ISO 13485 - Quality Management System for Medical Devices

What is ISO 13485?

ISO 13485 the specialised standard for Quality management systems specific to the medical device industry. This standard is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

By providing a framework for establishing and maintaining quality systems, ISO 13485 helps organizations improve customer satisfaction, reduce operating costs, and improve risk management.

Once certified, organisations can proudly promote themselves as certificate holders in any of their promotional materials and can include the URS certification logo free of charge.

Who requires an ISO 13485 certification?

Organisations involved in the design, production, installation and servicing of medical devices are required to have an ISO 13485 certificate. This includes:  

• Manufacturers


• Suppliers of components to medical device manufacturers


• Companies providing services relating to medical devices

How can ISO 13485 benefit your business?

Becoming certified for ISO 13485 can bring a wide range of benefits to your organisation, including:

 

• Facilitating market access


• Ensuring your organisation meets global regulatory requirements


• Improving process efficiency


• Identifying and mitigating risks


• Reducing costs


• Enhancing customer trust

How can you prepare for an ISO 13485 Certification?

Although the thought of starting the certification process may seem daunting, there are a variety of steps you can take to make the process to becoming certified far more streamlined:

• Familiarise yourself with the ISO 13485 standard and the requirements involved


• Appoint a management representative to oversee the implementation and maintenance of the QMS


• Conduct a gap analysis to identify areas for improvement


• Develop a quality policy that outlines your organisations commitment to the standard requirements


• Provide training for staff members to ensure that all employee competence meets the standard requirements


• Carry out internal audits to identify any further areas for improvement

What are the key requirements ISO 13485?

When working towards becoming certified for ISO 13485, there are various areas that will be a focus during the audit. These areas include:

 

• Establishment of a QMS


• Resource management


• Risk management


• Quality objectives


• Legal requirements


• Complaint handling

What clauses make up the structure of ISO 13485?

ISO 13485 consists of eight separate clauses which, in turn, outline the QMS requirements that must be met by any organisation involved in the production of medical devices and related services. These clauses are:

Clause 1-3 – Introductory Clauses

The first three clauses in ISO 13485 serve as an introduction to the standard and outline the scope, normative references and the terms and definitions. This also includes a brief exploration of the standard’s history, approach and compatibility with other standards.

The five remaining clauses cover the mandatory requirements for the Quality Management System.

Clause 4 - Quality management system

Clause 4 tackles two important aspects of the Quality Management System; the General Requirements, and the Documentation Requirements.

The general requirements address areas such as adhering to the standard, considering risk factors, and ensuring procedures are in place. Whereas the document requirements focus on the creation of policies, records and objective statements and the means of controlling documents and records related to the QMS.

Clause 5 - Management responsibility

This clause outlines what is expected from Top Management in relation to implementing and maintaining a quality management system. This includes their commitments, customer requirements, and their overall responsibilities. In addition, requirements for planning and management reviews are also covered in this section.

Clause 6 - Resource management

A requirement of ISO 13485 is to ensure that the correct resources are available to the organisation in order to function. Clause 6 summarises the types of resources that may be required and exhibits the requirements for each.

Clause 7 - Product realization

In this section of the ISO 13485 standard, requirements for the processes used during product development are outlined. Involved processes include those that are related to customers, design, development, purchasing, production, service provision and monitoring.

Clause 8 - Measurement, analysis and improvement

Clause 8 covers the processes that are required for monitoring an organisations QMS once a product has been manufactured and released. The main aspects of monitoring include feedback, complaints, regulatory authorities, internal audits, nonconformities and improvements.

How long will your ISO 13485 certificate be valid for?

Your ISO 13485 certificate will be valid for at least three years; dependent on the type of site that is being certified.  

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