claude-scientific-skills/scientific-skills/iso-13485-certification/assets/templates/quality-manual-template.md

# Quality Manual Template

# [COMPANY NAME]
## QUALITY MANUAL

**Document Number:** QM-001
**Revision:** 00
**Effective Date:** [DATE]
**Page:** 1 of [X]

---

## DOCUMENT CONTROL

### Approval Signatures

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Chief Executive Officer | [NAME] | | [DATE] |
| Quality Manager | [NAME] | | [DATE] |
| Management Representative | [NAME] | | [DATE] |

### Revision History

| Revision | Date | Description of Changes | Approved By |
|----------|------|------------------------|-------------|
| 00 | [DATE] | Initial release | [NAME] |
|  |  |  |  |

### Distribution List

| Copy No. | Holder | Location | Date Issued |
|----------|--------|----------|-------------|
| 001 | Master Copy | Document Control | [DATE] |
| 002 | [NAME/DEPT] | [LOCATION] | [DATE] |
|  |  |  |  |

---

## TABLE OF CONTENTS

1. [Introduction](#1-introduction)
   - 1.1 [Company Overview](#11-company-overview)
   - 1.2 [Purpose of the Quality Manual](#12-purpose-of-the-quality-manual)
   - 1.3 [Document Control and Revisions](#13-document-control-and-revisions)
   - 1.4 [Definitions and Abbreviations](#14-definitions-and-abbreviations)

2. [Scope and Exclusions](#2-scope-and-exclusions)
   - 2.1 [Scope of QMS](#21-scope-of-qms)
   - 2.2 [Products Covered](#22-products-covered)
   - 2.3 [Applicable Regulatory Requirements](#23-applicable-regulatory-requirements)
   - 2.4 [Exclusions and Justifications](#24-exclusions-and-justifications)

3. [Quality Policy and Objectives](#3-quality-policy-and-objectives)
   - 3.1 [Quality Policy Statement](#31-quality-policy-statement)
   - 3.2 [Quality Objectives](#32-quality-objectives)
   - 3.3 [Communication of Policy and Objectives](#33-communication-of-policy-and-objectives)

4. [Quality Management System](#4-quality-management-system)
   - 4.1 [General Requirements](#41-general-requirements)
   - 4.2 [Documentation Requirements](#42-documentation-requirements)

5. [Management Responsibility](#5-management-responsibility)
   - 5.1 [Management Commitment](#51-management-commitment)
   - 5.2 [Customer Focus](#52-customer-focus)
   - 5.3 [Quality Policy](#53-quality-policy)
   - 5.4 [Planning](#54-planning)
   - 5.5 [Responsibility, Authority and Communication](#55-responsibility-authority-and-communication)
   - 5.6 [Management Review](#56-management-review)

6. [Resource Management](#6-resource-management)
   - 6.1 [Provision of Resources](#61-provision-of-resources)
   - 6.2 [Human Resources](#62-human-resources)
   - 6.3 [Infrastructure](#63-infrastructure)
   - 6.4 [Work Environment and Contamination Control](#64-work-environment-and-contamination-control)

7. [Product Realization](#7-product-realization)
   - 7.1 [Planning of Product Realization](#71-planning-of-product-realization)
   - 7.2 [Customer-Related Processes](#72-customer-related-processes)
   - 7.3 [Design and Development](#73-design-and-development)
   - 7.4 [Purchasing](#74-purchasing)
   - 7.5 [Production and Service Provision](#75-production-and-service-provision)
   - 7.6 [Control of Monitoring and Measuring Equipment](#76-control-of-monitoring-and-measuring-equipment)

8. [Measurement, Analysis and Improvement](#8-measurement-analysis-and-improvement)
   - 8.1 [General](#81-general)
   - 8.2 [Monitoring and Measurement](#82-monitoring-and-measurement)
   - 8.3 [Control of Nonconforming Product](#83-control-of-nonconforming-product)
   - 8.4 [Analysis of Data](#84-analysis-of-data)
   - 8.5 [Improvement](#85-improvement)

