Audit Check list for ISO 9001:2000

ISO 9001 Clauses Audit Check list questions

4.1 Quality Management 1. Has the key work processes of the organization been
systems General identified?
Requirements 2. Does the company measure efficiency and effectiveness of
the work process?
3. How does the company achieve control of the processes?
4. Are there any outsourcing or subcontracted work to external
party(s), if yes how the organization control those processes
and identify relevant Controls within them?
5. Is continuous improvement on performance being
implemented?
6. Are the process management activities supported by
appropriate operational records (to show planning, operation
and control)
4.2.1 General 1. Are the six mandatory documented procedures documented,
Documentation namely, control of documents, control of records, internal
requirements audits, and control of nonconforming product, corrective
action, and preventive action?
2. Are there documents such as flow charts, memos, policies
that guide the work for the employees?
3. Are there appropriate records kept to show evidence of the
implementation of the processes?

4.2.2 Quality Manual 1. Does the company compile has a quality manual (QM)
established and maintained? Are the following included?
a) the work processes within the scope of the quality
management systems,
b) scope of the QMS,including details and justification for any
exclusions,
c) the reference to the documented systems, and
d) descriptions of the interactions between the processes of the
quality management system?
2. Are there documented statements of a quality policy and
quality objectives?
3. Are there documented procedures required by the standard,
(Viz,control of documents, control of records, control of
nonconforming product, corrective action, preventive action,
internal audit)

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4.2.3 Control of 1. Has the company appointed designated personnel for the
documents approval and issue of the documents?
2. Is there a documented procedure for the control, issue, review
and approval for changes to existing documents and issues of
the new documents?
3. How was the quality management system and its documented
procedures implemented?
4. Are external documents used within the organization? Are
these documents being identified properly to preclude uses of
obsolete documents?
5. Does the company distribute its quality management systems
documents with identification to ensure proper references?
6. Have all controlled documents, including forms, been defined?
(e.g. QA manual, procedures, forms, quality plans, work
instructions, user manuals, training manuals, LIA manuals,
etc.)
7. Who is responsible for the control of documents? Where this
responsibility defined (documented)?
8. How is electronic (computer) data controlled? Where is this
defined?
9. How are documents of external origin, such as standards and
circulars, identified and controlled?
10. Who is responsible for the identification and control of
document and control of documents from external sources,
such as standards, regulatory standards and circulars?
11. Is the pertinent issues of appropriate documents are available
at all locations where operations essential to the effective
functioning of the quality management system are performed
12. Invalid and/or obsolete documents are promptly removed
from all points of issue or use, or otherwise assured against
unintended use
13. Any obsolete documents retained for legal and /or knowledge
preservation purposes are suitably identified.
14. Who is responsible ensuring that invalid and/or obsolete
documents are promptly removed from all points of issue or
use, or otherwise protected from unintended use? How is this
accomplished?.
15. Who is responsible for ensuring that any obsolete documents
retained for legal and/or knowledge preservation purposes are
suitability identified? How is this accomplished?

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4.2.4 Control of Records 1. Is there a documented procedure for the identification,

storage, protection, retrieval, retention times and disposition of
the records related to quality management system?
2. Who is responsible for the collection of each record?
(Remaining questions are usually directed toward the
appropriate person in each area.)
3. How records are identified, indexed and filed? Can you show
me example in process?
4. How do you ensure that records are legible?
5. How do these records are demonstrate conformance to the
specified requirements and effective operation of the quality
management system
6. Who has access to these records? Are all the records stored
in here? (To determine whether off-site storage if used)
7. What is the retention time for each record? Were applicable
regulatory and legal requirements taken in to consideration in
establishing these retention times? If so, can you show me the
applicable regulatory and legal requirements that were
consulted?
8. Who is responsible for maintaining these records? Does that
person also dispose of records where in this process defined
in your quality plan ad /or documented procedures?
9. How do you store and retain records in such a way that they
are readily retrievable in facilities that provide a suitable
environment to prevent damage or deterioration and prevent
loss?
10. Do you keep electronic (computer) records? Do you create
backups of this data? How often? Who is responsible for
initiating these backups? Can you load a recent back up (bring
up the header) so that I can verify the date? Where is this
process defined in your quality plan and /or documented
procedures?
11. Do you maintain pertinent suppliers’ records? Can you show
me examples of this?
12. Are quality records available for evaluation by the customer or
the customer’s representative, where agreed by contract, for
the agreed period? How is this accomplished?

