising of tests and calibrations obliges the lab to direct and pursue approval from
the customer, rather in writing (partial or specific)
• Lab is liable for subcontractor's work except they are specified by the customer of
controlling authority
• Keep a register of all subcontractors comprising records
• Procedures are required for the choosing service/supplies
Resource Management
(Continued)
• Formal approval or techniques to make
sure that materials and services should
meet the terms with stipulations
• Retain records on the history and QA
consents of suppliers if any
117
Customer Management
• This procedure’s aim to define all the activities allied to the customer service process
for receiving and recording customer requests, contracts and tenders
• The activities which are recognised under this procedure are a compulsory requirement
that is to be documented
• This applies to both external and internal laboratory customers
• The clause of 7.1.7 ‐ the laboratory shall cooperate with clients to clarify the request
and to enable the client to monitor the performance of the laboratory
Operations Management
• This International Standard is used by laboratories in making their management system
developed for administrative, quality, and technical operations
• Laboratory customers, accreditation bodies, and regulatory authorities can also use it in
identifying and confirming the competency of laboratories
• The word 'management system' in this International Standard refer to the quality,
technical systems and administration that direct the operations of a laboratory
• The agreement with governing and safety requirements on the operation of laboratories
is not included in the International Standard
118
Operations Management
• There are 5 fundamental (auditable) clauses in ISO/IEC 17025:2017
1. General Requirements (clause 4)
2. Structural Requirements (clause 5)
3. Resource Requirement (clause 6)
4. Process Requirement (clause 7)
5. Management System Requirements (clause 8)
• Management requirements (clause 8) deals with the effectiveness and operation of the
quality management system in the laboratory, that is very similar to the ISO 9001.
• Calibrations, tests, and other laboratory operations should follow the earlier defined
terms such as client‐defined specifications, laboratory specifications. These are
addressed in Process Requirements (clause 7).
• It explains to confirm that nonconforming test and calibration results are properly
followed up, and that rectifications are instigated.
• Clause 4, 5 and 6 are related mainly to setting of ethics, working structure, scope and
resources which are needed for effective and efficient operation of laboratory activities.
Module 37: Monitoring, Measurement,
and Continuous Improvement
119
Monitoring, Analysis, and Evaluation
• The word “ Monitoring” is used in all processes of the ISO 9001: 2015 standard and it
always come along with calibration or measurement
• Monitoring is the method of analysing, evaluating, and inferring results from data
which is a measured parameter in a prescribed time to prove conformity
• Each monitoring activities require measurement results to have effective data to analyse
and evaluate
• Calibrated measuring instruments are used while monitoring activities, to achieve
confidence with our monitoring results
(Continued)
Reasons to Monitor
1. Quality maintenance
2. Develop or to make better processes
3. To know defects, if any
4. Maintaining safety
5. Make sure to maintain the efficiency of operation and control of these processes
120
(Continued)
6. Validate the conformity of services and products as per requirements
7. Maintenance of monitoring and measurement resources through adjustments,
deterioration, damage or that would undermine the calibration status and following
results of measurements
(Continued)
Techniques Applied to Analyse and Evaluate Monitoring and Evaluation of Results
Control charts
Tables
Graphs
Mean and standard deviation (Basic Statistical Data
Analysis)
121
(Continued)
• Use of Monitoring and Measurement as per the Requirements of ISO 17025:2017
1. Monitoring of competence of personnel
2. Monitoring of environmental conditions
3. Monitoring performance of external providers
4.Monitoring of controlled conditions for handling of items
5. Monitoring of validity of results
Treating Problems and Nonconformities
Non‐conformance
• It is noncompliance of a condition
• It is a problem‐solving method which aims to identify the root cause(s) of a problem
• The goal is to inhibit the repetition of the non‐conformance
• It is quite tedious to perform and thus requires discussion with people involved knowing
the best about the process
122
(Continued)
• It occurs after the immediate
rectification of a non‐conformance
• It is required when a non‐conformance
is important
• It is needed for non‐conformances
recognised by audits and for
deteriorating proficiency of test reports
(Continued)
Process for Treating Problems
• Using different methods for problem solving to identify the fundamental causes of
problems or incidents, the problems can be treated effectively
• Who should work on problem?
o It is best if it is done by those who are in touch of a work on a daily basis
• Define problem
123
(Continued)
• At times “Why” isn’t the first question
o What, when, where, how can form the
first question
• Be simple, draw an outline
• Anlayse and prevent
• It leads to remedial action, which is proposed
to prevent repetition of nonconformance
(Continued)
• It leads to remedial action, which is proposed
to prevent repetition of nonconformance
• Preventive Action is the action taken to
eradicate the cause of a probable
nonconformance or other detrimental
possible situation
124
• When the root cause is recognised, you must apply a fix corrective action to check it
does not happen again
o Find possible corrective actions
o Choose and execute the action that is much suitable to eradicate the problem and
avert repetition
o Corrective actions are suitable to the scale and risk of the problem
