Nabl - Iso 17025

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The document discusses ISO/IEC 17025 requirements for testing and calibration laboratories seeking accreditation.

Management requirements include organization structure, management system, document control, reviews, subcontracting, purchasing, customer service, complaints, nonconforming work, records, audits and reviews.

Technical requirements include general criteria, personnel, facilities, methods, equipment, traceability, sampling, test items, quality assurance, and results reporting.

NABL

ISO 17025 : 2005


Introduction to ISO 17025 : 2005

Management requirements for


accreditation

Technical requirements for


accreditation

IS 9001
Accreditation bodies that recognize the
competence of testing and calibration
laboratories should use this International
Standard as the basis for their
accreditation. Clause 4 specifies the
requirements for sound
management. Clause 5specifies the
requirements for technical competence for
the type of tests and/or calibrations the
laboratory undertakes.

The use of this International Standard


will facilitate cooperation between
laboratories and other bodies, and assist
in the exchange of information and
experience, and in the harmonization of
standards and procedures.
Management requirements for
accreditation methodology

Management Review of Subcontracting of


Organization Document Control requests, tenders, tests and
system
and contracts calibrations

Purchasing Service to the Complaints Control of


services and customer nonconforming
supplies testing and/or
calibration work
Improvement Corrective
action

Preventive Control of Internal audits Management


action records reviews
Technical Requirements for
accreditation methodology

Accommodation & Test & Calibration


General Personnel Environmental Methods and Equipment
Conditions Method Validation

Measurement Sampling Handling of Test Assuring the


Traceability and Calibration Quality of Test
Items and Calibration
Results

Reporting the
Results
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4 Management Requirements
4.1 Organization
4.1.1 Entity is legally identifiable?

4.1.2 Does entity conduct activities to be compliant


with 17025, the needs of the customer,
regulatory authority, or organization providing
recognition?

4.1.3 Does the management system cover all work,


including permanent location, and on-site,
mobile or temporary facility?

4.1.4 Is the organization structure defined in order to


identify potential conflicts of interest?

4.1.5 The laboratory shall:

a) Provide personnel with the authority and


resources to carry out their duties.

b) Have provisions to assure that staff is free from


undue internal and external pressures.
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c) Protect the customers confidential information
and proprietary rights.
d) Avoid involvement in activities that diminish
confidence in competence, impartiality,
judgment or operational integrity.
e) Define the organization and management
structure.

f) Specify the responsibility, authority and


interrelationships of all personnel affecting
quality of work.

g) Provide adequate supervision.

h) Have a technical manager.

i) Have a quality manager (however named) who


is responsible for the management system.
j) Appoint deputies for key managerial personnel.

k) Ensure the awareness of its personnel to their


activities and contribution to the achievement
of their management system objectives
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4.1.6 Top management shall ensure the
communication process establishment and the
effectiveness to the management system

4.2 Management System


4.2.1 The laboratory shall establish, implement and
maintain a management system appropriate to
its scope of activity.
4.2.2 The laboratorys management system policies
and objectives shall be defined in a quality
manual (however named).

4.2.2 The overall objectives shall be documented in a


quality policy, and a statement issued under the
authority of the chief executive and shall
include:
a) Managements commitment to good
professional practice and quality of its tests and
calibrations.
b) Laboratorys standard of service.
c) Purpose of the management system related to
quality.

d) Requirement that personnel familiarize


themselves with the quality documentation and
implement the policies and procedures in their
work.
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e) Managements commitment to compliance with
17025 and continually improve the
effectiveness of the management system.

4.2.3 Top Management shall provide evidence of


commitment to the development and
implementation of their management system
and continually improving its effectiveness
4.2.4 Top management shall communicate to the
organization the importance of meeting
customer requirements
4.2.5 The quality manual includes or makes reference
to supporting procedures, and outlines the
structure of the documentation used.

4.2.6 The quality manual defines the roles and


responsibilities of the technical and quality
managers for ensuring compliance with 17025.
4.2.7 Top management shall ensure the integrity of
the management system when the changes to
the system are planned and implemented

4.3 Document Control


4.3.1 General

Have procedures to control all documents that


form part of its quality system, both internal and
external documents.
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4.3.2 Document Approval & Issue
4.3.2. Documents issued as part of the quality system
1 are reviewed and approved by authorized
personnel.
4.3.2. Have a master list or equivalent identifying the
1 current revision and distribution of documents.

