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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 ISO9001:2000 standard and also to gather the necessary information to develop aquality 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 orless of the questions are relevant to you, unless you are the QA Manager.

3. Please also provide a copy (where available) of the organisation missionstatement 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 todescribe:

a) the existing quality policy/objectives which will describe your organisationslong-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 ISO9001:2000 requirements.

5. Please list out the top 5-8 key activities performed by your dept/function thatcovers at least 80% of all the work done within your dept/function:

a)

b)

c)

d)

e)

f)

g)

h)

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ISO 9001 Clauses Yes No Partial N.A.

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 ISO9001 standard?

b) Are processes needed for the quality mgmt systemidentified?

c) Are the following determined for these processes:1. The sequence and

interaction2. The criteria &

methods to ensure effective operation & control?

d) Are information necessary to support operation andmonitoring of these processes available?

e) Are there measurement, monitoring and analysis ofthese processes to achieve planned results andcontinual improvement?

f) Are control of out-sourced processes identified in thequality mgmt system?

Remarks (if any):

4.2 General QMS Documentation Requirementsa) Quality Manual : Is there a quality manual that

documents the3. Quality policy and

objectives4. Scope of the QMS &

details of and justifications for any exclusions5. Procedure for control

of documents6. Procedure for control

of quality records

7. Procedure for conductof internal audits8. Procedure for control

of non-conformity9. Procedure for

corrective action10. Procedure for

preventive action?b) Control of Documents : Are documents required by the

QMS under document control? Are the followingcontrols documented:

11. Approve documents

for adequacy before issue12. Review, update and

re-approve documents

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13. Changes & currentrevision status are identified

14. Relevant versions are

available at point of use15. Documents are

legible and readily identifiable16. Documents of

external origin are identified and distributioncontrolled

17. Obsolete documentsare suitably identified, if they are to be retained

c) Control of Records : Are records maintained to provideevidence 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 disposalof records?

d) Are the following records maintained:20. mgmt review records21. records of education,

training, qualification/skill and experience22. records to provide

evidence of conformity to established processes& product requirements

23. product

requirements/contract & review records24. design and

development review records25. verification &

validation records26. records for design &

development changes27. purchase evaluation

records28. validation records for

special processes29. record for unique

identification of product/service30. records of customer-

supplied items31. records for equipment

calibrations & verification32. records of person

authorising release of product33. records of non-

conformities & actions taken34. 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 thedevelopment, implementation & improvement of theQMS through:

35. Communicating tothe organisation the importance of meetingcustomer, statutory & regulatory requirements

36. Establishing thequality policy

37. Ensuring the qualityobjectives are met

38. Conducting mgmtreview of the QMS

39. Ensuring theavailability of resources for QMS implementation& improvement?

Remarks (if any):

5.2 Customer Focusa) Does top mgmt ensure customer requirements are:

40. Determined41. 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 thepurpose of the organisation43. Include a

commitment to meeting customer and regulatoryrequirements

44. Include acommitment to continual improvement

45. Provide a framework for establishing and reviewing quality objectives

46. Is communicated andunderstood at appropriate levels in theorganisation

47. Is reviewed for continuing suitability?

Remarks (if any): What is the mission statement for yourdept/function?

5.4 Quality Objectives/QMS Planning

a) Quality Objectives : Does top mgmt ensure that qualityobjectives are established at relevant functions andlevels with the organisation?

b) Are the quality objectives measureable and consistentwith the quality policy?

c) Are quality objectives established to ensure thatproduct requirements met?

d) QMS Planning : Does the top mgmt ensure that48. QMS planning is

carried out in order to meet requirements given insection 4.1, as well as the quality objectives

49. The integrity of theQMS 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 yourdept/functions?

5.5 Responsibility, Authority and Communicationa) Responsibilities & Authority : Are the responsibilities &

authority for various functions defined &communicated to facilitate effective quality mgmt?

b) Mgmt Representative : Is a mgmt representativeappointed by top mgmt to50. Ensure the processes

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of the QMS are established, implemented andmaintained

51. Report to top mgmt

of the performance of the QMS, including needsfor improvement

52. Promote awareness of customer requirements throughout theorganisation

53. Liaise with externalparties on matters relating to the QMS?

c) Internal Communication : Are the processes of the QMSand their effectiveness communicated between variouslevels and functions within the organisation?