Continual Improvement
• Continual Improvement is the regular activity to enhance the capacity to fulfil
requirements
• Thus, a continual improvement is the approach that is repeated having pauses between
recurrences
• It is a phased system, whereby developments are made
• And also, there is brake to measure and study the success, when improvements are
made
125
(Continued)
• The key to continual improvement is to consume the tools which are needed by the
standard, such as:
Management Reviews
Internal Quality Audits
Corrective and Preventive Actions
Regular Review of Controlled Documents
(Continued)
• It helps the company to endure growth while preserving competence and compliance
• In the sphere of continual improvement, these should be positive
• Even after the standards are achieved, while looking from the potential of learning and
improving, the audit can also find protective actions that makes the system better,
cooperative, and more efficient
126
Accreditation Preparation
• The following are the steps for Accreditation Preparation
Know About the Standard
Conduct a Gap Analysis
Plan your Project
Provide Training
Accreditation Preparation
(Continued)
Document your Quality Management System
Implement QMS and Hold Business
Audit Your QMS
Accreditation Audit
127
Implementers Evaluation
• Implementing a quality management system that is built on the requirements stated in
ISO/IEC 17025 standard is challenging, because of two main reasons:
1. The intense technical difficulty in degree of some tests used for materials
characterisation
2. Most science laboratories offer materials characterisation tests and also conduct
development and research activities
(Continued)
• Quality Manual, Quality Plan, Job descriptions, Standard Operating Procedures (SOPs),
work instructions, and records are some documents that are required to make or
reviewed
• The formation of these documents will help all laboratory personnel and so,
improvement in the quality system will influence the work load
• While implementing the QMS, training should also be considered
• The laboratory will need to employee further personnel to maintain the QMS and
guiding consultant will be the advantage in the implementation process
128
(Continued)
Results of the Evaluation via Accreditation Body
• Evaluation for implementation begins with
Impartiality Confidentiality
Module 38: Planning ISO 17025 Audit
129
Planning ISO 17025 Audit
• The quality manager is responsible for planning
the audit, but the plan for the future must be
considered and approved at the quality system
review meeting
• An annual plan must be prepared, and the
suggested timing of audit must be pointed on the
plan and, when the audit plan is finished, the real
date and auditor name must be added
• The quality manager should be given the
complete authority to assure that the plan is
adhere to
• The reviews and audits must be treated as a vital
issue and should not put off for any reason
• It is shown by the experience that once the
programme is falling behind, it is not easy to
catch up
• Especially audits are a crucial issue in an ISO
17025 quality system since the complete
philosophy is that the design of laboratory and
execution of the quality management system and
then takes the audits to assure that it is working
well
130
• When the audits are not present, problems will
be detected only when they lead to failure of
quality
• Approach to quality control aimed at error
detection; compliant quality management system
of an ISO 17025 concentrates on the prevention
of error by quality insurance, and with the help of
audit working of the system is ensured by the
laboratory
• When the laboratory does not consider its audits
seriously, makes assessors more uncomfortable
Frequency of Audit and Review
• In general practice, an audit programme must be conducted on a rolling basis such that
in any one year, every perspective of the quality system will be included at least once
• At least two vertical audits must be there in any one year
• Auditor in vertical audit did not examine one aspect of the system but tracks a particular
sample or samples within the laboratory, from receipt to results reporting, and verify
the documented procedures have been followed and all the maintained records
131
(Continued)
• There is nothing in ISO 17025 that prevents an annual, one‐off, audit of the entire
system, but it is not considered as good practice except in very small companies where
external auditors need to be used
• It is described by the rolling system, where the audit is seen as a continuous part of
management, is usually preferred
• Annual management reviews are usually executed by accreditation bodies, and it is
doubtful that this will change
(Continued)
• It is recommended that the frequency of internal audit will be more in the first year of
operation of a new quality management system, i.e. a review after every six‐month in a
rolling audit programme of six‐month.
• The audit programme must be phased within the execution of the different elements of
the quality system and not delayed till it is all in place.
• This gives a quality check on the elements of the quality system as they are set.
132
(Continued)
• Settling period of two to three months must be permitted for every part of the system
and then that part should be audited
• In establishing the quality system a responsive and effective audit system is a powerful
tool
• Necessarily people will not remember to do the things needed by the quality system
from time to time, but when they understand that any negligence will be quickly noticed
and corrections would be asked for, then they will rapidly get good habits and will make
less mistakes.
Preparing the ISO 17025 Audit
Introduction
• Preparing for an audit is a very vital step for the laboratory. The external audit makes a
3rd party accreditation body is the last step before the laboratory gets accreditation to
ISO 17025
• These are the following objectives that auditors have:
