Chapter 8B ISO 9001 Audit Checklist

Chapter – 8B : ISO 9001:2015 Clause-Wise and Department-Wise Audit Checklist
Part-1: ISO 9001:2015 Clause-Wise Audit Questionnaire

ISO 9001:
Requirement
2015 Clause
4. Context of the organization
4.1 Understanding the organization and its context
Have you determined external and internal issues in the Quality management
1)
system (QMS)?
Are these issues relevant to the purpose and ability to achieve intended
2)
outcome of Quality management system (QMS)?
Have you considered the context of the organization’s overall business
3) activities? Does QMS scope cover all the activities or any exclusion for any
areas or functions?
4.2 Understanding the needs and expectations of interested parties
How many interested parties are identified by you and are they relevant to your
1.
Quality management system in implementing ISO 9001:2015?
What are the requirements for interested parties in Quality management
2. system? What procedure or process is followed to understand interested
parties requirements?
3. Have you defined any other quality-related requirements in the organization?
4.3 Determining the scope of the Quality management system
Have you determined the boundaries and applicability of the Quality management
system?
Have you documented the scope of the organization considering below details?
Have you determined the scope of the organization and considered external
a)
and internal issues?
b) Have you considered any requirement of interested parties in the scope?
Have you considered interfaces and dependencies between activities
c)
performed by the organization and other organization?
Have you prepared documented QMS scope?
4.4 Quality management system and its process
Have you established and implemented QMS in accordance with ISO 9001:2015?
How do you establish the QMS?
How do you maintain QMS in your organization? What kind of documentation structure
is made by you?
How do you bring continual improvement in Quality management system in accordance
with this international standard?
Does the organization determine processes for quality management system and their
application throughout the organization for inputs required and the outputs expected
from the processes?
Have you identified the sequence and interaction of the processes?
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How do you define criteria, methods, including measurements and related performance
indicators to ensure effective operation and control of these processes? How do you
determine resources needed and ensure their availability?
Who is given assignment of the responsibilities and authorities?
How do you identify the risks and opportunities and plan to implement the appropriate
actions to address them? Have you defined the methods for monitoring, measuring, as
appropriate, and evaluation of processes, and if needed, the changes to processes to
ensure that they achieve intended results? How do you Improve the processes of
QMS?
Have you maintained Documented Information to support operation of processes? How
it is kept? How do you ensure by documented information that the processes are
carried out as planned?
5. Leadership
5.1 Leadership and Commitment
How the top management demonstrates leadership and commitment for QMS?
Has the Top Management signed and established a quality policy? Has he
approved QMS objectives? Is he active in formulation of quality policy and
a)
objectives? Are the QMS objectives in line with strategic direction of the
organization?
How do you ensure the integration of the Quality management system
b)
requirements with the organization’s processes?
How do you ensure that the resources related to Quality management systems
(QMS) are available? If any resources are lacking then whom do you contact?
c) What is the formal process for getting approval of resources? How do you carry
out capacity planning and budget approval to get management approval for
resources related to Quality management system?
Have you communicated QMS system requirements in the organization? How
do you communicate the importance of effective Quality management system
d)
implementation and its benefits? What are the methods followed for
communication?
e) How do you ensure that the QMS achieves its intended outcome?
How many people are directing and supporting to contribute for the
f)
effectiveness of QMS system? Have you defined QMS Supporting Team?
g) How do you promote continual improvement?
What are the roles of the management?
h) How do you support and demonstrate leadership for QMS? How do you
demonstrate your leadership and commitment for ISO 9001:2015 QMS?
5.2 Policy
Have you established quality policy?
Is the quality policy appropriate to the purpose and context of the organization?
Who has defined the organization's Quality policy? What is the framework for setting up
the QMS objectives? Where do you document QMS objectives?

Have you included the commitment to satisfy applicable requirements related to quality
in the quality policy?
Do you include quality policy to ensure commitment for continual improvement of the
Quality management system? How do you track the continual improvements? What
benefits are achieved by you by implementing this ISO 9001:2015 standard?
How do you communicate quality policy within the organization?
Have you prepared quality policy and kept it on notice board? Is it available as
documented information for all the employees and interested parties? How is it made
available? How do you provide the Quality policy to the interested parties?
5.3 Organizational roles, responsibilities and authorities
Have you assigned and communicated job description, including responsibilities and
authorities for roles relevant to QMS? How?
In the job description, have you defined clearly the authorities and responsibilities of all
concerned persons for how they contribute to meet the requirements of ISO 9001-2015
standard? Are the roles clearly defined in job description to avoid conflict? Are the
authorities and responsibilities communicated to concerned employees?
Have you defined responsibilities and authorities for reporting performance of the QMS
within organization? Do you report the performance of the Quality management system
to the top management? How is it reported and who is responsible?
Who has to ensure provision of resources for implementation of Quality management
system? Which resources are required to include?
Who is appointed as a QMS coordinator? What are the defined roles, responsibilities
and authority of QMS coordinator?
How do you ensure promotion of customer focus throughout the organization?
6. Planning
6.1 Action to address risks and opportunities
Have you established, implemented and maintained process for QMS planning? Can
you explain how it is followed? How do you determine the risks and opportunities that
need to be addressed?
How do you ensure the Quality management system can achieve its intended
a)
outcome?
b) How do you prevent, or reduce, undesired effects related to risk?
c) How do you achieve continual improvement?
How do you plan actions to address risks and opportunities? How do you integrate and
implement these actions into Quality management system processes?
How do you evaluate the effectiveness of the actions related to risk and opportunity?
What do you evaluate to ensure the effectiveness of action?
How do you define a quality risk assessment process?

6.2 Quality objectives and planning to achieve them

How do you establish Quality objectives at relevant functions and levels? Where are
they documented? Who monitors the quality objectives?
a) Are these Quality objectives consistent with the Quality policy?
b) Are your Quality objectives measurable? Show me. Are there any objectives not
measurable?
c) How do you communicate the Quality objectives?
d) At what frequency do you update the Quality objectives?
Where are objectives documented? Who monitors them?
How do you retain documented information on the quality objectives?
Do you have plan for how to achieve quality objectives?
Have you considered the below things in planning the objectives:
 What will be done?
 What resources will be required?
 Who will be responsible to plan the objectives and implement the task?
 When it will be completed?
 How are the results of quality objectives evaluated?
How do you establish, implement and maintain documented Quality objectives? How?
Have you considered compliance obligations and risk and opportunities in framing
these objectives?
Which types of objectives are defined? What parameters need to be taken into account
while establishing and reviewing objectives?
Have you done any planning for how to achieve the Quality objectives? Does this plan
cover what will be done, resource details, responsibilities, and target date? How the
results are evaluated including indicators for achievement of these objectives?
6.3 Planning of changes
Have you determined the needs and opportunities for change to the QMS?
How do you carry out the change in organization?
What are the things that you consider at the time of change in organization?
Have you considered the availability of resources at the time of change in organization?
Have you considered the purpose of the change and their potential consequences?
Have you considered the allocation or reallocation of responsibilities and authorities at
the time of change in organization?
7. Supports
7.1 Resources
Have you determined and provided resources needed for:
 Establishment,
 Implementation,
 Maintenance, and
 Continual improvement?

Who is responsible for providing resources?

