There are six (6) implementable clauses within ISO 9001:2015 Quality Management System Standard.

Within this series of posts over the next six weeks we will discuss the requirements to all six clauses and the correct interpretation thereof.

CLAUSE 5

5.0 Leadership

5.1.1 General

This is a new requirement. You should seek and record evidence that Top

management is taking a ‘hands-on’ approach to the management of the

QMS. Be prepared to constructively challenge Top management’s

commitment to the QMS. Auditing this tier of management is likely to be a

new experience for many people, so it is important that you have a good

understanding of management activities in order to effectively engage

with them.

5.1.2 Customer Focus

This requirement is comparable to the requirements of ISO 9001:2008

Clause 5.2 but now requires that Top management ensure that risks and

opportunities that affect product conformity or which could affect

customer satisfaction are identified and addressed.

You should seek and record evidence that Top management are ensuring

that the impact of any risks and opportunities, that have the potential to

affect your organization’s ability to deliver products which comply with

your customer’s requirements, statutory and regulatory requirements, or

those which might adversely affect customer satisfaction, are identified

and addressed.

You are likely to find that there is a good focus on risk, which may even be

formally documented via risk assessments, but you should also ensure that

opportunities are also considered.

You should also determine whether these groups’ requirements are reviewed and updated as changes in their requirements occur, or when changes to your organization’s QMS are planned.

5.2.1 Establishing the Quality Policy

This requirement is comparable to the requirements of ISO 9001:2008 Clause 5.1 – Quality Policy. You should check that there is evidence that Top management have participated in the creation of the quality policy, and are reviewing and maintaining it.

You should review the quality policy to determine whether the quality policy is appropriate to the context of the organization and its purpose, that there is a commitment to continually improving the QMS, and the quality objectives are consistent with the quality policy. Top management should demonstrate that the quality policy is compatible with the strategic direction and context of the organization, as required by Clause 5.1.1b.

5.2.2 Communicating the Quality Policy

This is a new requirement. ISO 9001:2015 requires the policy to be maintained as documented information, refer to Clause 7.5.1a. You should check whether the quality policy has been applied throughout the organization and that the quality policy is available to any relevant interested parties.

5.3 Organizational Roles, Responsibilities and Authorities

This requirement is comparable to the requirements of ISO 9001:2008 Clause 5.5 – Responsibility, Authority and Communication. You should seek and record evidence that your organization’s personnel have not only been advised of their QMS duties and authorities but that they also understand their duties and authorities in the context of what the QMS is intended to achieve.

Note that there is no longer a requirement for your organization to have a Management Representative; you should determine how Top management has assigned the responsibility and authority for preserving the integrity of the organization’s QMS during revisions or updates. Determine whether Top management has assigned the responsibility and authority for determining opportunities for improvement, refer to Clause 10.1.