9. [Appendices](#9-appendices)
   - Appendix A: [List of Documented Procedures](#appendix-a-list-of-documented-procedures)
   - Appendix B: [Organization Chart](#appendix-b-organization-chart)
   - Appendix C: [Process Map](#appendix-c-process-map)
   - Appendix D: [Definitions and Abbreviations](#appendix-d-definitions-and-abbreviations)
   - Appendix E: [Applicable Regulatory Requirements](#appendix-e-applicable-regulatory-requirements)

---

## 1. INTRODUCTION

### 1.1 Company Overview

**Company Legal Name:** [FULL LEGAL COMPANY NAME]
**Business Address:** [STREET ADDRESS, CITY, STATE/PROVINCE, ZIP/POSTAL CODE, COUNTRY]
**Manufacturing Site(s):** [LIST ALL MANUFACTURING SITES]
**Type of Business:** [e.g., Medical Device Manufacturer, Contract Manufacturer, etc.]

[COMPANY NAME] was [established/founded] in [YEAR] and specializes in [BRIEF DESCRIPTION OF BUSINESS FOCUS].

**Mission Statement:** [INSERT COMPANY MISSION STATEMENT]

### 1.2 Purpose of the Quality Manual

This Quality Manual documents the Quality Management System (QMS) of [COMPANY NAME]. The purpose of this manual is to:

- Describe the QMS established and maintained in accordance with ISO 13485:2016
- Demonstrate compliance with applicable regulatory requirements
- Serve as the primary reference document for the structure and operation of the QMS
- Provide guidance for employees, customers, regulatory authorities, and certification bodies

This manual applies to all activities affecting the quality of medical devices designed, manufactured, distributed, and/or serviced by [COMPANY NAME].

### 1.3 Document Control and Revisions

This Quality Manual is a controlled document. The Document Control Coordinator maintains the master copy and distribution list.

- **Approval Authority:** Chief Executive Officer and Quality Manager
- **Review Frequency:** Annually, or as needed when significant changes occur
- **Revision Process:** Changes are reviewed and approved per SOP-4.2.4 Control of Documents
- **Distribution:** Controlled copies are issued to individuals listed in the Distribution List

All recipients of controlled copies are responsible for ensuring they are using the current revision.

### 1.4 Definitions and Abbreviations

| Term/Abbreviation | Definition |
|-------------------|------------|
| CAPA | Corrective and Preventive Action |
| CFR | Code of Federal Regulations |
| DHF | Design History File |
| DHR | Device History Record |
| DMR | Device Master Record |
| FDA | U.S. Food and Drug Administration |
| IFU | Instructions for Use |
| ISO | International Organization for Standardization |
| MDF | Medical Device File |
| MDR | Medical Device Regulation (EU) |
| M&M Equipment | Monitoring and Measuring Equipment |
| NCR | Nonconformance Report |
| QMS | Quality Management System |
| QMSR | Quality Management System Regulation (FDA) |
| QSR | Quality System Regulation (FDA - former) |
| SOP | Standard Operating Procedure |
| WI | Work Instruction |

---

## 2. SCOPE AND EXCLUSIONS

### 2.1 Scope of QMS

This Quality Management System applies to [COMPANY NAME] and covers all activities related to [LIST ACTIVITIES: e.g., design, development, production, storage, distribution, installation, servicing] of medical devices.

**Organizational Scope:**
- All departments and functions at [COMPANY NAME]
- All employees, contractors, and temporary staff performing work affecting product quality

**Physical Locations:**
- [LIST ALL FACILITIES AND ADDRESSES]

**Activities Covered:**
- [✓ / ✗] Design and Development
- [✓ / ✗] Manufacturing and Production
- [✓ / ✗] Installation
- [✓ / ✗] Servicing
- [✓] Storage and Distribution
- [✓] Purchasing
- [✓] Customer Communication

### 2.2 Products Covered

This QMS covers the following medical device product families:

| Product Family | Device Classification | Intended Use | Applicable Markets |
|----------------|----------------------|--------------|-------------------|
| [PRODUCT NAME/FAMILY] | [Class I/II/III] | [BRIEF INTENDED USE] | [FDA/EU/Other] |
|  |  |  |  |