4.3.2. The procedure shall ensure:


2

a) Authorized editions of documents are available,


where necessary, for the effective functioning of
the laboratory.

b) Documents are periodically reviewed and


revised as necessary to ensure continued
suitability.
c) Invalid and obsolete documents are promptly
removed from service, or assured against
unintended use.
d) Obsolete documents retained are suitably
marked.

4.3.2. Quality system documents generated are


3 uniquely identified.
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4.3.3 Document Changes
4.3.3. Changes shall be reviewed and approved by the
1 same function. The designated person shall
have access to background information.
4.3.3. Altered or new text shall be identified, where
2 practical.

4.3.3. Hand amendments shall be clearly marked,


3 initialed and dated. The new document shall be
issued ASAP.

4.3.3. Computerized maintenance for documents shall


4 be established in a procedure.

4.4 Review of requests, tenders and contracts

4.4.1 Procedures for review of requests, tenders &


contracts.
4.4.1 Policies and procedures for review shall ensure:

a) Requirements are adequately defined,


documented and understood.
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b) Lab has the capability and resources.
c) Appropriate method is selected and can meet
the clients requirements
Differences between request or tender and the
contract shall be resolved.

4.4.2 Records of reviews are maintained. Records of


pertinent discussions with clients should be
maintained.

4.4.3 Review shall include subcontracted work.

4.4.4 Customer informed of deviation from contract.

4.4.5 Contracts amended after work starts must have


the same review as the original.

4.5 Subcontracting of Tests & Calibrations

4.5.1 Subcontracted work is placed with a competent


subcontractor.
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4.5.2 Customer is advised in writing of the intention
to subcontract, and where necessary gain client
approval.
4.5.3 Lab is responsible for the subcontractors work,
except where the customer specifies the
subcontractor.
4.5.4 An approved subcontractor list, and evidence of
compliance with 17025 exist for all
subcontractors.
4.6 Purchasing Services and Supplies

4.6.1 Have policies and procedures for purchase of


services and supplies.
4.6.1 Have policies and procedures for purchase,
reception and storage of reagents and laboratory
consumable materials.
4.6.2 Purchased supplies and reagents and
consumables are inspected or otherwise verified
prior to use. Records of such actions are
maintained.
4.6.3 Purchasing documents shall contain data
describing the services and supplies ordered and
be reviewed and approved for technical content
prior to release.
4.6.4 Suppliers of critical consumables, supplies and
services shall be evaluated, and records of the
evaluations and a list of those approved
maintained.
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4.7 Service to the Client

4.7.1 Will customers cooperation to clarify request


and monitor performance in relation to the work
performed by the lab, provided confidentiality
of other customers is maintained.
4.7.2 Seek the feedback from the customers. The
feedback shall be used and analysed to
improve
4.8 Complaints

Policies and procedures shall exist for handling


complaints.

Records of complaints and their investigations


and corrective actions shall be maintained.

4.9 Control of Nonconforming Work


4.9.1 Policies and procedures shall be implemented
when work or the results of work do not
conform to its own procedures or the
requirements of the client.
4.9.1 The policies and procedures shall ensure:
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a) Responsibility and authority for handling of
nonconforming work are designated, and
actions are defined and taken when
nonconforming work is identified.
b) Evaluation of the significance of the
nonconformance
c) Corrective action is taken immediately, together
with any decision about the acceptability of the
nonconforming work.
d) Where necessary, the client is notified and work
recalled

e) Responsibility for authorizing the resumption of


work is defined.
4.9.2 If nonconformance can recur, or doubt about
compliance of the labs operations with its own
policies and procedures exists, corrective action
in accordance with 4.10 shall be promptly
followed.
4.10 Improvement
The laboratory shall continually improve the
effectiveness of its Management system
through the use of the quality manual, quality
objectives, audit results, analysis of data,
corrective and preventive action and
Management review.
4.11 Corrective Action
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4.11.1 General
Establish policy and procedure and designate
authorities for implementing corrective action.
4.11.2 Cause Analysis (CA)

Investigate to determine root


cause.