5.1 Management 1. How does the management demonstrate leadership,

commitment commitment and involvement?
2. Does top management actively involved in establishing,
maintaining and reviewing the quality management system?
3. Does the top management develop specific programs for
communicating customer and regulatory requirements and
creating awareness of the importance and establish a list of
quality objectives or is there any communication to the

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organization the importance of meeting customer and well as

statutory and regulatory requirements?
4. Is there evidence of top management commitment example in
the management review minutes.
5. Does top management review resource requirements to
ensure the availability of relevant resources?
6. Is there top commitment on the continual improvement of the
effectiveness of the quality management system?

5.2 Customer focus 1. Does top management ensure that customer requirements are
determined and fulfilled with the aim of enhancing customer
satisfaction?
2. How does the company identify customer needs on continual
basis?
3. How does the company management identify peoples’ needs
for recognition, work satisfaction, competence and personal
development?
4. How does the company consider potential benefits of
establishing partnerships with suppliers?
5. How does the company ensure that statutory and regulatory
requirements are met?
5.3 Quality policy 1. What is the organization quality policy?
2. Does the quality policy consider the vision of meeting
requirements, customer requirements and continual
improvement?
3. How does the quality lead to visible and expected
improvements?
4. Where is your quality policy, including objectives for quality
and commitment to quality documented?
5. How does the quality policy ensure that the needs and
expectation of the customers are understood?
6. How is the quality policy appropriate to the purpose of the
company?
7. Who is responsible for ensuring that your company quality
policy and quality objectives are communicated to all levels of
the organization?
8. How are your quality policy communicated and understood
within the organization?
9. How do you ensure that the quality policy is understood at all
level of the organization? Can you provide evidence that
demonstrates this?
10. Is the quality policy being reviewed for continuing suitability
and address in management review minutes?
11. Is the quality policy includes a commitment to continually
improve the effectiveness of the quality management system
by top management?

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5.4 Planning
5.4.1 5.4.1 Quality Objectives
5.4.2 Quality
management system planning
Responsibility, authority and
communication
5.5.1 Responsibility and
authority
1. Are suitable quality objectives being set to translate quality
policy in to measurable goals?
2. Are the objectives deployed by functions, and by individuals
so as to assure individuals contribution to the achievement of
the objectives?
3. Are resources allocated to implement the stated quality
objectives?
4. Are quality objectives established at relevant function and
levels within the organization (cascading formula)?
5. Are these quality objectives measurable and consistent with
the quality policy?
1. Does the management ensure that responsibility are
documented and communicated to people in the organization?
2. Who in your company has the organizational freedom and
authority to initiate action to prevent the occurrence of any
nonconformity relating to product, process and quality
system? Where is the defined and documented?
3. Who is in your company is authorized or responsible for
verifying the implementation of solutions?
Where is this defined and documented?

5.5.2 Management 1. Is a management representative appointed to promote the

Representative quality management system implementation and to raise
awareness of customer requirements within the organization?
2. Who is your management representative and where is this
documented?
3. Is the management representative member of management?
4. What evidence are in place to show the management
representative promote awareness of customer requirements
within the organization?
5.5.3 Internal 1. Does the management communicate to all parties on the
communication quality requirements, quality procedures to all employees of
the company to ensure improvement and implementation of
procedures?
2. Is there internal communication established and carried out for
each individual level?

5.6 Management Review 1. Does top management review the effectiveness of the quality
management systems at least once year? Are records kept for
the management review?
2. Does the review input and output conform to the standard
requirements? How to ensure valid information is collected for
management review?
3. Who is/are involve in its continued suitability and effectiveness
in satisfying the requirements of ISO 9001 standard?

