ISO 13485 Standard for Medical Devices: Everything Explained

Medical devices or products contribute towards the wellbeing of people by making treatment and care services safe, easily accessible, and more reliable. Naturally, the manufacturing of medical devices needs immense administration and experts’ handling to ensure they are designed to meet the absolute needs of the patients and doctors in the treatment process. For this, most responsible manufacturers have one thing in common—they all align their product designing and development procedures with ISO 13485 medical devices standard. It is the world’s most recognised standard known to specify regulatory requirements for maintaining a quality management system (QMS) of medical devices. 

Here are some of the key details of the standard including how it helps manufacturers to enhance the effectiveness of their QMS.

ISO 13485 Standard Definition

As a standard meant for medical devices manufacturing, ISO 13485 focuses on the requirements of an effective QMS, which helps ensure quality products and services. Typically this standard provides a harmonised model for formulating a QMS and maintaining quality control processes, all of which aim at safe design, manufacture, and delivery of medical devices.  

In addition to being a QMS regulatory framework, ISO 13485 also helps medical device manufacturers to minimise variations in their processes, maintain consistency in products, and keep up with customer expectations. This in turn provides manufacturers with economic advantages which can include creating a steady customer base and flow of income.

Manufacturers of Which Countries Can Obtain ISO 13485 Standard?

Manufacturers of medical devices in all over EU (European Union), USA, Canada, Australia, Japan and many other nations worldwide can get compliant with ISO 13485 requirements. This standard is actually applicable to all 165 countries who are members of the ISO (International Organisation for Standardisation).

In What Ways ISO 13485 is Different from ISO 9001?

This question arises since both are standards for QMS. However, we all know that ISO 9001 is a widespread and encompassing standard which specifies the general requirements of QMS focusing on customer satisfaction and continuous quality improvement. ISO 9001 standard applies to almost all businesses, irrespective of products or services they provide. However, it is not fitting for medical devices companies because its requirements are quite subjective. Thereby, meeting those requirements is a bit challenging for them.

ISO 13485 sets out specific metrics for quality performance which companies need to meet with their QMS. The metrics are associated with maximising customer satisfaction, reducing inefficiencies, and improving the competence of QMS.

Some significant areas where ISO 9001 and ISO 13485 differ are:

• Documentation requirements for QMS procedures
• Work environment requirements
• Production requirements for maintaining cleanliness, sterilisation of products
• Requirement related to compliance of medical regulatory authorities

Who is Eligible for ISO 13485 Certification?

Organisations, manufacturers, research institutions and pharmaceutical companies that deal with design, production, or testing of medical devices are eligible to get this ISO standard.

All of them have to implement a cohesive QMS that meets every ISO 13485 requirement and maintains it effectively. An authorised certification body will conduct an audit, and once they ensure that their QMS is compliant with every requirement, they will issue the certificate which will be valid for three years.  

Key Steps to Certification

1. Implementation of QMS is the first step. A medical manufacturer may hire assistance from ISO consultants for that. They will help to understand the requirements of the standard, document a QMS based on them, and plan ways to implement it.
2. Internal auditing is the next crucial step. Professional auditors from a hired agency will review your QMS and ensure that everything is in compliance with ISO 13485. They will also help to recognize any flaws or weaknesses in your QMS, which otherwise might remained undiscovered.
3. Formal management review by top management officials of the company is done next to ensure the QMS is effective enough in meeting their quality objectives and customers’ requirements.
4. Corrective actions is next. After the reports of the internal audit as well as management review, the company needs to plan for corrective actions or improvements in QMS accordingly.

In summary,  the ISO 13485 medical devices standard is meant to assure best-in-class quality products with safe usability in the medical sector. Every manufacturer of medical devices must aim to achieve this ISO standard to ensure creation of a QMS that helps deliver quality and reliable devices.