4.11.3 Selection and Implementation of Corrective


Action

Identify, select and implement appropriate


corrective action that is likely to prevent
recurrence.
CA is appropriate to the magnitude and risk of
the problem.
Document and implement changes resulting
from CA.

4.11.4 Monitoring of CA
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Monitor CA to ensure that it is effective.
4.11.5 Additional Audits
Where nonconformances or departures cast
doubts on compliance with policies, procedures,
or 17025, the area of activity is audited per 4.13
ASAP.
4.12 Preventive Action

4.12.1 Improvements and potential nonconformances


shall be identified.

4.12.1 If action is required, plans shall be developed,


implemented and monitored to reduce the
likelihood of occurrence.
4.12.2 Procedures shall include initiation of actions
and controls to ensure they are effective.
4.13 Control of Records

4.13.1 General
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4.13.1 Establish and maintain procedures for handling
.1 of quality and technical records.
4.13.1 Records shall be legible and stored to be
.2 readily retrievable in suitable environments to
prevent damage, deterioration or loss.
4.13.1 Retention times established.
.2

4.13.1 Records held secure and in confidence.


.3

4.13.1 Procedures to protect and back-up electronic


.4 records and prevent unauthorized access.

4.13.2 Technical Records

4.13.2 Retain sufficient records to establish an audit


.1 trail of work for a defined period.
4.13.2 Observations, data and calculations shall be
.2 recorded at the time they are made and be
identifiable to the specific task.
4.13.2 Mistakes are single-line crossed out, correct
.3 entry made, and signed or initialed by person
making correction. Electronic records shall be
handled to prevent loss of original data.
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4.14 Internal Audits
4.14.1 Schedule and procedure for periodic audits of
labs activities that addresses all elements of
17025 and the quality system.
4.14.2 When findings cast doubt on operations or
validity of results, the lab shall take corrective
action and notify clients in writing if
investigations show results may have been
affected.
4.14.3 The audits, findings and CA shall be recorded.

4.14.4 Follow-up activity shall verify and record


implementation and effectiveness of CA.

4.15 Management Review

4.15.1 Scheduled review of the quality system and


testing/calibration activities to ensure their
continued suitability and effectiveness, and to
introduce changes or improvements.
4.15.1 Review shall include:

- Suitability of policies and procedures


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- Corrective and preventive actions
- Assessments by external bodies
- Results of interlaboratory comparisons or
proficiency tests

- Changes in volume and type of work

- Client feedback

- Complaints

- Recommendation for Improvement

- Other relevant factors

4.15.2 Records of findings and actions that arise from


them. Management ensures that actions are
carried out in a timely fashion.
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5 Technical Requirements
5.1 General
5.1.1 Many factors determine correctness and
reliability.

5.1.2 Extent to which factors contribute to total


uncertainty differs considerably between tests
and calibrations.

5.2 Personnel

5.2.1 Ensure competence of all who operate


equipment, perform test/calibrations (t/c),
evaluate results & sign reports/certificates.
5.2.2 Formulate goals for education, training and skill
of personnel.
5.2.2 Policy and procedure to identify training needs
and provide training of personnel.
Effectiveness of training actions shall be
evaluated
5.2.3 Shall use personnel employed by or contracted
to the laboratory. Where contractors or
additional key personnel are used, the lab shall
ensure supervision to evaluate competence of
work.
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5.2.4 Maintain current job descriptions.
5.2.5 Authorize and maintain records of such
authorization for personnel to perform
particular tasks.
5.2.5 Shall maintain records of competence,
educational and professional qualifications,
training, skills and experience. Information
shall be readily available.
5.3 Accommodation & Environmental Conditions

5.3.1 Facilities shall facilitate correct performance of


t/c.

5.3.2 Monitor, control and record environmental


conditions where necessary to maintain quality
of t/c.
5.3.3 Effective separation between areas that are
incompatible and to prevent cross-
contamination.
5.3.4 Access to controlled areas limited.

5.3.5 Good housekeeping ensured.


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5.4 Test & Calibration Methods and Method
Validation
5.4.1 General
The laboratory shall use appropriate methods
and procedures.

Instructions on use and operation of all


equipment and handling and preparation of t/c
items, where absence would jeopardize results.

Instructions, standards, manuals, and reference


data available where necessary.

