ISO 9001:2000 Interview Checklist

ISO 9001:2000 Interview Checklist

Interviewee: ____________________
Designation: ____________________
Interviewer: ____________________
Date: ____________________
Instructions on Use:
1. This interview checklist is used to gauge level of compliance to the ISO
9001:2000 standard and also to gather the necessary information to develop a
quality mgmt system complying to the ISO 9001:2000 standard.
2. Please spend about 1-2 hours going through the checklists, answering the
questions to the best of your knowledge. Note that typically only about half or
less of the questions are relevant to you, unless you are the QA Manager.
3. Please also provide a copy (where available) of the organisation mission
statement and work objectives, procedures, forms, work instructions, flow-
charts, check-lists, templates, organisation charts, monthly report(s),
process/product measurements job descriptions, etc. which will help to
describe:
a) the existing quality policy/objectives which will describe your organisation’s
long-term mission and measurable objectives
b) the work processes under your purview (what, when and who)
c) your authorities and responsibilities within the organisation.
4. This checklist also serves as a training material for understanding the ISO
9001:2000 requirements.
5. Please list out the top 5-8 key activities performed by your dept/function that
covers at least 80% of all the work done within your dept/function:
a)

b)

c)

d)

e)

f)

g)

h)

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4 Quality Mgmt System (QMS) Requirements
4.1 General Quality Mgmt System (QMS) Requirements
a) Is a quality mgmt system established, documented,
implemented and maintained according to the ISO
9001 standard?
b) Are processes needed for the quality mgmt system
identified?
c) Are the following determined for these processes:
1. The sequence and
interaction
2. The criteria &
methods to ensure effective operation & control?
d) Are information necessary to support operation and
monitoring of these processes available?
e) Are there measurement, monitoring and analysis of
these processes to achieve planned results and
continual improvement?
f) Are control of out-sourced processes identified in the
quality mgmt system?
Remarks (if any):

4.2 General QMS Documentation Requirements

a) Quality Manual: Is there a quality manual that
documents the
3. Quality policy and
objectives
4. Scope of the QMS &
details of and justifications for any exclusions
5. Procedure for control
of documents
6. Procedure for control
of quality records
7. Procedure for conduct
of internal audits
8. Procedure for control
of non-conformity
9. Procedure for
corrective action
10. Procedure for
preventive action?
b) Control of Documents: Are documents required by the
QMS under document control? Are the following
controls documented:
11. Approve documents
for adequacy before issue
12. Review, update and
re-approve documents

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13. Changes & current
revision status are identified
14. Relevant versions are
available at point of use
15. Documents are
legible and readily identifiable
16. Documents of
external origin are identified and distribution
controlled
17. Obsolete documents
are suitably identified, if they are to be retained
c) Control of Records: Are records maintained to provide
evidence of conformance to QMS?
18. Are they legible,
readily identifiable & retrievable
19. Are there documented
procedures for the identification, storage,
protection, retrieval, retention time and disposal
of records?
d) Are the following records maintained:
20. mgmt review records
21. records of education,
training, qualification/skill and experience
22. records to provide
evidence of conformity to established processes
& product requirements
23. product
requirements/contract & review records
24. design and
development review records
25. verification &
validation records
26. records for design &
development changes
27. purchase evaluation
records
28. validation records for
special processes
29. record for unique
identification of product/service
30. records of customer-
supplied items
31. records for equipment
calibrations & verification
32. records of person
authorising release of product
33. records of non-
conformities & actions taken
34. records of preventive
actions taken?
Remarks (if any):

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5 Management Responsibility
5.1 Management Commitment
a) Are there evidence of top mgmt commitment to the
development, implementation & improvement of the
QMS through:
35. Communicating to
the organisation the importance of meeting
customer, statutory & regulatory requirements
36. Establishing the
quality policy
37. Ensuring the quality
objectives are met
38. Conducting mgmt
review of the QMS
39. Ensuring the
availability of resources for QMS implementation
& improvement?
Remarks (if any):

5.2 Customer Focus

a) Does top mgmt ensure customer requirements are:
40. Determined
41. Fulfilled with the aim
of enhancing customer satisfaction?
Remarks (if any):

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5.3 Quality Policy
a) Does top mgmt ensure that the quality policy:
42. Is appropriate to the
purpose of the organisation
43. Include a
commitment to meeting customer and regulatory
requirements
44. Include a
commitment to continual improvement
45. Provide a framework
for establishing and reviewing quality objectives
46. Is communicated and
understood at appropriate levels in the
organisation
47. Is reviewed for
continuing suitability?
Remarks (if any): What is the mission statement for your
dept/function?

