Here are the following stages to becoming and staying certified to ISO 13485:
1. Establish a system that complies with the standard
2. Understand how the Medical Device Regulations [MDR] affect you.
3. Complete a technical file for each product
4. Brief staff
5. Operate the system to make sure it is working correctly
6. Carry out internal audits and management reviews
7. Appoint a “notified body” to audit you against the standard and the MDR
8. Keep using the system once it has been certified (to keep the certificate)
There is more detailed information below about the various stages you need to go through.
There are the following costs that will arise
Episode always gives a fixed fee proposal for a project, and we include guaranteed certification. A typical project is about £9,500, but this does depend on the size and complexity of your business.
You will need an external company certify the system as being compliance with the standard. There are a few notified bodies in the UK (see here) and the costs will be in the region of £8,000 to £10,000.
Sometimes, but rarely, you may have to invest in things such as having machinery serviced &/or calibrated.
For a fixed cost we will do as much of the work as possible, and guarantee certification.
Episode has worked with over 40 clients, many of whom have more than one standard they comply with (one has 5). All have been successfully certified and many subsequently ask us to help them maintain certification, and get more out of the system.
The standard and MDR are detailed requirements to work though and comply with. It is difficult to give precise timescales, as it depends on a number of things such as how complex the business is, how close you are to complying with the standard already, and so on. We recommend planning for it taking at least 6 months.
Done wrong, absolutely. Too many systems we see have a form or document to cover every aspect of the standard. That’s the easy way to build a system, and an equally easy way to cripple you operationally. You know when this is the case when you spend a month “updating” (i.e. creating false) records, etc. before the auditor next comes.
Done right, as we will make sure it is, the system should be at the core of how you work. Remember, we make ISO work for you, not the other way around.
The standard is written to help you arrive at your business strategy, if you haven’t already, and then tailor systems and processes to achieving that strategy. ISO even considered renaming ISO 9001 Business, rather than, quality, management systems. It is actually a really good business model to adopt (we have).
ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, is a stand-alone QMS standard, derived from the ISO 9001 quality management standard. ISO 13485 adapts the ISO 9001 process-based model for a regulated medical device manufacturing environment.
While ISO 13485 is based on ISO 9001, it is designed for regulatory compliance. It is therefore more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
There is an emphasis on risk management and risk-based decision making for processes outside the realm of product realisation. The focus is on risks associated with the safety and performance of medical devices and compliance with regulatory requirements. In addition, the standard asks companies to be very stringent when it comes to outsourcing processes by putting into place controls, such as written agreements, for assessing their suppliers – again based on risk. 6
ISO 13485 also reflects the increased regulatory requirements for organisations across the medical devices supply chain.
It was only by utilising the expert guidance and experience of Episode that Thurston Group was able to attain certification within an exceptionally challenging time frame. We therefore offer our thanks to Episode Ltd. For the diligent and professional services provided. We also look forward to working with them again soon and would not hesitate to recommend their services."
Peter Spieight, Senior Divisional Director, Thurston Group, Wakefield
Roger's support was invaluable in terms of gap analysis, recommendations for improvement, and facilitation of the certification process. I would strongly recommend Roger to any organisation wishing to develop or improve its management systems, in a way which minimizes bureaucracy, and focuses on best serving the needs of the organization.
Gary Evans, Flour Corporation, Abu Dhabi
Harvey Mills, Managing Director, Forge Recycling, Leeds.
If Sandy hasn’t already updated you we are delighted to say we passed the transition audit for ISO 9001 and ISO 14001. Sandy did an absolutely fab job and all credit to her, we have loved having both of you here it’s been a pleasure.
I have had a brief chat with Morgan[the CEO] about the next steps and how we manage things going forwards. Morgan will be in touch with you soon about this and getting Episode/Sandy back in on a regular basis. Once again many thanks for everything and especially to Sandy!!
Morag Tearne, HR and Health & Safety Manager, H. Slingsby plc, Shipley
Episode is always prepared to go the extra mile. When in a tight spot the lead consultant carried out an audit for us at very short notice (on a Sunday afternoon) to keep us on track. What is important to us is the advice they give us is practical and tailored to us. The quality of output Episode produces is very high.
This has resulted in us having a multi-year managed service from Episode so as a company we know our ISO 9001, ISO 14001 and ISO 45001 integrated system is up to date and working for us.
Gareth Walters, Financial Controller, Sports Turf Research Institute, Bingley.
When asked by Episode what three things they do well, and what three things they could improve upon, my answers were:
1. Client Communication, responded to queries very quickly
2. Requirements of the standard were communicated in a simple manner.
3. Assistance from initial implementation to date of assessment was very good.
I can honestly there is nothing I feel they should improve upon.
Paul Hunneybell, Operations Manager, Fenland Fire Contracts Limited, Luton
The consultant worked with the team in Scott Bader Middle East Ltd. to completely re-engineer our Integrated Management System incorporating ISO 9001, ISO 14001 and OHSAS 18001. Until then we were slaves to the ISO audits, with the systems not adding much value beyond certification. Now we have a business management system that really works for us and is truly integrated into our operations. We were also successfully re-certified along the way.
John Kemp, CEO Scott Bader Middle East, Africa and Asia
The consultant really focused on making our systems and processes work better for us, not just help us comply with ISO 9001. He was able to work with Department Heads and Senior Management to shape their strategic thinking about quality and business objectives without telling them what they had to do because the standard says so.
Karim D'Alessandro, HSE Director, Shelf Drilling Inc.