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获取原文件assets/templates/quality-manual-template.md
STATUS: DRAFT EXAMPLE — NOT APPROVED — NO CONFORMITY OR COMPLIANCE CLAIM
This generic structure is an authoring aid. It cannot determine applicability, establish an effective QMS, support a certification claim by itself, or replace authorized management, RA/QA, legal, regulatory, notified-body, or certification- body review. Obtain ISO standards from ISO or an authorized source; do not paste copyrighted ISO text into this file.
0. Controlled-document metadata
| Field | Required entry |
|---|---|
| Document ID | <assigned controlled ID> |
| Revision | <revision> |
| Status | draft / in-review / approved |
| Owner | <accountable role> |
| Effective date | <YYYY-MM-DD after approval> |
| Supersedes | <document ID/revision or none> |
| Evidence repository | <controlled location> |
| Confidentiality | <classification> |
Approval
| Approval role | Named approver | Decision | Date | Approval evidence ID |
|---|---|---|---|---|
| Authorized management | <name/role> |
pending |
<YYYY-MM-DD> |
<record ID> |
| RA/QA | <name/role> |
pending |
<YYYY-MM-DD> |
<record ID> |
| Document control | <name/role> |
pending |
<YYYY-MM-DD> |
<record ID> |
Release gate: keep status draft until every required approver records a decision,
open placeholders are resolved, referenced procedures exist, and training/change
impacts are approved.
1. Purpose and limits
- Intended use of this manual:
<organization-specific purpose> - What this manual does not establish: certification, regulatory applicability, product authorization, FDA compliance, MDSAP acceptance, or EU conformity.
- Authorized roles that own those determinations:
<roles and escalation route>
2. QMS scope
| Scope element | Declared information | Owner | Status | Evidence ID | Approval ID |
|---|---|---|---|---|---|
| Legal entity/entities | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Sites and addresses | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Product families | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Lifecycle activities | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Outsourced processes | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Markets considered | <entry> |
<role> |
draft |
<ID> |
<ID> |
2.1 Applicability decisions
Do not infer applicability from a checklist. Record each decision made by an authorized human.
| Topic/process | Decision | Rationale | Source/version | Decision owner | Approval/date |
|---|---|---|---|---|---|
<topic> |
applicable / not-applicable / undetermined |
<rationale> |
<official source> |
<role> |
<record> |
Undetermined is a blocking status. A not-applicable entry requires a documented,
approved rationale and must not be described as an automatic exclusion.
3. Controlled source and version basis
| Source ID | Official title | Edition/version/date | Authorized location | Currency review date | Owner | Impact approval |
|---|---|---|---|---|---|---|
<ID> |
<title> |
<version> |
<location/URL> |
<YYYY-MM-DD> |
<role> |
<record ID> |
At minimum, distinguish the source basis used for:
- ISO 13485 certification preparation;
- FDA QMSR and current 21 CFR Part 820;
- MDSAP audit preparation;
- EU MDR or IVDR conformity assessment;
- product- and market-specific requirements.
4. Governance, authority, and responsibilities
| Role | Authority and responsibility | Independence/escalation | Delegate | Competence evidence | Approval |
|---|---|---|---|---|---|
| Top management | <entry> |
<entry> |
<entry> |
<ID> |
<ID> |
| Authorized management representative | <entry> |
<entry> |
<entry> |
<ID> |
<ID> |
| RA/QA owner | <entry> |
<entry> |
<entry> |
<ID> |
<ID> |
| Process owner | <entry> |
<entry> |
<entry> |
<ID> |
<ID> |
| Document/record owner | <entry> |
<entry> |
<entry> |
<ID> |
<ID> |
5. Process architecture and interactions
Use organization-specific processes. Do not copy a standard's clauses as procedures.
| Process | Inputs | Outputs | Owner | Controlled procedure | Records/evidence | Measures | Approval |
|---|---|---|---|---|---|---|---|
| Scope and quality planning | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Document and record control | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Risk management | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Design and development | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Supplier controls | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Production/service | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Validation and software assurance | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Identification/traceability | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Complaints, feedback, vigilance | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Nonconformity and CAPA | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Internal audit | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Management review | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Training and competence | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
| Change control | <entry> |
<entry> |
<role> |
<ID> |
<IDs> |
<measure> |
<ID> |
Attach an approved process interaction map as evidence: <record ID/location>.
6. Documentation and record controls
- Document lifecycle and approval method:
<procedure ID> - Record integrity, retrieval, retention, and disposition:
<procedure ID> - External-source version monitoring:
<procedure/register ID> - Electronic signatures/access controls:
<validated control IDs> - Training before effective use:
<procedure/evidence IDs> - Change-impact and linked-document updates:
<procedure/evidence IDs>
7. Product lifecycle controls
For each applicable process, describe the policy-level approach and reference controlled evidence. Cover, as applicable:
- requirements and product planning;
- risk management through production and postmarket feedback;
- design/development planning, reviews, transfer, and changes;
- supplier and outsourced-process controls;
- production, service, infrastructure, work environment, and process controls;
- process, test-method, equipment, and software validation;
- identification, distribution, and traceability;
- acceptance, release, preservation, installation, and servicing.
| Topic | Policy summary | Owner | Procedure | Evidence set | Status | Approval |
|---|---|---|---|---|---|---|
<topic> |
<organization-specific summary> |
<role> |
<ID> |
<IDs> |
draft |
<ID> |
8. Feedback, postmarket, and improvement controls
Document the links among feedback, complaints, reportability/vigilance decisions, risk updates, nonconformity, CAPA, change control, and management review.
| Link | Method | Owner | Input evidence | Output evidence | Approval |
|---|---|---|---|---|---|
| Complaint → reportability review | <entry> |
<role> |
<IDs> |
<IDs> |
<ID> |
| Postmarket signal → risk update | <entry> |
<role> |
<IDs> |
<IDs> |
<ID> |
| Nonconformity → CAPA decision | <entry> |
<role> |
<IDs> |
<IDs> |
<ID> |
| CAPA → effectiveness review | <entry> |
<role> |
<IDs> |
<IDs> |
<ID> |
| Change → validation/training | <entry> |
<role> |
<IDs> |
<IDs> |
<ID> |
9. Assurance and oversight
| Activity | Scope/frequency basis | Independence | Owner | Evidence | Open actions | Approval |
|---|---|---|---|---|---|---|
| Internal audit | <risk-based basis> |
<controls> |
<role> |
<IDs> |
<IDs> |
<ID> |
| Management review | <planned basis> |
n/a |
<role> |
<IDs> |
<IDs> |
<ID> |
| Supplier monitoring | <risk-based basis> |
<controls> |
<role> |
<IDs> |
<IDs> |
<ID> |
| Validation review | <change/risk basis> |
<controls> |
<role> |
<IDs> |
<IDs> |
<ID> |
10. Appendices
- Controlled procedure and record index:
<ID> - Source/version ledger:
<ID> - Organization chart and role authorizations:
<ID> - Process interaction map:
<ID> - Product/site/scope register:
<ID> - Risk-design-production-postmarket traceability matrix:
<ID> - Open gap and change register:
<ID>
Final release checklist
- No placeholder remains.
- Scope and applicability decisions have authorized owners and approvals.
- Every referenced document and record exists at its controlled revision.
- Source versions and currency-review dates are recorded.
- Process interactions and risk/postmarket feedback links are evidenced.
- Product-specific and jurisdiction-specific requirements were reviewed separately.
- Training and change impacts were approved.
- No certification, conformity, compliance, or readiness claim is made by this template.
- Final human approvals are recorded before the effective date.