5.4 Quality Objectives/QMS Planning

a) Quality Objectives: Does top mgmt ensure that quality
objectives are established at relevant functions and
levels with the organisation?
b) Are the quality objectives measureable and consistent
with the quality policy?
c) Are quality objectives established to ensure that
product requirements met?
d) QMS Planning: Does the top mgmt ensure that
48. QMS planning is
carried out in order to meet requirements given in
section 4.1, as well as the quality objectives
49. The integrity of the
QMS is maintained when changes to the QMS are
planned & implemented?
e) Is the output of this planning documented?
Remarks (if any): What are the quality objectives for your
dept/functions?

5.5 Responsibility, Authority and Communication

a) Responsibilities & Authority: Are the responsibilities &
authority for various functions defined &
communicated to facilitate effective quality mgmt?
b) Mgmt Representative: Is a mgmt representative
appointed by top mgmt to
50. Ensure the processes

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of the QMS are established, implemented and
maintained
51. Report to top mgmt
of the performance of the QMS, including needs
for improvement
52. Promote awareness of
customer requirements throughout the
organisation
53. Liaise with external
parties on matters relating to the QMS?
c) Internal Communication: Are the processes of the QMS
and their effectiveness communicated between various
levels and functions within the organisation?
Remarks (if any):

5.6 Mgmt Review of QMS

a) Is there a review of the QMS by top mgmt at planned
intervals to ensure its continuing suitability, adequacy
and effectiveness?
b) Does the review include:
54. Assessing
opportunities / recommendations for
improvements
*0 Improvement of the QMS & its processes
*1 Improvement of product related to customer
requirements
55. Assessing need to
change the QMS, including quality policy &
objectives
56. Review of audit
results & customer feedback
57. Process performance
& product conformance
58. Status of corrective &
preventive actions
59. Follow-up actions
from earlier review meetings
60. Changes that could
affect the QMS
61. Resource needs for
QMS implementation & improvement?
c) Are the results of the mgmt review recorded?
Remarks (if any) :

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6 Resource Management
6.1 Provision of Resources
a) Are resources determined and provided for:
62. Implementing,
maintaining and improving the processes of the
quality mgmt system
63. Enhancing customer
satisfaction by meeting customer requirements?
Remarks (if any):

6.2 Human Resources

a) Are personnel assigned responsibilities defined in the
QMS competent on the basis of applicable education,
training, skills/qualifications and experience?
b) Competence, Awareness & Training: Are competency
needs for personnel performing activities affecting
quality identified?
c) Are training provided to satisfy the competency
needs?
d) Is effectiveness of training provided evaluated?
e) Are employees aware of the relevance and importance
of their activities and how they contribute to the
achievement of the quality objectives?
f) Are appropriate records of education, experience,
skills/qualifications and training maintained?
Remarks (if any):

6.3 Infrastructure / Facilities

a) Are infrastructure / facilities needed to achieve
conformity of products identified, provided
and maintained?
b) Do they include:
64. Building, workspace
and associated utilities
65. Process equipment,
hardware and software
66. Supporting services
(e.g. transport or communication)?
Remarks (if any):

6.4 Work Environment

a) Are the human and physical factors of the
work environment needed to achieve
conformity of product identified and managed?
Remarks (if any):

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7 Product Realisation
7.1 Planning of the Product Realisation Processes
a) Are the processes needed for product
realization planned, developed & documented
in a quality plan?
b) Are the following determined in the quality
plan, as appropriate:
67. Quality objectives for
product, project or contract
68. Need to establish
processes / documents
69. Need to provide
resources / facilities
70. Required verification,
validation, monitoring, inspection, test activities
& criteria for acceptance
71. Records to provide
evidence of conformity to established processes
& product requirements?
Remarks (if any):

7.2 Customer Related Processes

a) Determination of Product Requirements:
72. Requirements
specified by the customer, including delivery &
post-delivery activities
73. Requirements not
specified by the customer but necessary for
intended or specified use
74. Statutory, regulatory
requirements and any other requirements
determined by the organisation.
b) Product Requirement/Contract Review:
75. Product requirements
are adequately defined & documented
76. Contract or order
requirements that differ from those previously
expressed are resolved
77. The organisation has
the ability to meet the defined requirements.
c) Are the results of the product/contract review
and subsequent follow-up actions recorded?
d) Note: For internet sales, formal review is not
practical for each order. Instead the review can
cover the relevant product catalogue or
advertising material.
e) Are customer requirements confirmed, if the