Have you provided the infrastructure necessary for the operation?
What is the formal process for budget approval? How the capacity planning is done and
resources are provided? Do you get timely resources or there is delay to get
resources? Due to unavailability of resources, does your work get affected?
Have you provided the environment necessary for the operation of your process?
How do you ensure that resources are suitable for the specific type of monitoring and
measurement activities? How do you maintain and ensure that resources are
continuing fitness for their purpose?
Have you determined how to acquire or access any necessary additional knowledge
and use it when addressing changing needs and trends? Who is appointed as a QMS
coordinator? What are the defined roles, responsibilities and authority for QMS
coordinator?
7.2 Competence
Does the organization determine necessary competence for personnel
performing activities affecting QMS? How do you determine competency? Do
a) you prepare the competency matrix related to QMS activity?
Have you ensured that the necessary competence has been achieved? If in any
areas the competency is not achieved, then what action is taken?
Do you provide training or take other actions to achieve the necessary
competence? Have you defined what are appropriate education, training and
b)
experience for different categories of persons? Where do you maintain such
documented information?
Have you ensured that the necessary competence has been achieved? What
actions are taken to acquire the necessary competence? How do you evaluate
c) the effectiveness of action taken, for example, written test, mock trail, review of
effectiveness of training, etc.? What action was taken to upgrade the
competence of people?
Are you maintaining appropriate information and documented information of
d) education, training, skills and experience and qualifications as an evidence of
competence?
What are the parameters covered under competence? How are you maintaining
training records of all employees? What is the mechanism for identification of training
needs and providing training to all employees? Are all employees trained for ISO
9001:2015 QMS requirements?
What are the trainings provided by you to all employees? Show me your training
records?
How do you plan and impart training? Are you having a list of in-house trainers? What
is the mechanism of providing induction training to new employees? What is the
mechanism of providing induction training to new employees? What is your training
plan for next six months?

7.3 Awareness
Are your employees aware of quality policy and quality objective? How do you
a)
contribute your work to implement the quality policy in your work area?
How do you contribute to Quality management system? What benefits are
b) achieved by implementing the QMS? What is your improved quality
performance?
Are the employees aware of the implication of not conforming to QMS
c) requirements and not fulfilling Quality obligations? How do you provide such
awareness to all concerned persons?
7.4 communication
How do you determine the needs of internal and external communication relevant to
QMS? Do you have any communication plan?
a) What do you communicate regarding QMS?
b) When do you communicate regarding QMS?
c) Whom do you communicate regarding QMS?
d) How do you communicate regarding QMS?
e) Who will communicate regarding QMS?
Do you respond to relevant communication on Quality management system? Is there
any documented information of this communication?
Have you internally communicated information relevant to QMS at various levels and
functions? How?
Do you ensure such communication enables persons to contribute for continual
improvement? How?
Have you externally communicated information relevant to QMS? Show us what kind of
communication is done by you externally? Does it cover all information required by all
applicable compliance obligations?
7.5 Documented Information
7.5.1 General
a) Do you require documented information as per ISO 9001:2015?
b) How do you decide the need for effective documentation of information?
c) Do you require paper copy or electronic copy of documented information?
1) What is your documented information for competence of person?
2) Have you documented quality policy and QMS objectives?
3) Have you documented scope of the QMS?
Have you any documented information compliance with ISO 9001:2015
5)
requirements?

7.5.2 Creating and Updating

Have you created and updated documented information covering proper
a) identification and description of the title, date, and author and reference
number?
Have you made format for documented information, including its identification,
b) language, software version, graphics, and media like paper copy and electronic
copy?
c) Who reviews, updates and re-approves documented, information?
Have you approved information for adequacy and suitability prior to issue? Who
is authorized to approve and review the documented information? How do you
d) ensure documented information is adequate and suitable for the purpose?
Where did you define such authority for approval and review of documented
information
7.5.3 Control of documented information
Have you defined any control mechanism for documented information? How do
a) you ensure documented information is available for use when it is required?
How do you protect documented information? How do you adopt system like
b) confidentiality, improper use, or loss of integrity?
Are the documents required by the QMS protected and controlled? How? Who
is authorized to control QMS documents? How do you distribute the
c) documented information? Have you prepared authorized copy-holder list to
understand who is having access to information? How do you retrieve
documented information and use it?
Is documented information established and maintained to provide evidence of
conformity to requirements and the effective operation of the QMS? How do you
d) store and preserve the documented information? How do you ensure it is
legible?
Is it protected and controlled? How do you change the documented
information? How do you establish version control for your documented
e) information? Are you using any automated tool for such version control and
configuration management?
Is there documented information to define the controls needed for the
identification, storage, protection, retrieval, retention time and disposition of
f) documented information? Have you defined the retention period for various
types of documented information? How do you dispose of such documented
information in hard copy as well as soft copy?
Is the master list for documented information with revision no. made and updated?
Show us the latest revision of Quality Manual and other documented information? How
do you maintain master list of page-wise amendment? How do you inform all the
persons for changes in any documented information? Who is responsible for approval
and control of different types of documents? Do you change the whole document or
carry out page-wise amendment? How do you get information for changes in the
documented information? How do you inform to all the concerned persons?
How is documented information identified for control / uncontrolled and obsolete?
Do you preserve obsolete documents? Where do you preserve them?

8.0 Operation
8.1 Operational Planning and control
Have you planned and implemented processes as per ISO 9001:2015 QMS system
Standard?
Do you implement action for risks and opportunities?
How do you determine the requirement for products and services? Have you
established the criteria for the processes and acceptance of product and services?
Do you have any documented information for the processes carried out as per plan?
How do you document information to have confidence that processes have been
carried out as planned? Where do you keep such information? Based on such
information, if any delay happens then what actions are taken?
How do you ensure that implemented control of the processes is as per defined
criteria?
How do you control planned changes and review the consequences of unintended
changes? Who is responsible for the same?
How do you ensure that outsourced process is controlled or influenced? What type and
extent of control or influence applied to the Process is defined within the QMS for such
outsourced process? Have you established system for selection of vendors and
outsourced activities, and how do you communicate such controls to them?
What is to be considered as operational control? Which operations need to be covered
under operational control plan?
Have you prepared defined operational control parameters for the identified process?
Which processes are covered?
8.2 Requirements for products and services
8.2.1 Customer communication
How do you determine and implement effective arrangements for communicating with
customers regarding:
a) Information related to products and services?
b) Enquiries, contracts or order handling, including changes?
c) Customer feedback, including customer complaints?
d) Control of customer property?
e) Establishing specific requirements for contingency actions?
8.2.2 Determining the requirements related to product & services
How do you determine statutory and regulatory requirements applicable to the product
and services? Have you identified any additional requirements considered necessary by
the organization?
Does the organization have capability to meet the claims for the products and services it
offers? How do you ensure it?

