Quality Management System (QMS) ISO 13485 Certification

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of 'cessation of presumption of conformity' of EN ISO 13485:2012 stated as 31 March 2019.

Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 2020 and 2022, respectively. Find out more about MDR transition and IVDR transition.

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.

Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives and Regulations, it is recognized as a harmonized standard by the European Commission. As one of the leading notified bodies for CE marking, we can support you on selecting the most efficient conformity assessment routes to achieve CE marking.

BSI ISO 13485 Certification is one component of the comprehensive portfolio of quality management assurance services that we provide.

Popular services that compliment ISO 13485 include:

Use our transition resources to support you as you plan and implement your transition.

We provide a full range of services to support your path to certification. Our business development staff can help you and your organization understand each phase of the assessment and certification process to ensure you fully understand the ISO 13485 process and its available guidelines. Our training courses allow you to develop a thorough understanding of the complexities of complying with the standard, as well as the laws and regulations the standard helps to address.

The MDSAP is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements. RAs include Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW.

Find our more about MDSAP and how it impacts your ISO 13485 certification.

BSI has a range of courses on ISO 13485, from an introduction course for those new to the standard, to internal and lead auditor courses for those actively involved in the implementation of the standard in their organization.