Exercise 1 - / s The following statements relates to various ISO 9001 concepts, principles and requirements. Indicate whether these are true or false in the adjacent column. Please note that some statements are deliberately vague. Be prepared to support your answer through discussion. 1 Improvement in systems and processes so that continual improvement of quality can be achieved is not a major purpose of ISO 9001 quality management systems 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Customer requirements are often incorporated in specifications Use of specifications guarantee that a customer s requirements will be met consistently. Quality system standards can substitute for relevant product requirements provided in technical specifications. The management system of an organization is influenced by its specific objectives, products, processes and practices. It is expected that organizations with similar products or services to have similar quality management systems. ISO standards and guidelines are intended to be specific to economic or industry sectors, whenever possible. The ISO 9001 standard provides guidance for quality management and general requirements for quality control An organization should strive to improve the quality of its products as well as its operations Ensuring product quality meets customer needs also ensures that internal management, employees and other stakeholders needs are met An organization s stakeholders have the same needs and expectations Because of varying stakeholder needs such as quality, health & safety, environment protection and security, it is not required that management systems (to address these needs), be compatible. The ISO 9001 QMS standard addresses quality system requirements as well as provide technical standards for product quality. The ISO 9001 QMS standard provides quality system objectives to be met and guidance on controls to achieve them. It is generally not typical for an organization to provide two or more generic product categories in its product offering Besides meeting requirements, a product must also provide value to customers and other stakeholders. /
17 18 19 20 21 22 23 Understanding ISO 9001:2008 Exercise 1 - / s A process must have inputs and outputs which may only exist in tangible form Product value involves both quality and price and as such price is a facet of quality. Every process involves people and/or resources in some way Inputs, outputs and activities within the process are all capable of being measured and improved A process serves no purpose if it does not add value to the output or organization Not all work is accomplished by a process Quality system management is accomplished by managing the structure and operation of processes as well as the quality of product and information flowing through them. / 24 Every organization exists to accomplish value-adding work through a network of processes. The structure of the network is usually a simple sequential structure. 25 A fundamental basis of the ISO 9001 QMS standard is for organizations to create, improve and provide consistent quality of product through controlling its network of processes. 26 Every process should have an owner to clarify interfaces, responsibilities and authorities 27 To be effective, a quality system needs coordination and compatibility of its component processes and definition of their interfaces. 28 Management reviews of quality management systems cannot take into account additional factors beyond the requirements of ISO 9001 29 Documented standard operating procedures are essential for maintaining the gains from quality improvement activities 30 The best time to implement a QMS is in response to demands by customers and other interested parties 31 When implementing an ISO 9001 based QMS, all of the requirements listed in the standard must be selected and applied. 32 Organizations implementing a QMS based on ISO 9001 are required to be certified by a Registrar. 33 Organizations using ISO 9001 based QMS must demonstrate adequacy and effectiveness of the QMS as well as capability to achieve product conformity to specified requirements
Exercise 1 - / s 34 As per ISO 9001 customers cannot allow an organization to delete certain quality system clauses and sub-clauses from its QMS. 35 Customers may not specify supplementary QMS requirements beyond those specified by ISO 9001 / 36 A service can have tangible as well as intangible components to it. 37 A service cannot be linked with the manufacture and supply of tangible product 38 Quality control is defined as the planned and systematic activities implemented within the quality management system and demonstrated as needed to provide confidence that the organization will fulfill requirements for quality 39 A product is generated by activities at the interface between an organization and the customer and by the organizations internal activities to meet the customer s needs 40 Materials used in a process could include liquids and gases transported through pipelines and containers 41 A service can be delivered automatically with no human involvement or intervention 42 Product characteristics and/or quality characteristics are absolute and cannot be changed 43 Product quality relates to its ability to satisfy stated as well as implied needs 44 As required by ISO 9001 qualification of certain processes may refer to demonstrating that specific personnel are competent to perform those processes 45 According to ISO 9001 the terms nonconformity and defect can be used interchangeably 46 Verification refers to checking conformance of product design and validation refers to checking conformance of the product design process both to specified requirements 47 An organizations quality policy may be stated in qualitative and/or quantitative terms 48 Quality management is the responsibility of top management within the organization 49 According to ISO 9001, the terms quality planning and quality plans can be used interchangeably
