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.