ISO 13485 Quality Management System

What is an ISO 13485 Quality Management System?

QMS ISO 13485 medical devices BSI

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.

Maintain regulatory compliance by being ISO 13485 certified

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

With over 280 BSI QMS assessors globally supported by BSI product experts, our ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.

What are the benefits of being certified to ISO 13485?

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

Local Mask Production Subsidy Scheme

To tackle the shortage of surgical masks, some new factories and production lines are set up or re-activated.  Hong Kong Government has launched the Local Mask Production Subsidy Scheme. To be eligible for a subsidy from the Government, a production line must satisfy a number of stringent conditions, including having a clean room in the factory, having production machinery and raw materials for producing at least 500,000 masks every month, the masks meeting at least the ASTM Level 1 standard, and the factory obtaining ISO 13485 certification.

Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. The services we provide include standards subscription, training, gap assessment, assessment and certification.

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We also provide product testing and certification for mask and PPE. Our services include direct testing and verification at product development stage, providing evidence you need for the CE marking of your products, to giving you a competitive edge with a BSI Kitemark. CE marking indicates that the minimum levels of quality and health & safety have been met. 

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EN ISO 13485:2016 - The harmonized standard is here

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.

BSI can now offer UKAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. Talk to us to find out more.

Key resources to help your transition to ISO 13485:2016

ISO 13485, CMDR and CE marking services from a Notified Body

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.

ISO 13485 certification with BSI

Our business development staff can help your organization with each phase of the assessment and certification journey to ensure you fully understand the ISO 13485 process and guidelines. We train to help develop a thorough understanding of the complexities of complying with the standard, as well as the laws and regulations the standard helps to address.

Medical Device Single Audit Program (MDSAP)

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.