8.2.3 Review of requirements related to the products and services

How do you review the requirements related to the product and services?
Does the review include:
Requirements specified by the customer, including the requirements for delivery
a)
and post delivery activities?
Requirements not stated by the customer but necessary for specified or intended
b)
use, where known?
c) Any additional requirements specified by the organization?
d) Statutory and regulatory requirements applicable to the product & services?
e) Contract or order requirements differing from those previously expressed?
How do you ensure that product and services-related requirements are defined? Who
ensures that the contract or order requirements differing from those previously
expressed are resolved? How it is communicated? Show us related documented
information.
Are documented information of the results of the review and any new requirements for
the products and services maintained? How?
Where the customer provides no documented statement of requirement, are the
customer requirements confirmed by the organization before acceptance? How?
Where product requirements are changed, does the organization ensure that relevant
documents are amended and that relevant personnel are made aware of the changed
requirements? Show us evidence.
8.3 Design and development of products and services
8.3.1 General
Have you established, implemented and maintained a design and development process
to ensure the subsequent provision of product and services?
8.3.2 Design and development (D&D) planning
How do you plan and control the design and development of product?
During the design and development planning, do you consider:
a) The nature, duration and complexity of design and development activities?
b) The design and development stages?
The review, verification, and validation that is appropriate to each design and
c)
development stage?
d) The responsibilities and authorities for design and development?
Internal and external resource needs for the development of products and
e)
services?
The need to control interfaces between persons involved in the design and
f)
development process?
The need for involvement of customers and users in the design and
g)
development process?

h) The requirements for subsequent provision of products and services?

The level of control expected for the design and development process by
i)
customers and other relevant interested parties?
The documented information needed to demonstrate that design and
j)
development requirements have been met?
8.3.3 Design and development Inputs
Are inputs related to product requirements determined and documented information
maintained?
In preparing design and development inputs, do you consider:
a) Functional and performance requirements?
b) Applicable statutory and regulatory requirements?
c) Where applicable, information derived from previous similar designs?
d) Other requirements essential for design and development?
Standards or codes of practice that the organization has committed to
e)
implement?
f) Potential consequences of failure due to the nature of products and services?
Are the inputs reviewed for adequacy?
Are requirements complete and not in conflict with each other? How do you ensure that?
How do you retain documented information on Design and development Inputs?
8.3.4 Development controls
How do you establish controls applied to the design and development process? Where
do you define the result to be achieved by the development activities? How the reviews
are conducted to evaluate the ability of the results of D&D to meet requirements?
What verification activities are conducted to ensure that outputs meet the input
requirements? How Validation activities are conducted to ensure that the resulting
products and services meet the requirements for the specified application or intended
use? What actions are taken on problems determined during the reviews, or verification
and validation activities? How do you maintain Documented information for design and
development controls?
8.3.5 Design and development outputs
How do you ensure design and development outputs are adequate for the subsequent
processes for the provision of products and services? Do you ensure design outputs
meet the input requirements for design and development? How do you ensure it?
Where do you include or reference monitoring and measuring requirements, and
acceptance criteria, in your D&D outputs?
How do you specify the characteristics of the product that are essential to its safe and
proper use?

8.3.6 Design and Development changes

Are design and development changes identified, reviewed and controlled by
organization to ensure that there is no adverse impact on conformity of requirements?
Is documented information of the results of the review of changes, authorization of the
changes and any necessary actions to prevent adverse impacts maintained?
8.4 Control of externally provided processes, products and services
8.4.1 General
How do you ensure that externally provided processes, products, and services conform
to specified requirements?
Have you determined the controls to be applied on externally provided products and
services when;
a. Products and services are provided by external providers for incorporation into the
organization’s own products and services?
b. Products and services are provided directly to the customer(s) by external
providers on behalf of the organization?
c. A process or part of a process is provided by an external provider as a result of a
decision by the organization to outsource a process or function?
Have you determined and applied criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers in accordance with requirements?
8.4.2 Type & extent of control – external provision
What controls are established for externally provided processes, products and services
which adversely affect the organization’s ability to consistently deliver conforming
products and services to its customers?
How do you ensure that externally provided processes remain within the control of its
QMS? Where do you define the controls that it intends to apply to an external provider
and those it intends to apply to the resulting output?
How do you ensure the effectiveness of the controls applied by the external provider and
what mechanism is checked to ensure the same?
What kind of verification, or other activities, is carried out to ensure that the externally
provided processes, products and services meet requirements? Show us evidence.
8.4.3 Information for external providers
Does the organization communicate to external providers applicable requirements for
the following:
a. The processes, products and services to be provided?
b. The approval of products and services; methods, processes & equipment and the
release of products and services?
c. Competence of personnel, including necessary qualification?
d. The external provider’s interactions with organization?
e. The control and monitoring of the external provider’s performance to be applied?
f. Verification or validation activities that the organization, or its customer, intends to
perform at the external provider’s premises?

8.5 Production and service provision

8.5.1 Control of production and service provision
Does the organization carry out the production and service provision under controlled
conditions?
Where do you keep the information that describes the characteristics of the product and
the results to be achieved? How do you ensure that same is available with related
person? Have you identified the use of suitable monitoring and measuring resources?
How do you ensure that it is suitable? How do you ensure implementation of monitoring
and measurement activities at appropriate stages?
Who ensures the use and control of suitable infrastructure and environment? How does
he ensure it? How do you ensure the appointment of competent persons, including any
required qualification? How do you ensure validation and periodic revalidation for special
processes? What actions are taken for implementation of actions to prevent human
error? What process is followed for implementation of product release, delivery and post
delivery activities?
8.5.2 Identification and traceability
How do you identify the output by suitable means throughout product and service
provision? Does the organization identify the product status with respect to monitoring
and measurement requirements throughout product and service provision? How do you
establish inspection and test status for inspected by, rejected, etc.
Where traceability is a requirement, does the organization control the unique
identification of the product and retain documented information? How do you establish
such traceability?
8.5.3 Property belonging to customers (CSP) or external providers
How do you exercise care with customer’s property while it is under the organization's
control or being used by the organization?
How do you identify, verify, protect and safeguard customers or external provider’s
property provided for use or incorporation into the product and services?
If any customer’s property is lost, damaged or otherwise found to be unsuitable for use,
how do you report this to the customer or external provider and retain documented
information?
8.5.4 Preservation of goods and services
How do you preserve output during production and service provision in order to maintain
conformity to requirements?
Does this preservation include identification, handling, contamination control, packaging,
storage, transportation and protection?
8.5.5 Post- delivery activities
How do you meet requirements for post-delivery activities associated with the products
and services?
In determining the extent of post-delivery activities how do you consider:
a) Statutory and regulatory requirements?

b) The potential undesired consequences associated with its products and services?
c) The nature, use and intended lifetime of its products and services?
d) Customer requirements?
e) Customer feedback?
Does the Post-delivery activity include warranty provisions, contractual obligations like
maintenance and supplementary services like recycling or final disposal? How such
things are taken care of? Show us evidences.
8.5.6 Control of changes
How do you review and control unplanned changes essential for production or service
provision to the extent necessary to ensure continuing conformity with specified
requirements?
8.6 Release of products and services
What is the procedure for release of products and services to the customer?
Are the products and services approved by a relevant authority / customer before
release?
Have you implemented the planned arrangements at appropriate stages to verify that
product and service requirements have been met?
Does the company retain documented information which includes evidence of conformity
with the acceptance criteria and traceability?
8.7 Control of nonconforming outputs
Does the organization ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery?
Does the organization deal with nonconforming product by one or more of the following
ways:
a) By correction?
b) By segregation, containment, return or suspension of provision of products and
services?
c) By informing the customer?
d) Obtaining authorization for acceptance under concession?
Are documented information of the nature of the nonconformities and any subsequent
actions taken including concessions obtained maintained? How it is maintained and who
is authorized for disposal of such nonconformity?
9.0 Performance evaluation
9.1 Monitoring, measurement and analysis and evaluation
9.1.1 General
How do you monitor and measure quality processes?
a) Do you have any document information control? Who is authorized for control of
process? What is monitored and measured?
b) How do you monitor, measure, analyze data and evaluate it? How do you ensure

to get valid result? When is the monitoring and measurement performed?

