Whether you are just starting or have been on the ISO journey this sales management procedure template is sure to improve proposal and delivery process. Thirty-one pages covering ISO 9001 Clause 8.2 and ISO 13485 Clause 7.2 in a single procedure. Device-scope content is marked inline and in the headings. Where the standards differ, the stricter requirement is taken as the house standard and the decision is recorded.
Appendix D is what you are paying the difference for. Every genuine divergence between the two standards, what this procedure does about it, and what the alternative was — followed by the decisions you need to confirm before adopting it. When two certification bodies ask the same question separately, that appendix is your answer. It is not something a buyer can easily assemble alone.
Every appendix, form and worked example is part of the document. Nothing is sold separately.
01
Organisations running both standards almost always maintain two sales procedures, and almost always know the second one is out of date. One document means one review cycle, one training event and one set of records.
02
The most common failure in an integrated system is a device transaction running down the general path because scope was assigned late, or never. That is why scope determination comes first here, and why uncertain defaults to device scope rather than to convenience.
03
ISO 13485's documented-arrangements requirement applied generally, and ISO 9001's contingency clause applied to device scope. Each standard covers a gap the other leaves, and taking the stricter of the two is what makes a single procedure defensible to both auditors.
Organisations running an integrated management system across a device line and a non-device line. Contract manufacturers with mixed portfolios. Consultants supporting clients through integration. Anyone maintaining two sales procedures who knows the second one has drifted.
Not sure which version you need? The free Sales Management Maturity Check has a path for ISO 9001, ISO 13485, or both. Under five minutes, and your score appears without entering anything.
Appendix D. Merging two standards is not a matter of combining two documents — it requires deciding, at every point where they diverge, which requirement governs and why. That analysis is the part a buyer cannot easily do alone, and it is recorded here as a table of decisions with the rejected alternative stated alongside each one.
Both, deliberately. It is written as a filled-in worked example so you can see what each element looks like when done properly, with bracketed placeholders wherever a value is genuinely yours to set. You are editing a working document rather than filling in a hollow outline.
It is marked inline and in the headings, so commercial staff learn one process with the device additions visible rather than separated into a second document nobody reads. Scope determination comes first, and an uncertain determination defaults to device scope pending resolution.
Yes. Since 2 February 2026 the FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference into 21 CFR Part 820. The cross-reference maps obligations across ISO 9001, ISO 13485 and Part 820 together.
Editable Microsoft Word (.docx). Adapt it, rebrand it, and adopt it into your own document control system. The licence permits the buying organisation to use it across its own sites and issue it to employees, contractors and auditors, and permits consultants to adapt it for engagements they deliver.
Purchasers receive the updated template at no charge when it publishes. The cover states which template version you hold and which editions of the standards it was built to.
