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5 Management Responsibility (ISO 13495:2016) (5.6 Management Review (5.6…
5 Management Responsibility
(ISO 13495:2016)
5.1 Management Commitment
Provide evidence of its commitment by including items (a-e)
5.6 Management Review
5.6.2 Review Input
To include, but not limited to, information arising from items (a-l)
5.6.3 Review Output
To record any decisions and actions related to items (a-d)
5.6.1 General
Assess opportunities for improvement & need for changes to QMS
Review QMS at planned intervals
Maintain records from management review
Document procedures for management review
5.2 Customer Focus
Determine and meet customer & regulatory requirements
5.4 Planning
5.4.1 Quality Objectives
Established at relevant functions and levels within organization
Measurable and consistent with quality policy
5.4.2 QMS Planning
Carried out to meet 4.1 requirements & quality objectives
Ensure integrity of QMS when changes are planned and implemented
5.3 Quality Policy
Include items (a-e)
5.5 Responsibility, Authority & Communication
5.5.2 Management Representative
A member of management who irrespective of other responsibilities, has responsibility and authority that includes items (a-c)
5.5.3 Internal Communication
Establish communication processes that takes place regardless of effectiveness of QMS
5.5.1 Responsibility & Authority
Define, document and communicate responsibilities & authorities
Document interrelation of all personnel who manage, perform and verify work affecting quality
Ensure independence and authority necessary to perform these tasks