Remarks (if any):

5.6 Mgmt Review of QMSa) Is there a review of the QMS by top mgmt at planned

intervals to ensure its continuing suitability, adequacyand effectiveness?

b) Does the review include:54. Assessing

opportunities / recommendations forimprovements*0 Improvement of the QMS & its processes*1 Improvement of product related to customer

requirements55. Assessing need to

change the QMS, including quality policy &objectives

56. Review of auditresults & customer feedback

57. Process performance& product conformance

58. Status of corrective &preventive actions

59. Follow-up actionsfrom earlier review meetings60. Changes that could

affect the QMS61. 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 thequality mgmt system

63. Enhancing customer satisfaction by meeting customer requirements?

Remarks (if any):

6.2 Human Resourcesa) 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 affectingquality identified?

c) Are training provided to satisfy the competencyneeds?

d) Is effectiveness of training provided evaluated?e) Are employees aware of the relevance and importance

of their activities and how they contribute to theachievement 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 achieveconformity of products identified, providedand 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 thework environment needed to achieveconformity 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 productrealization planned, developed & documentedin a quality plan?

b) Are the following determined in the qualityplan, as appropriate:

67. Quality objectives for product, project or contract

68. Need to establishprocesses / documents

69. Need to provideresources / facilities

70. Required verification,validation, monitoring, inspection, test activities& criteria for acceptance

71. Records to provideevidence of conformity to established processes& product requirements?

Remarks (if any):

7.2 Customer Related Processes

a) Determination of Product Requirements :72. Requirementsspecified by the customer, including delivery &

post-delivery activities73. Requirements not

specified by the customer but necessary forintended or specified use

74. Statutory, regulatoryrequirements and any other requirementsdetermined by the organisation.

b) Product Requirement/Contract Review :75. Product requirements

are adequately defined & documented76. Contract or order

requirements that differ from those previouslyexpressed are resolved

77. The organisation hasthe ability to meet the defined requirements.

c) Are the results of the product/contract reviewand subsequent follow-up actions recorded?

d) Note: For internet sales, formal review is notpractical for each order. Instead the review cancover the relevant product catalogue or

advertising material.e) Are customer requirements confirmed, if the

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customer provide no documentedrequirements?

f) Where product/contract requirements arechanged, does the organisation ensure78. That relevant

documentation is amended79. Relevant personnel

are made aware of the changed requirements?

g) Customer Communication : Does the organisationidentify & implement arrangement for communicationwith the customers relating to:

80. Product information81. Enquiries, contract or

order handling, including amendments82. Customer feedback,

including customer complaints.

Remarks (if any):

7.3 Product Design and Development

a) Design and Development Planning : Are thefollowing determined:

83. Design anddevelopment stages

84. Review, verificationand validation activities85. Responsibilities &

authority for design and/or developmentactivities?

b) Are the interfaces between different groupsmanaged to ensure effective communication &clarity of responsibilities?

c) Are planning output kept up-to-date?

d) Design and Development Inputs : Are thesedefined, documented and do they include:

86. Functional &performance requirements

87. Applicable statutory& regulatory requirements

88. Applicable info.derived from similar design

89. Any other essentialrequirements?

e) Design and Development Outputs : Are thesedocumented, approved before issue and dothey

90. Meet thedesign/development input requirements

91. Provide appropriate

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information for production & service operations92. Contain or reference

product acceptance criteria

93. Define thecharacteristics of the product that are essential toits safe and proper use?

f) Design and Development Review : At suitablestages, are systematic reviews of design / dev.conducted to:

94. Evaluate ability tofulfil requirements

95. Identify problems &propose follow-up actions?

g) Design and Development Verification : Is this

performed to ensure that thedesign/development outputs meets its inputs?

96. Are the results of theverification and resulting follow-up actionsrecorded?

h) Design and Development Validation : Is thisperformed to confirm that the resulting productis capable of meeting the requirements forintended use?

97. Wherever applicable,is validation completed before delivery or

implementation of the product?98. Are results of validation & subsequent follow-up actionsrecorded?

i) Design and Development Changes : Are theseidentified, documented, reviewed, verified andvalidated, as appropriate beforeimplementation?

99. Are there evaluationof 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 supplierand purchased product dependent on theeffects 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 berecorded?

b) Purchasing Information : Do purchasing

documents contain information describing the product to be purchased, including whereappropriate:

102. Requirements for product approval, procedures, processes andequipment

103. Requirements for qualification of staff

104. QMS requirements?

c) Verification of Purchased Products : Areactivities necessary for verification of

purchased products established andimplemented?

d) Where verification needs to be performed atthe suppliers premises, are intendedverification arrange-ment & method of productrelease documented?

Remarks (if any):

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7.5 Production & Service Operations

a) Operations & Service Control : Are production

& service operations controlled through, asapplicable:105. Availability of info

on characteristics of product106. Availability of work

instructions107. Use & maintenance

of suitable equipment108. Availability & use of

measuring & monitoring devices109. 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 outputcannot be verified by subsequent monitoring ormeasurement, are the production and service

processes validated through (e.g. for packingof parachutes), as applicable:

111. Defined criteria for review and approval

112. Approval of equipment and qualification of personnel113. Use of specific

methods and procedures114. Requirements for

records and re-validations?

c) Identification & Traceability : Are various products suitably identified throughoutproduction and service operations?

