ISO 9001 Lead Auditor Training

True/False Questions - Exercise 9

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.

46 According to the ISO 9000 family of standards, the terms nonconformity and defect can be used interchangeably.

47 Verification refers to checking conformance of product design; and validation refers to checking conformance of the product design process – both to specified requirements.

48 A company’s quality policy may be stated in qualitative or quantitative terms.

49 Quality management is the responsibility of top management within the organization.

50 According to the ISO 9000 family of standards, the terms quality planning and quality plans can be used interchangeably.

51 A quality plan may be combined with a production plan to facilitate control of processes.

52 Where services are offered in combination with product, it is necessary to have separate quality plans.

53 Quality control ensures adequate control of processes, whereas quality assurance ensures that no nonconforming product gets shipped to customers.

54 It is necessary that an organization use a QMS to implement quality management.

55 Corrective and preventive actions are important tools to achieve QMS improvement.

56 An audit observation may relate to either conformity or nonconformity to a specified requirement.

57 Actions taken to eliminate the causes of an existing nonconformity must include a corrective as well as preventive element.

58 Repair and rework can be used interchangeably as defined by the ISO 9000 family of standards.

59 A deviation authorization and a concession cannot be used interchangeably as defined by the ISO 9000 family of standards.

60 It is generally understood that if customers needs and expectations are taken care, the interests of other stakeholders will be also be addressed.

61 Only the inputs and outputs of processes can be measured.

62 All processes are measurable in terms of customer satisfaction.

63 In general, the extent of QMS documentation is inversely proportional to the education, training, experience and stability of personnel within an organization.

64 An ISO 9001 certified organization must require some or all of its suppliers to also be certified to the ISO 9001 standard.

65 An organization may provide audit results from an audit done by a customer to the external Registrar auditor, as evidence of demonstrating an adequate and effective QMS.

66 Each requirement of ISO 9001 will vary in importance for different organizations depending upon their products and processes.

67 Since ISO 9001 requirements are generic, it is expected that application of QMS requirements to different products and organizations will be uniform.

68 In demonstrating an effective QMS, an organization needs to meet both the customer’s needs and expectations as well as it’s own

69 Since cost is not a quality factor, only process benefits and risks should be considered by an organization in developing a well structured QMS.

70 The definition of nonconformity does not include product returned for repair or rework.

71 Activities contributing to quality, whether directly or indirectly, should be defined and documented.

72 Measures to control and coordinate the interface between different activities and processes should be defined.

73 An organization’s QMS quality objectives should relate to product fitness for use, performance, safety and dependability.

74 Resources to achieve QMS quality objectives must be planned but there is no necessity to provide them on a timely basis.

75 The scope of management reviews under ISO 9001 should include the impact of new technology and market strategies on the QMS.

76 Management must regularly monitor quality costs and other benchmarks to determine if the QMS is achieving its quality policy and objectives

77 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

78 It is necessary that an organization’s QMS documentation include narrative procedures and work instructions for its operations.

79 In ISO 9001 based quality systems, quality planning should be viewed as the same as quality plans.

80 An organization's quality policy must include policies and objectives related to products, processes, QMS system and cost.

81 Quality plans should specify on one document the quality objectives, practices, criteria, resources, operational sequence and quality activities related to a product or service.

82 All customer requirements must be documented and agreed to by the customer and supplier.

83 The capability of an organization under ISO 9001 clause 7.2 only relates to it’s ability to produce and deliver quality product

84 In order to ensure consistency of control, it is necessary that all customer orders be subject to the same contract review before acceptance

85 Verbal orders received from customers do not need to be documented by the organization.

86 ISO 9001 does not require marketing activities to be included within the scope of the QMS.

87 Product safety, environmental and other regulations should also be considered in designing new product.

88 Design verification requires that the developed product be checked against the design input requirements.

89 The design review activity should consider safety, cost, compatibility, quality acceptance criteria, prototype test results, etc.

90 It is necessary that design changes be subjected to all design controls described in ISO 9001 clause 7.3.

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