How do you ensure that result of monitoring and measuring instrument is
c)
adequate? Have you analyzed and evaluated such results?
d) Who is authorized to approve, analyze and evaluate these results?
e) How do you maintain evidence of monitoring and measurement of results?
What methods for monitoring, measurement, analysis and evaluation are followed to
ensure valid results? What parameters are covered under the monitoring and
measurements? When do you monitor it?
Which equipment needs to be calibrated under the monitoring and measurement? Show
us the evidence that instrument is calibrated?
9.1.2 Customer satisfaction
How do you monitor customers’ perceptions of the degree to which their needs and
expectations have been fulfilled? Have you determined the methods for obtaining,
monitoring and reviewing this information?
9.2 Internal Audits
Have you conducted Internal audit? What is the frequency to carry out internal audit?
How do you perform audits to ensure Organization’s requirements for Quality
management system is maintained? When and how?
How do you ensure during internal audit that ISO 9001:2015 requirements as well as
international standard requirements are implemented by the organization?
How do you ensure during the audit that QMS is implemented and maintained
effectively?
Have you planned, established, implemented and maintained audit program? Who is the
authorized person reporting for audit and to whom it is reported? How do you ensure
processes and audit results mentioned in Internal audit program is implemented
effectively?
How do you define audit criteria and scope of internal audit?
How do you select auditors and conduct audits to ensure objectivity and impartiality of
the audit process? Are identified employees/ functional heads trained for internal
auditor? Are you having a list of trained Auditors?
Who is authorized person to review results of the audits?
How do you maintain evidence of the audit program and the audit results? Where? Who
has access to such documented information?
Do you have list of trained auditors? Who has given training to them as per ISO 9001
QMS? How many days? Have you made audit plan? During auditing, do the auditors
check and monitor results of Objectives reported by the functional heads? Are all the
NCRs communicated to respective function heads? Are they closed? Have you
prepared plan for internal audit for the whole year? How do auditors carry out internal
audit? Explain us how do you use audit checklist? Have you prepared any audit
summary of department-wise / Clause-wise audit findings? How do you close NCR?

Do you maintain records for the actual audit carried out against audit planned, as well as
summary of audit done? Where do you maintain such records?
How do you ensure that all departments covered for all the clauses applicable to that
department are audited in internal audit? How do you see effectiveness of action taken
on audit NCR? Where is it recorded?
9.3 Management Review
How does Top management review the organization’s Quality management system?
What is the frequency of review to ensure its continuing suitability and adequacy? How
do you ensure its effectiveness? When do you conduct such QMS reviews?
Does this review include assessing opportunities for improvement and the need for
changes to the QMS, including quality policy and quality objectives?
Do you have documented information of actions emerged from the QMS management
review meetings?
What action is taken from previous management reviews? Have you any mechanism for
monitoring action from previous management reviews?
Do you report to Top Management for effectiveness of Quality Management System?
How do you measure effectiveness of system for working of your Organization? How do
you collect necessary information for the same? Are you getting information on
corrective action taken on the identified non-compliances and its effectiveness for
discussion in the management review meeting? What is the frequency of the
Management Review Meeting?
Do you take any feedback? Do you review result of feedback on the quality? Who is
performing it? Have you implemented any improvement based on nonconformities and
corrective action, monitoring and measurement of results, results of QMS audits and
reviews, fulfillment of quality objectives, etc., in the management review meetings?
Have you defined adequacy resources and discussed it in MRM? How do you measure
opportunities for continual improvement?
How do you plan for management review meeting and who are committee members?
Do you circulate the agenda for Management review meeting in advance? Do you
prepare minutes of Management review meeting with the actions decided in that
management review meeting? How do you monitor effectiveness of the system? Do you
review objectives and targets in the management review? When do you review it?
Does the output of management review include the following?
a) Any improvement opportunity as effectiveness of the QMS and documented as

action plan?
b) Any need for changes in QMS?
c) Any requirement of resources?
Have you identified any changes in existing QMS system or resource requirements?

10.0 Improvement
10.1 General
Have you defined any improvement to meet the customer requirements?
How do you determine opportunities for improvement and implement necessary actions
to achieve the intended outcomes of Quality management system?
10.2 Nonconformity and corrective action
How do you control nonconformity and what documented information are
a) maintained? Have any action been taken of nonconformity?
How do you deal with the consequences of nonconformity?
Who is the authorized person for reviewing nonconformity? Which causes are
applicable to the nonconformity? Are you doing route cause analysis for such
nonconformity? How do you determine that nonconformities exist? Have you
b)
determined the causes of nonconformities? Have you reviewed NCR and
correction of NCR, and evaluated nonconformities? What is potential occurrence
of nonconformities?
What action is taken for NCR? How do you implement action needed to meet
c)
How do you monitor effectiveness of corrective action? Who is authorized person
d)
reviewing it?
e) Have you updated risks based on such investigation in documented information?
f) Have you taken any corrective action and made any change in QMS for NCR?
g) How do you monitor effectiveness of results of corrective action?
What is the base for taking corrective actions? Do you take corrective action for all the
nonconformities?
What is the mechanism to take corrective action?
Are you taking corrective action for process, product, system and interested parties’
complaints? When do you take corrective actions? Who reviews the effectiveness of
corrective action taken by concerned department? How do you monitor it?
How do you maintain documented information for nature of the nonconformity and
subsequent actions taken as well as result of corrective action? Who maintains it?
10.3 Continual improvement
How do you ensure that organization has continually improved the adequacy, suitability,
and effectiveness of QMS?
(1) How do you improve the suitability, adequacy, and effectiveness of the QMS to
enhance Quality performance? Have you determined is there needs or
opportunities that are addressed as a part of continual improvement?

Part-2: ISO 9001:2015 Department-Wise Audit Questionnaire
1. QMS Coordinator & General Procedures:-

