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For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2015, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.

Where the organization has no specific documented information for a particular activity, and this is not required by the standard, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2015. In these situations, both internal and external audits may use the text of ISO 9001:2015 for conformity assessment purposes.

*Documented information

Issues

Input to business planning; helping to define risks and opportunities.

Issue definition-An important topic or problem for debate or discussion.

Context 4.1

*Scope

The scope of certification is derived from the scope of the QMS and is dependent on what the organization decides to have certified.

Clause 4.3

*Policy

The intent s to ensure that the quality policy is communicated, understood and applied by persons in your organization so they are able to contribute to the effectiveness of the quality management system, and that it is available to relevant interested parties.

Clause 5.2

Interested parties

Relevant interested parties” are groups or individuals who have the ability to impact (or potentially impact) the organization’s ability to consistently supply products and services that meet customer and applicable statutory and regulatory requirements.

Clause 4.2

*Process model

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Clause 4.4

*Objectives

Objectives should be established at relevant functions, levels and processes, as appropriate, to ensure the effective deployment of the organisations strategic direction and its Policy.

Clause 6.2

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Robb Walters