5 Management Responsibility
(ISO 13495:2016)

5.1 Management Commitment

5.6 Management Review

5.2 Customer Focus

5.4 Planning

5.3 Quality Policy

5.5 Responsibility, Authority & Communication

Provide evidence of its commitment by including items (a-e)

Determine and meet customer & regulatory requirements

Include items (a-e)

5.4.1 Quality Objectives

5.4.2 QMS Planning

Established at relevant functions and levels within organization

Measurable and consistent with quality policy

Carried out to meet 4.1 requirements & quality objectives

Ensure integrity of QMS when changes are planned and implemented

5.5.2 Management Representative

5.5.3 Internal Communication

5.5.1 Responsibility & Authority

5.6.2 Review Input

5.6.3 Review Output

5.6.1 General

Define, document and communicate responsibilities & authorities

Document interrelation of all personnel who manage, perform and verify work affecting quality

A member of management who irrespective of other responsibilities, has responsibility and authority that includes items (a-c)

Establish communication processes that takes place regardless of effectiveness of QMS

Assess opportunities for improvement & need for changes to QMS

Review QMS at planned intervals

To include, but not limited to, information arising from items (a-l)

To record any decisions and actions related to items (a-d)

Maintain records from management review

Document procedures for management review

Ensure independence and authority necessary to perform these tasks