Medical Devices Management

ISO 13485

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



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What is ISO 13485?

What is ISO 13485?

ISO 13485 is the medical industry's optimal device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

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.

This standard allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognized standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognized as more reputable, trustworthy providers. The most recent version of ISO 13485 is reviewed every five years and revised according to new requirements and needs of the industry.

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.

The standard contains specific requirements for manufacture, installation and servicing of medical devices 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.

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.

Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing.

Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management where ISO 9001 removed this in many aspects. Interestingly ISO 9001 has a lot more requirement for monitoring external providers for performance than the old version and this is something always required by ISO 13485.

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

ISO 13485 certification is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

Your Questions Answered

What does it mean to be ISO 13485 certified? A higher level of quality control is achieved than ISO 9001 alone and closer matches the requirements for a QMS needed in the EU and UK medical device regulations. It also may carry more favour with medical device manufacturers if you have the standard as a supplier of components for them.

Is ISO 13485 mandatory? No but as above it closer meets requirements in the regulation and may better meet requirements of your customers if they manufacture medical devices. 

What’s the difference between EN ISO 13485 and ISO 13485? EN is the Euro Norm, effectively the only difference is the inclusion of the Z Annex which highlights which of the regulation elements the standard helps to achieve. 

What is a Class 3 medical device? Class III medical devices are the highest risk level of medical device and typically include devices that support or maintain life. These require a notified body to review the technical file and permit sale by application of a CE mark, amongst other activities. 

Why is ISO 13485 important? To implement a QMS with a higher level of control, focus on safety and tougher requirements and standards which can benefit manufacture of medical devices, or components for them.

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.

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