ISO 9001:2015 and ISO 13485:2016 Procedure Templates and Guides Package

One quality system · Two standards

The complete quality management system for an organization that supplies both general product and medical devices from one commercial operation — every procedure written to both ISO 9001:2015 and ISO 13485:2016 at once, with the divergences between them decided and recorded rather than left for you to reconcile.

Why one integrated package rather than two

ISO 13485 branched from ISO 9001:2008 and kept four requirements the 2015 revision of ISO 9001 removed — a quality manual, a management representative, preventive action, and mandatory documented procedures. A company certified to ISO 9001:2015 extending into 13485 has to put all four back. Run the two systems from one set of documents adapted by hand and those gaps open quietly, usually surfacing at the worst moment: a device audit.

These procedures are written to both standards in a single document each, so the device obligation that has no 9001 counterpart is carried where it belongs, and the handful of requirements that exist only in 9001 are not lost in a device-first rewrite. Where the two genuinely diverge, the procedure names the point, states which standard governs, and records why.

What’s included

The full set of MSI procedure templates and guides in editable Microsoft Word, each covering both standards:

• Sales Management — the commitment point where you become bound to supply
• Document & Records Control — creation, release, retention, documents of external origin
• Purchasing & Supplier Control — criticality rated on effect, not spend
• Control of Monitoring & Measuring Equipment — calibration as a release gate
• Risk Management — quality-system risk and device product risk, kept distinct
• Design & Development — Clause 8.3 and Clause 7.3 in one document, with design transfer and the design file
• Production & Operational Control — Clause 7.5 with its labeling and UDI obligations
• Human Resource Management — competence recorded against four bases, with personnel qualification for process validation
• Management Review & Leadership — the management representative role preserved, twelve inputs
• Compliance and further procedures added during the founding period, delivered at no extra cost as each releases

In every procedure

• An integration decision record naming every point where 9001 and 13485 diverge, the decision taken, and the reason
• Records tables with no blanks — every record with a location, an owning role, and a retention period
• A maturity ladder: eight elements, four levels each, described as observable behavior
• Event-based review triggers, with the calendar as backstop only
• A full clause cross-reference mapping both standards to where each requirement is met
• MSI implementation notes throughout — the pattern observed across 200+ audits, not a restatement of the clause
• Desk-level work instructions with worked examples for the procedures people actually get stuck on

Who this is for

Quality managers and regulatory leads at organizations running — or building — a single quality system that has to satisfy both ISO 9001 and ISO 13485. If you are certified to one and extending into the other, this is the document set that keeps the two from contradicting each other.

Not sure a full set is what you need? Each procedure is also sold individually, and every one is built from the same architecture — so nothing you buy on its own is wasted if you scale up to the package later.