ISO 13485 Training Courses in Scotland & UK | QCS International

part of the phsc group

ISO 13485 - Let QCS Help You

iso 9001

"Excellent course, Alistair did well to make the course interesting and supplemented the slides/prepared content with interesting examples from his auditing experiences to demonstrate his points."

ISO 13485 Internal Auditor Delegate

Training courses for ISO 13485 - Quality Management Systems

We provide IRCA and CQI certified ISO 13485 training courses that will help you on your journey towards certification and ensure your auditors deliver positive change to your organisation.  We also offer ISO 13485 training for lead auditor grade, which contributes directly towards achieving the status of a third-party approved body auditor.

Our ISO 13485 courses are led by highly trained and qualified experts who teach in an interactive and engaging manner, making your journey to recognition as easy and rewarding as possible. Our available courses can be viewed on these pages:

As well as in-house and public training courses, we also offer ISO 13485 consultancy services.

What is ISO 13485?

ISO 13485:2016 is the internationally recognised standard for a quality management system applied to the manufacture of medical devices (MD-QMS).

Organisations can be certified to this standard to showcase that their products have been subject to rigorous and detailed processes. The standard covers all aspects of a medical device's lifecycle, including design, development, production, storage, installation, use, servicing, and decommissioning.

Compliance with ISO 13485 is a crucial part of the medical device industry and demonstrated to regulatory bodies that a company has a fully effective QMS in place.

Benefits of ISO 13485 Training

Like other ISO standards, certification may not be compulsory. However, certification to ISO 13485 demonstrates regulatory compliance and provides potential customers, clients, regulators, and other professionals within the supply chain with the level of assurance that they seek before deciding to authorise, purchase, or use your product.

One of the key components of ISO 13485 is the necessity to demonstrate that staff within the organisation are competent to perform the tasks that they are required to do. Having highly competent staff minimises risk to the organisation, the manufacturing process, and the end user. Personnel responsible for the application of ISO 13485 requirements have a particular relevance to the company as they will deliver processes, procedures and advice that will be relied upon to fulfil certification ambitions quickly and successfully.

As the standard places particular emphasis on risk management, having competent staff is one of the key actions to take to address any risks that are identified. Our courses provide guidance on understanding the requirements of the standard and ensuring your internal auditors are competent and deliver results that drive improvement - a key element of ISO 13485.

iso 9001

How to get ISO 13485 Certification

The standard stipulates many and varied requirements that must be all be fulfilled in order to achieve certification. It is likely that an organisation will already be fulfilling some of these  (e.g. mechanisms for maintaining the competency of staff, record keeping of customer requirements/orders, and controls that allow you to deliver the goods/services you provide of the correct type and on time).

However, there are some requirements that organisations will find harder to achieve if they are unfamiliar with quality management or the manufacture of medical device products. Gaining certification requires you to self-examine and to commit to improvement in your organisation’s processes. We can help you with this and train your staff to be able to take your certification forward.

We’ve outlined the steps to ISO 13485 certification below.

The first stage will be to review your current arrangements against the clauses of the standard, highlighting any gaps and what you have to do to gain certification.  We can complete this gap analysis for you and supply you with the training and support to deliver the identified actions.

Some gaps can take several months to fill as a certification body will want to see whatever systems you have are operating and that there is evidence that they have been for some time. The types of things you may have to action include:

  • A review of risks and opportunities and how you manage these (including risks associated with manufacture and the use of the medical device)
  • Setting and delivering key business objectives and targets
  • Introducing robust measures for tracing work flow and your products through the production process
  • A mechanism for maintaining equipment and infrastructure
  • A system for dealing with product failures and rework
  • Internal auditing
  • Meetings and review to monitor progress and decide upon next steps
  • Maintaining the work environment (in particular if this is a sterile environment)
  • Working with suppliers

When ready, you invite a certification body to undertake a stage one and stage two audit of your organisation. Stage one reviews the design, structure and elements of your quality management system and stage two seeks evidence that it is working effectively.

There can be up to several months between the stage one and two audits, but it can be just a few weeks if everything has been set up successfully. If all is satisfactory after stage two, you will be awarded certification. Certificates from UKAS accredited bodies are valid for three years.

Unfortunately, being awarded is not the end of the process. ISO 13485 requires a commitment to continual improvement and maintenance of the effectiveness of your quality management system. Your certification body will develop a programme of audits over three years (the frequency of audits depends on the size of your organisation and the risk profile of your product).  Most small businesses have an annual visit.  If there are no significant findings, or if you can resolve them, then you retain your certificate.  Note, unlike other ISO management system certification you may be subject to unannounced audits.

After three years a review is held and, if you have no major non-conformances that signify deviation from the requirements of the standard, a new three-year certificate will be awarded.

QCS only works with companies that are seeking a certificate awarded by a UKAS accredited body. The United Kingdom Accreditation Service (UKAS) is the only body based in this country that authorises organisations to award fully recognised certification to ISO 13485. Non-UKAS bodies exist but some organisations shall not recognise their certificates (be careful who you get your certificate from and for how long you are tied into a contract). If you are unsure what is best for you, then do get in touch.