Organization, Responsibilities, and Authority Procedure

The Organization, Responsibilities, and Authority Procedure defines management and departmental roles in the quality system. It assigns authority for the quality policy, objectives, resources and review of customer and applicable regulatory requirements.

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Editable Microsoft Word procedure supplied as a digital download. Adapt responsibilities and workflows to your organization before approval and implementation.

Quality-system roles and decision authority

The procedure distinguishes senior management, management representative and departmental responsibilities. Defined reporting relationships and decision authority help personnel escalate quality issues, obtain resources and identify the owner of a process or record.

The revised procedure references ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820.

Related quality-system documents

Use this role definition with the Quality Management System Manual for the high-level system map and the Management Review Procedure for scheduled leadership review. These are separate products.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device QMS Responsibilities and Management Review for workflow guidance, a checklist and common mistakes.