o Checks that documentation meets all the needs of the standard
o Assure your employees that they must know their roles in QMS and are well‐known
with the needs of ISO 17025 that concern to their role in the organisation
o The processes and procedures are followed correctly
133
(Continued)
• The results will award your certification or need corrective actions that your
organisation should meet before becoming accredited
• On the day of the accreditation audit, show your QMS and how have your addressed the
needs
• Being audited is costly and consume more time, so you need to make sure that you are
prepared well
• These are the following steps that can assist you laboratory:
Give the laboratory Prepare the
ample time to prepare employees
Documented Processes and
Information Procedures
Prepare the facility
134
1. Give the Laboratory ample time to Prepare
• Effort and time is needed to prepare your lab
for an audit
• When you have decided that getting
accreditation is important for the laboratory,
you must set goals and provide a proper
amount of time to meet the need of the
standard
2. Prepare the Employees
• Your employees will show that your lab is executing with the needs of ISO 17025
• You will need to ensure that all the employees must know what the scope of the audit is
and when the audit will take place
• Every employee must have a clear thought of the competence objectives od lab, and
how their job role contributing to them
• Every employee must have proper training on the tasks that they will do
135
3. Documented Information
• Another vital aspect of preparing for your audit is Documented information
• During the audit preparation, you are required to be assured that the records and
documents have been updated
• Along with this, all the documents must be reviewed, approved, communicated and
must be followed by everyone included in the activity or process
• You also must assure that old documents are not used by anyone
4. Processes and Procedures
• Procedures and Processes need to be followed
carefully
• Your laboratory need to make sure that every
process is meeting the planned arrangement
that you have targeted to achieve, then they
are being followed and performed in the right
and same way by each employee
136
5. Prepare the Facility
• Your lab must be cleaned and organised well when you prepare the audit. It is simple to
drop non‐conformance if your facility is chaos
• You need to make sure that you are well aware of each area of the facility so that you
are not required to find any hidden concerns during the audit
• When your organisation is getting ready for the audit, check bulletin boards, drawers,
counters for uncontrolled documents, examining instruments, uncalibrated measuring
and non recognised parts or supplies
Conducting an Opening Meeting
• The main objective of an opening meeting of an
audit is to affirm the audit plan and previous
arrangements
• This is an opportunity to introduce the team
members of the audit and describing the audit
approach
• This opening meeting is headed by the Lead
Auditor and held with the organisational
management and the areas that need to be
audited
137
• The meeting must be conducted in a friendly way
and put the auditee at rest. From the beginning of
the audit you want to make a trust and
cooperation
• If you will be specified guides, or be followed by
observers, the opening meeting may be used to
explain their roles fully to avoid probable
disturbances when the audit is going on
• Keep in mind to allot time in the opening meeting
for the auditee so that they can ask a question
• The opening meeting may also provide insights into
the management's commitment level and support
• If you will be specified guides, or be followed by
observers, the opening meeting may be used to
explain their roles fully to avoid probable
disturbances when the audit is going on
• Keep in mind to allot time in the opening meeting
for the auditee so that they can ask a question
• The opening meeting may also provide insights into
the management's commitment level and support
138
• The detail included in an opening meeting must be
compatible with the auditee's familiarity with the
audit process
• In a small organisation, for audit, the opening
meeting consists of communicating that an audit is
being conducted and describing the audit's nature
• For other audit situations, especially third‐party
audits, the opening meeting might be formal and
even take attendance records
• These are the following topics of agenda that must be considered, as suitable:
Introduction of meeting participants
Roles of auditor; auditee; guide; observer
Attendance list (names, titles, contact information)
Audit objective (purpose or reason for the audit)
139
(Continued)
Audit scope (coverage of areas; processes; clauses)
Audit criteria (applicable requirements)
Documentation status (changes since plan developed)
Agenda plan (agenda; assignments; meetings; times)
(Continued)
Audit methods (procedure; sampling; forms)
Risk management (reduce risk from presence of audit
team)
Communications (auditee to be kept well‐informed)
Language (to be used during the audit)
140
(Continued)
Confirmation of resources and facilities
Confidentiality (results only to the auditee)
Safety, security, and emergency considerations
Reporting method (including severity grading, if any)
(Continued)
Closing meeting (date, time, and location)
Acknowledgments (who accepts nonconformities)
Complaints or appeals (system for feedback)
Concerns or questions (ready to begin audit?)
141
Module 39: Conducting the ISO 17025
Audit
Initiating Audit
1. General
• The obligation for conducting the audit must remain with the audit team leader which is
until the audit is completed
2. Establishing contact with auditee
• The audit team leader must assure that contact is made with the auditee majorly to:
o Confirm communication channels with the representatives and authority of the
auditee and to conduct the audit
o Give suitable information on the audit scope, objectives, criteria, methods and audit