### 2.3 Applicable Regulatory Requirements

The QMS is designed to comply with the following standards and regulatory requirements:

**International Standards:**
- ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes
- ISO 14971:[YEAR] - Medical devices — Application of risk management to medical devices
- [OTHER APPLICABLE ISO/IEC STANDARDS]

**Regulatory Requirements:**
- **United States:** FDA 21 CFR Part 820 (QMSR) - Quality Management System Regulation
- **European Union:** EU MDR 2017/745 - Medical Devices Regulation [or IVDR 2017/746 for IVDs]
- **Canada:** Canadian Medical Devices Regulations (SOR/98-282)
- [OTHER APPLICABLE REGIONAL REQUIREMENTS]

**Recognized Standards:**
- [LIST PRODUCT-SPECIFIC STANDARDS, e.g., IEC 60601, ISO 10993, etc.]

### 2.4 Exclusions and Justifications

The following clauses of ISO 13485:2016 are excluded from the scope of this QMS:

[IF NO EXCLUSIONS:]
> There are no exclusions from ISO 13485:2016. All clauses are applicable and have been implemented.

[IF EXCLUSIONS EXIST, USE THIS FORMAT:]

**Clause 7.3 - Design and Development**

**Status:** [EXCLUDED / PARTIALLY EXCLUDED / FULLY IMPLEMENTED]

**Justification (if excluded):**
> [COMPANY NAME] [operates as a contract manufacturer and produces medical devices according to complete design specifications provided by customers / only distributes medical devices designed and manufactured by third parties / etc.]. All design and development activities are [performed by customers / performed by a separate corporate entity / not applicable to business model]. [COMPANY NAME] has no responsibility for design inputs, outputs, verification, validation, design changes, or design history files.

**Clause 7.5.3 - Installation Activities**

**Status:** [EXCLUDED / PARTIALLY EXCLUDED / FULLY IMPLEMENTED]

**Justification (if excluded):**
> The medical devices manufactured by [COMPANY NAME] are [supplied ready for use and do not require installation / intended for installation by customer personnel under separate contractual arrangements]. Installation activities are [not performed / performed by authorized distributors or customers].

**Clause 7.5.4 - Servicing Activities**

**Status:** [EXCLUDED / PARTIALLY EXCLUDED / FULLY IMPLEMENTED]

**Justification (if excluded):**
> [COMPANY NAME] does not provide servicing of medical devices after delivery. Products are [intended for single use / serviced by authorized service partners under separate arrangements / serviced by customer personnel]. Post-delivery activities are limited to technical support and complaint handling.

---

## 3. QUALITY POLICY AND OBJECTIVES

### 3.1 Quality Policy Statement

**QUALITY POLICY**

[INSERT YOUR COMPANY-SPECIFIC QUALITY POLICY HERE. The policy should include:
- Commitment to meeting customer and regulatory requirements
- Commitment to maintaining QMS effectiveness
- Framework for quality objectives
- Signature of top management
- Date

Example:]

> At [COMPANY NAME], quality is our highest priority. We are committed to designing, manufacturing, and delivering medical devices that meet the highest standards of safety, performance, and reliability.
>
> Our commitments include:
> - Compliance with ISO 13485 and all applicable regulatory requirements
> - Understanding and meeting customer and patient needs
> - Establishing and achieving measurable quality objectives
> - Managing risks throughout the product lifecycle
> - Continually improving our processes and products
> - Maintaining competent and motivated personnel
> - Responding promptly and effectively to feedback and complaints
>
> This policy applies to all employees, contractors, and suppliers. This policy is reviewed annually and communicated throughout the organization.
>
> [SIGNATURE]
> [NAME], Chief Executive Officer
> [DATE]

