- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- ISO 13485:2016 · EU MDR 2017/745 Article 10(9)
Structure of the standard
| Clause | Scope |
|---|---|
| 4 Quality management system | General requirements, documentation, quality manual, medical device file, control of documents and records |
| 5 Management responsibility | Commitment, policy, objectives, responsibility and authority, management representative, management review |
| 6 Resource management | Human resources and competence, infrastructure, work environment and contamination control |
| 7 Product realisation | Planning, customer requirements, design and development, purchasing, production and service provision, monitoring and measuring equipment |
| 8 Measurement, analysis and improvement | Feedback, complaint handling, reporting to regulatory authorities, internal audit, monitoring of processes and product, nonconforming product, data analysis, CAPA |
How ISO 13485 differs from ISO 9001
- Regulatory requirements are part of the QMS objectives, not just customer requirements
- More documented procedures are required, for example for complaint handling, design transfer and sterilisation validation
- Risk management is required in product realisation, typically according to ISO 14971
- Continual improvement is replaced by maintaining effectiveness
- A medical device file is required for each device type or family
ISO 13485 and MDR Article 10(9)
MDR Article 10(9) lists aspects the QMS must address, including a regulatory compliance strategy, identification of applicable GSPRs, clinical evaluation, UDI, PMS, communication with authorities and notified bodies, and vigilance. ISO 13485 covers most of the process framework; the MDR-specific topics need explicit procedures. The Annex Z of EN ISO 13485 shows the relationship to the regulation.
The core document set
- Quality manual including scope and justified exclusions
- Control of documents and control of records
- Management review, internal audit and training
- Design and development, including design transfer and design changes
- Purchasing and supplier evaluation
- Production and process validation, identification and traceability
- Complaint handling, regulatory reporting and vigilance
- Nonconforming product, CAPA and data analysis
- Risk management and, for MDR, PMS, clinical evaluation and PRRC
Building the procedures in the right order
Start with document control and record control: every later procedure depends on how documents are numbered, approved and stored and how long records are kept. Then define the organisation and responsibilities, then risk management, then CAPA. Procedures written in this order reference each other consistently, which auditors notice.
How MDRpilot supports ISO 13485 work
MDRpilot provides a quality manual wizard, a procedure set in a layered folder structure, document control with reviewer, approver and release steps, and a document register. General facts such as sites, roles and retention periods come from the company profile, procedure-specific decisions are asked before each procedure is drafted, and undecided points appear as [TO BE CONFIRMED]. Operational records for CAPA, complaints, audits, training and suppliers are in the same workspace.
References
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes — International Organization for Standardization.
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
This guide is general information about the regulation and standards named above. It is not legal or regulatory advice for a specific device.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.