ISO 13485 Quality Management System

ISO 13485 Quality Management System

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ISO 13485
ISO 13485
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Introduction to a medical device QMS

Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.

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 regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

What is ISO 13485?

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 previous version of ISO 9001, ISO 9000:2008 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; therefore it is more prescriptive in nature and requires a more thoroughly documented QMS.

ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.

ISO 13485 after brexit

ISO 13485 after brexit

Read the news article to learn more about the validity of accredited management system certificates issued by UK based conformity assessment bodies following the UK's departure from the EU.

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The importance of ISO 13485

ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification in order to do business with a vendor.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. certificate of registrationIt provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.

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ISO 13485 resources to support you

Medical Device Single Audit Program

Medical Device Single Audit Program

If you are a medical device manufacturer wishing to sell your products across multiple global markets, an MDSAP audit can help you minimise disruption from multiple audits and meet regulatory requirements.

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ISO 13485 and CE marking

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 QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002. ISO 13485:2016 remains a state-of-the-art document.

BSI, as one of the leading EU notified bodies and UK approved bodies, can verify medical device manufacturers’ selection of the most efficient conformity assessment routes to achieve CE and UKCA marking.

Find out more about CE marking >
Find out more about UKCA marking >

BSI's approach to excellence

BSI selects and recruits professionals to conduct ISO 13485 audits. Candidates must have design, manufacturing or process knowledge in addition to general knowledge on use of medical devices. Our assessment staff come to BSI with exceptional real industry experience. They then go through rigorous internal training and BSI qualification processes including best practice quality systems auditing techniques, understanding critical manufacturing processes and interpretation of regulatory compliance expectations.

BSI auditors are experts in current state-of-the-art and are constantly trained on new requirements and future changes. BSI is always looking ahead to ensure that our clients are prepared and well placed for future changes to compliance and the regulatory landscape.

What are the benefits of being certified to ISO 13485?

High performing organizations expect ISO 13485 auditing to be thorough, competent, relevant and challenging of the manufacturers' QMS. Effective auditing provides significant benefits for the manufacturer. The beneficial outputs of an effective audit include:

  • Meaningful feedback on the effectiveness of the quality
    management system
  • Confidence in compliance with regulations
  • Identification of areas requiring attention
  • Detection of areas of non-compliance and risk
  • Reporting and certification that is valuable and recognized