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The quality impact of ISO 13485:2016 on medical device manufacturers.

ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) was published on 1 March 2016.  Two months on, we continue to receive enquiries from medical device manufacturers around the new requirements and how these affect their quality management system (QMS) and their organisations as a whole.

In this second interview, John Howlett, LRQA Medical Devices Technical Manager, shares his opinions on the revised standard and its potential impacts on medical device manufacturers.

Q: What advice do you have for manufacturers planning to get certified to ISO 13485:2016?

John Howlett: Before considering certification to ISO 13485:2016, your company should confirm that the devices you produce fall under the definition of a medical device, or that the services you offer are related to a product classified as a medical device in at least one jurisdiction globally.

Additionally, you should list out your company’s key business objectives, and evaluate whether having ISO 13485:2016 certification can contribute towards achieving them.

As a starting point, you will need to confirm at least one of the following:

  • You are a medical device manufacturer and place products on the market in your own name

  • You design or manufacture medical products for supply to other organisations

  • You carry out activities that are related to medical device manufacturing

The International Accreditation Forum (IAF) has stated that two years from publication, all new ISO 13485 certifications after March 2018 must be to ISO 13485:2016. 

LRQA can verify the requirements relating to your products, and work with you to determine your best options for certification against ISO 13485:2016.

Q: You mentioned in our previous interview that risk management is one of the key changes in the revised standard, but what does it really mean for manufacturers?

John Howlett: Risk management was required within the product realisation process of the ‘old’ standard, but ISO 13485:2016 includes a much greater emphasis on risk management which is shared by the other QMS standards, including ISO 9001.

In the new ISO 13485:2016 standard, a risk-based approach and risk management are incorporated into the QMS itself and emphasised throughout the product life cycle, including outsourced processes.

Manufacturers should expect this increased focus on risk to be challenging, as it is quite different from the current process approach.

Also, though not mandated, ISO 13485:2016 maintains its reference to ISO 14971, so you will want to make sure your workforce is sufficiently up to speed and have a good working knowledge on the standard, which could prove beneficial as it is very likely to impact more people than before.

Q: How important is it for manufacturers to create a quality plan?

John Howlett: If you’re looking to transition to the new ISO 13485:2016 standard, you will at the very least need to write a quality plan.  This will ensure that you have timelines in place and be able to demonstrate to stakeholders the steps you intend to take towards a successful transition.

Now that ISO 13485:2016 has been published, manufacturers can already start developing a transition plan with the help of their Certification Body.  This should ideally include some form of training, and open discussions with your Certification Body regarding any concerns you may have regarding your QMS or the assessment process.  

LRQA offers a range of ISO 13485-related services and can help you determine what would best suit your organisation’s current needs.

Q: This all sounds like a lot of commitment for manufacturers. Would you say a certification audit should be scheduled sooner rather than later?

John Howlett: Yes.  The sooner an organisation can start on transition planning, the better.

With both ISO 13485:2016 and ISO 9001:2015 having been published recently and with the EU Medical Device Directive (MDD) and In Vitro Diagnostic Device Directive (IVDD) scheduled to be revised sometime this year, Certification Bodies and Notified Bodies everywhere are going to be busy and diaries are already being filled.

In addition, the IAF has stated that a three-year transition will apply, so all re-certification audits must be conducted in time to ensure full transition and certification to ISO 13485:2016 is completed by March 2019.

This means that if you are currently holding ISO 13485:2003 certification, you may have slightly less than two years to prepare for transitioning to the new standard.  It therefore makes sense to plan for your certification audit well in advance of when you want to transition.

LRQA will be in a position to offer gap analysis and preliminary assessment services, which can help you estimate realistic timescales to transition based on where your current management system is from the new ISO 13485:2016 standard.

Q: What would you say to manufacturers currently evaluating Certification Bodies purely based on cost?

John Howlett: Whilst the medical devices industry is highly competitive and manufacturers are constantly under cost pressure, it is also a highly regulated industry where the cost of failure often leads to irreparable damage to the company’s brand reputation.

My recommendation is for manufacturers to think long-term beyond just having a ‘ticket to trade’, and bear in mind that it is an investment in the quality and consistency of their products.  

Q: What else should medical device quality and regulatory professionals bear in mind when planning for ISO 13485:2016 certification?

John Howlett: Registrars typically will work with their Accreditation Bodies and submit their plans and procedures associated with the transition process, and assessment of these plans will need to be accepted before any formal transitional audits can be undertaken.

That said, there is nothing stopping an organisation from getting prepared by having sufficient trained resources and going through a gap analysis or preliminary assessment. LRQA offers a range of ISO 13485 assessment and training services that can help organisations through the transition process.

In fact, LRQA recently launched a series of ISO 13485:2016 training courses designed to provide manufacturers an overview of the new and changed areas of the standard as well as an opportunity to identify how their own management systems may need to be adapted to ensure a smooth transition:

ISO 13485:2016 Update Workshop gives an overview of the new and revised areas of the standard. 

Preparing for ISO 13485:2016 caters to the learning needs of those with knowledge of either ISO 13485:2003 or EN ISO 13485:2012, and those responsible for coordinating the transition of their management system to the revised standard.

ISO 13485:2016 Implementation provides companies preparing for ISO 13485 certification with knowledge on how to design and implement an effective QMS based on ISO 13485:2016, and how to improve the effectiveness of an existing QMS.

ISO 13485:2016 Internal Auditor equips participants with best practices of conducting an effective internal QMS audit in accordance with ISO 13485:2016 and ISO 19011:2011, and the necessary skill sets to add value to, and improve, the effectiveness of an existing QMS.

ISO 13485:2016 Appreciation and Interpretation is aimed at helping anyone within an organisation understand the standard and how certification bodies interpret it.

LRQA offers accredited certification to ISO 13485 through United Kingdom Accreditation Service (UKAS) and Standards Council of Canada (SCC). We will be launching more such medical devices-related training courses and transition solutions including Gap Analysis, Preliminary Assessment and Transitional Assessment, to help medical device manufacturers manage their transition to ISO 13485:2016 effectively, and ensure their products are fit for purpose, safe to use and conform to the relevant regulations in their desired markets.


About John Howlett

John Howlett is widely recognised for his expertise within the medical device industry, having had a long career at BSI where he was the medical directives’ Head of Notified Body for more than 10 years prior to joining LRQA in March 2015.  In 2012, John was selected as an expert witness in the UK’s House of Commons Select Committee inquiry into the regulation of medical implants in the EU and UK.  John also participated in a wide range of European and UK medical device committees and has been actively involved in the review and implementation of the medical device directives and associated guidance documents.

About ISO 13485

ISO 13485 is the international standard that defines quality management system requirements for organisations that design and develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. It is derived from the same basic principles as ISO 9001, but places additional emphasis on areas such as documentation, the work environment, risk management, design control and medical device reporting to meet regulatory requirements.

Through our extensive range of training and assessment services, LR is helping organisations worldwide transition to the new and revised ISO standards. 

Please note that as of January 2018, we have moved to the Lloyd's Register brand and retired the LRQA name.

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