ISO 13485 Medical Devices

ISO 13485:2016 Certification – Medical Devices Quality Management Systems

Requirements for Regulatory Purposes for Medical Device Manufacturers and the Supply Chain     

Poor management of processes at any element within the medical device life-cycle – from design and development to production, storage and distribution, installation, or servicing of a medical device and design and development or the provision of associated activities such as technical support – can have dire consequences resulting in inconsistency in the quality of products, where non-conforming devices can filter through the production line and into the market.

However, when quality management processes are adequately managed under an ISO 13485:2016 certified quality management system, medical device manufacturers and their supply chain are better equipped to help ensure that quality system requirements positively influence and protect all phases in the medical device life cycle.

What is ISO 13485:2016?

ISO 13485 is the international standard that defines quality management system requirements for organizations that are or may be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device, and design and development or provision of associated activities such as technical support. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services to such organizations.

The 8 quality management principles of ISO 13485:2016 include:

ISO 13485-2016 Flowchart

ISO 13485:2016 also provides an effective base model for compliance with:

  • European Medical Devices Directive (MDD) 93/42/EEC
  • European In Vitro Medical Devices Diagnostic Directive (IVDD) 98/79/EC
  • Canadian Medical Devices Regulations SOR/98-282
  • Medical Device Single Audit Programme (MDSAP), and
  • Requirements of other regulatory bodies in countries around the world

View ISO 13485:2016 Infographic!


ISO 13485:2016 vs ISO 9001:2015

Annex SL provides the basic structure for the majority of ISO Management System Standards, such as ISO 9001:2015; however, ISO 13485:2016 is not based on the Annex SL framework. Some of the major differences between ISO 13485:2016 and ISO 9001:2015 include:

  • Scope of Each Standard
  • Structure (8 versus 10 Sections)
  • Organization context
  • Documentation requirements
  • Planning: consideration of risks and opportunities
  • Process approach
  • No management representative clause in ISO 9001:2015
  • No quality manual clause in ISO 9001:2015
  • Performance evaluation
  • Improvement

Benefits of ISO 13485 Certification

ISO 13485:2016 certification from LRQA provides organizations a process-based approach towards developing, implementing and improving the effectiveness of a quality management system in order to meet customer and global regulatory requirements.

When applied to the manufacturing process, ISO 13485:2016 certification helps ensure strict quality assurance criteria on every aspect of production, resulting in a tightly controlled manufacturing system that reduces the likelihood of non-conforming products. This provides consistency in product quality and provides a solid basis for greater reliability in device safety and performance.

Perhaps the most critical advantage of ISO 13485:2016 is that it represents a preventive approach to assuring medical device quality as opposed to a reactive approach to inspection and rejection at the end of the manufacturing line.

In addition, ISO 13485:2016:

  • Is recognized globally as the best quality management practices within the medical device industry.
  • Meets regulatory requirements in many countries, as well as contractual obligations of many organizations, enabling you to do business with new customers.
  • Helps create a systematic framework in which organizations monitor, measure and analyze their processes and customer feedback.
  • Helps provide a framework for implementation of actions (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements.
  • Can provide improved performance in areas such as sales, product delivery, and process efficiency.
  • Can reduce costs as a result of minimizing product failures.

Why Choose LRQA for ISO 13485:2016 Certification?

  • Client focus and proven client satisfaction – LRQA shares the same objectives as our clients - to help ensure safe and compliant products into the market in an expedient manner, thereby protecting consumers as well as the brands and reputations of our clients. LRQA medical device clients report a 92% satisfaction rating across key areas of our service.
  • Accessibility to technical expertise – LRQA medical device experts are industry specialists who are available at any time and are only a phone call, text message or email away. Our medical assessors have some of the most extensive ISO 13485 experience in the world. Many are hand-selected to provide input into the work of the ISO technical committees and are able to provide first-hand insight into requirements of the standard and the standard’s logic. In addition, LRQA has a distinguished team of microbiologists who assess compliance within the sterile products area as part of a routine QMS assessment.
  • Globally recognized and accredited – LRQA is one of the world’s leading Notified Bodies, recognized for our technical contributions to industry regulations and standards development. More than half of the world’s top 200 companies choose LRQA. Around the world, LRQA has been independently accredited by multiple accreditation bodies to provide ISO 13485 certification.
  • Impartiality and objectivity – With no shareholders of our own, we are independent and impartial in everything we do. We are committed to acting with integrity and objectivity at all times.
  • Assessment methodology – LRQA helps you manage your systems and risks to improve and protect the current and future performance of your organization. Our approach is built on three pillars and extends the focus beyond the certificate to an assessment approach designed to help organizations meet their strategic objectives.
  • Extended range of services – We offer you direct access to electrical safety testing, usability testing and much more.

Transitioning from ISO 13485:2003 to ISO 13485:2016

LRQA is ready to support your certification transition from ISO 13485:2003 to ISO 13485:2016. Contact us today to discuss how we can help you with a Gap Analysis, Preliminary Assessment, Training and Transition.

Contact us to learn more about ISO13485:2016 certification and training

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