Exercise 1 - / s 50 A quality plan may be combined with a production plan to facilitate control of processes 51 Where services are offered in combination with product, it is necessary to have separate quality plans 52 Quality control ensures adequate control of processes, whereas quality assurance ensures that no nonconforming product gets shipped to customers 53 It is necessary that an organization use a QMS to implement quality management 54 Corrective and preventive actions are important tools to achieve quality improvement 55 Actions taken to eliminate the causes of an existing nonconformity must include correction as well as corrective action. / 56 Repair and rework cannot be used interchangeably 57 A deviation authorization and a concession may be used interchangeably 58 It is generally understood that if customers needs and expectations are taken care, the interests of other stakeholders will be also be addressed 59 Only the inputs and outputs of processes can be measured 60 All processes are measurable in terms of customer satisfaction 61 In general, the extent of quality system documentation is inversely proportional to the education, training, experience and stability of personnel within an organization 62 An organization that is ISO 9001 certified must require some or all of its suppliers and subcontractors to also be certified to ISO 9001. 63 Each requirement in the ISO 9001QMS standard varies in importance from one type of activity to another and from one product to another 64 Since ISO 9001 requirements are generic, it is expected that application of QMS requirements to different products or businesses will be uniform 65 In demonstrating an effective quality management system, an organization needs to meet both the customer s needs and expectations as well as its own 66 Since cost is not a quality factor, only benefits and risks should be considered by an organization in developing a well structured QMS
Exercise 1 - / s 67 The definition of nonconformity does not include product returned for repair or rework 68 Activities contributing to quality, whether directly or indirectly, should be defined and documented 69 Measures to control and coordinate the interface between different activities and processes should be defined 70 Management should identify quality related factors affecting market position and objectives relative to products, processes and associated services, in order to allocate organization resources on a planned and timely basis, 71 An organization s quality objectives should relate to fitness for use, performance, safety and dependability 72 Resources to achieve quality objectives must be planned but there is no necessity to provide them on a timely basis 73 The scope of management reviews under ISO 9001 should include the impact of new technology and market strategies on the quality management system 74 Management must regularly monitor quality costs and other benchmarks to determine if the QMS is achieving its quality policy and objectives 75 In structuring an ISO 9001 QMS to suit it s needs, an organization can exclude selective phases in the life-cycle of its products and related processes 76 It is necessary that an organization s QMS documentation include narrative procedures, work instructions and other documentation, regardless of other factors 77 In ISO 9001 based QMS, quality planning should be viewed as the same as quality plans 78 An organizations quality policy should include policies and objectives related to products, processes, quality system and cost 79 Quality plans should specify on one document the quality objectives, practices, criteria, resources, operational sequence and quality activities related to a product or service 80 All customer requirements must be documented and agreed to by the customer and the supplying organization 81 The capability of an organization under ISO 9001 clause 7.2 only relates to its ability to produce and deliver quality product /
Exercise 1 - / s 82 In order to ensure consistency of control, it is necessary that all customer orders be subject to the same contract review criteria before acceptance 83 Verbal orders received from customers do not need to be documented by the supplier 84 The ISO 9001 standard does not require marketing activities to be included within the scope of the QMS 85 Product safety, environmental and other regulations should also be considered in designing new product. 86 Design verification requires that the developed product be checked against the design input requirements 87 The design review activity should consider safety, cost, compatibility, quality acceptance criteria, prototype test results, etc 88 It is necessary that design changes be subjected to all design controls described in ISO 9001 clause 7.3 89 All design and development activities must be included in the design project plan and cannot be changed 90 Product validation cannot be completed until the customer approves the product 91 The design review activity must be conducted by personnel assigned to the design project 92 Documents retained for legal and knowledge purposes must be controlled to the same extent as active documents 93 ISO 9001 requires that all quality system documentation be made available to personnel at their specific work stations 94 The ISO 9001 standard requires the use of a master list to identify the current status of its documents 95 The ISO 9001 standard requires the use of an approved vendor list to ensure purchases affecting product quality, are made from approved suppliers and subcontractors 96 ISO 9001 requires that the impact of document changes should be considered, on product, process or quality system 97 If your subcontractor is ISO 9001 certified, it is not necessary for your organization to monitor its ongoing performance /