5.4.2 Selection of Methods

Use appropriate t/c methods, preferably


international, regional or national standards.
Ensure use of latest valid edition of standards,
unless it is not appropriate or possible to do so.

Laboratory shall select appropriate published


methods when client has not specified method.
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Laboratory methods or methods adopted may be
used if appropriate for the intended use and
validated. Client informed of method selected.
Confirm that it can perform standard methods
before introducing the t/c. If standard method
changes, confirmation shall be repeated.
5.4.3 Laboratory-developed Methods

When necessary to use methods developed by


the lab, the activity is planned and development
assigned to a qualified person equipped with
adequate resources.
Plans shall be updated and communicated to
personnel involved.

5.4.4 Non-standard Methods

Subject to agreement with the client, and


include a clear specification of clients
requirements and purpose. Method developed
shall be validated.
5.4.5 Validation of Methods

5.4.5. Validation definition


1
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5.4.5. Validate non-standard and laboratory-developed
2 methods, those used outside their intended
scope and amplification or modifications of
standards methods, to confirm fitness for use.
5.4.5. The range and accuracy of the values obtainable
3 from validated methods shall be relevant to the
clients needs.
5.4.6 Estimate of Uncertainty of Measurement

5.4.6. Calibration laboratories or test laboratories


1 performing their own calibrations shall have
and apply a procedure to estimate uncertainty.

5.4.6. Testing laboratories shall have and where


2 necessary apply procedures for estimating
uncertainty.

5.4.6. All uncertainty components are taken into


3 account.

5.4.7 Control of Data


5.4.7. Calculations and data transfers shall be
1 checked.

5.4.7. When computers or automated equipment are


2 used, the lab shall ensure that:
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a) Developed software is documented and
validated.
b) Procedures are established and implemented for
protection of data.
c) Computers and automated equipment are
properly maintained and in an environment that
ensures proper functioning.
5.5 Equipment

5.5.1 Lab is furnished with all items of equipment


required for correct performance of t/c.

5.5.1 Equipment outside its permanent control shall


be controlled to meet 17025.

5.5.2 Equipment and software shall meet the accuracy


necessary for the t/c and comply with
specifications.
5.5.2 Calibration program established for key
quantities or values of the equipment where
these properties have a significant effect on
results.
5.5.2 Equipment shall be calibrated or checked to
establish that it meets the specification
requirements and complies with relevant
standards before being put into service.
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5.5.3 Equipment operated by authorized personnel.
Up-to-date instruction on the use and
maintenance readily available to operating
personnel.
5.5.4 Equipment and software uniquely identified.
5.5.5 Records shall be maintained for each item of
equipment, and shall include:

a) Identity of item

b) Manufacturers name, type identification and


serial number or other unique identification.

c) Checks that equipment complies with the


specification.

d) Current location, where appropriate.


e) Mfr.s instructions, if available, or reference to
their location.

f) Dates, results and copies of reports and


certificates of calibration, adjustments,
acceptance criteria, and due date of next
calibration.
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g) Maintenance plan, where appropriate, and
maintenance carried out to date.
h) Damage, malfunction, modification or repair to
equipment.
5.5.6 Procedures for safe handling, transport, storage,
use and planned maintenance of equipment.

5.5.7 Overloaded or mishandled equipment that


gives suspect results taken out of service until
repaired and calibrated.

5.5.7 Examine the effect of the defect or departure on


previous t/c and initiate Control of
nonconforming work procedures.
5.5.8 Equipment shall be labeled, coded or otherwise
identified to indicate status of calibration,
including date calibrated, and date or expiration
criteria when calibration is due.
5.5.9 If equipment goes outside the control of the lab,
it shall be proven that the function and
calibration status are satisfactory before being
returned to service.
5.5.10 Procedure for intermediate checks.

5.5.11 Procedure to ensure that correction factors are


updated correctly.
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5.5.12 Equipment and software shall be safeguarded
from adjustments that would invalidate the t/c
results.
5.6 Measurement Traceability
5.6.1 General

Programs and procedures for the calibration of


t/c equipment that has a significant effect on
results.

Equipment calibrated before being placed in


service.

