Medical Devices Management

ISO 13485

ISO 13485:2016 the International Quality Management Systems for Medical Devices.

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What is ISO 13485?

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realisation
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems.

How To Get Certified To ISO 13485

 

Helps you with

  • Quality Control
  • Risk Management
  • Legal Compliance
  • Traceability and Recall
  • Process Improvement
  • Product Improvement
  • Operational Efficiency

Benefits of ISO 13485 Certification

Customer satisfaction

Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.

Reduced operating costs

Continual improvement of processes and resulting operational efficiencies mean money saved.

Improved stakeholder relationships

Improve the perception of your organization with staff, customers and suppliers.

Legal compliance

Understand how statutory and regulatory requirements impact your organization and its customers.

Proven business credentials

Independent verification against a globally recognized industry standard speaks volumes.

Ability to win business in regulated sectors

Certification helps to win business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.

Improved risk management

Greater consistency and traceability of products and services means problems are easier to avoid and rectify.

Steps to Certification

  1. Step 1

    Complete a Quote Request Form so that we can understand your company and requirements. You can do this by completing either the online quick quote or the online formal quote request form. We will use this information to accurately define your scope of assessment and provide you with a proposal for certification.

  2. Step 2

    Once you’ve agreed your proposal, we will contact you to book your assessment with an NQA Assessor. This assessment consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.

  3. Step 3

    Following a successful two stage audit, a certification decision is made and if positive, then certification to the required standard is issued by NQA. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and is maintained through a programme of annual surveillance audits and a three yearly recertification audit.

See more details

Medical Devices Toolkit

ISO 13485 Transition Checklist

Download Certification Logos

ISO 13485 Transition Gap Guide

Gap Analysis

Ready to start your journey?

We'll give you a clear indication of the costs of gaining and maintaining certification.
Not ready yet? Call us on 01819 227535 or request a callback to discuss your certification requirements.