QMS Context and Planning Procedure | ISO 9001:2026 + ISO 13485:2016
Determine your organization's context, interested parties and QMS scope, then plan how risks, opportunities and quality objectives are addressed. This editable QMS context and planning procedure is part of the A.P. Lyon Dual-Standard QMS family for ISO 9001:2026 and ISO 13485:2016.
Building a set? Use Build Your QMS to choose 5–9 procedures for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. Discounts are applied at checkout.
Scope and intended use
This procedure applies to top management, the Management Representative and QMS process owners. It covers internal and external issues, interested-party requirements, the QMS scope statement, QMS risks and opportunities, and quality objectives planning, supporting ISO 9001:2026 clauses 4.1–4.4, 6.1 and 6.2 and ISO 13485:2016 clauses 4.1, 5.4.1 and 5.4.2.
Device safety risk management under ISO 14971 stays in your risk management procedure; this procedure does not replace it.
What you receive
One digital ZIP containing the editable SOP 5-003-C Word procedure, a PDF copy, and three editable Word forms:
FORM 0035-C Context, Interested Parties and Scope Register
FORM 0036-C Risk and Opportunity Register
FORM 0037-C Quality Objectives Plan
The gallery shows representative pages from the procedure.
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.
Related procedures
These procedures address connected work and are sold separately:
Systems containing this procedure
A system package includes this procedure with other documents. Review its content list before purchasing both.
Before implementation
Adapt responsibilities, process steps, acceptance criteria and records to your organization, device and intended markets. Confirm the applicable standards and regulatory requirements before approval and use. This download supplies documentation, not executed testing, regulatory authorization or certification.