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customer provide no documented
requirements?
f) Where product/contract requirements are
changed, does the organisation ensure
78. That relevant
documentation is amended
79. Relevant personnel
are made aware of the changed requirements?
g) Customer Communication: Does the organisation
identify & implement arrangement for communication
with the customers relating to:
80. Product information
81. Enquiries, contract or
order handling, including amendments
82. Customer feedback,
including customer complaints.
Remarks (if any):

7.3 Product Design and Development

a) Design and Development Planning: Are the
following determined:
83. Design and
development stages
84. Review, verification
and validation activities
85. Responsibilities &
authority for design and/or development
activities?
b) Are the interfaces between different groups
managed to ensure effective communication &
clarity of responsibilities?
c) Are planning output kept up-to-date?
d) Design and Development Inputs: Are these
defined, documented and do they include:
86. Functional &
performance requirements
87. Applicable statutory
& regulatory requirements
88. Applicable info.
derived from similar design
89. Any other essential
requirements?
e) Design and Development Outputs: Are these
documented, approved before issue and do
they
90. Meet the
design/development input requirements
91. Provide appropriate

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information for production & service operations
92. Contain or reference
product acceptance criteria
93. Define the
characteristics of the product that are essential to
its safe and proper use?
f) Design and Development Review: At suitable
stages, are systematic reviews of design / dev.
conducted to:
94. Evaluate ability to
fulfil requirements
95. Identify problems &
propose follow-up actions?
g) Design and Development Verification: Is this
performed to ensure that the
design/development outputs meets its inputs?
96. Are the results of the
verification and resulting follow-up actions
recorded?
h) Design and Development Validation: Is this
performed to confirm that the resulting product
is capable of meeting the requirements for
intended use?
97. Wherever applicable,
is validation completed before delivery or
implementation of the product?
98. Are results of
validation & subsequent follow-up actions
recorded?
i) Design and Development Changes: Are these
identified, documented, reviewed, verified and
validated, as appropriate before
implementation?
99. Are there evaluation
of the effect of changes on constituent parts and
products already delivered?
Remarks (if any):

7.4 Purchasing
a) Purchasing Process/Control: Are type &
extend of control to be applied to the supplier
and purchased product dependent on the
effects on subsequent product realisation
process or the final product?
100. Are criteria for
selection & periodic evaluation defined?
101. Are results of

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supplier evaluations & follow-up actions shall be
recorded?
b) Purchasing Information: Do purchasing
documents contain information describing the
product to be purchased, including where
appropriate:
102. Requirements for
product approval, procedures, processes and
equipment
103. Requirements for
qualification of staff
104. QMS requirements?
c) Verification of Purchased Products: Are
activities necessary for verification of
purchased products established and
implemented?
d) Where verification needs to be performed at
the supplier’s premises, are intended
verification arrange-ment & method of product
release documented?
Remarks (if any):

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7.5 Production & Service Operations
a) Operations & Service Control: Are production
& service operations controlled through, as
applicable:
105. Availability of info
on characteristics of product
106. Availability of work
instructions
107. Use & maintenance
of suitable equipment
108. Availability & use of
measuring & monitoring devices
109. Implementation of
monitoring activities
110. Implementation of
defined processes for release, delivery and post-
delivery activities?
b) Production & Service Operation Validation /
Special Processes: Where resulting output
cannot be verified by subsequent monitoring or
measurement, are the production and service
processes validated through (e.g. for packing
of parachutes), as applicable:
111. Defined criteria for
review and approval
112. Approval of
equipment and qualification of personnel
113. Use of specific
methods and procedures
114. Requirements for
records and re-validations?
c) Identification & Traceability: Are various
products suitably identified throughout
production and service operations?
115. Are the product status
identified w.r.t. measurement & monitoring
requirements?
116. Where traceability is
a requirement, are unique identification of
product controlled and recorded.
d) Customer Property: Are customer property provided
for use or incorporation into the product identified,
verified, protected & safeguarded?
117. If the customer
property that is lost, damaged or otherwise
unsuitable for use, is this reported to the
customer and recorded? (customer property may
include intellectual property, e.g. information
provided in confidence).
e) Preservation of Product: Are the conformity of
product during internal processing and
delivery to intended destination preserved?
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7.6 Control of Measuring and Monitoring Devices
a) Are the following determined?
119. Monitoring and
measurement to be undertaken
120. Monitoring and
measurement devices needed to provide evidence
of conformity of product to determined
requirements
b) Are processes to ensure that monitoring &
measure-ments can be carried out determined?
c) Is the measuring equipment:
121. Calibrated or verified
at specified intervals
122. Adjusted or re-
adjusted as necessary
123. Identified to enable
the calibration status to be determined
124. Safeguarded from
adjustments that would invalidate the
measurement result
125. Protected from
damage & deterioration during handling,
maintenance & storage?
d) When a measuring equipment is found not to
conform to requirements:
126. Is the validity of the
previous measuring results assessed and
recorded?
127. Are appropriate
actions taken on the equipment and any affected
products?
e) Are records of equipment calibration &
verification maintained?
f) When used for monitoring or measurement, is
the ability of the computer software to satisfy
the intended application confirmed before
initial use?
Remarks (if any):

