ISO 13485 Quality Management System

EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. ISO 13485 requires organisations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in.

ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance. Therefore, ISO 13485 includes particular requirements for organisations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate. This makes it more prescriptive in nature and requires a more thoroughly documented QMS.

ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices. Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, so ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements.

It can also help to minimise any surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.

An ISO 13485 certification gives both suppliers and service providers the opportunity to greatly enhance an organisation's marketability as more and more manufacturers require certification in order to do business with a vendor.

ISO 13485 is the internationally accepted standard a medical device organisation can implement to demonstrate compliance with MedTech legislations.

Obtaining an ISO 13485 Certification with BSI ensures worldwide recognition for your organisation compliance with ISO 13485 requirements.

It also represents a solid starting point if you are thinking of applying for MDR, IVDR or UK MDR:

• European Regulations: (MDR) (EU) 2017/745 and (IVDR)(EU) 2017/746
• UK Regulation: UK MDR 2002

BSI has a very selective recruitment process for the professionals we hire to conduct ISO 13485 audits.

Candidates must have suitable qualifications and sufficient background and knowledge of medical devices design, manufacturing and application of the device technology.

Our assessment staff come to BSI with exceptional real industry experience. They then go through rigorous internal training and BSI qualification processes including best practice quality systems auditing techniques, understanding critical manufacturing processes and interpretation of regulatory compliance expectations.

BSI auditors are experts in current state-of-the-art technology and are constantly trained on new requirements and expected future changes. BSI is always looking ahead to ensure that our clients are well informed of future changes to compliance and the regulatory landscape.