ISO 13485 certification for medical device businesses
ISO 13485 is the quality management standard for medical devices. If you make, distribute or service devices and want to supply the NHS or other healthcare buyers, it is often the first thing they ask for.
Why we understand medical device suppliers
Jürgen Visser runs 1 Stop Medical Supplies in Northern Ireland, a supplier on NHS Supply Chain's Laboratory Diagnostics, Point of Care Testing and Pathology Managed Services framework (Lot 4).
That gives first-hand experience of the quality and compliance questions NHS buyers put to suppliers.
What ISO 13485 covers
Risk management across the product life cycle, design and development controls where relevant, purchasing controls, traceability, complaint handling and regulatory requirements.
Who needs ISO 13485
Manufacturers, importers, distributors and service providers of medical devices, including suppliers bidding for NHS and UK Government healthcare contracts.
How we get you certified
Free first call. We look at what you do, which contracts you want and what you already have in place.
Gap review. We compare how you work now with the standard and list what is missing.
A system built around your business. We write the procedures, records and policies with you, based on how your team already works.
Training and internal audit. Your team learns what the auditor will ask. We run an internal audit and a management review.
Certification audit. An IAF-accredited certification body audits your system and issues the certificate.
Timescale
ISO 13485 certification typically takes 4–8 weeks. Businesses that design devices may need longer than distributors, so we confirm your timescale after the first call.
How our fee works
One fixed fee, agreed before we start, including the certification body's audit fee. Ask for a quote.
Who certifies you
Certification is issued by Assurance Quality Certification LLC (AQC World), a certification body accredited by UAF and EGAC. Both are members of the IAF, so your certificate is IAF-accredited. AQC World's accreditation covers ISO 13485.
Frequently asked questions
Is ISO 13485 the same as a UKCA or CE mark?
No. ISO 13485 is a quality management system certificate. Product marking has its own regulatory route. A certified ISO 13485 system is often part of the evidence for it.
We only distribute devices. Do we still need ISO 13485?
Many buyers ask distributors for it. The scope can be set to match what you actually do.
Are annual audits included?
No. Our fixed fee covers getting you certified. Annual surveillance audits and recertification are quoted separately. We send you each quote 3 months before the audit is due, so there are no surprises.
Is IAF-accredited certification accepted for UK tenders?
IAF-accredited certificates are recognised internationally through the IAF agreement. Some buyers name UKAS in their tender documents, so we check the wording of the tenders you are targeting before you commit.
Talk to us about ISO 13485 for your medical device business. Email info@kingmakerconsulting.co.uk or call M: +44 7395 304625 | WhatsApp: +27 82 214 8106