Audit Preparation

  • Review corrective actions for previous IA findings

  • Review corrective actions for previous EA findings

  • Review corrective actions for any customer complaints

  • Review corrective actions for any customer audit findings

6.1 Provision of Resources

  • Has the organization determined and provided the resources needed:

  • a) to implement and maintain the quality management system & continually improve its effectiveness? and

  • b) to enhance customer satisfaction by meeting customer requirements?

6.2.1 Human Resources - General

  • How does the organization determine personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience?

  • NOTE: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

6.2.2 Competence, Awareness & Training - How has the organisation:-

  • a) determined the necessary competency for personnel performing work affecting conformity to product requirements?

  • b) where applicable, provided training or taken other actions to achieve the necessary competence?

  • c) evaluated the effectiveness of the action(s) taken?

  • d) ensured that its personnel are aware of the relevance & importance of their activities & how they contribute to the achievement of the quality objectives? And

  • e) maintained appropriate records of education, training, skills & experience (see 4.2.4)

6.3 Infrastructure - How does the organization determine, provided and maintain the infrastructure needed to achieve conformity to product requirements? Infrastructure includes, as applicable:

  • a) Buildings, workspace and associated utilities,

  • b) Process equipment (both hardware and software), and

  • c) Supporting services (such as transportation, communication or information systems).

6.4 Work Environment -

  • Has the organization determined and managed the work environment needed to achieve conformity to product requirements?

  • NOTE: The term “work environment” relates to those conditions under which work is performed including physical, environmental & other factors (such as noise, temperature, humidity, lighting or weather).

  • Assessor

  • Process owner

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