ISO 13485 is a standardization guideline furnished by the International Organization for Standardization to establish a quality management system for medical devices. The certification was first introduced in 1996. From then on, more than 26,000 companies have gotten ISO 13485 certificates, issued by accredited organizations worldwide.
What is ISO 13485?
ISO 13485 is a globally-accepted proof that the certified entity has complied with all the necessary clauses to ensure quality management in the manufacturing process (also in pre and post manufacturing phases) of medical devices. ISO 13485 is an extension of another quality management certification i.e. ISO 9001.
Therefore, in general terms they both are harmonized with each other. However, there is one major difference between the two. ISO 9001 has a dynamic nature where it is issued and renewed only when an organization demonstrates that they have successfully implemented continual improvement process. On the other hand, ISO 13485 is a standalone document which only shows that a company has put an effective quality management system in place.
Eligibility for ISO 13485 Certification
ISO 13485 is issued to organizations that are directly or indirectly involved in one or more stages of the life-cycle of a medical device. Any organization that oversees one or more of these processes are directly involved in manufacturing of a medical device:
- Research, design and development
- Storage, distribution, installment and servicing
Indirect involvement entails the provision of the products and services to the companies directly involved in the manufacturing of medical devices. Therefore, contractors and suppliers offering raw material, components and services of calibration, sterilization and maintenance to sustain the medical device life cycle are also eligible for ISO 13485 certification.
To get ISO 13485, a company has to establish its role and responsibilities the in medical device industry to fulfill a set of regulatory requirements established by the ISO for that particular role.
For instance, manufacturers and distributors of medical devices will need to integrate different set of measures in their quality management system to comply with ISO 13485.
Who Issues ISO Certificates?
An accredited quality assessment organization verifies and then issues a certificate that a company is in compliance with respective quality management guideline issued by the standardization entity.
ISO 13485 and its Status in EU
ISO 13485 is a comprehensive outline of regulatory requirements, thus it’s recognized worldwide and some countries have even made it mandatory for the manufacturers of medical devices to acquire.
Meanwhile in the European Union, it is not a regulatory requirement for any class and subclass of medical devices. Obtaining this certification, however, can set a presumption of conformity for the company. The directive 93/42/EEC of EU doesn’t mention requirement of ISO certifications (9001, 13485 etc) for medical device manufacturers to do business in European territory. Quality management system, reviewed and certified by a notified body, is sometimes required for particular medical devices.
Nevertheless, this ISO certification is a harmonized regulation framework which often helps regulators to set a standardized general benchmark to ensure quality management in the manufacturing of medical devices. Moreover in exceptional cases, especially in non-EU markets, this ISO quality management system can be used as a proof that the manufacturer is also complying with European Conformity.