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Iso is an international quality standard document. This standard determines the conditions of an organization’s quality management system for medical device design and development, production, facility and service. This process is based on the ISO 9001 model and standard structure approach. Speaking generally, ISO 13485 is a standard applied for medical devices. ISO 13485 quality system certification is among the indispensable requirements of manufacturers to use CE marking. The ISO 13485 certification system has been applied for a long time in companies serving in our country and around the world. Companies that produce medical devices, sales, services or raw materials must apply this certification requirement.

ISO 13485 Certification System Requirements

-Technical documentation in accordance with Medical Device Law MDD and IVD requirements

-Quality planning including directive and harmonized standards

-Risk Management

-Special Process Validation

-Change management

-Clinical evaluation

-Biolagical evaluation

-Vigilance system

-Current Technical Documentation

-After Sales Market Tracking

Who Should Apply ISO 13485 Certification Standard?

In medical devices, this standard is complementary to the quality management system requirements and product technical requirements. The wide variety of medical devices also makes the usage area of ??this standard wide. All public or private sector organizations that manufacture, store or service medical devices can use the standard. In order to benefit the standard, first of all legal obligations should be met and always safe and appropriate product production and marketing should be done. The main purpose of the standard is to ensure continuity in this direction.

How can ISO 13485 be obtained?

Companies who want to obtain ISO 13485 certification must go through stages in a certain period. If we look at these stages in items;

-Obtaining the standard,

-Determining the scope to be applied,

-Establishing the Quality Management System,

-Operating the QMS prepared in accordance with the ISO 13485 standard and creating sufficient records,

-Submission of application and documentation to an accredited organization in accordance with the standard,

-Performing Stage 1 and Stage 2 audits the accredited institution,

-Closing the observed nonconformities and completing the inspections,

-Participation in periodic surveillance audits for the continuation of certification.

Manufacturers, distributors, importers, sales companies, service and assembly companies, medical service providers and component providers in the medical sector can obtain ISO 13485 certification.

What are the Benefits of ISO 13485 Certification?

If we look at the benefits of ISO 13485 Certification in terms of items;

-ISO 13485 certification standard systematically monitors the activities of the institution or organization,

-Thanks to the ISO 13485 standard, the faulty sides in the system are detected and corrected,

-Thanks to the standard, customer satisfaction reaches the maximum level,

-Document returns are provided for current system efficiency and continuity,

-It reveals that the legal requirements are fulfilled. It is a kind of guarantee,

-ISO 13485, an internationally recognized standard, enables the expansion of the customer portfolio,

-Thanks to the effect of the standard, customer complaints and product errors are reduced.

Structure of ISO 13485 Certification Clauses

If to list the structure of the articles of the ISO 13485 Standard,


2-Information references

3-Terms and definitions

4-Quality Management Systems

5-Management Responsibility

6-Resource Management

7-Product Realization

8-Measurement, analysis and improvement

Articles 4, 5, 6, 7 and 8 of the eight articles mentioned above are not compulsory

The Way to be Followed in ISO 13485 Certification System

In ISO 13485 Certification, it is obligatory to receive standard training as a starting point. Later, the Strategies of the working team should be determined and the quality handbook should be created. After these stages, the Creation of Support Procedures and Implementation of the System are provided. Following the Application for Certification, the Certification Inspection is provided and the ISO 13485 Certification system is completed.

Differences between ISO 13485 and ISO 9001

If we look at the differences between ISO 13485 and ISO 9001 in four items;

-ISO 13485 is a more subjective standard than ISO 9001, prepared on the basis of the special conditions of medical devices.

-In the ISO 13485 standard, the obligation to comply with legal regulations is made more effective and mandatory.

-When we look at the documentation studies, it is more comprehensive than ISO 9001.

-Meeting customer needs and conditions in ISO 13485 standard, and customer satisfaction in ISO 9001 are sufficient.


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