ISO 13485
MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS
'ISO; It is an abbreviated form of the Inter-Country Standards Organization. Founded in 1947, the Swiss city of Geneva is the center of this organization. ISO certificate; It is a document that proves that the enterprises operating in different sectors of the service area offer services in accordance with a certain standard and that they have competence in their fields.
ISO 13485 Standard is the Quality Management System standard in the Medical Sector. The ISO 13485:2016 standard is an international standard based on ISO 9001:2015 standard, which includes special requirements for Medical Devices.
This is a management standard that can be applied by organizations that subcontract medical device manufacturing and provide medical device distribution and technical service. For those who work on medical devices, it determines the specific requirements required by the quality system and the quality management system requirements that any organization operating in the medical device industry must meet.
ISO 13485 Certification proves the reliability of your organization and proves your commitment and skills to providing design, manufacturing, testing, and sales services that consistently meet customers' needs and legal requirements. The main objective of the standard is to ensure the legal requirements of medical devices.
- 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
- Work site control (physical and microbiological qualification)
Benefits of Having
ISO 13485:2016 Certification
- Increase quality awareness in employees
- Increasing the reputation of the organization in the market
- Possibility of competition against other companies
- To provide more reliable and clear control for suppliers
- To keep customer satisfaction at the highest level by providing standard in business activities, improving product performance and safety, design, production, service quality
- Increasing trust in devices
- Human health protection due to an increase in the quality of devices
- Proof that your organization is working efficiently and securely.
Who is ISO 13485:2016
required for?
- Medical Companies
- Health Institutions
- Manufacturers such as Mask, Overalls, Gloves, Bonnets
- Medical Device Manufacturers
- Medical Device Training Companies
- Medical Device Certification Companies
- Wholesale Trading Companies
- Retail Trading Companies
- Analysis, Testing and Calibration Companies
- All companies operating in the medical device, such as laboratories
- Semi-finished producers, Raw Material manufacturers
- Companies providing transportation and distribution services for medical devices
- Medical device Consulting, packaging, sterilization, etc. services.
CERTIFICATION
PROCESSES
1
RECEIPT OF APPLICATION
2
APPLICATION
3
AUDIT SCOPE
4
QUOTE
5
BETWEEN THE PARTIES
6
AUDIT
PLANNING
There is a two-stage audit process in the first certification.
AUDIT
Phase I
- Confirmation of General information about the company (Number of employees, official documents, etc.)
- Verification of quality management system
- Verification of documentation
- Verification of the production site
- Verification of certification scope
- Elimination of nonconformities detected in Phase I after these verification studies
- Giving a Phase 2 audit date after these stages
Phase II
- Review of objective evidence
- In-depth control of records and documentation
- Publication of the report containing nonconformities to the controls
- Confirmation of the company's verification activities for nonconformities
- Presentation of company audit documents to the committee
- Publication of the certificate after the committee decision
- Certification
- Determination of surveillance audits and re-certification processes.