team composition, involving any technical experts
142
Initiating Audit
(Continued)
o Request access to appropriate information for planning purposes; make
arrangements for the audit involving the schedule
o Define applicable statutory and regulatory needs and other requirements – confirm
the agreement with the auditee about the extent of the disclosure and the
treatment of confidential information
3. Defining possibility of audit
• The possibility of the audit must be defined to give reasonable confidence that the audit
objectives can be attained
• Where the audit is not possible, an alternative should be proposed to the audit
customer, in agreement with the auditee
Preparing Audit Activities
1. Performing a review of the documented information
• The appropriate management system documented information of the auditee should be
reviewed in order to: –
o Collect information to understand the operations of the auditee and to prepare the
applicable audit work documents and audit activities, e.G. On processes, functions
o Establish an overview of the documented information's extent to determine feasible
conformity to the audit criteria and detect possible areas of concern, like
deficiencies, conflicts or omissions, an alternative must be proposed to the audit
client, in agreement with the auditee
143
2. Audit Planning
• A risk‐based approach to planning
• The team leader of an audit must adopt a risk‐based approach to planning the audit on
the basis of information in the audit programme and the documented information given
by the auditee
• The detail amount given in the audit plan must reflect the complexity and scope of the
audit, and the risk of not attaining the audit objectives
• Risks to the auditee can result from the audit team member's preference negatively
influencing the arrangements of an auditee for health and safety, environment and
quality, and its services, products, personnel or infrastructure (e.g. contamination in
cleanroom facilities)
(Continued)
• For combined audits, special attention must be provided to the communications
between operational processes and any competing objectives and priorities of the
various management systems
• The audit planning's scale and content can vary from case to case
• Audit planning should be adequately flexible to allow changes which can become
essential as the audit activities progress
• Audit planning must address or reference the essential information of audit such as
objectives, methods, scope, criteria, schedule, audit team etc.
144
(Continued)
• Audit plans must be presented to the auditee
• Any issues with the audit plans must be resolved among the audit team leader, the
auditee and, if required, the individual(s) handling the audit programme
3. Assigning work to the audit team
• In consultation with the audit team, the audit team leader should assign to every team
member responsibility for particular auditing processes, functions, activities or locations
and, as relevant, authority for decision‐making
(Continued)
• Take into account the objectivity and impartiality and competence of auditors and the
efficient utilisation of resources, as well as various roles and responsibilities of auditors,
auditors‐in‐training and technical experts
• The audit team leader must hold audit team meetings as appropriate
4. Preparing documented information for audit
• The audit team members must gather and review the information suitable to their audit
assignments and prepare documented information for the audit, utilising any relevant
media
o digital or physical checklists
145
(Continued)
o audit visual information, audit sampling details
o audio visual information
• Documented information prepared for, and resulting from, the audit must be preserved
at least until the completion of audit, or as particularised in the audit programme
• Documented information made throughout the audit process including proprietary or
confidential information must be suitably safeguarded by the audit team members
Conducting Audit Activities
1. Conducting the opening meeting
• The primary purpose of the opening meeting is to: –
o Confirm the agreement of all participants to the audit plan (e.g. Auditee, audit
team)
o Introduce the audit team and their roles
o Assure that all planned audit activities can be done
• An opening meeting must be held with the auditee's management and, where suitable,
those responsible for the processes o functions to be audited
• During the meeting, a chance should be given to ask questions
• The team leader of an audit should chair the meetin
146
2. Communicating during audit
• The audit team must confer periodically to exchange information, evaluate audit
progress and reassign work among the audit team members, as required
• Evidence gathered during the audit that recommends an instant and significant risk
should be reported without delay to the auditee and, as suitable, to the audit client
• Where the available audit evidence shows that the audit objectives are unachievable,
the audit team leader must report the reasons to the audit client and the auditee to
define appropriate action
4. Audit information availability and access
• How, where, and when to access audit information is important to the audit
• It is independent of where the Information is created, used and/or stored
• The audit methods need to be defined according to these issues. The audit can use a
combination of methods
• Additionally, audit circumstances may mean that the methods required to change
throughout the audit
147
5. Reviewing documented information while conducting audit
• The relevant documented information of an auditee should be reviewed to:
• Define the conformity of the system, as far as documented, with audit criteria
• Collect information to assist the audit activities
• The audit team leader should inform both the individual(s) managing the audit
programme and the auditee if sufficient documented information cannot be given
within the time frame given in the audit plan
