Does ISO 9001 still require a quality manual?
No, and it has not since 2015. The 2015 revision removed the term entirely, replacing "quality manual" with requirements to maintain documented information. ISO 13485:2016 Clause 4.2.2 still requires one. Even so, most ISO 9001 organizations still keep a manual, because it is the quickest way to show a registrar how the system fits together. If yours was written to the 2015 edition, it is now out of date in leadership, planning, context and improvement. The ISO 9001:2026 Quality Manual Template includes a clean edition for a first manual and a transition edition for updating an existing one.
What changed in ISO 9001:2026 that affects a quality manual?
The changes land in the sections a manual summarizes: context of the organization, leadership, planning and improvement. A manual written to the 2015 edition describes those clauses as they used to read, so it needs revising before your transition audit rather than after it. The transition edition of the ISO 9001:2026 Quality Manual Template shows every change from 2015, and its worksheet maps your existing manual section by section.
What is the difference between exclusion and non‑application in ISO 13485?
Two different mechanisms with two different tests. Exclusion reaches design and development controls only, and only where applicable regulatory requirements permit it — a regulatory question, not an operational one. Non‑application reaches requirements within Clauses 6, 7 and 8 only, on grounds of the activities you undertake or the nature of your device. Clauses 4 and 5 admit neither. Using the words interchangeably is one of the most common findings in a quality manual.
Can I exclude design and development controls because we outsource design?
No. Outsourcing a process does not remove it from your quality management system. Clause 4.1.5 is explicit that where a process affecting product conformity is outsourced, the organization retains responsibility for conformity and the controls include written quality agreements. Outsourcing changes how you control a process, not whether you are answerable for it.
Can one manual serve both ISO 9001 and ISO 13485?
One manual is both possible and preferable, provided the divergences are recorded rather than smoothed over. Two manuals means two places where the scope, the policy and the process descriptions are stated, and two places they can drift apart. The risk with one manual is different: over years of editing, content that existed to satisfy one standard gets trimmed as redundant. That is precisely what the integration record prevents.
Are these usable if we do not manufacture anything?
Yes. The ISO 13485 manual includes five organization‑type adaptations covering specification developers using contract manufacture, contract manufacturers with no design authority, design services firms, distributors and importers, and servicing or refurbishment organizations. Each names the specific sections to edit.
Do I need the procedures as well?
The manual states what the system covers and where each requirement is discharged. The procedures are what discharge it. MSI's ISO Procedure Templates and Guides are written to the same architecture, so the manual's clause map and the procedure set line up rather than having to be reconciled.
Is there a version for nonprofits?
Yes. MSI provides an Operating Quality Manual free to nonprofit organizations. It is separate from the paid templates on this page; request it on the nonprofit page to receive it.