8 Measurement, Analysis & Improvement

8.1 Measurement & Monitoring Planning
a) Are measurement & monitoring activities
planned and implemented to
128. Demonstrate
conformity of the product
129. Ensure the
conformity to QMS
130. Continually improve

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the effectiveness of the QMS
b) Are applicable methods, including statistical
techniques and the extent of their use
determined?
Remarks (if any):

8.2 Measurement and Monitoring

a) Customer Satisfaction: Are the methods for
obtaining and using this information
determined?
b) Internal Audit: Are internal audits conducted at
planned intervals to determine whether the
QMS
131. Conforms to the ISO
9001 requirements
132. Is effectively
implemented & maintained?
c) Is audit program planned, taking into
consideration the status/importance of the
activities/areas to be audited and the results of
previous audits?
d) Is the audit scope, frequency & methodology
defined?
133. Are audits conducted
by personnel other than those who perform the
activity being audited?
e) Are the following documented in a procedure:
134. Responsibility /
requirement for planning & conducting audit
135. Reporting results and
maintaining records?
f) Does mgmt ensure that timely actions are
taken to eliminate detected non-conformities
and their causes?
136. Are follow-up actions
verified & verification results reported?
g) Measurement & Monitoring of Processes: Are
suitable methods for monitoring and, where
applicable measurement of QMS processes
applied?
137. Do these methods
demonstrate the ability of the processes to
planned results?
138. When planned results
are not achieved, are appropriate corrective action
taken, to ensure conformity of the product?
h) Measurement & Monitoring of Product: Are
the characteristics of the products monitored &

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measured to verify that requirements of
product have been met?
139. Are these carried out
at appropriate stages of the product realisation
process in accordance with planned
arrangements?
140. Are the evidences of
conformity with acceptance criteria maintained?
141. Are records
indicating the person authorising the release of
the product maintained?
142. Are product release
and service delivery held back until the planned
arrangements have been satisfactorily completed,
unless otherwise approved by the customer or
relevant authority?
Remarks (if any):

8.3 Control of Non-Conformity

a) Are products which do not meet requirements
identified & controlled to prevent unintended
use or delivery?
b) Are the controls, responsibility and authority
for dealing with non-conforming products
defined in a documented procedure?
143. Are actions taken to
eliminate the detected non-conformity or
concessions provided by relevant authority or the
customer for use, release or acceptance?
c) Are records on the nature of the non-
conformity and follow-up actions including
concessions, maintained?
d) Where the non-conforming product is
corrected, is it subjected to re-verification?
e) Where the non-conforming product is detected
after delivery or use, are actions appropriate to
the effects or potential effects, taken?
Remarks (if any):

8.4 Analysis of Data

a) Are appropriate data to determine suitability &
effectiveness of the QMS (and to identify
improvements) determined, collected and
analysed?
b) Are data relating to the following analysed:

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144. Customer
satisfaction/dis-satisfaction
145. Conformance to
customer requirements
146. Characteristics &
trends of process & products
147. Suppliers?
Remarks (if any): What existing measures are collected and
analysed?

8.5 QMS Improvement, Corrective & Preventive Actions

a) Continual Improvement: Are the effectiveness
of the QMS continually improved through the
use of:
148. quality policy &
objectives
149. audit results, analysis
of data
150. corrective &
preventive actions
151. mgmt review?
b) Corrective Action: Are corrective action taken to
eliminate the cause of the non-conformities to prevent
recurrence?
152. Corrective action
shall be appropriate to the impact of the problems
encountered.
c) Do the documented procedures define
requirements for:
153. Identifying &
reviewing non-conformities (including customer
complaints)
154. Determining the
cause(s) of the non-conformity
155. Evaluate need for
actions
156. Determining,
implementing, recording & verifying the
corrective action(s)?
d) Preventive Action: Are appropriate actions
taken to eliminate cause(s) of potential non-
conformities in order to prevent their
occurrence?
157. Preventive action
shall be appropriate to the impact of the potential
problems.
e) Do the documented procedures define
requirements for:

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158. identifying potential
non-conformities & their causes
159. evaluating the need
for action
160. determining,
implementing, recording and verifying the
preventive action(s)?
Remarks (if any):

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