What is ISO 13485?
ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Benefits of Certification
- ✔Meet global medical device regulatory expectations
- ✔Support CE marking and market access
- ✔Reduce risk across the device lifecycle
- ✔Improve traceability and documentation control
- ✔Build trust with healthcare customers and regulators
Scope
For organisations involved in the design, production, installation and servicing of medical devices, and providers of associated services.
Who it applies to
- ●Manufacturing & engineering
- ●Construction & infrastructure
- ●IT & software services
- ●Automotive & aerospace
- ●Professional & B2B services
- ●Trading & distribution
What the scope covers
- ▸Design, development and delivery of products/services
- ▸Procurement and supplier control
- ▸Production and service provision
- ▸Customer requirements and satisfaction
- ▸Monitoring, measurement and internal audit
- ▸Corrective action and continual improvement
Key Requirements
- ▸Risk management throughout product realisation
- ▸Design and development controls
- ▸Rigorous documentation and record control
- ▸Cleanliness and contamination control
- ▸Traceability and device identification
- ▸Regulatory and post-market requirements
Certification Process
- 1
Application & Quotation
Submit your details and receive a tailored, fixed-price quotation based on scope, sites and headcount.
- 2
Gap Analysis (Optional)
An optional pre-audit review identifies gaps between your current practices and the standard.
- 3
Stage 1 Audit
Documentation review to confirm your management system is designed and ready for assessment.
- 4
Stage 2 Audit
On-site (or remote) assessment of the implementation and effectiveness of your system.
- 5
Certification Decision
An independent technical review leads to the certification decision and issue of your certificate.
- 6
Surveillance & Renewal
Annual surveillance audits maintain your certification over the three-year cycle before recertification.
Documents Required
- 📄Company registration / incorporation details
- 📄Organisation chart and list of sites
- 📄Scope statement of activities
- 📄Management system manual / documented information
- 📄Key policies and procedures relevant to the standard
- 📄Records demonstrating implementation (audits, reviews, training)
Frequently Asked Questions
How long does ISO 13485 certification take?
Typical timelines range from 4 to 12 weeks depending on the size of your organisation, the number of sites and how mature your existing management system is.
How long is a ISO 13485 certificate valid?
Certificates are issued for a three-year cycle, subject to successful annual surveillance audits, after which recertification renews the cycle.
Can the audit be conducted remotely?
Yes. Where appropriate, UKCTL can conduct Stage 1 and parts of Stage 2 remotely, combined with on-site verification as required.
Is ISO 13485 certification accredited?
UKCTL issues accredited certificates recognised internationally, giving your customers and stakeholders confidence in the assessment.
Get ISO 13485 certified with UKCTL
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