(1) How do you measure effectiveness of system for working of your company? How do you
collect necessary information for the same? Are you getting information for corrective
action taken and its effectiveness for discussion in the management review meeting?
(2) Have you considered the context of the organization’s overall business activities and issues? To
whom you have identified your interested parties?
(3) What are the needs and expectations of interested parties in quality management system (QMS)?
What procedure or process is followed to understand interested parties’ requirements? How do
you establish the QMS? How do you bring continual improvement in quality management
system in accordance with ISO 9001:2015?
(4) How do you plan for management review meeting and who are committee members? Do
you circulate the agenda for Management review meetings in advance? Do you prepare
minutes of Management review meeting with the actions decided in that management
review meeting? How do you monitor effectiveness of the system? Are you having any
quantifiable objectives for management review? When do you review it?
(5) Have you done any planning for how to achieve the environmental objectives? Does this plan
cover what will be done, resource details and responsibilities, target date? How the results are
evaluated including indicators for achievement of this objective?
(6) Have you updated risks based on investigation and opportunities determined during planning?
How do you ensure corrective action taken is appropriate to the effects of the Nonconformities
encountered?
(7) How do you improve the suitability, adequacy, and effectiveness of the QMS to enhance
performance? Have you determined needs or opportunities that are addressed as a part of
continual improvement?
(8) Are you doing follow-up for completion of action decided in management review meetings?
How? What is input and output of management review meetings?
(9) Do you have the master list for documented information? Show us the latest revision of
Quality Manual and other documented information? How do you inform all the persons for
changes in any documents? Who is responsible for approval and control of different types
of documents? How do you get information for changes in the procedure / documented
information? How do you inform to all the concerned persons?
(10) How documents are identified for control/uncontrolled and obsolete?
(11) Do you preserve obsolete documents? Where do you preserve it?
(12) Do you have list of trained auditors? Who has given training to them as per ISO
9001:2015? How many days? Have you made audit plan and audit schedule? During
auditing, do the auditors check and monitor results of Quantifiable criteria reported by the
functional heads? Are all the NCRs communicated to respective function heads? Are they
closed? Have you prepared plan for internal quality audit for the whole year? How do
auditors carry out internal quality audit? Explain us how do you use audit checklist? Have

you prepared any audit summary for department-wise / clause-wise audit findings? How
do you close NCR?
(13) How do you carry out audit for Purchase department? Have you checked effectiveness of
training given and competence of auditors? How?
(14) Do you maintain documented information for the actual audit carried out against audit
planned, as well as summary of audit done? Where do you maintain such documented
information?
(15) How do you ensure that all departments are covered for all the clauses applicable to that
department are audited in internal quality audit? How do you see effectiveness of action
taken on audit NCR? Where is it documented?
(16) Is the Quality Policy well understood at all levels? Have you arranged training on Quality
policy?
(17) Have you documented customer requirements based on the customers’ need? Have you
documented statutory and regulatory requirements applicable to your product? How do
you ensure that it is fulfilled at all the levels? How do you promote customer requirements
within the organization?
(18) How do you identify maintain and store documented information? Are they legible? Where
do you maintain documented information retention period? How do you establish control
for computerized documented information?
(19) Who is responsible for control of data? How is it controlled? How do you establish control
on computerized data?
(20) Are you taking corrective action for process, product, system and customer’s complaint?
When do you take corrective actions? Who reviews the effectiveness of corrective action
taken by concerned department? Explain details of corrective action procedure? How do
you monitor it? Have you done analysis of audit NCRs? Based on that, have you taken
any corrective action?
(21) Show us the master copy of format with approval for all the formats and exhibits applicable
in QMS area? Have you made Quality Plan for different activities and inter-linkage of your
various departments?
(22) Have you prepared job description with specification for different level of employees in the
company? How do you communicate the same to the various employees?
(23) Who identifies the need for statistical techniques? How is it identified and implemented?
(24) Have you identified the process needed for the Quality Management System? How is it
applied throughout the organization? Have you identified critical processes? How do you
identify interaction of processes as well as criteria and methods needed to ensure that
both the operation and control of the processes are effective? How do you monitor,
measure and analyze the processes?
(25) Have you identified any exclusion? What justifications are given for the same? Have you
documented the same? Where?
(26) Can you show any evidence that top management has given commitment for the
development and implementation of the Quality Management System? Has he

communicated the importance of meeting customer as well as statutory and regulatory
requirements?
(27) Have you made any mechanism for ensuring availability of resources vs. further
requirements? How do you identify resource requirements? How do you fulfill the same?
(28) Have you identified customer requirements to enhance the customer satisfaction? How do
you ensure promotion of awareness of customer requirements throughout the
organization?
(29) What kind of communication process is established within the organization? How the
communication takes place regarding the effectiveness of Quality Management System?
Have you made any procedure for the same? How is it implemented?
(30) How do you ensure competence of persons performing work affecting conformity of the
product? What kind of infrastructure do you provide? How do you identify and convey your
need for the resources?
(31) How do you ensure customer satisfaction? Have you done any customer survey? Have
you analyzed data for the Questionnaire submitted by the customer? Have you taken
actions based on the same?
(32) How do you measure effectiveness of training? How do you ensure training given to the
auditor is effective?
(33) Have you analyzed the data for:
a) Customer satisfaction.
b) Product conformities like inspection for incoming, in-process and final stage inspection.
c) Process trends and opportunities for the improvement, for example: yield control, time
cycle reduction etc.
d) Suppliers.
(34) When do you carry out corrective actions? How do you identify causes of nonconformity?
Have you documented results of actions taken? Where? How do you review the
effectiveness of the action taken?
(35) Have you fixed any action plan for the achievement of Quantifiable criteria? By which data
and how it will be achieved? Show us action plan for achieving the same.
2. QUALITY CONTROL: -
(1) Are acceptance and rejection criteria specified for different process parameters and
products tested by your company? Have you prepared overall inspection test plan
covering references of work instruction, acceptance criteria, format and parameters tested
for different types of products for incoming, in-process and final stage of inspection?
(2) Are you inspecting / verifying all the critical products, new developed products or
purchased material? How? Are any documented information kept for the same? Are you
testing raw materials? How?
(3) Have you trained staff for follow-up of operating procedures and work instruction for Q.A.,
Laboratory, and test methods for testing of various products? Have you received any test
method given by your customer?

(4) How do you carry out calibration of laboratory instruments used by your personnel for
department testing work? How do you maintain calibration status? How do you control and
maintain instruments in your department?
(5) Have you done calibration of equipment like laboratory instruments, weighing balance,
etc? Is it traceable to an approved national /International standard? If such traceability is
not available then is it calibrated against documented method or established
methodology?
(6) How do you identify un-inspected, inspected and non-conforming samples in your
department? How do you downgrade the materials after lab testing? How do you identify
downgraded material? Are you putting remarks as O.K. / not O.K. in the test reports? Who
is authorized for the review and approval of test reports?
(7) How do you get details for third party inspection or product approval by customers? How
do you get information for the statutory and product-related regulatory requirements? How
do you ensure fulfillment of the same?
(8) How do you get information for the customer requirements and ensure its fulfillment? Are
you inspecting reprocessed material? Show us documented information?
(9) Are you carrying out testing of all the critical incoming materials in process and final stages
for each lot? How do you maintain documented information? How do you maintain status
of inspection?
(10) What action have you taken after receiving customer complaints? How do you analyze
customer complaints?
(11) How do you ensure that product has passed through all the inspection and meets
customer requirements? How do you carry out final inspection of product to be supplied to
different segment like replacement market, defense, exports etc.? Where are you keeping
(12) Have you attended management review meetings? Which discussion was related to your
areas? Have you completed actions decided in management review meeting in your area?
(13) How do you get special test requirements of customers and how it is carried out? Do you
get any test method for testing of product from the customer? How do you follow it?
(14) How do you maintain master list of documented information with retention period? Are all
types of documented information, including computerized documented information
maintained by you, covered in the master list of documented information? In all your files,
are record name and format no. (If applicable) written? Have you established a proper
document control?
(15) Have you been audited? How many NCRs are given to you? Have you taken actions to
close the same?
(16) Are you using any subjective criteria for inspection and testing? How do you establish
control for the same?
(17) What is the process approach in your department? What is the input and output in your
laboratory? Have you prepared Quantifiable criteria for your area? How do you monitor it?

