ISO 9001:2008 -Checklist

ISO 9001:2008 Clauses Yes/ Remarks

No
4 Quality Management System (QMS)
Requirements

4.1 General Quality Management System (QMS)

Requirements

a) Is a quality management system established, documented,

implemented and maintained according to the ISO 9001:2008
standard?
b) Are processes needed for the quality management 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
management system?
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
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. management 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 authorizing release of product
33. records of nonconformities & actions taken
34. Records of preventive actions taken?

5 Management Responsibility

5.1 Management Commitment

a) Are there evidence of top management commitment to the

development, implementation & improvement of the QMS
through:
35. Communicating to the organization the importance of
meeting customer, statutory & regulatory requirements
36. Establishing the quality policy
37. Ensuring the quality objectives are met
 38. Conducting management review of the QMS
39. Ensuring the availability of resources for QMS implementation
& improvement?
5.2 Customer Focus

a) Does top management ensure customer requirements are:

40. Determined
41. Fulfilled with the aim of enhancing customer satisfaction?

5.3 Quality Policy

a) Does top management ensure that the quality policy:

42. Is appropriate to the purpose of the organization
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
organization
47. Is reviewed for continuing suitability?
5.4 Quality Objectives/QMS Planning

a) Quality Objectives: Does top management ensure that quality

objectives are established at relevant functions and levels with
the organization?
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 management 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?
5.5 Responsibility, Authority and Communication

a) Responsibilities & Authority: Are the responsibilities & authority for

various functions defined & communicated to facilitate effective
quality management?
b) Management Representative : Is a management representative
appointed by top management to
50. Ensure the processes of the QMS are established,
implemented and maintained
51. Report to top management of the performance of the QMS,
including needs for improvement
52. Promote awareness of customer requirements throughout the
organization
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 organization?
5.6 Management Review of QMS

a) Is there a review of the QMS by top management 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 management review recorded?
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 management system
63. Enhancing customer satisfaction by meeting customer
requirements?
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 product conformity
 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?
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 communication or
information systems)?
6.4 Work Environment

a) Are the human and physical factors of the work environment

needed to achieve conformity of product identified and managed?
7 Product Realization

7.1 Planning of the Product Realization 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?
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 organization.
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 organization 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 customer provide no
documented requirements?
f) Where product/contract requirements are changed, does the
organization ensure
 78. That relevant documentation is amended
79. Relevant personnel are made aware of the changed
requirements?
g) Customer Communication : Does the organization 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.
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 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 / development conducted to:
94. Evaluate ability to fulfill requirements
95. Identify problems & propose follow-up actions?
g) Design and Development Verification: Is this performed to ensure
that the design/development outputs meet 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?
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 realization process or the final
 product?
100. Are criteria for selection & periodic evaluation defined?
101. Are results of 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 suppliers
premises, are intended verification arrangement & method of
product release documented?
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, personnel data e.g. information provided in
confidence).
e) Preservation of Product : Are the conformity of product maintained
during internal processing and delivery to the intended
destination
118. Identification, handling, packaging, storage and protection of
the product to be taken care of
7.6 Control of Measuring and Monitoring Equipment

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 & measurements can be
carried out determined?
c) Is the measuring equipment:
121. Calibrated or verified at specified intervals
122. Adjusted or readjusted 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?

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 the effectiveness of the QMS
b) Are applicable methods, including statistical techniques and the
extent of their use determined?
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 management 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 & measured to verify that requirements of
product have been met?
139. Are these carried out at appropriate stages of the product
realization process in accordance with planned
arrangements?
140. Are the evidences of conformity with acceptance criteria
maintained?
141. Are records indicating the person authorizing 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?
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 nonconformity 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?
8.4 Analysis of Data

a) Are appropriate data to determine suitability & effectiveness of

the QMS (and to identify improvements) determined, collected
and analyzed?
b) Are data relating to the following analyzed:
144. Customer satisfaction/dissatisfaction
145. Conformance to customer requirements
146. Characteristics & trends of process & products
147. Suppliers?

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. Management 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
effectiveness corrective action(s)?
d) Preventive Action: Are appropriate actions taken to eliminate
cause(s) of potential nonconformities 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:
158. identifying potential non-conformities & their causes
159. evaluating the need for action
160. Determining, implementing, recording and verifying the
effectiveness of preventive action(s)?