ISO 9001 Lead Auditor Training

True/False Questions - Exercise 8

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.

1 Improvement in QMS systems and processes so that continual improvement of quality can be achieved is not a major purpose of quality management

2 Customer requirements are often incorporated in “specifications”

3 Use of specifications guarantee that a customer’s requirements will be met consistently.

4 QMS standards can substitute for relevant product requirements provided in technical specifications.

5 The QMS of an organization is influenced by its specific objectives, products, processes and practices.

6 It is expected that organizations with similar products or services to have similar QMS's.

7 ISO standards and guidelines are intended to be specific to economic or industry sectors, whenever possible.

8 The ISO 9000 family of standards provides guidance for quality management and general requirements for quality control.

9 An organization should strive to improve the quality of its products as well as its operations

10 Ensuring that product quality meets customer needs also ensures that internal management, employees and other stakeholders needs are met.

11 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.

12 The ISO family of quality system standards address quality system requirements as well as provide technical standards for product quality.

13 The ISO 9000 family of quality standards provide quality system objectives to be met and guidance on achieving them.

14 It is generally not typical for an organization to provide two or more generic product categories in its product offering

15 Besides meeting requirements, a product must also provide value to customers and other stakeholders.

16 Product value involves both quality and price and as such price is a facet of quality.

17 A process must have inputs and outputs which may only exist in tangible form

18 Every process involves people and/or resources in some way

19 Inputs, outputs and activities within the process are all capable of being measured and improved

20 A process serves no purpose if it does not add value to the output or organization

21 Not all work is accomplished by a process

22 Quality management is accomplished by managing the structure and operation of processes as well as the quality of product and information flowing through them.

23 Every organization exists to accomplish value-adding work through a network of processes. The structure of the network is usually a simple sequential structure.

24 A fundamental basis of the ISO 9000 family of standards is for organizations to create, improve and provide consistent quality of product through its network of processes.

25 Every process should have an owner to clarify interfaces, responsibilities and authorities

26 To be effective, a QMS needs coordination and compatibility of its component processes and definition of their interfaces.

27 Management reviews of QMS cannot take into account additional factors beyond the requirements of ISO 9001

28 First party internal audits may only be conducted by members of the organization

29 QMS audits should keep in mind the balance between the extent of documentation and the extent of training

30 Documented standard operating procedures are essential for maintaining the gains from quality improvement activities

31 The ISO 9004 standard is intended for use in interpreting the requirements of the quality assurance standards ISO 9001.

32 ISO 9004 provides generic guidelines for the application and implementation of the clauses in the ISO 9001 quality assurance standard.

33 When implementing an ISO 9001 based QMS, all of the requirements listed  must be selected and applied.

34 Organizations implementing a QMS based on ISO 9001 are required to be certified by a Registrar.

35 ISO 9004 can be used as a reference by an organization wishing to improve its effectiveness, but only after it has implemented a formal QMS.

36 ISO 19011 provides guidance on the education, training and experience requirements for certification of QMS and EMS auditing.

37 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.

38 Pre-contract and post-contract assessments of an organization's QMS may be conducted by the customer, the customer’s agent or an agreed third party.

39 Organizations and their customers may not specify supplementary QMS requirements beyond those specified by ISO 9001.

40 Quality control is defined as the part of quality management focused on ulfilling quality requirements.

41 A service can have tangible as well as intangible components to it.

42  A product is generated by activities at the interface between an organization and the customer and by the organization's internal activities to meet the customers needs.

43 A service cannot be linked with the manufacture and supply of tangible product.

44 Product characteristics and/or quality characteristics are absolute and cannot be changed.

45 Product quality relates to its ability to satisfy stated as well as implied needs.

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