Exercise 1 - / s 98 To ensure conformity of purchased product, clause 7.4 of ISO 9001 requires that all your organizations suppliers be evaluated in the same manner. 99 The ISO 9001 standard requires that a record be kept of the reasons why a change was made to documents. 101 If an organization accepts delivery of material based on conducting verification at source, it may not be necessary for it to conduct any receiving inspection 102 According to clause 7.4 of ISO 9001, purchasing documents must clearly describe the quality system requirements for all of its qualified suppliers 103 A list of approved suppliers constitutes sufficient objective evidence of acceptable suppliers. 104 Where customers provide product certification with customer supplied product, it is not necessary for your organization to conduct any further verification of such product 105 It may not be necessary to use physical identification methods if computer records are used to control the identity of product. 106 Product identification relates to details of manufacture to facilitate tracking of a nonconformity back to its source and containing the batch or lot 107 According to ISO 9001 it is not necessary to conduct in-process product verification if there is adequate control of manufacturing processes 108 According to ISO 9001, it is expected that all products be subject to the same inspections and tests 109 According to ISO 9001 it is required that acceptance criteria be described on the inspection record 110 There is no nonconformity if a company is unable to provide any organization charts to show it s organization structure 111 It is a nonconformity if calibration status indicators are not affixed directly on measuring instruments used to verify product quality 112 It is a nonconformity if a customer is not notified when product is shipped to them, that was inspected and passed using defective measuring equipment 113 There is a nonconformity if a company allows it s operators to use personally owned measuring devices /
Exercise 1 - / s 114 It is a nonconformity if an organization does not have a designated quarantine area for nonconforming product 115 It is a nonconformance if an organization does not perform any audits on any of its suppliers 116 There is no nonconformity if material is released for urgent production without required receiving inspection being done 117 Statistical techniques should be used to identify adverse trends for products and processes before nonconformities actually occur 118 Correction of product nonconformities should not compromise the quality of adjacent, attached or incorporated product 119 Verification must be made as close as possible to the point of realization of the product characteristic 120 Manufacturing jigs, fixtures, test hardware, comparative references and process instrumentation that can affect product or process characteristics do not need to be controlled 121 Besides controlling measuring devices, the measuring process itself must be controlled 122 For fully automated processes, physical location of product is an acceptable method of assuring the inspection and test status of product 123 The inspection and test status of product is only required as a control until the time the product is shipped to the customer 124 ISO 9001 requires that nonconforming product be segregated, identified and put in an identified quarantined area 125 The ISO 9001 requirement for preventive action may be addressed by taking steps to prevent a root cause from happening again 126 The control requirements for storage in clause 7.5.5 of ISO 9001 includes conforming and nonconforming product 127 As per ISO 9001, an organization is not responsible for the protection of product quality after shipment, if the terms of delivery are FOB your organizations facility 128 The retention times for quality records required by clause 4.2.4 of ISO 9001are minimal time periods and therefore such records never need to be disposed off 129 As per clause 8.2.2 of ISO 9001, it is required that the frequency of audits of specific areas or departments be increased based on their status and importance /
Exercise 1 - / s 130 There is a nonconformity if a company allows it s operators to use personally owned measuring devices 131 As per ISO 9001, training of personnel should include permanent, newly hired and temporary personnel 132 According to ISO 9001, management should create an environment that fosters health and safety, involvement and help realize employee potential 133 Under clause 4.1 and 7.1 of ISO 9001, it may be necessary to apply some or all ISO 9001 requirements to control servicing activities 134 An organization that does not perform servicing activities cannot be certified to ISO 9001 135 The use of statistical techniques has limited application and benefit to the service sector 136 The use of statistical techniques is not applicable for the evaluation of qualitative data 137 Since SPC is a tool to verify the output of processing, it is viewed as a detective control rather than preventive 138 ISO 9001 requires that the standard of acceptability of product characteristics that have a subjective element, must be clarified /