### 3.2 Quality Objectives

The organization has established the following measurable quality objectives to support the Quality Policy:

| Objective | Measurement | Target | Responsibility | Review Frequency |
|-----------|-------------|--------|----------------|------------------|
| Customer Satisfaction | Survey rating | ≥ [X] out of 5.0 | [ROLE] | Quarterly |
| Product Quality | Defect rate | < [X]% | [ROLE] | Monthly |
| On-Time Delivery | % on-time | ≥ [X]% | [ROLE] | Monthly |
| CAPA Effectiveness | % closed on time | ≥ [X]% | [ROLE] | Monthly |
| Training Completion | % complete on schedule | 100% | [ROLE] | Quarterly |
| Internal Audit Findings | Findings addressed | ≥ [X]% within 30 days | [ROLE] | After each audit |
| [OTHER OBJECTIVES] |  |  |  |  |

Quality objectives are monitored, reported in management review, and revised as necessary to drive continual improvement.

### 3.3 Communication of Policy and Objectives

The Quality Policy and Quality Objectives are communicated to all personnel through:

- Employee orientation and training
- Posting in common areas of the facility
- Inclusion in employee handbook
- Management review meetings
- Department meetings
- This Quality Manual (available to all personnel)
- [OTHER COMMUNICATION METHODS]

All employees are made aware of the relevance and importance of their activities and how they contribute to achieving quality objectives.

---

## 4. QUALITY MANAGEMENT SYSTEM

### 4.1 General Requirements

#### 4.1.1 QMS Establishment

[COMPANY NAME] has established, documented, implemented, and maintains a Quality Management System in accordance with ISO 13485:2016 and applicable regulatory requirements. The QMS covers all processes necessary to ensure medical device safety, performance, and regulatory compliance.

The QMS processes have been identified and are documented in this Quality Manual and referenced procedures. These processes include:

**Management Processes:**
- Management commitment and review
- Quality planning
- Internal communication
- Resource management

**Product Realization Processes:**
- [Design and development - if applicable]
- Purchasing
- Production and service provision
- Customer-related processes

**Support Processes:**
- Document and record control
- Human resources and training
- Infrastructure and maintenance
- Software validation

**Monitoring and Measurement Processes:**
- Customer feedback and complaints
- Internal audits
- Process and product monitoring
- Nonconformance control
- Corrective and preventive action
- Data analysis

#### 4.1.2 Process Interactions

The QMS processes are interconnected and operate as a system. Process interactions are illustrated in the Process Map (Appendix C). Key interactions include:

- Management review provides direction and resources for all processes
- Product realization processes transform customer requirements into conforming products
- Support processes enable effective product realization
- Monitoring processes provide feedback for improvement
- Risk management is integrated throughout all processes
- All processes contribute to meeting quality objectives

#### 4.1.3 Outsourced Processes

[IF APPLICABLE - otherwise state "Not applicable"]

The following QMS processes are outsourced to external parties:

| Process | Service Provider | Control Method | Responsible Party |
|---------|-----------------|----------------|-------------------|
| [e.g., Sterilization] | [PROVIDER NAME] | Supplier qualification, contract, ongoing monitoring | [ROLE] |
| [e.g., Calibration] | [PROVIDER NAME] | Qualified service provider, certificates reviewed | [ROLE] |
|  |  |  |  |

Outsourcing does not relieve [COMPANY NAME] of responsibility for conformity to customer and regulatory requirements. Control of outsourced processes is documented in [REFERENCE PROCEDURE].

#### 4.1.4 Risk Management

[COMPANY NAME] has established documented requirements for risk management throughout product realization in accordance with ISO 14971. Risk management is integrated into:

- Design and development (when applicable)
- Production and process control
- Purchasing and supplier management
- Post-market surveillance and feedback
- Corrective and preventive action

Risk management files are maintained as part of the Medical Device File for each device type. Risk management activities, methods, and records are defined in SOP-[NUMBER] Risk Management.

#### 4.1.5 Software Validation

Computer software applications used in the QMS are validated prior to initial use and after changes that could affect their intended use. Software requiring validation includes:

- [QMS/ERP software]
- [Electronic document management systems]
- [Production control software]
- [Automated test equipment software]
- [Other software affecting product quality or QMS effectiveness]

Validation is based on risk assessment and includes:
- Documented validation approach
- Risk-appropriate validation activities
- Defined acceptance criteria
- User responsibilities
- Validation records maintained

Software validation procedures and records are documented in SOP-[NUMBER] Software Validation.

