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quality-manual-template.md

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1# Quality Manual Working Template
2
3> **STATUS: DRAFT EXAMPLE — NOT APPROVED — NO CONFORMITY OR COMPLIANCE CLAIM**
4>
5> This generic structure is an authoring aid. It cannot determine applicability,
6> establish an effective QMS, support a certification claim by itself, or replace
7> authorized management, RA/QA, legal, regulatory, notified-body, or certification-
8> body review. Obtain ISO standards from ISO or an authorized source; do not paste
9> copyrighted ISO text into this file.

Quality Manual Working Template

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.
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11## 0. Controlled-document metadata
13| Field | Required entry |
14|---|---|
15| Document ID | `<assigned controlled ID>` |
16| Revision | `<revision>` |
17| Status | `draft` / `in-review` / `approved` |
18| Owner | `<accountable role>` |
19| Effective date | `<YYYY-MM-DD after approval>` |
20| Supersedes | `<document ID/revision or none>` |
21| Evidence repository | `<controlled location>` |
22| Confidentiality | `<classification>` |

0. Controlled-document metadata

FieldRequired entry
Document ID<assigned controlled ID>
Revision<revision>
Statusdraft / 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>
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24### Approval
26| Approval role | Named approver | Decision | Date | Approval evidence ID |
27|---|---|---|---|---|
28| Authorized management | `<name/role>` | `pending` | `<YYYY-MM-DD>` | `<record ID>` |
29| RA/QA | `<name/role>` | `pending` | `<YYYY-MM-DD>` | `<record ID>` |
30| Document control | `<name/role>` | `pending` | `<YYYY-MM-DD>` | `<record ID>` |
32**Release gate:** keep status `draft` until every required approver records a decision,
33open placeholders are resolved, referenced procedures exist, and training/change
34impacts are approved.

Approval

Approval roleNamed approverDecisionDateApproval 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.

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36## 1. Purpose and limits
38- Intended use of this manual: `<organization-specific purpose>`
39- What this manual does not establish: certification, regulatory applicability,
40 product authorization, FDA compliance, MDSAP acceptance, or EU conformity.
41- Authorized roles that own those determinations: `<roles and escalation route>`

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>
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43## 2. QMS scope
45| Scope element | Declared information | Owner | Status | Evidence ID | Approval ID |
46|---|---|---|---|---|---|
47| Legal entity/entities | `<entry>` | `<role>` | `draft` | `<ID>` | `<ID>` |
48| Sites and addresses | `<entry>` | `<role>` | `draft` | `<ID>` | `<ID>` |
49| Product families | `<entry>` | `<role>` | `draft` | `<ID>` | `<ID>` |
50| Lifecycle activities | `<entry>` | `<role>` | `draft` | `<ID>` | `<ID>` |
51| Outsourced processes | `<entry>` | `<role>` | `draft` | `<ID>` | `<ID>` |
52| Markets considered | `<entry>` | `<role>` | `draft` | `<ID>` | `<ID>` |

2. QMS scope

Scope elementDeclared informationOwnerStatusEvidence IDApproval 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>
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54### 2.1 Applicability decisions
56Do not infer applicability from a checklist. Record each decision made by an
57authorized human.
59| Topic/process | Decision | Rationale | Source/version | Decision owner | Approval/date |
60|---|---|---|---|---|---|
61| `<topic>` | `applicable` / `not-applicable` / `undetermined` | `<rationale>` | `<official source>` | `<role>` | `<record>` |
63`Undetermined` is a blocking status. A `not-applicable` entry requires a documented,
64approved rationale and must not be described as an automatic exclusion.

2.1 Applicability decisions

Do not infer applicability from a checklist. Record each decision made by an authorized human.

Topic/processDecisionRationaleSource/versionDecision ownerApproval/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.

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66## 3. Controlled source and version basis
68| Source ID | Official title | Edition/version/date | Authorized location | Currency review date | Owner | Impact approval |
69|---|---|---|---|---|---|---|
70| `<ID>` | `<title>` | `<version>` | `<location/URL>` | `<YYYY-MM-DD>` | `<role>` | `<record ID>` |
72At minimum, distinguish the source basis used for:
74- ISO 13485 certification preparation;
75- FDA QMSR and current 21 CFR Part 820;
76- MDSAP audit preparation;
77- EU MDR or IVDR conformity assessment;
78- product- and market-specific requirements.