5.6.2 Specific Requirements

5.6.2. Calibration
1
5.6.2. Calibration laboratorys program for calibration
1.1 shall ensure traceability to the International
System of Units (SI).
5.6.2. Calibration certificates shall contain the
1.1 measurement results, including the
measurement uncertainty and/or a statement of
compliance with an identified metrological
specification.
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5.6.2.1 Certain calibrations cannot be strictly made in SI
.2 units. In these cases, calibration shall provide
confidence in measurements by establishing
traceability to appropriate measurement standards
such as:
- Use of certified reference materials provided by a
competent supplier.
- Use of specified methods and/or consensus
standards that are clearly described and agreed by
all parties concerned.
5.6.2.1 Participation in a suitable program of
.2 interlaboratory comparisons is required where
possible.

5.6.2.2 Testing

5.6.2.2 Test labs requirements given in 5.6.2.1 apply for


.1 measuring and test equipment, unless it has been
established that the calibration contributes little to
the overall uncertainty of the results.
5.6.2.2 Where traceability to SI units is not possible or
.2 relevant, certified reference materials, agreed
methods and/or consensus standards are required
as for calibration labs (see 5.6.2.1.2).
5.6.3 Reference Standards & Reference Materials

5.6.3.1 Reference Standards


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Programs and procedures for calibration of
reference standards.
Reference standards shall be calibrated by a
body that can provide traceability, as described
in 5.6.2.1
Reference Standards used for calibration
purposes only, unless shown that their
performance as a standard is not invalidated.
Reference standards shall be calibrated before
and after any adjustment.

5.6.3. Reference Materials


2

Where possible, traceable to SI units, or to


certified reference materials.

Internal reference materials shall be checked as


far as technically and economically possible.
5.6.3. Intermediate Checks
3

Carried out according to defined procedures and


schedules.
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5.6.3. Transportation and Storage
4
Procedures for safe handling, transport, and use
of reference standards and materials.
5.7 Sampling

5.7.1 Where necessary, a sampling plan and


procedures. Where possible, based on statistical
methods

5.7.1 Sampling plan and procedure are available


where sampling takes place.

5.7.2 Client-required deviations, additions or


exclusion from the documented procedure shall
be recorded in detail, with actual sampling data,
and included in the documents containing the
results.
5.7.3 Procedures for recording data.
5.8 Handling of Test and Calibration Items

5.8.1 Procedure for transporting, receipt, handling,


protection, storage, retention and/or disposal of
items
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5.8.2 Items identified and identity retained
throughout life of item in lab.
5.8.3 Upon receipt of item, abnormalities or
departures from normal or specified conditions
are recorded. When suitability is in doubt, the
client is notified.
5.8.4 Procedures and facilities to avoid deterioration,
loss or damage to t/c item.

5.9.1 Assuring the Quality of Test and Calibration


Results

Procedures for monitoring validity of t/c results;


which may include:

a) Regular use of certified reference materials


and/or internal qc using secondary reference
material.
b) Participation in interlaboratory comparison or
proficiency testing.
c) Replicate t/c using same or different methods.

d) Retesting or recalibration of retained items.


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e) Correlation of results for different characteristics of
an item.
5.9.2 Quality control data shall be analysed and, where
they are found to be outside pre-defined criteria,
planned action shall be taken to correct the problem
and to prevent incorrect results from being reported.
(assuring quality of test and calibrations results)
5.10 Reporting the Results

5.10.1 General

Results reported accurately, clearly, unambiguously


and objectively, in accordance with instructions in the
method.
Results reported in test report or calibration certificate
includes information requested by the client and
necessary for interpretation of results.
For internal clients, or with written agreement with
client, results may be reported in a simplified way.
All information required by 5.10.2 to 5.10.4 shall be
readily available in the lab that performed the t/c.
5.10.2 Test Reports and Calibration Certificates

Test reports and calibration certificates include


17025-listed information, unless they have a valid
reason for not doing so.
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a) Title
b) Name and address of lab and location where t/c
was performed, if different from lab.
c) Unique identification of report or certificate, on
each page an identification that the page is
recognized as a part of the whole and a clear
indication of the end of the report or certificate.
d) Name and address of client.

e) Identification of the method(s) used.

f) Description, condition, and unambiguous


identification of the item tested or calibrated.

g) Date of receipt of item(s), where critical to


results. Date(s) of performance of t/c.
h) Reference to the sampling plan and procedure.

i) T/c results with, where appropriate, the units of


measure.
NO REQUIREMENT YOUR DOCUMENT ASSESSMENT
DOCUME COMPLIANCE COMPLIANCE
NT Y N NOTES Y N REMARKS /
OBJECTIVE
(Doc. EVIDENCE
Ref./Clause
No.)
j) Name(s), functions(s), and signatures of
personnel authorizing the report/certificate.
k) Where relevant, a statement that the results
relate only to the items t/c.

