ISO 13485 standard is a customized quality management system for medical device manufacturers. It is a management standard to be implemented by manufacturers, organizations providing subcontracting, distribution and technical services related to medical devices.
The main goal of the standard is harmonization of the legal requirements of medical devices.
ISO 13485 contains special requirements;
- Implementation of the quality management system
- Application of risk management approach to product development and production realization processes
- Validation of processes (Sterilization, software, production etc.)
- Effective recall and product traceability
- Installation activities
- Service activities
- Workplace control (physical and microbiological qualification)
- Compliance with legal requirements - competent technical documentation
- Development and improvement of risk management approach according to ISO 14971 requirements
- Improvement of design and development process - validation reports, product tests, clinical evaluation, design dossier etc.
- Customer satisfaction
- Development of critical supplier control
- Application - Determination of the scope of the audit and collection of information on the producer
- Audit - There is a two-stage audit in the initial certification process.
I. Verification of the quality management system
Ii. Documentation verification
Iii. Verificaiton of production area
Iv. Verification of certificaiton scope
V. Issuing audit report including improvement opportunities and nonconformities
Vi. Determination of Stage 2 audit date
I. Reviewing of objective evidence
Ii. In-depth control of records and documentation
Iii. Publishing a report including improvement opportunities and nonconformities
I. Issuing certificate upon committee decision
Ii. Determination of annual surveillance audits and re-certification processes.