The ISO 13485 Certification Standards for Medical Device Manufacturers

Posted Jan 4, 2016 10:42:03 AM
By Natalya Koshnitsky

Customers Benefit from ISO 13485 Certification

iso-13485-microPrecision Coating Company is the first PTFE coating applicator to achieve ISO 13485 certification. Achieving the ISO 13485 certification does not only mean reaching a higher level of the quality system platform, but it also means gaining trust of various stakeholders, including medical device manufacturers, contract manufacturers, investors, and regulatory agencies. It provides objective evidence of the commitment of the company to continuous improvement in providing the highest possible quality, while satisfying applicable requirements. What is the ISO 13485 certification? What are the benefits? Finally, how did Precision Coating come to the decision to obtain the certification?

What Is ISO 13485?

The ISO 13485 standard is an internationally accepted quality management system standard that a medical device manufacturer or a supplier to a medical device manufacturer can certify to in order to demonstrate compliance to applicable laws and regulations of the medical device industry. The standard has been developed on the basis of the ISO 9001 quality management standard with specific requirements to meet regulatory needs within the medical device industry. Both of the standards follow the same basic principles of “say what you do and do what you say.” As 9001, the ISO 13485 focuses on customer satisfaction and continual improvement, but in addition, it requires satisfying applicable requirements identified by the company.

Internationally, there are two current versions of the ISO 13485 standard: the ISO13485:2003 and EN ISO 13485: 2012. The first version is the harmonized version adapted in the United States for certification. It is not a requirement for a medical device company in the U.S.A. to obtain the ISO 13485 certification in order to operate; in fact, the U.S. Food and Drug Administration (FDA) does not formally recognize ISO 13485 certification, instead it requires compliance to the U.S. Good Manufacturing Practice (GMP), which is very similar to the standard in many areas.

The latter is the European standard, EN ISO 13485:2012, Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, which is not yet harmonized in the United States. If it is not yet harmonized in the United States, companies operating and selling their products in the United States do not have to comply with it. The main body of both versions remains the same, while the annexes of the 2012 European version have been revised to link the standard to European regulations, including: Medical Device Directives 90/385/EEC (Active Implantable Medical Devices), 93/42/EEC (Medical Device Directive), and 98/79/EC (In Vitro Diagnostic Medical Devices).

So if the certification to the ISO 13485 is not required in order to do business in the United States, why do companies still do it? What are the benefits of gaining the ISO 13485 certification for a medical device manufacturer and are they any different for a supplier?

What Are the Benefits of ISO 13485?

For medical device manufacturers, especially those who operate globally, the benefits are clear. They include, but are not limited to:

  • Entering the markets that recognize or require the certification, such as Canada and Europe
  • Reduction in operational cost through correcting deficiencies and improving efficiency
  • Improving customer satisfaction by delivering high-quality product and systemically and timely addressing complaints
  • Adding transparency to the way complaints, post market surveillance, or field corrective actions are handled

Why Did Precision Coating Obtain ISO 13485 Certification?

While design control and market commercialization are often not applicable areas within the quality system for most suppliers, the same benefits still apply. Precision Coating saw a number of additional benefits when seeking the certification. Additional benefits included, but were not limited to:

  • An ability to communicate and present records in the same format as accepted within the medical device industry
  • A faster supplier approval during qualification by a medical device manufacturer
  • Decreased frequency of supplier audits
  • A better reputation and trust from various business stakeholders
  • Tighter controls and less process variation

Quality Management System Is the Foundation

A medical device manufacturer’s quality management system (QMS) is the foundation for maintaining regulatory compliance, driving improvement, effectiveness, and achieving stakeholder confidence in the manufacturer and their product. A well implemented QMS, if integrated with overall quality and business goals of the organization, provides business and financial benefits through reduction in process variation, reduction in scrap, and overall process improvement. At last, achieving the ISO 13485 certification serves as objective evidence of conformance to the requirements of the internationally recognized medical device quality system.

Precision Coating applies the same rigorous quality standards to all aspects of the projects we handle for customers. Contact us so we can evaluate how we can provide you with the best solution for your next order.

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