• A decision should be made as to whether the audit should be continued or suspended
until documented information concerns are resolved, and it depends upon the audit
scope as well as objectives
6. Collecting and verifying information
• During the audit, information appropriate to the audit objectives, criteria and scope,
involving information associating with interfaces among functions, processes, and
activities must be collected by means of proper sampling and should be verified, as far
as practicable
• The only information which can be subject to some extent of verification must be
accepted as audit evidence
• Where the degree of verification is low, the auditor should utilise their professional
judgement to define the degree of reliance that can be placed on it as evidence
• Methods of collecting information involve: interviews; observations; review of
documents, involving records
148
(Continued)
Source of Information
Gathering using suitable Sampling
Audit Evidence
Evaluating against Audit Criteria
Audit Findings
(Continued)
Reviewing
Audit Conclusions
149
7. Determining audit conclusions
• Preparation for a closing meeting: The audit team must confer before the closing
meeting in order to
o Review the audit findings and any other suitable information gathered during the
audit, against the audit objectives;
o Agree on the audit conclusions, consider the uncertainty inherent in the audit
process;
o Prepare recommendations, if particularised by the audit plan;
o Discuss the audit follow‐up, as applicable
8. Conduct audit conclusions
• Audit conclusions should address issues such as:
o The degree of conformity with the audit criteria and strongness of the management
system, involving the management system's effectiveness in meeting the expected
outcomes, the risk's identification and effectiveness of actions taken by the auditee
to address the risks
o The efficient implementation, maintenance and improvement of the management
system
o Attainment of audit objectives, coverage of audit scope and fulfilment of audit
criteria
150
(Continued)
o Similar findings made in various areas that were audited or from a previous or joint
audit to recognise trends
9. Conducting Closing Meeting
• A closing meeting should be held to present the audit findings and conclusions
• The closing meeting should be chaired by the audit team leader and attended by the
management of the auditee and involve, as applicable:
o Those accountable for the functions or processes which have been audited
(Continued)
o Other members of the audit team
o Other relevant interested parties as defined by the audit client and/or auditee
o Meeting can be formal or less formal
• Any diverging opinions about the audit findings or conclusions among the audit team
and the auditee should be considered and, if possible, resolved. If not resolved, these
should be recorded
151
10. Preparing audit report
• The audit team leader must report the conclusions of audit in accordance with the audit
programme
• The audit report should give a complete, correct, short and clear record of the audit,
and should involve or refer to
o Audit scope, audit objectives, and the functions or processes audited
o Identification of the audit team, audit client, and auditee’s participants in the audit
o Locations and dates where the audit activities were conducted
o Audit criteria, audit findings and associated evidence, audit conclusions
o A statement on the extent to which the audit criteria have been fulfilled
o Any unresolved diverging opinions among the audit team and the auditee
11. Distributing audit report
• Within an agreed period of time, the audit report should be issued
• The audit report should be dated, reviewed and accepted, as suitable, in line with the
audit programme
• The audit report should then be distributed to the appropriate interested parties
described in the audit programme or audit plan
• Consider suitable measures to assure confidentiality
152
12. Completing audit
• When all planned audit activities have been carried out, or as otherwise agreed with the
audit client then the audit is completed
• Documented information concerning the audit should be retained or disposed
• If disclosure of the contents of an audit document is needed, the audit client and
auditee should be informed as soon as possible
• Lessons learned from the audit can identify risks and possibilities for the audit
programme and the auditee
13. Conducting audit follow‐up
• The result of the audit can be depending on the audit purposes, show the necessity for
corrections, or corrective actions, or possibilities for improvement
• Such actions are normally determined and undertaken by the auditee within an agreed
timeframe
• The completion and effectiveness of these actions should be verified. This verification
may be part of a subsequent audit
• Results should be reported to the individual managing the audit programme and the
audit client for management review
153
Module 40: Concluding and ensuring
follow‐up of ISO 17025 Audit
Audit Documentation
• The quality manual is an important piece of quality documentation, that explains its
policies, the structure of Quality system documentation and agreement to ISO/IEC
17025:2017 & appropriate accreditation particular criteria
• Generally, quality manual is made and verified by laboratory management, normally
under the entire co‐ordination of the quality manager
• However it must be officially authorised to issue a point in a management hierarchy as
high as possible; the typical points are chairman, chief executive and director‐general
• This assures that the manual has the strongest authority and it also shows that to the
accreditation body, there is a commitment on the side of the senior management to the
quality system
154
Audit Documentation
(Continued)
Policies and Quality Manual
Processes
Standard Operating Procedures (SOPs) and
Work Instructions
Records
Audit Documentation
Policies and Quality Manual
• Policies that involve the statement of the quality policy must be documented in the