115. Are the product statusidentified w.r.t. measurement & monitoringrequirements?

116. Where traceability isa requirement, are unique identification of

product controlled and recorded.

d) Customer Property : Are customer property providedfor use or incorporation into the product identified,verified, protected & safeguarded?

117. If the customer property that is lost, damaged or otherwiseunsuitable for use, is this reported to thecustomer and recorded? (customer property mayinclude intellectual property, e.g. information

provided in confidence).e) Preservation of Product : Are the conformity of product during internal processing anddelivery to intended destination preserved?

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7.6 Control of Measuring and Monitoring Devices

a) Are the following determined?

119. Monitoring andmeasurement to be undertaken120. Monitoring and

measurement devices needed to provide evidenceof conformity of product to determinedrequirements

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 intervals122. Adjusted or re-

adjusted as necessary123. Identified to enable

the calibration status to be determined124. Safeguarded from

adjustments that would invalidate themeasurement result

125. Protected fromdamage & deterioration during handling,maintenance & storage?

d) When a measuring equipment is found not toconform to requirements:

126. Is the validity of the previous measuring results assessed andrecorded?

127. Are appropriateactions taken on the equipment and any affected

products?

e) Are records of equipment calibration &verification maintained?

f) When used for monitoring or measurement, isthe ability of the computer software to satisfythe intended application confirmed before

initial use?Remarks (if any):

8 Measurement, Analysis & Improvement

8.1 Measurement & Monitoring Planning

a) Are measurement & monitoring activitiesplanned and implemented to

128. Demonstrateconformity of the product

129. Ensure theconformity to QMS

130. Continually improve

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the effectiveness of the QMS

b) Are applicable methods, including statisticaltechniques and the extent of their usedetermined?

Remarks (if any):

8.2 Measurement and Monitoring

a) Customer Satisfaction : Are the methods forobtaining and using this informationdetermined?

b) Internal Audit : Are internal audits conducted at planned intervals to determine whether the

QMS131. Conforms to the ISO

9001 requirements132. Is effectively

implemented & maintained?

c) Is audit program planned, taking intoconsideration the status/importance of theactivities/areas to be audited and the results of

previous audits?

d) Is the audit scope, frequency & methodologydefined?

133. Are audits conductedby personnel other than those who perform theactivity being audited?

e) Are the following documented in a procedure:134. Responsibility /

requirement for planning & conducting audit135. Reporting results and

maintaining records?

f) Does mgmt ensure that timely actions aretaken to eliminate detected non-conformitiesand their causes?

136. Are follow-up actionsverified & verification results reported?

g) Measurement & Monitoring of Processes : Aresuitable methods for monitoring and, whereapplicable measurement of QMS processesapplied?

137. Do these methodsdemonstrate 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 ofproduct have been met?

139. Are these carried outat appropriate stages of the product realisation

process in accordance with plannedarrangements?

140. Are the evidences of conformity with acceptance criteria maintained?

141. Are recordsindicating the person authorising the release ofthe product maintained?

142. Are product releaseand service delivery held back until the plannedarrangements have been satisfactorily completed,unless otherwise approved by the customer orrelevant authority?

Remarks (if any):

8.3 Control of Non-Conformity

a) Are products which do not meet requirementsidentified & controlled to prevent unintendeduse or delivery?

b) Are the controls, responsibility and authorityfor dealing with non-conforming productsdefined in a documented procedure?

143. Are actions taken toeliminate the detected non-conformity orconcessions provided by relevant authority or thecustomer for use, release or acceptance?

c) Are records on the nature of the non-conformity and follow-up actions includingconcessions, maintained?

d) Where the non-conforming product iscorrected, is it subjected to re-verification?

e) Where the non-conforming product is detected

after delivery or use, are actions appropriate tothe 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 identifyimprovements) 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 requirements146. Characteristics &

trends of process & products147. Suppliers?

Remarks (if any): What existing measures are collected andanalysed?

8.5 QMS Improvement, Corrective & Preventive Actions

a) Continual Improvement : Are the effectiveness

of the QMS continually improved through theuse of:

148. quality policy &objectives

149. audit results, analysisof data

150. corrective &preventive actions

151. mgmt review?

b) Corrective Action : Are corrective action taken toeliminate the cause of the non-conformities to prevent

recurrence?152. Corrective action

shall be appropriate to the impact of the problemsencountered.

c) Do the documented procedures definerequirements for:

153. Identifying &reviewing non-conformities (including customercomplaints)

154. Determining thecause(s) of the non-conformity

155. Evaluate need for actions

156. Determining,implementing, recording & verifying thecorrective action(s)?

d) Preventive Action : Are appropriate actionstaken to eliminate cause(s) of potential non-conformities in order to prevent theiroccurrence?

157. Preventive actionshall be appropriate to the impact of the potential

problems.

e) Do the documented procedures definerequirements for:

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158. identifying potentialnon-conformities & their causes

159. evaluating the need

for action160. determining,

implementing, recording and verifying thepreventive action(s)?

Remarks (if any):

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