Have you conveyed the same to the concerned person? Have you prepared any action
plan for the achievement of Quantifiable criteria?
(18) How do you carry out process audit?
(19) How do you prevent, or reduce, undesired effects related to risk?
(20) Have you define a quality risk assessment process? Show me.
(21) What are the things that you consider in your department at the time of change in
organization?
(22) Is there necessary infrastructure and environment in your department for the operation of
process?
(23) Do you implement action on risks and opportunities?
(24) Have you updated risks based on investigation in documented information?
3. MARKETING: -
(1) How do you carry out marketing of your product? Are you having agents? How do you
select channel of distribution? Who is authorized for their selection? Are you having a list
of approved Dealers / Agents list for the same?
(2) Have you prepared your company’s brochure? Are you having a price list? Who approves
it? How do you finalize price of the new product?
(3) How do you participate in defining requirements for new products? How do you get
information on new products? How do you provide information on your product to your
customers as well as plant people?
(4) Have you defined customer expectations and product requirements? How do you
communicate it to Design, Manufacturing, Q.C., packing, etc.?
(5) How do you sale your products? Do you understand requirements related to the products
as below:
1. Requirements specified by the customer.
2. Requirements not specified by the customer for intended use.
3. Statutory and regulatory requirements applicable to the product.
4. Any additional requirements considered necessary by the organization.
Can you show us evidence that above four types of requirements are determined and
understood before execution of order? How do you ensure your capability for the above
requirements? How do you maintain contract review report? How do you keep track of
completion of order and compilation of all such orders?
(6) What are the Quantifiable criteria for your department? How do you monitor them? Have
you given any further criteria for your other sales staff? What process approach do you
adopt? What is input and output of your department? Have you done any analysis for
timely completion of orders or delay in delivery? How do you amend the order?

(7) How do you monitor effectiveness of department? Can you show us your action plan for
achievement of your quantifiable criteria? How do you monitor your results for
achievement of Quantifiable criteria vs. planned action?
(8) How do you know plant capability for manufacture of different types of product? How
delivery schedule is given to you? Have you done internal contract review any time?
Where is contract review report? How do you convey the same to the plant? How do you
confirm capability for new product development with the customer as well as convey the
same to plant?
(9) What are the things that you consider in your department at the time of change in the
organization?
(10) How do you handle customer complaints? Are any documented information maintained for
the same? When do you close such complaints? How fast you close the customer
complaints? Have you done any analysis for customer complaints and warranty claims
attended by the company? What corrective actions are taken for the same?
(11) How do you convert customer inquiry into contract? Are the total requirements laid down?
(13) Have you defined a quality risk assessment process? Show me.
process?
(16) Have you attended management review meeting? Have you decided any action for your
department? How? Does marketing department monitor and report customer feedback in
management review meeting?
(17) How do you maintain documented information in your area? Are all types of documented
information, including computerized documented information maintained by you, covered
and maintained?
close the same?
(19) Have you updated risks based on such investigation in documented information?
(20) How do you determine and implement effective arrangements for communicating
customers for product information (List of your brand products), order handling,
complaints, etc. Have you fixed any timeframe for the effective communication with
customers?
(21) How do you measure customer satisfaction? Have you defined methods for the same?
Have you analyzed such data? Have you taken any corrective action for the same? What
is input for customer satisfaction survey? Have you fixed any criteria for customer
satisfaction?]

4. PRODUCTION AREAS: -
(1) Are the Production Head, In-charge, Supervisors and workers trained on the methods and
skills to perform their task as well as on applicable ISO 9001:2015 documented
information? Are the operators aware of their work instructions for operation in respective
work area?
(2) What is the process approach in your manufacturing activity? What is the input and output
in your various processes? Have you prepared Quantifiable criteria for your process? How
do you monitor it? Have you conveyed the same to the concerned person like supervisors
and workers?
process?
(4) Have you identified operational control points of your activities? Are you having documented
operational control plan? Are you maintaining documented information as per the requirements of
operational control plan? Show me documented information.
(6) Have you updated risks, based on such investigation in documented information?
(7) Are you having any special process? What do you mean by it? Do you operate for special
process? How do you monitor such special process? Do you keep any documented
information for the same? Before finalizing process parameters, have you done study for
your past process data to consider the process parameters?
(8) How do you identify the material and parameters at incoming, in process, and final storage
area?
(9) Are equipment / instruments used by your departments calibrated? What is your mechanism for
calibration?
(10) How do you ensure that implemented control of the processes is as per defined criteria? How do
you control planned changes and review the consequences of unintended changes? Who is
responsible for the same?
(11) How do you ensure that outsourced process is controlled or influenced? Have you defined what
type and extent of control or influence is applied to the Process within the QMS for such
outsourced process? Have you established system for selection of vendors and outsourced
activities and how do you communicate such controls to them?
(13) What methods for monitoring, measurement, analysis and evaluation are followed to ensure valid
results?
(14) What are the things that you consider in your department at the time of change?
(15) Have you established any traceability system to recall defective product based on
customer complaint or production feedback for a particular lot? How do you identify
finished materials as well semi-finished lot? Have you established any codification system
for the lot numbering?

(16) Is production planned for the different departments? Do you carry out production planning
and product realization? How do you monitor plan vs. actual? How do you carry out
routine work? What process do you follow for internal communication?
(17) Have you defined risk and opportunity? How risk assessment process is followed? Show
me.
(18) Is there appropriate control of materials, equipment and critical parameters of process?
How do you monitor and control your processes? Are you maintaining documented
information for process control monitoring? How do you get the information for the mixing
of various products?
(19) Is there inspection and test status given for downgrade materials? How? Are there
appropriate documented information for disposal of nonconforming materials and who is
authorized for the same?
(20) Have you finalized critical limits for you processes? Have you documented the same?
Where? How do you control process parameters? How do you monitor the same? Do you
maintain the documented information for the same? Are adequate equipment used for
storage and handling?
(21) Is training provided at all levels of workman in the company? Where is documented
information? Does management evaluate training effectiveness? Based on training
effectiveness documented information, are you giving retraining?
(22) Do you analyze your documented information to find out route cause for taking corrective
actions on product and process nonconformity? Where have you documented results of
effectiveness of corrective actions?
(23) Are you following the methods for process control, process qualification and process
monitoring on manufacturing machines? What are the control parameters during the
manufacturing processes? What are Standard Values and Tolerances? Are you using any
subjective criteria for inspection or process control? How do you maintain documented
information for the same? Have you ensured that eye checking of the personnel is done?
(24) How do you receive and issue materials within and outside your department? Where is it
documented?
(25) What are the steps followed for identification and disposal of non-conforming materials?
How do you identify uninspected, conforming and not O.K. material?
close the same?
(27) Have you attended management review meetings? Which discussions were related to
your area? Have you completed actions in your area as decided in management review
meeting?
(28) What kind of communication process is established within the organization? How does the
communication take place regarding the effectiveness of Quality Management System?
How is it implemented?
(29) How do you ensure competence of persons performing work affecting the Quality? Have
you identified competence level for employees? What kind of infrastructure do you
provide? How do you identify and convey your need for the resources?
(30) When do you take actions for the effect of the potential problems? How do you determine
potential nonconformity and their causes? How do you document results of action taken?
How do you review the effectiveness of the action taken? How do you review actions in
the management review meetings?
(31) Have you analyzed documented information for the conformity of product requirements of
characteristics and trends of processes and products, including opportunities for
improvement?
(23) How do you ensure achievement of Quantifiable criteria? By which date you will achieve
it? How? Where is action plan for the same?
5. ENGINEERING (UTILITY AND MAINTENANCE): -

