PLANREFERENCE OUTLINE

QMS Starter Pack — Quality Manual and Procedure Index

The top-level quality manual for an early-stage device company: regulatory basis and applicability, QMS scope with outsourced processes, justified exclusions, quality policy and objectives, roles, a process map, and a procedure index tying each procedure to its ISO 13485 clause and the US-specific provisions of the QMSR. Closes with a phase-appropriate implementation plan and where the former QSR record terms now live. Maps to 21 CFR Part 820 (QMSR) and ISO 13485:2016.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 820ISO 13485:2016
DOCUMENT TYPE
Plan
LAST UPDATED
October 2026
PURPOSE

The first document of a device company's quality management system: what the system covers, what it deliberately leaves out and why, who owns it, and which procedure carries each requirement. It is sized for a company that does not yet have a quality organisation and is written to grow with it, so the founder can answer "do you have a QMS?" with a document that is true rather than one that is aspirational.

What's Inside

✓Regulatory basis and applicability — Part 820 as amended to the QMSR, ISO 13485:2016 incorporated by reference, ISO 9000:2015 clause 3 terms, and FD&C Act definitions
✓QMS scope covering devices, life-cycle stages, sites and the processes others perform for the company
✓Exclusions and non-applicable requirements with recorded justification, including the § 820.10(c) test for design and development
✓Quality policy, measurable objectives, and a role table that records when one person holds several roles
✓A process map and a procedure index tying each procedure to its ISO 13485 clause and the US-specific provisions (UDI, traceability, MDR, advisory notices, records, labeling)
✓Documentation structure, the record content § 820.35 adds, and a medical device file index
✓A phase-appropriate implementation plan and a table of where the former QSR record terms now live

How to Use It

1Complete the applicability table first and record who decided whether the company is a manufacturer subject to Part 820, and from when
2List every outsourced process in the scope; for a virtual company that list is most of the system
3Record a justification for every exclusion — do not exclude design and development while the device is still unclassified
4Assign an owner and target date to each procedure-index row, and combine rows into fewer documents where that keeps them followed
5Bring document and record control, design and development, and supplier selection under control first, because those produce records that cannot be recreated later
6Revisit the pack at each stage in the implementation plan, and at management review
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and How to Use This Pack
2Regulatory Basis and Applicability
3Scope of the Quality Management System
4Exclusions and Non-Applicable Requirements
5Quality Policy and Objectives
› Quality policy› Quality objectives
6Organisation, Responsibility and Authority
7Process Map and Interactions
8Procedure Index
9Documentation Structure and Records
10Medical Device File Index
11Phase-Appropriate Implementation Plan
AAppendix A — Former QSR Terms and Where They Now Live
BAppendix B — Approval
REGULATORY CONTEXT

Since 2 February 2026, 21 CFR Part 820 is the Quality Management System Regulation: a manufacturer must document a quality management system that complies with the applicable requirements of ISO 13485:2016, which § 820.7 incorporates by reference, together with the US-specific provisions in §§ 820.10(b)–(d), 820.35 and 820.45. ISO 13485 lets a requirement in clauses 6, 7 or 8 be left out only with a recorded justification, and design and development only where the regulation permits; in the US, § 820.10(c) applies clause 7.3 to class II and III devices and to listed class I devices, including all devices automated with computer software. The QMSR final rule (89 FR 7496) retired the QSR record terms and did not keep the exception that shielded management review and audit reports from inspection. Whether your company is subject to Part 820, and from when, is your determination; this pack records it and does not make it.

MAPPED STANDARDS
21 CFR Part 820ISO 13485:2016
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