3. Controlled source and version basis

Source IDOfficial titleEdition/version/dateAuthorized locationCurrency review dateOwnerImpact 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.
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80## 4. Governance, authority, and responsibilities
82| Role | Authority and responsibility | Independence/escalation | Delegate | Competence evidence | Approval |
83|---|---|---|---|---|---|
84| Top management | `<entry>` | `<entry>` | `<entry>` | `<ID>` | `<ID>` |
85| Authorized management representative | `<entry>` | `<entry>` | `<entry>` | `<ID>` | `<ID>` |
86| RA/QA owner | `<entry>` | `<entry>` | `<entry>` | `<ID>` | `<ID>` |
87| Process owner | `<entry>` | `<entry>` | `<entry>` | `<ID>` | `<ID>` |
88| Document/record owner | `<entry>` | `<entry>` | `<entry>` | `<ID>` | `<ID>` |

4. Governance, authority, and responsibilities

RoleAuthority and responsibilityIndependence/escalationDelegateCompetence evidenceApproval
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>
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90## 5. Process architecture and interactions
92Use organization-specific processes. Do not copy a standard's clauses as procedures.
94| Process | Inputs | Outputs | Owner | Controlled procedure | Records/evidence | Measures | Approval |
95|---|---|---|---|---|---|---|---|
96| Scope and quality planning | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
97| Document and record control | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
98| Risk management | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
99| Design and development | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
100| Supplier controls | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
101| Production/service | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
102| Validation and software assurance | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
103| Identification/traceability | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
104| Complaints, feedback, vigilance | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
105| Nonconformity and CAPA | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
106| Internal audit | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
107| Management review | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
108| Training and competence | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
109| Change control | `<entry>` | `<entry>` | `<role>` | `<ID>` | `<IDs>` | `<measure>` | `<ID>` |
111Attach an approved process interaction map as evidence: `<record ID/location>`.

5. Process architecture and interactions

Use organization-specific processes. Do not copy a standard's clauses as procedures.

ProcessInputsOutputsOwnerControlled procedureRecords/evidenceMeasuresApproval
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>.

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113## 6. Documentation and record controls
115- Document lifecycle and approval method: `<procedure ID>`
116- Record integrity, retrieval, retention, and disposition: `<procedure ID>`
117- External-source version monitoring: `<procedure/register ID>`
118- Electronic signatures/access controls: `<validated control IDs>`
119- Training before effective use: `<procedure/evidence IDs>`
120- Change-impact and linked-document updates: `<procedure/evidence IDs>`

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>
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122## 7. Product lifecycle controls
124For each applicable process, describe the policy-level approach and reference
125controlled evidence. Cover, as applicable:
127- requirements and product planning;
128- risk management through production and postmarket feedback;
129- design/development planning, reviews, transfer, and changes;
130- supplier and outsourced-process controls;
131- production, service, infrastructure, work environment, and process controls;
132- process, test-method, equipment, and software validation;
133- identification, distribution, and traceability;
134- acceptance, release, preservation, installation, and servicing.
136| Topic | Policy summary | Owner | Procedure | Evidence set | Status | Approval |
137|---|---|---|---|---|---|---|
138| `<topic>` | `<organization-specific summary>` | `<role>` | `<ID>` | `<IDs>` | `draft` | `<ID>` |

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.
TopicPolicy summaryOwnerProcedureEvidence setStatusApproval
<topic><organization-specific summary><role><ID><IDs>draft<ID>
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140## 8. Feedback, postmarket, and improvement controls
142Document the links among feedback, complaints, reportability/vigilance decisions,
143risk updates, nonconformity, CAPA, change control, and management review.
145| Link | Method | Owner | Input evidence | Output evidence | Approval |
146|---|---|---|---|---|---|
147| Complaint → reportability review | `<entry>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
148| Postmarket signal → risk update | `<entry>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
149| Nonconformity → CAPA decision | `<entry>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
150| CAPA → effectiveness review | `<entry>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
151| Change → validation/training | `<entry>` | `<role>` | `<IDs>` | `<IDs>` | `<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.

LinkMethodOwnerInput evidenceOutput evidenceApproval
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>
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153## 9. Assurance and oversight
155| Activity | Scope/frequency basis | Independence | Owner | Evidence | Open actions | Approval |
156|---|---|---|---|---|---|---|
157| Internal audit | `<risk-based basis>` | `<controls>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
158| Management review | `<planned basis>` | `n/a` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
159| Supplier monitoring | `<risk-based basis>` | `<controls>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |
160| Validation review | `<change/risk basis>` | `<controls>` | `<role>` | `<IDs>` | `<IDs>` | `<ID>` |

9. Assurance and oversight

ActivityScope/frequency basisIndependenceOwnerEvidenceOpen actionsApproval
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>
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162## 10. Appendices
164- Controlled procedure and record index: `<ID>`
165- Source/version ledger: `<ID>`
166- Organization chart and role authorizations: `<ID>`
167- Process interaction map: `<ID>`
168- Product/site/scope register: `<ID>`
169- Risk-design-production-postmarket traceability matrix: `<ID>`
170- Open gap and change register: `<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>
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172## Final release checklist
174- [ ] No placeholder remains.
175- [ ] Scope and applicability decisions have authorized owners and approvals.
176- [ ] Every referenced document and record exists at its controlled revision.
177- [ ] Source versions and currency-review dates are recorded.
178- [ ] Process interactions and risk/postmarket feedback links are evidenced.
179- [ ] Product-specific and jurisdiction-specific requirements were reviewed separately.
180- [ ] Training and change impacts were approved.
181- [ ] No certification, conformity, compliance, or readiness claim is made by this template.
182- [ ] Final human approvals are recorded before the effective date.

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.
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