The Importance of ISO 13485 Standard

Being ISO 13485 certified helps consolidating business and employees’ trust, an essential requirement in the medical device manufacturing industry. ISO 13485 has become the worldwide accepted standard in medical manufacturing industry and certifies the conformity to regulatory requirements. Organizations in the industry are expected to provide proof for quality management system implementation throughout the entire production cycle. This is why getting ISO 13485 certified is so important.

ISO 13485 certification guarantees the conformity to international standards throughout all phases of medical devices’ life cycle: design, manufacturing, installing, technical assistance and sales. This QMS standard also covers other post production aspects like storage, distribution, provision of associated services. Furthermore, disposal and decommission of used/damaged medical devices is regulated by this ISO.

This standard is based on the ISO 9001 QMS standard, adapted for the medical device manufacturing environment. Being certified for both standards ensures competitiveness, transparency, effectiveness and will only bring more trust to potential business partners.

For manufactures, the certification means expanded market access. Being able to work with a worldwide network of potential customers and business partners is one of the top reasons why any company should require certification. National and international regulatory authorities prefer manufactures with a third-party audited and certified quality management system in. Investing in such a system speeds access into those countries that require it. Expanding production or sales operation to a new country with this QMS is difficult and in some cases, impossible.

Investing into implementation and recognition of ISO 13485 has the potential of saving a lot of money. First of all, by providing proofs for meeting high quality standards, finding potential customers takes significantly less time. All major companies which buy medical equipment require credibility and commitment to qualify for all business partners.

Although this standard does not emphasize the need for continual improvement, pointing strictly to meeting the quality requirements and achieving customer satisfaction, implementing it the company will get process control which will allow it further development and improvement.

The latest version of this ISO highlights more the need for effective risk management and risk-decision management. Risk management of any medical device must be fully documented and applied during the entire life-cycle of any product. Proving that the risk was fully understood and documented will help companies get not only ISO 13485, but also ISO 14971, which is the ISO standard for the application of risk management to medical devices.

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