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.

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

Medical Device Single Audit Program

MDSAPThe Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as BSI, authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

A BSI MDSAP Audit can also be combined with assessment for CE and ISO 13485.

MDSAP audits can be performed by a recognized MDSAP AO, such as BSI, which has performed MDSAP audits worldwide and issued a significant number of global sites with MDSAP certifications; we are currently processing many more.

Find our more about MDSAP.

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 quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.

Although ISO 13485 certification is not mandatory for CE marking medical devices under the European Medical Device Directives (AIMDD, MDD, IVDD), it is harmonized, which allows the presumption of conformity to the Directives.

ISO 13485 is also not mandatory for CE marking under the European Medical Device Regulations (MDR, IVDR). Although there are currently no standards harmonized to the Regulations, ISO 13485:2016 remains a state-of-the art document. BSI, as one of the leading Notified Bodies for CE marking, can verify medical device manufacturers’ selection of the most efficient conformity assessment routes to achieve CE marking.

Key resources to help your transition to ISO 13485:2016

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