### 4.2 Documentation Requirements

#### 4.2.1 General

The QMS documentation includes:

**Tier 1:** Quality Policy and Quality Manual (this document)

**Tier 2:** Documented Procedures (SOPs)
- The [31+] documented procedures required by ISO 13485:2016
- Additional procedures established by the organization
- Referenced in Appendix A

**Tier 3:** Work Instructions (WIs)
- Detailed step-by-step instructions for specific tasks
- Department or process-specific documents

**Tier 4:** Records and Forms
- Evidence of conformity to requirements
- Evidence of effective QMS operation
- Maintained per retention requirements

**Additional Documentation:**
- Medical Device Files
- Risk management files
- Design and development files (when applicable)
- Validation and verification documents
- External documents (standards, regulations, customer specifications)

#### 4.2.2 Quality Manual

This Quality Manual is established and maintained to describe the scope of the QMS, document or reference QMS procedures, describe process interactions, and outline the documentation structure.

This manual is controlled per SOP-[NUMBER] Control of Documents and is reviewed annually for continuing suitability.

#### 4.2.3 Medical Device File

A Medical Device File (MDF) is established and maintained for each medical device type or device family. The MDF contains all documentation required by ISO 13485:2016 Clause 4.2.3, including:

- General description of device and intended use/purpose
- Label and instructions for use specifications
- Product specifications
- Manufacturing specifications
- Procedures for purchasing, manufacturing, and servicing
- Procedures for measuring and monitoring
- Installation requirements (when applicable)
- Risk management file(s)
- Verification and validation information
- Design and development file(s) (when applicable)

MDF structure, content, and control are defined in SOP-[NUMBER] Medical Device File.

**Current Medical Device Files:**
- [LIST MDFs MAINTAINED]

#### 4.2.4 Control of Documents

All QMS documents are controlled to ensure:
- Approval before issue
- Review and update as necessary
- Current revision status identified
- Relevant versions available at point of use
- Documents remain legible and identifiable
- External documents controlled
- Obsolete documents prevented from unintended use
- Obsolete documents identified if retained for reference

Document control responsibilities, requirements, and procedures are defined in SOP-[NUMBER] Control of Documents.

The Document Control Coordinator is responsible for document control system operation.

#### 4.2.5 Control of Records

QMS records provide evidence of conformity to requirements and effective QMS operation. Records are controlled to ensure:
- Legibility, identification, and retrievability
- Proper storage, security, and integrity
- Appropriate retention time (minimum: device lifetime)
- Proper disposition
- Changes remain identifiable

Record control responsibilities, requirements, and procedures are defined in SOP-[NUMBER] Control of Records.

Records are retained for at least [X years or device lifetime, whichever is longer], in accordance with applicable regulatory requirements.

---

## 5. MANAGEMENT RESPONSIBILITY

[CONTINUE WITH SECTIONS 5-8 FOLLOWING THE SAME PATTERN: State requirement, describe implementation, reference procedure, identify responsibility]

[Note: For brevity, I'm providing the format. The user can expand each section following this pattern]

---

## 9. APPENDICES

### APPENDIX A: LIST OF DOCUMENTED PROCEDURES

[CREATE TABLE OF ALL 31+ PROCEDURES]

### APPENDIX B: ORGANIZATION CHART

[INSERT ORGANIZATION CHART]

### APPENDIX C: PROCESS MAP

[INSERT PROCESS INTERACTION DIAGRAM]

### APPENDIX D: DEFINITIONS AND ABBREVIATIONS

[EXPAND FROM SECTION 1.4]

### APPENDIX E: APPLICABLE REGULATORY REQUIREMENTS

[DETAILED LIST OF ALL APPLICABLE REGULATIONS]

---

**END OF QUALITY MANUAL**

---

**Document Number:** QM-001
**Revision:** 00
**Page:** [X] of [X]