ISO 13485 is an international standard which defines quality management system (QMS) requirements for manufacturers of medical devices. The new version, published in 2016, aims to provide an effective framework for manufacturers to address the strict regulatory requirements of the medical devices industry.
ISO 13485:2016 was originally derived from ISO 9001 and shares many of the basic principles; however, it requires more thorough documentation and places more emphasis on areas such as the work environment, risk management, design control and regulatory requirements. The revised standard now includes:
- A much greater emphasis on the need for a risk-based approach to the QMS
- An enhanced focus on regulatory requirements and the responsibilities of top management
- Increased controls over suppliers and outsourced activities
- More emphasis on risk management throughout the product lifecycle
What we offer
LR provides a wide range of ISO 13485 certification and training services designed to ease your journey towards compliance. We will work closely with you to determine the best options for certification and whether any other assessment would be applicable dependent on regional regulatory requirements.
Gap Analysis - Our gap analysis is an assessor-delivered activity that focuses on identifying the critical, high-risk or weak areas of your system in preparation for certification.
Assessment - Certification is a formal two-stage process which ensures you have a quality system that meets the new requirements.
Training - We provide a range of practical training courses worldwide, in multiple languages. All of which are led by trained and qualified tutors and endorsed by relevant professional bodies.
Our range of ISO 13485 training courses includes:
- Update workshop
- Preparing for ISO 13485 workshop
- Appreciation and Interpretation
- Auditor and Lead Auditor
- Internal Auditor
What are the benefits?
A licence to trade
ISO 13485 certification is quickly becoming an essential pre-requisite for doing business within the medical devices industry. With more and more manufacturers requiring suppliers and service providers to be certified, it has become a viable means to provide a competitive advantage and enhance marketability.
Increased confidence for manufacturers
Patient safety greatly depends on the quality and consistency of medical products. As a result, the value of certification is not just in its implementation, but the higher level of confidence it provides manufacturers in ensuring organisations will consistently achieve and maintain compliance.
A minimised risk for both patients and manufacturers
Certification can help to prevent incidents from occurring – this keeps patients safe and minimises the risk of reputational damage to the manufacturer.
Why choose LR?
LR is accredited by United Kingdom Accreditation Service (UKAS) and Standards Council of Canada (SCC) to provide ISO 13485:2016 certification, and by SCC and Health Canada to provide CMDCAS certification. Our assessors are industry specialists who are matched with your business needs, enabling an effective and robust audit of your system. We’re experts in not only understanding the potential of cutting-edge ideas but applying this pragmatically in ways which guarantee impact today and in the long-term.
Your business helps LR to help others
The profits we generate fund the Lloyd’s Register Foundation, a charity that supports engineering-related research, education and public engagement around everything we do. All of this helps us stand by the purpose that drives us every single day: working together for a safer world.
Independent & Impartial
We maintain our independence and impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services. We will not offer consultancy services for any management system that is in the process of or has completed accredited third-party certification with LR. Further, if we are already providing consultancy services relating to a management system, we will not offer any accredited third-party assessment services.
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