5.10.3 Test Reports

Where necessary for the interpretation of


results, the following shall be included in test
reports:

a) Deviations, additions, or exclusions from the


test method, and information on specific test
conditions.

b) Where relevant, a statement of compliance/non-


compliance with the requirements/specification.

c) Where applicable, a statement of the estimated


uncertainty.
d) Where appropriate and needed, opinions and
interpretations.

e) Additional information required by methods,


clients or groups of clients.
NO REQUIREMENT YOUR DOCUMENT ASSESSMENT
DOCUME COMPLIANCE COMPLIANCE
NT Y N NOTES Y N REMARKS /
OBJECTIVE
(Doc. EVIDENCE
Ref./Clause
No.)
5.10.3 Sampling in reports shall include:
.2
a) Date of sampling.
b) Unambiguous identification of the substance,
material or product sampled.

c) Location of sampling.

d) Reference to sampling plan and procedure.

e) Environmental conditions during sampling that


may affect the interpretations of results.

f) Standard or specification for the sampling


method or procedure, and deviations, additions
to or exclusions from the specification
concerned.
5.10.4 Calibration Certificates

5.10.4 Calibration certificates shall also include:


.1
NO REQUIREMENT YOUR DOCUMENT ASSESSMENT
DOCUME COMPLIANCE COMPLIANCE
NT Y N NOTES Y N REMARKS /
OBJECTIVE
(Doc. EVIDENCE
Ref./Clause
No.)
a) Conditions (e.g. environmental) under which
the calibrations were made that influenced the
results.

b) Uncertainty of measurement and/or a statement


of compliance with an identified metrological
specification or clauses thereof.
c) Traceability of measurements.

5.10.4 Certificates shall relate only to quantities and


.2 results of functional tests. If a statement of
compliance with a specification is made, this
shall identify which clauses of the specification
are met or not met.
5.10.4 When a statement of compliance is made
.2 omitting the results and associated uncertainties,
the lab shall record those results and maintain
them for future reference.
5.10.4 When a statement of compliance is made, the
.2 uncertainty shall be taken into account.

5.10.4 When an item for calibration is adjusted or


.3 repaired, the results before and after adjustment
or repair, if available, shall be reported.
5.10.4 Calibration certificates and labels shall not
.4 contain recommendation on the cal interval,
except where agreed with the client.
5.10.5 Opinions and Interpretations
NO REQUIREMENT YOUR DOCUMENT ASSESSMENT
DOCUME COMPLIANCE COMPLIANCE
NT Y N NOTES Y N REMARKS /
OBJECTIVE
(Doc. EVIDENCE
Ref./Clause
No.)
Basis for opinions and interpretations. Opinions
and interpretations clearly marked in report.
5.10.6 Testing and Calibration Results Obtained from
Subcontractors
Subcontracted test results clearly identified.

On subcontracted calibrations, the laboratory


performing work shall issue the calibration
certificate.

5.10.7 Electronic Transmission of Results

Results transmitted by telephone, telex, fax, or


other electronic or electromagnetic means shall
follow the requirements of 17025.
5.10.8 Format of Reports and Certificates

Designed to minimize the possibility of


misunderstanding or misuse.

5.10.9 Amendments to Reports or Certificates


NO REQUIREMENT YOUR DOCUMENT ASSESSMENT
DOCUME COMPLIANCE COMPLIANCE
NT Y N NOTES Y N REMARKS /
OBJECTIVE
(Doc. EVIDENCE
Ref./Clause
No.)
Made in the form of a further document which
includes statement: Supplement to Test Report
[or Calibration Certificate}, serial number[or
as otherwise identified] or equivalent wording.
Amendments shall meet the requirements of
17025.

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