Quality Manual
• The quality policy statement must be written by the Senior management, that must
outline the commitment of laboratory to quality
• The quality manual must explain the documents the goal of laboratory and quality
system and entire idea for how to comply to ISO/IEC 17025
• It must also explain how the remains of the quality system documentation are prepared.
It must be enhanced by working groups that represent various departments
155
Audit Documentation
Processes
• Standard procedures or Processes explain how different needs of ISO/IEC 17025 can be
attained
o For example, it explains how the needs ‘All personnel included in testing and
calibration must be capable for the given task’ can be executed
• Another instance is the approach of the laboratory to verify and calibrate various types
of equipment
• For a good understanding, process flowcharts must be involved in the description
process
Audit Documentation
Standard Operating Procedures (SOPs) and Work Instructions
• Generally these are defined as Standard Operating Procedures (SOPs) or Work
Instructions
• Whereas processes and quality manuals explains approaches and tasks, procedures and
work instructions provide instructions step‐by‐step on doing tasks. The examples of
SOPs are calibration of equipment and procedures for verifying
• Every laboratory SOPs must use the same format, so as to make reading and writing
easier. A good method is to have an SOP for how to author, review, approve, distribute,
and update the SOPs
• Senior members of expected user groups must write SOPs. This assist to assure that
SOPs have the correct level of information and are used and followed.
156
Audit Documentation
Records
• Records to show adherence with ISO/IEC 17025 and as needed by customers must be
retained for a particular time
o The examples are original laboratory observations, supporting documents, test
results like training certificates, chromatograms, and equipment calibration
protocols
• Checklists, templates, forms, and examples assist in executing the quality work
consistently and efficiently
o Examples of these involve worksheets and checklists to handle nonconforming test
results, vendor assessment. These things assist particular document tasks
consistently and efficiently
Audit Documentation
• The documents that are given below must‐haves as claimed by ISO 17025:2017
• Remember that if you omit any of the clauses from the scope of your implementation,
then the documents for those clauses shall not be needed for your lab
Document and Record Control Procedure (Clauses 8.2.1,
8.3 & 8.4)
Quality Policy (Clauses 8.2.1 & 8.2.2)
Competence, Training and Awareness Procedure (Clause
6.2.5)
157
Audit Documentation
(Continued)
Externally Provided Products and Services Procedure (Clause 6.6.2)
Facilities and Environment Procedure (Clause 6.3)
Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
Customer Service Procedure (Clauses 7.1.1 & 8.6)
Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
Audit Documentation
(Continued)
Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to
laboratories that do sampling)
Handling of Laboratory Test or Calibration Items Procedure (Clause
7.4)
Complaint, Nonconformity and Corrective Action Procedure
(Clauses 7.9 – 7.10 & 8.7)
158
Audit Documentation
(Continued)
Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to test
laboratories that write reports of the test)
Calibration Report and Certificate Requirements Procedure
(Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that
write calibration certificates)
Quality Review
• Quality manager is responsible for the audits’ organisation and reviews, though he/she
will usually include other staff in the actual carrying out audits
• It is the responsibility of the quality manager to check that any corrective actions agreed
sufficient, is carried out and is efficient
• The audit's frequency and review of systems is not compulsory in ISO 17025, but a note
in the standard requires that every aspect of the system will be audited at least yearly
and reviews will be conducted at least once in a year
159
Closing Meeting
• The main objective of a closing audit meeting is
to give the audit findings and results, assuring a
clear understanding of the results, and giving
consent on the timeframe of corrective action
• The closing meeting is managed by lead auditor
• The participants must involve management of
the auditee and mangers of that area that were
audited
Closing Meeting
• The following agenda topics should be considered, as appropriate:
Introductions Attendance Thanks Scope
Summary of
Disclaimer Criteria Conformity areas
Nonconformities
Conclusions
160
Closing Meeting
• When the closing meeting is being conducted, listen with interest and speak with
authority. Maintain your body language, good manners, and keep control of the meeting
• Keep a record of any concern that is being raised during the meeting
• When new audit proofs are given, remove nonconformities that were mentioned in
error. Still, one must keep valid nonconformities in the report, even when they are fixed
before the meeting
• If it is appropriate, the lead auditor must give a guide to the auditee when any condition
come during the audit that may reduce the confidence that may be placed in the audit
conclusions
Closing Meeting
• If it is defined in the management system, or by agreement with the client of the audit,
the participators must give his consent on the time frame for an action plan to address
any of the nonconformities of the audit
• The detail level in the closing meeting must be compatible with the auditee's familiarity
with the process of audit
• For some audits, the meeting may be formal with minutes being kept. In some cases,
the closing meeting can be less casual and communication of the audit findings and
audit conclusions is done
161
Closing Meeting
• If it is possible, then any auditee and audit team differences of views on the audit
findings or conclusions must bee considered and solved
