ISO 9001 Lead Auditor Training

True/False Questions - Exercise 10

The following statements relate to various ISO guidelines and standards. Indicate whether these are true or false. As some of these statements are deliberately vague, you might consider your supporting logic to defend your true/false determination.

You must read "Understanding ISO 9001" along with this ISO 9001 Lead Auditor training course to do this exercise. These statements relate to an ISO 9001 certified organization or one planning to implement an ISO 9001 QMS.

91 All design and development activities must be included in the project plan and cannot be changed.

92 Product validation cannot be completed until the customer approves the product.

93 The design review activity must be conducted by personnel assigned to the design project.

94 Service design verification, validation and review must address all three specifications – service design, service delivery and quality control of the design process.

95 Documents retained for legal and knowledge purposes must be controlled to the same extent as active documents.

96 ISO 9001 requires that all QMS documentation be made available to personnel at their specific work stations.

97 It is a nonconformity if an organization does not use a document master list to identify the current status of it’s documents.

98 It is not a nonconformance if an organization does not use an approved supplier list to ensure purchases affecting product quality, are made from approved suppliers.

99 ISO 9001 requires that the impact of document changes should be considered, on product, process or quality system.

100 If a subcontractor to your organization is ISO 9001 certified, it is not necessary for your organization to monitor the subcontractor's ongoing quality performance.

101 To ensure consistency of conformity of purchased product, clause 7.4 of ISO 9001 requires that all suppliers be evaluated in the same manner.

102 Clause 4.2.3 of ISO 9001 requires that a record be kept of the reasons why a change to a document was made.

103 If a organization accepts delivery of material based on conducting verification at source, it may not be necessary for it to conduct any receiving inspection.

104 According to clause 7.4 of ISO 9001, purchasing documents must clearly describe QMS requirements for all suppliers on it's approved supplier list.

105 A list of approved suppliers constitutes sufficient objective evidence of acceptable suppliers.

106 Where customers provide product certifications with customer supplied product, it is not necessary for the orgainzation to conduct any further verification of such product.

107 It may not be necessary to use physical identification methods if computer records are used to control the identity of product

108 Product identification relates to details of manufacture to facilitate tracking of a nonconformity back to its source and containing the batch or lot

109 According to ISO 9001 it is not necessary to conduct in-process product verification if there is adequate control of manufacturing processes.

110 According to ISO 9001, relationships should be developed between in-process controls, their specifications and final product specifications.

111 According to ISO 9001, it is expected that all products be subject to the same inspections and tests.

112 According to ISO 9001 it is required that acceptance criteria be described on the product inspection record.

113 There is no nonconformity if an organization is unable to provide any organization charts to show it’s organization structure.

114 It is a nonconformity if calibration status indicators are not affixed directly on measurement devices used to verify product quality.

115 It is a nonconformity, if a customer is not notified when product is shipped to them, that was inspected and passed using defective measurement devices.

116 There is no nonconformity if an ISO 9001 certified organization allows it’s operators to use personally owned measurement devices.

117 It is a nonconformity if an ISO 9001 certified organization does not have a designated quarantine area for nonconforming product

118 It is a nonconformance if an ISO 9001 certified organization does not perform any audits on any of it’s suppliers.

119 There is no nonconformity if material is released for urgent production without any receiving inspection being done.

120 Statistical techniques should be used to identify adverse trends for products and processes before nonconformities actually occur.

121 Correction of product nonconformities should not compromise the quality of adjacent, attached or incorporated product.

122 Verification should be made as close as possible to the point of realization of the product characteristic.

123 Manufacturing jigs, fixtures, test software, comparative references and process instrumentation that can affect product or process characteristics do not need to be controlled.

124 Besides controlling measurement devices, the measuring process itself must be controlled.

125 For fully automated processes, physical location of product is an acceptable method of assuring the inspection and test status of product.

126 The inspection and test status of product is only required to be maintained as a control, until the time the product is shipped to the customer. 

127 ISO 9001 requires that nonconforming product be segregated, identified and put in an designated quarantine area.

128 The ISO 9001 requirement for preventive action may be addressed by taking steps to prevent a root cause of a nonconformity from happening again.

129 The control requirements for storage in clause 7.5.5 of ISO 9001 includes both conforming and nonconforming product.

130 As per ISO 9001, the organization is not responsible for the protection of product quality after shipment, if the terms of delivery are FOB the organization’s facility.

131 The retention times for QMS records required by clause 4.2.4 of ISO 9001 are minimal time periods and therefore QMS records never need to be disposed off.

132 As per clause 8.2.2 of ISO 9001, it is required that the frequency of audits of specific areas and processes be increased based on their status and importance.

133 As per ISO 9001, training of temporary and subcontract personnel is not required.

134 The use of statistical techniques has limited application and benefit to the service sector.

135 The use of statistical techniques is not applicable for the evaluation of qualitative data.

136 Since SPC is a tool to verify the output of processing, it is viewed as a detective control rather than preventive.

137 ISO 9001 requires that the standard of acceptability of product characteristics that have a subjective element, must be clarified.

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.