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.

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.