ISO 13485

HPA have helped over 4,000 companies get registered to ISO Management System Standards and we can help you too.

Lost cost and certification guaranteed

For a low-cost fixed price, we provide:

• Interest free payments for up to 12 months
• A full service, including design, documentation, implementation support, training and a preliminary audit
• Certification by an independent UKAS accredited assessment body
• Help to get you a Government grant (where available)
• A guarantee: we will support you until you achieve certification at no extra cost

What is ISO 13485?

ISO 13485 is the universally recognised professional management standard for the design and production of medical devices. First published in 2003, with the current version published in 2016, it dovetails neatly into an organisations’ compliance with the most widely adopted management standard in the world, ISO 9001. The first step to attaining full compliance with wider European regulations, ISO 13485 gives your company the right to use CE Marking on medical equipment sold within the European Union. HPA can assist your company in achieving compliance with ISO 13485, together with its sister standard ISO 9001.

What are the benefits of ISO 13485?

Achieving ISO 13485 certification clearly demonstrates your organisation’s commitment to high quality product design and manufacturing procedures. It also shows your company’s ability to adhere to industry recognised management standards. The use of the CE mark on your products shows customers you take quality seriously and will show your company in a more favourable light to the wider business community. The standard positively enhances client and employee interaction with your brand as they will feel a sense of pride in being associated with you. It has been proven that achieving ISO 13485 creates greater working efficiencies, with our clients saying that it has helped them streamline their daily operations, whilst at the same time simplifying management practices and making them more effective. It may also be possible to save money through gaining joint accreditation for both the ISO 13485 and ISO 9001 standards at the same time.

How do you go about fulfilling the elements of ISO 13485?

The elements of ISO 13485 include:

• Context of the organisation
• Leadership
• Planning
• Support
• Operation
• Performance Evaluation

To achieve certification for ISO 13485 your organisation must demonstrate adherence to industry best practice through all stages of a product’s lifecycle, from concept to prototype to manufacture and maintenance.

How do we achieve ISO 13485 certification?

To gain certification to ISO 13485 standard, you must have documented systems and procedures that comply with the Standard, all of which HPA can help you achieve. These must be audited by an accredited third-party assessment body. HPA only recommends using an assessment body registered with the United Kingdom Accreditation Service (UKAS).