(1) Have your documented preventive maintenance schedule? Is it based on manufacturer’s
suggestions? Are you following it timely? Where is it documented? Are you having
equipment history data? Are you maintaining breakdown maintenance data? Are you
doing analysis of breakdown maintenance and taking necessary corrective actions?
(2) Are you following methods for process control and process monitoring on utility
equipment? What is the control parameter during the processes? What are Standard
Values and Tolerances?
(3) Is there appropriate control of materials, equipment and critical parameters of utility
process? How do you monitor and control your processes? Are you maintaining
documented information for process control monitoring?
close the same?
your area? Have you completed actions decided in management review meeting in your
area?
(6) What is the process approach in your maintenance activity? What are the inputs and
outputs in your various processes of your utilities as well as plants? Have you prepared
Quantifiable criteria for your department to monitor the effectiveness? How do you monitor
it? Have you conveyed the same to the concerned persons like supervisors and workers?
What is action plan for achievement of quantifiable criteria? How do you achieve it?
(7) How do you ensure competence of persons performing work affecting the Quality? What
kind of infrastructure do you provide? How do you identify and convey your need for the
resources?
(12) Are you analyzing breakdown data? How? Are you taking any corrective actions based on
it? When do you take actions for the effect of the potential problems? How do you

determine potential nonconformity and their causes? How do you document results of
actions taken? How do you review actions in the management review meetings?
(9) What competence, education and experience are required for your employees? Have you
documented it? Based on that, is any gap found in your department? How do you maintain
the documented information for the same?
organization?
process?
6. PURCHASE: -
(1) Have you selected vendor and suppliers? Have you prepared Approved Vendor List
(AVL)? What are the selection criteria? Do you maintain documented information for AVL
and Vendor selection/ evaluation?
organization?
(6) Have you prepared any questionnaire for selection of vendor? Can you show the same?
(7) Have you prepared clear specifications for all the purchase items? How do you get
information on purchasing data form user department? Have you prepared purchase
specifications for raw materials and are you referring the same document in the purchase
order? How are you getting details for the spares and hardware and job work items? How
are you getting specifications for the same? How do you give codification for part
number?
(8) Have you made agreement for quality assurance with your subcontractor? Have you
established any control on them? How do you select subcontractor for job contract? How
do you establish control on them?
(9) Can you show me documented information for the trial run or sample approval for the
vendor selection/evaluation?
(10) How do you ensure that outsourced process is controlled or influenced? Is the type and extent of
control or influence applied to the process defined within the QMS for such outsourced process?
(11) Have you established system for selection of vendors and outsourced activities and how do you
communicate such controls to them?
(12) Have you done periodic evaluation and vendor rating of your supplier? Which items are
included for the same?
(13) How do you carry out cash purchase? Who is authorized to purchase against letter of
intent?
process?

(15) Who is reviewing and approving purchase order for adequacy of the specified
requirements prior to release? Where is the list of authorized person for the same?
(16) How do you carry out purchase of services like labor contract, calibration of instrument,
transport, etc.? Do you prepare P.O. / Contract / work order for the same?
(17) Do you go to vendor’s place for inspection of the product and do you convey them test
certificate requirement as required by you?
(18) How do you keep track of requirement vs. purchase order release vs. materials receipt
and monitor your purchase activity? How do you keep track of pending requirements?
What is the procedure for purchase order cancellation? How do you keep track of
pending purchase order? How do you amend the purchase order? Show us documented
information?
(19) Are you using any vendor’s standard documents or master sample and who is controlling
the same?
(20) Do you outsource any of the processes?
(21) How do you control the subcontracted processes?
close the same?
your area? Have you completed actions decided in management review meeting in your
area?
(25) Have you documented job descriptions with authorities and responsibilities of all the
concerned persons in your department?
(26) What is the process approach in your department? What are the inputs and outputs of
various activities done by you? Have you prepared Quantifiable criteria for your
department to monitor the effectiveness? How do you monitor it? Have you conveyed the
same to the concerned person/ staff members in your department? What is the action
plan for achievement of quantifiable criteria? By which date?
(27) What kind of communication process is established within the organization? How does
the communication take place regarding the effectiveness of Quality Management
System? Have you made any documented information for the same? How is it
implemented?
7. STORES (RAW MATERIAL AND SPARES): -
(3) How do you maintain account of job work materials sent with gate pass?
(4) Which methods are followed for receipt and issue of materials form store? Are you having
a list of persons for the issue of materials? How do you maintain documented information
for the issue and receipt of materials?

(5) Is the method for preserving materials adequate? How do you take care of the
preservation of materials?
(6) What are the things that you consider in your department at the time of change in
organization?
process?
(9) Do you maintain proper inspection and test status for materials lying in store area?
(10) How do you identify uninspected, O.K. and not O.K. materials? How do you inform
concerned department to carry out necessary inspection on arrival of materials? How do
you control shelf life of materials?
(11) How do you maintain stock documented information? Have you specified location for the
storage of different items? How do you keep track of the same?
(12) Have you specified minimum inventory level at any place for critical items? Are you
involved in raising the indent and follow-up of indent raised by various departments? How
do you keep track of the pending indents?
(13) What types of controls are established to avoid deterioration of Quality of materials during
storage? What controls are followed for shelf-life of materials used?
(14) How do you dispose-off nonconforming materials?
(16) Do you verify quality, brand and type of materials with respect to purchase order on receipt
in the store
(17) What is the process approach in your department? What are the inputs for the various
activities done by you? Have you prepared quantifiable criteria for your department to
monitor the effectiveness? How do you monitor it? Have you conveyed the same to the
concerned staff members in your department?
(18) Are you having MSDS for all the chemicals stored in the raw materials stores? How do you
take care of the various symbols put on the packing of raw materials and what are their
meanings? Have you got any training on the safety issues?
8. PACKING AND DISPATCH: -
(1) Are you putting identification label as per contract made with customer?
(3) Do you control packaging materials and follow same packing method as per agreement
with customer?
(4) Are you inspecting and testing the packing materials? Show the documented information
of same.
(6) How do you get information for packing and dispatch of different types of pigments?

(7) How do you get carried out blending of materials? Do you inspect the blended lot? What is
the system of giving the lot number?
(8) How do you get information from the Q.C for the inspection test status, and who is
authorized to release the materials based on final inspection and testing? How are you
getting the information on the lot ready for dispatch?
(9) How do you get information on customer requirements, for example packing materials,
shipping mark, packing weight, etc.? How do you establish proper control for the same?
What care is taken for the same?
(10) Have you defined a risk assessment process? Show me.
(12) Are adequate instructions provided for packing? How do you take care of quality of
materials for delivery to destination or customer’s place?
(13) What care is taken for product quality during packing?
(14) How do you control and store materials in the packing area? Have you identified areas for
storage of different materials? How do you maintain stock for the same?
(15) What is input to your department? What is output from your department? Have you
identified any quantifiable criteria? How do you monitor the same?
(16) What are the things that you consider in your department at the time of change, and what
is the change management process followed by you?
process?
9. ADMINISTRATIONS AND TRAINING: -
(1) Have you determined competence of personnel performing work affecting conformity to
the product requirements? How? Based on that, how do you identify training needs or
recruitment of new person for the various levels of employees?
(2) Are you having competence chart for the various levels of employees? How do you
ensure competence and are you having annual appraisal to ensure competence of
employee?
process?
(5) How do you provide training or take necessary actions to achieve necessary competency
need for the various levels of employees?
(6) What mechanism is followed by you so that all the personnel are aware of the relevance
and importance of their activities and how can they contribute to the achievements of the
quality objectives?
(7) Can you show us the documented information for the education, skill, experience and
training of various levels of the employees? Who is recently recruited? Does he fulfill your
requirements? Show us his degree certificate?