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6 Resource management 1. How does the company allocate the resources in a timely manner
6.1 Provision of resources to ensure customer satisfaction?
6.2 Human Resources
6.3 Infrastructure
6.4 Work environment
7. Product realization
7.1 Planning for product
realization
4. How is determination as to the effectiveness of the quality
management system made?
5. How are the management reviews recorded?(documented)
6. When was last management review? May I see it?
1. Does the company implement processes/procedures to
ensure that the training needs for the employees are met?
2. What action is in place for improving the competency of
personnel, and employee awareness programs?
3. Are there activities to ensure that the employees in the
organization are capable and competent for the current and
future needs of the organization?
4. Are there objective evidence on the effectiveness of training
that are evaluated on specific training provided?
5. Does the HR process look at the competence of personnel
from recruitment to deployment right up till the staff leave the
organization (e.g., qualification or education of staff upon
recruitment, training of staff for the right job,etc)?
6. Are the effectiveness of the training evaluated?
1. Does the company provide adequate support for the product
requirement?
2. Are building, wok place, and utilities provided?
3. Is process equipment set up to meet the product requirement?
4. Are supporting services such as transportation, training in
place to ensure conformance to products requirements?
5. Are the infrastructure for example, building, workspace and
associated utilities, equipment and supporting services such
as transport etc appropriate to achieve conformity to product
requirements?
6. Are these infrastructure maintained?
1. Does the management ensure that work environment promote
motivation, satisfaction, development and performance of the
people in the organization?
2. Is the work environment suitable so as to achieve conformity
to product or service requirements?
1. Does the company determine the quality objectives related to
the product requirements?
2. Does the company in planning product realization, determine
the required verification, validation, monitoring, inspection and
test activities specific to the product and the criteria for product
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acceptance?
3. Are the processes planned to achieve the product
requirement?
4. Are monitoring and inspection activities in place?
5. Are these activities recorded to provide evidence of
implementation?
6. The identification and preparation of records.
7.2 Customer related 1. How are customer related processes activities coordinated?
processes Where is this defined (documented)?
7.2.1 Determination of 2. Does the organization determine
required related to the a) Requirement specified by the customer
products b) Requirement not stated by the customer
7.2.2 Review of the c) Statutory and regulatory requirements related to the
requirements related to product/service?
the product d) Any other additional requirements?
3. What is your system for receiving incoming orders/contracts?
Are personnel (pone operators, mail room personnel, fax room
personnel, etc) instructed as to how to recognize orders and
where to direct them?
4. Is there an established process to ensue that the product
requirements are communicated and understood by the
company?
5. Does the information collected include: requirements
specified by customers for delivery and post delivery activities,
requirements necessary for intended use of the product but
not stated by the customer, statutory requirements of the
product, and additional requirements of the organization on
the product?
6. The review requirements shall be carried out prior to the
supply of the product is there such a review to ensure that
product requirements are defined?
7. Are contract/order requirements differing from previously
expressed requirements are resolved?
8. Does the company have the capability to meet the order
requirements?
9. Are the records on the review kept?
10. How do you communicate contract requirements to necessary
functions (design, production, etc)? How are special contract
requirements communicated to the necessary functions?
7.2.2 Review of 1. When a product requirements are changes, is there a
requirements related to procedure to change the related document to inform people on
the product the change of the product requirements?
2. When the customer provide no documentary evidence of the
product requirements, the product requirements shall be
confirmed by the organization before supplying the products.
Are there any measures in this aspect?

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7.2.3 Customer 1. Are there arrangements within the organization for

communication communicating to the customers with respect to product
information, enquires including amendments?
2. Is there a channel for customer feed back, including customer
complaints?
3. What controls are in place to ensure that amendments to
contracts re correctly transferred to functions concerned? Can
you demonstrate that system to me using an example where
this was necessary?
4. Is there arrangements to communicating with customers on
a) Product information?
b) Enquiries, contracts or order handling, including
amendments?
c) Customer feedback, including customer complaints?

7.3 Design and 1. Are there any efforts or resources allocated for the design and
Development development of the products?
7.3.1 Design and 2. Are the design activities controlled through planning on:
development planning a) The design and development stages
b) The review, verification and validation of the each of
the stages
c) The responsibilities for design and development of the
each of the stages?

7.3.2 Design and 1. Are records provided to indicate that functional and
developments inputs performance requirement s are determined prior to the
design?
2. Are the statutory/regulatory requirement consider/included in
the product requirements?
3. Are the experiences from previous design work utilized?
4. Are the design input reviewed to ensure that there is no
conflict, ambiguity among them?

7.3.3 Design and 1. Are the requirements for the design out put define to ensure
development outputs that
 Out put meets the input requirements
 Provide adequate information for purchasing, production
and servicing
 Contain or reference product acceptance criteria
 Specify characteristic s that are essential for safe and
proper use of the product
 Specify characteristics that are essential for safe and
proper use of the products

