How to Obtain ISO 13485 Certification

How to obtain ISO 13485

Sistem Patent Kalite supports you through the ISO 13485 certification and testing process. ISO 13485 is the medical-device quality management standard that covers the entire medical-device supply chain. It builds on the ISO 9001 framework and adds the specific requirements that apply to medical-device manufacturing, distribution, and servicing.

Obtaining ISO 13485 follows a defined sequence. Before the procedure itself, it helps to be clear on which organizations fall within the scope of the standard.

Certification steps

• Application: The organization requesting certification completes Sistem Patent Kalite's application form and submits the ISO 13485 (Medical Devices Quality Management System) documentation along with the other supporting documents required for review.
• Document review: The organization submits copies of its system documentation at the application stage. Our Lead Auditor analyzes the documentation and checks whether it meets the clauses of the standard.
• Audit planning: In line with ISO 17021, the auditor and the client agree on the audit duration and the on-site audit dates based on the size and complexity of the organization. Once the schedule is confirmed, the audit takes place on the agreed dates.
• Audit: On the scheduled day, the auditor visits the organization. Following the audit programme, each department is reviewed on site: documentation and practice are examined against every clause of the standard. At the end of the audit, the auditors analyze their findings and issue a certification recommendation.
• Certification: Once the audit report is reviewed and approved, the certificate is prepared and issued to the organization.

Who the standard applies to

• Medical-device manufacturers
• Companies selling medical devices
• Companies providing technical service for medical devices
• Companies developing medical-device software

Before starting the certification project, the organization, the specific product, and the standards the product is subject to should be assessed carefully. The management system is then built up in stages against those requirements.

ISO 13485 project plan

The ISO 13485 Medical Devices Quality Management System standard should be obtained. Relevant norms and legal requirements for the product, if any, should be researched. Medical-device risk analysis should be carried out in accordance with ISO 14971.

• ISO 13485 awareness training
• ISO 13485 internal auditor training
• Assignment of roles, authorities, and responsibilities for ISO 13485
• Planning the ISO 13485 documentation
• Defining the hygiene rules relating to product use within ISO 13485
• Assessing risk factors relating to ISO 13485
• Measuring customer satisfaction
• Writing ISO 13485 procedures
• Writing work instructions for processes
• Creating the ISO 13485 internal audit plan
• Conducting the ISO 13485 internal audit
• Conducting the ISO 13485 management review
• Submitting the ISO 13485 certification application

You can obtain ISO 13485 consultancy from Sistem Patent Kalite's Izmir office, or from our offices in Istanbul, Ankara, Bursa, Adana, Antalya, Konya, Kayseri, Eskisehir, and other cities. Online consultation is also available.