![]() Obtaining this certification, however, can set a presumption of conformity for the company. Meanwhile in the European Union, it is not a regulatory requirement for any class and subclass of medical devices. 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. Who Issues ISO Certificates?Īn 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. 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.įor 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. 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. Indirect involvement entails the provision of the products and services to the companies directly involved in the manufacturing of medical devices. Storage, distribution, installment and servicing.Any organization that oversees one or more of these processes are directly involved in manufacturing of a medical device: 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. 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. 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. However, there is one major difference between the two. Therefore, in general terms they both are harmonized with each other. ISO 13485 is an extension of another quality management certification i.e. 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. From then on, more than 26,000 companies have gotten ISO 13485 certificates, issued by accredited organizations worldwide. The certification was first introduced in 1996. ISO 13485 is a standardization guideline furnished by the International Organization for Standardization to establish a quality management system for medical devices.
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