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7.3.4 Design and 1. Are records and participants defined for the review of the
Development review design and development activities? These review shall:
7.3.5 Design and  Evaluate the ability of the results in meeting the
development verification product, and organization requirements
7.3.6 Design and  Identify problems and provide solutions to the
development verification problems
7.3.7 Control of design 2. Records of verification that the design output meet in put
and development changes requirement shall be kept. Are the design verification carried
out?
3. Validation of the design shall be planned prior to the use of the
products and records shall be kept. Are design validation
activities carried out?
4. Design changes shall be verified and approved before
implementation. Are there activities to ensure these?
5. Are the actions to evaluate the impact of the design changes
recorded and is the review evidence on the design changes
kept?
7.4 Purchasing 1. Is the company purchasing materials and the services basing
7.4.1 Purchasing process on the requirements of the products?
2. Does the company review and approve its document/message
sent to the suppliers?
3. Does the organization select and evaluate the suppliers in
terms of their ability to supply material/ services to meet the
product requirements?
4. Are suppliers evaluated and selected on the basis of their
ability to meet organization requirements (including quality
management system and any specific quality assurance
requirements?)
5. Where is the type and extent of control exercised by the
organization over the suppliers defined (documented)? Is this
dependent upon the type of product and the impact of
subcontracted product on the quality of the final product?
6. Are the evaluation/selection criteria applied to suppliers of
critical and/ or custom product s different those applied to
suppliers of standard catalog items (distributors)?
7. Are the evaluation /selection criteria applied to suppliers of
product /raw materials different those applied to suppliers of
services (e.g. calibration or testing services)?
8. Are calibration services subcontracted? What evaluation
methods are applied to assure capability of the subcontractor
to meet the requirements of clause 7.6?
9. Do you use a “Vendor Rating System” ? If so where is this
system defined?
10. How does a suppliers become a disqualified? Where is this
defined?
11. May I see qualification records for the auditor who visited the

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suppliers? (If applicable)

12. Are records maintained for each acceptable suppliers?
13. Do you use an “Approved suppliers list”? Who supplies your
“Approved suppliers list” to you?
How do you know this one is the most current revision? Who
is responsible for its upkeep?
14. If calibration services are subcontracted, how are the
requirements of section 7.6 as a minimum, invoked? (Is the
quality management system standard to be applied
specifically stated?)
7.4.2 Purchasing 1. Does the company provide purchasing document s that
information describe the product to be purchased and include information
on :
 Requirements of approval
 Requirements of qualification for personnel
 Quality management systems requirements?
2. Who reviews and approved the purchase order? How can one
identify the individual who approved this one?
3. Are review parameters defined? (Are verification requirements
specified)
4. When complex requirement exist, are other departments
included in the review and approval process?
5. Do you issue documents (e.g. product specifications,
drawings, and workmanship standards) to subcontractors? If
so how are these documents controlled?
6. Are substitutions allowed from your suppliers? Who approves
and authorizes substitutions?
7. If substitutions are allowed, what instructions are given to your
suppliers regarding whom to contact for approval or
authorization? How are they given?

7.4.3 Verification of 1. Does the company have processes and activities to verify or
purchased products inspect materials to ensure that the purchased products meet
specified requirements?
2. Does the customer intend to verify the materials at suppliers
premises, has this information been include in the purchasing
documents sent to the supplier
3. Where applicable, how do you ensure that where you verify
purchased product at a suppliers premises, the verification
arrangements, and the method of product release are
specified in the purchasing documents?
4. When specified in a contract, how do you communicate to
your supplier that your customer or the customers
representative is afford the right to verify at the suppliers
premises that subcontracted product conforms too specified
requirements? Where is this procedure defined?

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Production and service
provision
7.5.1 Control of
production and service
provision
7.5.2 validation of
processes for production
an
7.5.3 Identification and
Traceability
7.5.4 Customer property
5. How do you ensure that, when specified in a contract, your
customer or customers representative is afford the right to
verify at your premises that subcontracted product conforms to
specified requirements? Where is this procedure defined?
1. Does the company plan its provision of products and services
to include?
 Availability of information on product requirements
 Availability of work instructions
 Implementation of monitoring and measurements
 Implementation of release, delivery and post delivery activities
1. Does the company validate the products prior to delivery to
ensure that the processes that cannot be validated after the
processes have been carried out?
2. The validation of the special process shall include:
 Defined criteria for the validation and approval of the
processes
 Approval of equipment and qualification of processes
 Use of specific method
 Requirements of records
 Revalidation
1. How is this product or service identified? Where is this defined
(documented)?
2. Does the company identify the product status throughout its
production processes?
3. How is product identification and traceability maintained from
receipt and during all stages of process?
4. Where and, to the extent that traceability is a specified
requirement; how is the need for traceability communicated to
respective process function? Can you show me examples of
how this works? How and where is traceability recorded? May
I see an example of this?
5. Are the monitoring/ measurement status, such as rejects,
accepts waived identified?
6. Are there any specific requirements for traceability of the
products?
1. Is there any usage of customer property such as documents
manual equipments
2. Are these customer property handled in appropriate manner?
3. Is customer property examined upon receipt to check for,
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correct quantity? Correct identity? Any transit damage?