• The concern of auditee must be recorded, and the process of the appeals explained to
them
• If the direction for the enhancement are presented, you must highlight that the
recommendations are not binding
• Complete the meeting having clear result and explain the next steps, tasks, and due
dates
Evaluation of Corrective Action plans
• Corrective action are needed each time when a quality problem is recognised
• The audit is a definite mechanism to find out whether corrective action is important,
but there are some other potential sources of information, and each of them must be
used
• Definite sources are information passed on from the staff of laboratory of the quality
issues, complaints from clients, detection of non‐conforming work, and direct detection
of quality failures resulting from the monitoring of quality control
• The ability of Interlaboratory testing and feedback from outsider assessors and auditors
will also fall in the category of useful sources external to the organisation
162
Evaluation of Corrective Action plans
• It helps separate the record system for reporting quality problems from the system to
plan and record corrective action because of the source variety providing for corrective
action
• This permits the same corrective action management and recording system to serve for
all the sources of information on quality problems
o For instance, the audit is reported on a form given to that purpose, and for the
corrective action requests, this is cross‐referenced
ISO 17025 Surveillance Audits
Surveillance Planning
• Surveillance audit can be recognised three
months before the due date by the AB, and the
client should be communicated of the
proposed date and due date of the Surveillance
audit
o If the client is not able to confirm the date
of the Surveillance audits latest within the
seven days of the due date, then the
suspension letter is issued to the client
163
(Continued)
• When the Suspension letter is issued, then the
cancellation letter is issued to the client on the
upcoming date of the due date
• These are on‐site audit, but they are not
certainly the entire system audit
• They are planned along with the other
Surveillance activities so that confidence is
maintained by the certification body that the
certified management system remains to
meets the needs between recertification audits
(Continued)
• It is the responsibility of the assigned team
leader to manage and conduct the assessment
with the other members of the team
• At least, the Team Leader should be of Auditor
status
o The team leader also assure that any of the
Technical Expert are not permitted to
independently function and are constantly
accompanied by Lead Auditor/Auditor
164
(Continued)
o Assure on‐site audit evaluating the certified
fulfilment of the management system of
the client of particularised needs regarding
the standard in which the certification is
granted
o Assure that the management system is
continuously suitable to the
product/service/process given by the client
with the ability to improve and manage the
performance
(Continued)
o Assess Continual Improvement in
management system of the client
o In addition to this the statements of the
client regarding its operations
o Enquiries from the certification body to the
certified client on aspect of certifications
o Requests to the client to give records and
documents
165
(Continued)
o Other means of observing and certified
performance of client
o Management reviews and internal audits
o Action’s review taken on non‐conformities
recognised during the previous audit
o Actions taken on complaints of the
customer
(Continued)
o Efficiency of the management system in
order to attain the purposes
o Advancement of planned activities aimed
at continuous enhancement
o Ongoing operational control
o Review the use of AB & CB marks
166
• The client file must be reviewed by the team
leader, specially the last audit report to create a
note of any concerns to be followed up, that
includes the corrective action plan and non‐
conformities
• The audit plan must be sent to the clients in
advance so that they can request any changes
regarding timing etc. it is seen inconvenient
because of administrative reasons
• The audit must be conducted according to the surveillance audit plan provided in the
last audit report when there are any changes due to any explained reasons, and the
same must be recorded in the auditor's notes, and in the report, surveillance audit plan
must be updated
• When opening and closing meeting are going on, the record sheet of attendance is
being circulated and record the names and designation of the client representative
present. Either one person can record the name & designation for all the present one or
each person can do so individually
• The corrective action that is taken on the nonconformities recognised in the last audit
must be checked for its efficacy. If the corrective action is not taken adequately, then
the sharpness of the minor NC need to be reissued escalated to Major and client should
be guided respectively
167
• If there is a change in address/ scope of site needed to again issue the certificate, then
the ‘certification Detail’ in the audit should be completed, and the database of the
client should be updated
o Any important change such as a change in manpower, a process requiring the
change in consequent audit duration should be recorded, and post review of the
contract is done by AB.
o Other changes such as a change in person/ contact number etc. should be recorded
in the report to update the database of the client
Congratulations
Congratulations on completing this course!
Keep in touch
Thank you
168
/The.Knowledge.Academy.Ltd /TKA_Training /the-knowledge-academy
/+TheKnowledgeAcademyWinkfield /TheKnowledgeAcademy
The world’s largest global training provider
theknowledgeacademy.com
To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication; however, we do not assume any liability whatsoever for the accuracy and completeness of the
above information.

