ISO is the abbreviated form of the International Organization for Standardization. Although it was established in 1947, the city of Geneva in Switzerland is the headquarters of this organization. The ISO certificate is a document proving that businesses operating in different sectors of the service field provide services in accordance with a certain standard and indicating that they are competent in their fields. The ISO 13485 Standard is the Quality Management System standard for the medical sector. The ISO 13485:2016 standard was created on the basis of the ISO 9001:2015 standard and is an international standard containing specific requirements for Medical Devices. This standard is a management standard that can be applied by manufacturers, organizations providing subcontracted services in the field of medical device manufacturing, and organizations carrying out medical device distribution and technical service. For those working in the field of medical devices, it defines the specific requirements required by the quality system and the quality management system requirements that any organization operating in the medical device sector must fulfill. ISO 13485 Certification proves the reliability of your organization and demonstrates your commitment and ability to provide design, manufacturing, testing, and sales services that consistently meet customer needs and legal requirements. The main objective of the standard is to ensure the legal requirements for medical devices.

What should ISO 13485 include?

• Implementation of the quality management system
• Application of the 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 area control (physical and microbiological qualification)

Benefits of Having ISO 13485:2016 Certification

• Increasing quality awareness among employees
• Increasing the reputation of the organization in the market
• Competitive advantage against other companies
• Providing more reliable and clearer control over suppliers
• Maintaining customer satisfaction at the highest level by ensuring the standard in business activities and increasing product performance and safety together with the improvement of design, production, and service quality
• Increasing confidence in devices
• Protecting human health depending on the increase in the quality of devices
• It is proof that your organization operates efficiently and safely.

Who Needs ISO 13485:2016?

• Medical Companies
• Healthcare Institutions
• Manufacturers of products such as masks, coveralls, gloves, and bonnets
• Medical Device Manufacturers
• Medical Device Training Companies
• Medical Device Certification Companies
• Wholesale Trading Companies
• Retail Trading Companies
• Analysis, Test and Calibration Companies
• All companies operating in the field of medical devices such as laboratories
• Companies providing transportation and distribution services for medical devices
• Companies providing services such as medical device consultancy, packaging, sterilization, etc.

CERTIFICATION PROCESSES

1. Application Stage – Receipt of the Application
2. Evaluation of the Application
3. Determination of the Audit Scope
4. Price Offer
5. Signing of the Contract Between the Parties
6. Audit Planning

AUDIT PLANNING

There is a two-stage audit process in initial certification.

Stage I

• Verification of general information about the company (number of employees, official documents, etc.)
• Verification of the quality management system
• Verification of documentation
• Verification of the production site
• Verification of the certification scope
• After these verification activities, elimination of the nonconformities identified in Stage 1
• After these stages, determination of the Stage 2 audit date

Stage II

• Review of objective evidence
• In-depth control of records and documentation
• Issuance of the report including nonconformities related to the controls
• Confirmation of the company’s verification activities regarding nonconformities
• Submission of the company audit documents to the committee
• Issuance of the certificate following the committee decision

Certification

Determination of annual surveillance audits and recertification processes.