4. How are discrepancy reported to the customer?
5. How is customer property identified to differentiate it from
other product? Where is this defined (documented)?
6. How is customer property stored? How are special storage
and maintenance requirements communicated form the
customer to those responsible for its storage and maintenance
7. Who is responsible for the storage and maintenance of
customer property? Where is this authority defined?
8. Is customer property periodically inspected to detect signs to
deterioration? verify that proper storage conditions are being
maintained? Identify the product that has exceeded its storage
time limitations (expiration date)?
9. If customer property is lost, damaged or otherwise unsuitable
for use, how is each instance recorded and reported to the
customer? Where is this documented?
10. Who is responsible for reporting customer property that is lost,
damaged, otherwise unsuitable for use to the customer?

7.5.5 Preservation of the 1. Are there handling, packaging, storage and protection and
product protection of the final product /services prior to customer
usage?
2. What methods have young adopted/developed for
handling products/services that prevent damage or
deterioration? Where is this defined(documented)
3. What criteria used in assessing the condition of product in
sock in order to detect deterioration?
Do any records substantiate that this has occurred?
4. How are packing, packaging, and marking processes
(including material used) controlled to the extent
necessary to ensure conformance to specified
requirements? What evidence support that this control is in
place and effective?
5. How are packing, packaging, and marking processes
(including material used) controlled to the extent
necessary to ensure conformance to specified
requirements? What evidence supports that this control is
in place and effective.
6. How do you arranger for the protection of the quality of
product/service after final inspection and test where
continually specified, does this protection extend to include
delivery to destination (e.g use of approved suppliers)?
How can this be verified?

7.6 Control of monitoring 1. Does the company determine and provide necessary

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and measuring devices monitoring and measuring devices to provide evidence of

conformity of the products to requirements?
2. Who is responsible for determining the measurements to
be made and the accuracy required? How is this
determined? Where is this documented?
3. Who is responsible for selecting the appropriate
inspection, measuring, and test equipment and ensuring
that it is capable of the necessary accuracy and precision?
Where is this documented?
4. Who is responsible for identifying all inspection,
measuring, and test equipment that can affect product
quality? Does this include employee –owned equipment?
Who ensure that this equipment is calibrated and adjusted
at prescribed intervals, or prior to use?
5. How is inspection, measuring and test equipment that has
exceeded its calibration due date identified and handled?
6. Does your calibration system define the process employed
for the calibration of inspection, measuring, and test
equipment, including details of
 Equipment type
 Unique identification
 Location
 Frequency of checks (Calibration interval)
 Check method (calibration procedure)
 Acceptance criteria
 Action to be taken when results are unsatisfactory
 Where is this defined?(Documented)

7. Are these devices:

 Calibrated or verified at defined intervals against national
and international standards. Where no such standards
exist, is the basis used for calibration documented? How
can this he verified?
 Adjusted and re-adjusted as necessary
 Safeguarded from unwanted adjustments
 Protected from damage and deterioration during handling,
maintenance and storage?
 Show the calibration status

8. How do you safeguard inspection, measuring and test

facilities, including both test hardware and both test
software, from adjustments that would invalidate the
calibration setting? (Do you require the use of tamper
resistant seals? Do you “Write protect” or “Password-
encrypt” test software?)

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9. How do you ensure that the environmental conditions are

suitable for the calibration, inspections, measurements,
and test being carried out? Is there any documented
evidence to support this?
10. Does the company validate past test results if there is a
failure of the measuring /monitoring devices?
11. What calibration records does your calibration system
require you to maintain?

8.Measurement, 1. Does the company use appropriate methods to

analysis and demonstrate conformity of the products, conformity of the
improvement quality management systems to requirements and
8.1 General continually improve of the effectiveness of the quality
management system?
2. What are these methods?
8.2 Monitoring and 1. Does the company monitor information relating to
measurements customer perceptions as to whether the company has met
8.2.1 Customer customer requirements?
satisfaction 2. The methods for obtaining such information shall be
defined?