ISO 17025 Lead Auditor - Delegate Pack

Uploaded by

Copyright:

Available Formats

ISO 17025 Lead Auditor - Delegate Pack

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

ISO 17025 Lead Auditor - Delegate Pack

Uploaded by

Copyright:

Available Formats

ISO/IEC 17025:2017

Lead Implementor / Lead Auditor

The world’s largest global training provider

© 2020 The Knowledge Academy Ltd 1

© 2020 The Knowledge Academy Ltd 2

© 2020 The Knowledge Academy Ltd 3

© 2020 The Knowledge Academy Ltd 4

© 2020 The Knowledge Academy Ltd 5

© 2020 The Knowledge Academy Ltd 6

© 2020 The Knowledge Academy Ltd 7

© 2020 The Knowledge Academy Ltd 8

© 2020 The Knowledge Academy Ltd 9

© 2020 The Knowledge Academy Ltd 10

© 2020 The Knowledge Academy Ltd 11

© 2020 The Knowledge Academy Ltd 12

© 2020 The Knowledge Academy Ltd 13

© 2020 The Knowledge Academy Ltd 14

© 2020 The Knowledge Academy Ltd 15

© 2020 The Knowledge Academy Ltd 16

© 2020 The Knowledge Academy Ltd 17

© 2020 The Knowledge Academy Ltd 18

© 2020 The Knowledge Academy Ltd 19

© 2020 The Knowledge Academy Ltd 20

© 2020 The Knowledge Academy Ltd 21

© 2020 The Knowledge Academy Ltd 22

© 2020 The Knowledge Academy Ltd 23

© 2020 The Knowledge Academy Ltd 24

© 2020 The Knowledge Academy Ltd 25

© 2020 The Knowledge Academy Ltd 26

© 2020 The Knowledge Academy Ltd 27

© 2020 The Knowledge Academy Ltd 28

© 2020 The Knowledge Academy Ltd 29

© 2020 The Knowledge Academy Ltd 30

© 2020 The Knowledge Academy Ltd 31

© 2020 The Knowledge Academy Ltd 32

© 2020 The Knowledge Academy Ltd 33

© 2020 The Knowledge Academy Ltd 34

© 2020 The Knowledge Academy Ltd 35

© 2020 The Knowledge Academy Ltd 36

© 2020 The Knowledge Academy Ltd 37

© 2020 The Knowledge Academy Ltd 38

© 2020 The Knowledge Academy Ltd 39

© 2020 The Knowledge Academy Ltd 40

© 2020 The Knowledge Academy Ltd 41

© 2020 The Knowledge Academy Ltd 42

© 2020 The Knowledge Academy Ltd 43

© 2020 The Knowledge Academy Ltd 44

© 2020 The Knowledge Academy Ltd 45

© 2020 The Knowledge Academy Ltd 46

© 2020 The Knowledge Academy Ltd 47

© 2020 The Knowledge Academy Ltd 48

© 2020 The Knowledge Academy Ltd 49

© 2020 The Knowledge Academy Ltd 50

© 2020 The Knowledge Academy Ltd 51

© 2020 The Knowledge Academy Ltd 52

© 2020 The Knowledge Academy Ltd 53

© 2020 The Knowledge Academy Ltd 54

© 2020 The Knowledge Academy Ltd 55