QMS Scope and Context Procedure

This procedure defines how your organisation determines, documents, communicates, reviews and changes the scope of its Quality Management System (QMS) and the context in which the QMS operates.

What's Inside

• Step 1 — Appoint the Context Review Team and Gather Inputs
• Step 2 — Determine Internal and External Issues
• Step 3 — Identify Interested Parties and Their Requirements
• Step 5 — Define Devices, Activities, Life-Cycle Stages and Sites
• Step 6 — Determine QMS Processes and Outsourced Processes
• Step 7 — Determine Exclusions and Non-Applications
• Step 8 — Draft the QMS Scope Statement
• Step 9 — Review, Approve and Communicate

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 4.1 and 4.2.2. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.