ISO 13485 Overview

ISO 13485 defines how an organisation controls the production of a medical device or associated services for one or more stages of the life-cycle of a medical device, including the design and development, production, storage and distribution, installation, servicing, final decommissioning and disposal of medical devices.

Benefits of achieving ISO 13485 Certification

  • Risk reduction

  • Reduction in errors

  • More effective management

  • Stand out from competitors

  • Process improvements

  • Regulatory compliance

Why ISO 13485?

ISO 13485 certification can help you provide your customers with an assurance that your product has been produced under controlled conditions that ensure the medical device, medical device components or associated support services are fit for purpose before release into the marketplace.

Enquire about ISO 13485 certification now
Why ISO 13485?

ISO 13485 Certification Costs

Annual Turnover Cert Cost (£) Annual Cost (£)
Up to £100,000 1,995.00 850.00
£100,000 - £250,000 2,495.00 950.00
£250,000 - £500,000 2,995.00 1,050.00
£500,000 - £1 Million 3,495.00 1,150.00
£1 - £1.5 Million 3,995.00 1,250.00
£1.5 - £2 Million 4,495.00 1,350.00
£2 - £3 Million 4,495.00 1,450.00
£3 - £5 Million 5,495.00 1,550.00
Over £5 Million Subject to separate quotation

Please note: All of the above fees are per certification, based on one location and exclusive of VAT which is chargeable at the prevailing rate. Travel and accommodation are only charged on the UK mainland under exceptional circumstances. Companies from outside mainland UK and multiple sites are quoted separately & may be subject to travel & accommodation costs.

Your ISO 13485 Certification in 6 Simple Stages

Enquire Now
1.

Client Agreement

  • Agree the service you require with respect to ISO 13485 Certification and sign a client agreement
  • Pay 25% of the certification fee as a deposit
  • Book your assessment date and we will email confirmation.
  • CQS will then issue you with a Pre-Assessment Pack of Medical Device Management System documents for you to complete prior to booking your assessment.
2.

Complete Pre-Assessment Documentation

  • Complete the Pre-Assessment Documentation and email to the office for review
  • Your appointed Assessor will review the Pre-Assessment Documentation and your assessment date will be confirmed.
3.

Assessment

  • Audit of your current procedures and working practices
  • Issue of assessment report detailing the findings and areas to be addressed to achieve certification to ISO 13485 Certification
  • Assistance with the issue of template documentation required to meet the requirements of the Standard
4.

Completion of Outstanding Actions

  • Your ISO 13485 Assessment Report will detail actions required in order for you to meet the requirements of the Standard
  • You must implement these actions in the timeframe between your Assessment and your Certification Audit
5.

Completion of Outstanding Actions

  • Further Audit of your Medical Device Management System procedures and working practices to confirm that you have rectified the areas highlighted in your Assessment
  • Discussion to confirm your understanding of commitment required to maintain your certification
  • Certificate and logo presentation upon successful completion of your Audit.
6.

Annual Audit

  • Surveillance Audits of your Medical Device Management System to confirm that you still meet the requirements of the ISO 13485 Standard
  • CQS will issue a new certificate every 3 years upon successful completion of your ISO 13485 audits.

ISO 13485 Implementation Training Courses

CQS (Certified Quality Systems) Limited can provide you with ISO 13485 Implementation Training which can be carried out on your premises or remotely for as many delegates as required.

A training pack on the ISO 13485 standard will be supplied to each delegate on the course and all attendees will receive a certificate on completion.

The course will cover the aims of the Medical Device Quality Management System, quality management principles, risk based thinking, the ISO 13485 clauses and the concepts of planning, performing, documenting, communication, evaluation and follow up activities that need to take place during the Internal Audit of your energy management system. The training provided is a mixture of direct discussion, interactive exercises and workshops which together help to encourage the participation of the attendees.

Internal Audit is a key component in monitoring and measuring the performance of your ISO 13485 Medical Device Quality Management System processes and an effective tool for enabling continual improvement so it is important that the Internal Auditor or Internal Audit Team have the knowledge required to implement this management tool effectively.

Internal Audit is also a useful business tool to help develop the skills of your staff to interrogate other business areas that may not be related to management systems. This course will help to develop the analytical skills of staff members which can be utilised in other areas of your business.

Course Costs
Delegates Cost (£)
Up to 8 450.00
9 - 12 600.00
13 - 15 750.00
15+ Quotation needed
Enquire About Our Auditor Training Course

ISO 13485 Certificate Transfer

If you already have ISO 13485 Certification and would like to transfer your certification to CQS we can carry out this process as follows:-

1.

Assessment

  • Desktop review of your medical device management system documentation
  • Site based Audit of your medical device management procedures and working practices
  • Issue of an ISO 13485 assessment report detailing the findings and areas to be addressed to achieve certification
2.

ISO 13485 Certification Audit

  • Further Audit of your medical device management procedures and working practices to confirm that you have rectified the areas highlighted in your Stage 1 ISO 13485 Assessment
  • Discussion to confirm your understanding of commitment required to maintain your ISO 13485 certification
  • Certificate and logo will be issued upon successful completion of your Audit and payment of 75% balance of the certificate fee.
3.

Annual Audit

  • Surveillance Audits of your medical device management system to confirm that you still meet the requirements of the ISO 13485 Standard
  • Issue new certificate every 3 years upon successful completion of your ISO 13485 annual audits.
Enquire About Your Certificate Transfer