(8) What is the input to your department? What is the output from your department? How do
you control them? Have you made any quantifiable criteria for your department? How do
you monitor it?
(9) Can you show us documented information for annual training as well as routine training?
How do you prepare training calendar? Can you show us the same?
(10) How do you ensure effectiveness of training given? Based on that, have you given
retraining in any case?
(12) Have you updated risks based on such investigation in documented information?
organization?
(14) Have you identified any training need for special activity based on multi-skill analysis?
(15) Do you get timely resources or is there any delay in getting resources? What step is taken
at the time of unavailability of resources?
(16) Do you provide training or take other actions to achieve the necessary competence? Have
you defined what are appropriate education, training and experience for different
categories of persons? Where do you maintain such documented information?
(17) Have you ensured that the necessary competence has been achieved? What actions are
taken to acquire the necessary competence? How do you evaluate the effectiveness of
action taken, for example written test, mock trail, review of effectiveness of training, etc.?
What action was taken to upgrade the competence of people?
(18) Are you maintaining appropriate information and documented information of education,
training, skills and experience and qualifications as an evidence of competence?
10. RESEARCH AND DEVELOPMENT: -
(1) How do you get information on the new R & D work and product or process related
development work? Are you carrying out any design and development planning?
(3) How do you identify various design and development stages covering design review,
verification and validation? How do you maintain the documented information for the
same?
(4) How do you carry out interfaces with different departments for R & D work? How do you
assign responsibility for R & D work to various team members?
(5) How do you get input for the design and development activities? Where do you maintain
documented information for the new products as well as application related changes in the
existing product or input for all the modification projects? How do you document design
input?
(6) Have you defined risk assessment process? Show me? What are the risk and opportunity
related to your activities?

(7) What are the things that you consider in your department at the time of change, and how
change management is followed by you?
(9) Are you considering all the statutory and regulatory requirements like use of banned
products, process limitation, and maximum pressure limits? Are you considering ASTM or
IS standards? Where do you maintain the documented information for the same?
(10) How do you make design calculations? How do you document design outputs?
(11) How do you plan for trial production, R & D experiments and new jig development during R
& D stage? Where do you maintain the documented information? How do you monitor
performance of the trial run?
(12) How do you document design output covering information related to purchase, production,
etc.? Where do you document acceptance criteria for the products? How do you ensure
product application, for example paper, textile, plastic etc. for the various products
developed by you?
(13) Where do you document stages of design review in the design plan? How do you carry out
design review? Who are the team members for the design review? Are you making any
action plan? Where have you documented information of results of review?
(14) How do you carry out design and development verification? Before releasing the product
from laboratory, are you documenting product specification in documented form? How do
you monitor the same?
(15) How do you validate the design? Where do you maintain the documented information for
the same?
process?
(17) What are the different documents generated from your department? How do you establish
control for design and development changes?
(18) What is the process approach made by you? What is input to your department? What is
output from your department? How do you monitor your quantifiable criteria? How do you
analyze results? What is your action plan for achieving the same?
(19) When do you take corrective actions on the effect of the potential problems? How do you
determine potential nonconformities and their causes? How do you document information
of results of action taken?
(20) Do you implement action from risks and opportunities?
11. TOP MANAGEMENT: -
(1) How do you make your Quality Policy? How do you demonstrate leadership and commitment
to QMS? Have you documented your Quality Policy objectives? Where? How do you
ensure that it is implemented by all the employees? Are the QMS objectives in line with
strategic direction of the organization?
(2) How do you provide evidence of your commitment to the development and implementation
of the Quality Management System and continually improving its effectiveness?

(3) How do you ensure that customer requirements are determined (stated product related,
application related or intended use, statutory and regulatory and additional) and met with
the aim of enhancing customer satisfaction as a part of customer focus? How do you
communicate the same to all the employees?
(4) Have you determined external and internal issues in the Quality management system (QMS)? Are
these issues relevant to organization’s purpose and ability to achieve intended outcome of QMS?
(5) Are there quantifiable objectives in the Quality Policy? How do you measure Quality Policy
objectives? Where? Is it supported with objective evidence?
(6) What are the prime objectives of going for ISO 9001:2015 Quality management system?
What is your experience after implementing ISO: 9000:2015 system in last four months?
(7) Have you determined the boundaries and applicability of the Quality management system?
(8) What are the advantages gained by the company after implementation of ISO 9001:2015
Quality management system?
(9) Have you considered the context of the organization’s overall business activities and issues and
conditions affected by your activities? Based on that, have you identified risk and opportunity and
what actions are planned? What is your vision for next 5 years? To achieve goals how do you see
organization’s commitment for Quality management system?
(10) Are regular Management Review Meetings held to review Quality system? How many
management review meetings are held? Is there any agenda or circular for the same?
How do you review effectiveness of system with respect to Quality objectives and ISO
9001:2015 requirements? Do you receive any report from HODs for review of
effectiveness of system? Which points are discussed in Management Review Meeting?
(11) How do you get information on requirement of resources? Does management provide
adequate resources for installation of Quality Management System components like: (1)
Human resources (Competence, awareness and training) (2) Skills (3) Infrastructure
(Building, workspace, Machinery, storage area, supporting services etc. (4) Inspection &
test equipment (5) Work Environment.
(12) What are the needs and expectations of interested parties in Quality management system? What
process is followed to understand interested parties’ requirements?
(13) Have you defined authorities and responsibilities of all personnel? Is delegation of
authority and responsibility clearly defined?
(14) Have you defined any growth rate percent? How do you see future of your industry? What
will be your company’s role in this industry? What is your future plan?
(15) How do you identify training need for senior personnel?
(16) How do you give feedback to R&D for new product development? How do you get such
information?

Chapter 8B ISO 9001 Audit Checklist

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Chapter – 8B : ISO 9001:2015 Clause-Wise and Department-Wise Audit Checklist

Part-1: ISO 9001:2015 Clause-Wise Audit Questionnaire

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6.2 Quality objectives and planning to achieve them

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Who is responsible for providing resources?

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7.5.2 Creating and Updating

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8.2.3 Review of requirements related to the products and services

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h) The requirements for subsequent provision of products and services?

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8.3.6 Design and Development changes

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8.5 Production and service provision

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to get valid result? When is the monitoring and measurement performed?

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a) Any improvement opportunity as effectiveness of the QMS and documented as

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Part-2: ISO 9001:2015 Department-Wise Audit Questionnaire

1. QMS Coordinator & General Procedures:-

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5. ENGINEERING (UTILITY AND MAINTENANCE): -

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