8.2.2 Internal Audit 1. Who is responsible for maintaining and managing your
internal audit program?
2. Does the company conduct internal audit at planned
interval on the conformance of the quality systems?
3. How are internal Audit scheduled? (On the basis of status
and importance of the activity?)
4. What criteria do you use for determining the effectiveness
of the quality management system?
5. Have training and qualification requirements for auditors
been defined and documented? Are records available that
detail the training and qualification of each internal
auditor?
6. Is a formal schedule for internal quality audits prepared
and authorized? May I see it? How can I verify that this
scheduled is being followed?
7. How are the results of internal audits recorded? How can I
verify that all of the applicable requirements of the ISO
9001:2000 have been audited?
8. Are auditors selected and trained so that they do not audit
their own work?
9. Is the procedure for internal audit documented? Does the
procedure include the necessity of corrective actions after
the audit?
10. How do you ensure that management personnel
responsible for the are audited take timely corrective

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action on deficiencies found during the audit? How do you

define the word “timely”?
11. When do you conduct follow up audit activities that verify
and record the implementation and effectiveness of the
corrective action taken? How is this documented?
12. Does the company keep records of audit and follow up
verification of the corrective actions?
13. How are the results of the audits input to management
review activities?

8.2.3 Monitoring and 1. Are the planned results for each of the processes defined?
measurement of the 2. Are there methods to track and monitor these planned
processes results areas?
3. Does the activities include the follow up and corrective
actions needed when the planned results are not
achieved?
8.2.4 Monitoring and 1. Does the company define the measurements of product
measurement of the characteristics at various stages of the production process
product or service provision process?
2. Are evidence /records of conformance kept?
3. Do such records indicate the authority for release of
products?
4. Are there measures to ensure that only products
conforming too all the requirements are dispatched to the
customers?

8.3 Control of 1. Are the procedures to ensure that the nonconforming

nonconforming product products are controlled to prevent inadvertent uses?
2. Is there a procedure documented to define authority and
responsibility for the disposition of nonconforming
products?
3. How do you ensure that product which does not conform
to specified requirements is prevented-from unintended
use or installation?
4. How do you provide for identification, documentation,
evaluation, segregation (when practical), disposition of
nonconforming product, and for notification to the functions
concerned?
5. Who is authorized and responsible for review and the
disposition of nonconforming products? where is this
defined (documented)
6. Are the records for the disposition for the nonconforming
products kept including the concession (waiver) of the
products?
7. Does the procedure specify clearly that corrected
nonconforming products shall be re verified for

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conformance?
8. Are the repair or rework instructions accessible and
utilized by the appropriate personnel?
9. When required by contract, how do you report the
proposed use or repair of product that does not conform to
specified requirements for concession to the customer or
customer’s representative?
10. How do you ensure that customer authorization is received
prior to shipping nonconforming material?
11. How is the description of nonconformity that has been
accepted, and any repairs, record to denote the actual
condition?
8.4 Analysis of Data 1. Does the company collect and analyse data to monitor and
improve quality management system?
The data analyzed shall include:
 Customer satisfaction
 Conformance of product requirements
 Trend of product characteristics including opportunities
for preventive actions
 Suppliers?

8.5 Improvement 1. Are processes established to continually improve on

8.5.1 Continual quality management systems such as the analysis of data
improvement implementation of corrective and preventive actions?
1. Does the organization have a documented procedure on
corrective actions on customer complaint and product
nonconformity?
2. Does the procedure address:
 Reviewing nonconformity
 Determining the causes
 Evaluating the needs for actions
 Determining the actions needed and implement the
actions
 Records of the results
 Reviewing of the corrective actions taken?
3. How do you ensure the effective handling of customer
complaints and reports of product nonconformities?
4. Who is responsible for investigation of the cause of
nonconformities relating to product, process, and quality
system, and recording the results of the investigation?
Where is this documented?
5. Who is responsible for determination of the corrective
action needed to eliminate the cause of nonconformities?
Where is this defined?

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Audit Check list for ISO 9001:2000

ISO 9001 Clauses Audit Check list questions

6. Who is responsible for the application of controls to ensure

that corrective action is taken and that it is effective? How
is this demonstrated?

8.5.3 Preventive action 1. What have you defined as “appropriate” sources of

information (such as processes and work operations that
affect product quality, concessions, audit results, quality
records, service reports, and customer complaints) to
detect, analyze and eliminate potentional causes of
nonconformities?
2. Who is responsible for determination of the steps needed
to deal with any problems requiring preventive action?
How is this determination made?
3. Who is responsible for initiation of preventive action and
application of controls to ensure that it is effective?
4. How is the “effectiveness” of preventive action determined
or measured?
5. How is relevant information on actions taken submitted for
management review? What form does this take? How can
I verify this?

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