Home/Medical Device Industry, Quality, Standard/Medical devices — Quality Management Systems

Medical devices — Quality Management Systems Certification

Demonstrate your ability to consistently meet customer and applicable regulatory requirements.

ISO 13485:2016 is a standard that focuses on the importance of the lifecycle of a medical device, including its design, development, production, storage, distribution, installation, servicing and final decommissioning. The standard is designed to assist organisations in focusing their management system and therefore practices on strengthening its risk management approach and meeting regulatory requirements.

Demonstrate your ability to consistently meet customer and applicable regulatory requirements

In the medical devices industry, safety and quality are non-negotiable. Regulatory requirements are increasing at every step of a product’s life cycle and public scrutiny is intensifying.

ISO 13485 is the internationally recognized industry-specific standard for quality management systems. It is designed and intended for organizations involved in related to design and development, production, installation, servicing and sales of medical devices.  A certified organization proves its ability to provide medical devices and that related services consistently meet customer and applicable regulatory requirements.

Benefits of becoming certified

While beneficial for any manufacturer, ISO 13485 implementation and certification is a very good starting point for companies seeking to enter the medical device industry. In particular, certified companies can:

  • Improve ability to contract with larger companies;
  • Improve internal processes and decision-making;
  • Create a culture of continual improvement;
  • Demonstrate commitment to safety and quality;
  • Prove ability to meet customer and legislative requirements.


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 harmonised medical device regulatory requirements. 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

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 the new requirements and needs of the industry.

Global recognition as a reputable supplier

Certification is recognized internationally and accepted throughout industry supply chains, setting industry benchmarks for sourcing suppliers.

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.

Legal Compliance

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

What is ISO 13485 ?

ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities as well as demonstrating their commitment to safety and quality. As a quality management system standard, it is not product specific, but covers processes relevant to the production of medical devices and related services.
Legal market access for products is essential for medical device manufacturers. National regulations often require ISO 13485 as part of the approval process for medical devices.


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.


Step 2

Once you’ve agreed your proposal, we will contact you to book your assessment with an WECERT 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.


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 WECERT. 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.