| ISO 13485:2016 Section | Document Section |
|---|---|
| 4.1.1 | 1. |
| 4.1.2 | 4. |
| 4.2.1 b) | (All) |
| 4.2.2 | (All) |
| 5.3 | 2. |
| 5.4.1 | 2. |
Overview
This Quality Manual outlines the scope of the Quality Management System (QMS), its documented procedures, and a description of how these procedures interact.
1. Scope
The Quality Management System detailed in this manual applies to all products produced by \
Company Role
Additional roles beyond “manufacturer” could include authorized representative or distributor.
\
Applicable Standards
The table below provides an overview of the most relevant standards and regulations. For a complete list, refer to the comprehensive list of applicable standards (reference provided).
| Standard / Regulation / Law | Relevance |
|---|---|
| EU Regulation 2017/745 | Governs medical devices for human use |
| EU Regulation 2021/2226 | Addresses electronic instructions for use |
| EN ISO 13485:2016 | Establishes QMS requirements per MDR/MDD |
| EN ISO 14971:2019 | Focuses on risk management for medical devices |
| IEC 62304:2006 | Relates to software development for medical devices |
| IEC 62366-1:2015 | Covers usability evaluations for medical devices |
Exclusions
Due to the product being standalone software, the following sections of ISO 13485:2016 are excluded:
- 6.4.2: Contamination control
- 7.5.2: Cleanliness of product
- 7.5.5: Requirements for sterile medical devices
- 7.5.7: Validation of processes for sterilization and sterile barrier systems
- 7.5.9.2: Requirements for implantable devices
- 7.5.11: Product preservation
2. Quality Policy & Objectives
Quality Policy
Detail the company’s mission, goals, and commitment to improving lives through its products. Include a commitment to meet legal requirements, maintain the QMS, and set quality objectives.
Quality Objectives
Objectives must be measurable and relevant to both the QMS and organizational performance. Examples include maintaining high customer satisfaction, ensuring excellent device performance, and hiring skilled personnel.
Key Performance Indicators (KPIs)
To ensure objectives are met, KPIs must be established for all QMS processes. These indicators allow for tracking progress and compliance.
- Define at least one KPI per QMS process.
- Align quality objectives with process KPIs where applicable.
- Document KPIs within each SOP or in a central document for ease of tracking and evaluation.
3. Roles
Clearly outline the roles within the organization using an organigram or a table. Include required qualifications and tasks related to QMS processes.
| Role | Assigned Personnel |
|---|---|
| CEO | Steve Jobs |
| CTO | Steve Wozniak |
| Product Manager | Ada Lovelace |
| QMO | Oliver Eidel |
Management Responsibilities
Management defines responsibilities, sets quality objectives, and ensures alignment across the organization (ISO 13485: Sections 5.1, 5.5.1).
Quality Management Officer (QMO)
The QMO oversees:
- Documentation of QMS processes.
- Reporting on QMS effectiveness and improvements.
- Promoting awareness of regulatory and QMS requirements.
Required Qualifications:
– Fluency in German and English.
– Minimum one year of experience in quality management and regulatory affairs.
Person Responsible for Regulatory Compliance (PRRC)
Responsibilities include:
- Reviewing and ensuring conformity checks for devices in accordance with the QMS.
- Maintaining up-to-date technical documentation and EU declarations of conformity.
- Compliance with post-market surveillance and reporting obligations under MDR.
Required Qualifications:
– Fluency in English.
– Expertise in Art. 15 MDR requirements.
– Relevant higher education or professional experience in quality management and regulatory affairs.
4. Processes
List all Standard Operating Procedures (SOPs). Identify whether processes are internal or outsourced.
| SOP | Process Category | Internal/Outsourced |
|---|---|---|
| SOP Corrective and Preventive Action | Management | Internal |
| SOP Clinical Evaluation | Core | Outsourced |
| SOP Product Certification and Registration | Core | Internal |
| SOP Change Management | Core | Internal |
| SOP Deployment | Core | Internal |
| SOP Document and Record Control | Support | Internal |
| SOP Integrated Software Development | Core | Internal |
| SOP Feedback Management | Core | Internal |
| SOP Internal Auditing | Management | Outsourced |
| SOP Management Review | Management | Internal |
| SOP Post-Market Surveillance | Management | Internal |
| SOP Problem Resolution | Core | Internal |
| SOP Software Validation | Support | Internal |
| SOP Update of Regulations | Support | Internal |
| SOP Vigilance | Core | Internal |