ISO 9001 Quality Management vs. ISO 13485 Certification

This article is going to highlight the major differences between ISO 9001 and ISO 13485 Standard. Go through this article to explore the subtle differences between the two.

ISO 9001:2015 was published in 2015. Most of the ISO experts were expecting the new 13485 version to be structured upon the latest version of ISO 9001. However, ISO had been working on the ISO 13485 standard for a long time, and it was about to be published when ISO 9001:2015 was finally published. Therefore, the medical device-manufacturing standard was structured on the previous version of ISO 9001 (ISO 9001:2008). In the present context, it is important to understand which factors are marking the difference between ISO 9001 quality management Standard and ISO 13485. In this article, we will dive into the deeper discussion about the differences between the two.

Let’s begin with five key areas that mark the difference between ISO 9001 and ISO 13485:

• Product Specification
• Regulatory
• Documentation
• Customer Satisfaction
• Continual Improvement

You might be thinking how these five areas are marking the difference between the quality assurance and medical device-manufacturing standard. Let’s have a look at a detailed analysis of each of these five areas.

1. Product Specification

The medical device industry is full of rigid controls. The application of the products has made this industry full with the rigorous controls. The latest version of ISO 13485 Certification (ISO 13485:2016) has highlighted this particular characteristic of the medical device industry. Even, the updated version includes certain sections, which were not included in the previous version. These sections are:

• Medical Device Terminology (3)
• Work Environment (Training and Supervision) (6.4)
• Document Process for Risk Management in the Area of Product Realization (7.1)
• Communication: Advisory Notes (7.2.3)
• Clinical, or Performance, and Evaluation (7.3.7)
• Contamination Control (7.5.2)
• Assessment and Measurement (7.5.8)
• Custom Property (7.5.10)
• Nonconforming Products (8.3)

1. Regulatory

ISO Medical Device Manufacturing Standard intends to maintain balance among numerous regulations related to the quality management systems around the globe. This standard wants the certified organizations to meet the product regulation requirements. What is ISO’s aim behind this requirement? Well, this requirement is to produce safe products having an excellent performance regarding quality. Each organization is expected to adopt the current national and international regulations and audit their business process to demonstrate their compliance with the regulatory requirements. ISO 9001 Standard also demands the regulatory documents; but unlike ISO 13485, these regulatory documents are not confined only to medical devices.

• Documentation

The documentation requirements are heavier in ISO 13485:2016 than in ISO 9001 quality management standard (2008 version). Documents required by the last updated version of ISO 13485 are:

• A File for Medical Device (4.2.3)
• Quality Manual (4.2.2)
• Controlled Document (4.2.4)
• Responsibilities, Authorities, and Interrelation of the personnel (5.5.1)
• Maintenance Activities (6.3)
• Contamination (6.4)
• Communication (7.2.3)
• Customer Feedback and Compliant (8.2.2)
• Advisory Notes (7.2.3)
• Traceability of Purchased Products (7.4.2)
• Service Provision (7.5)
• Documentation of Controls (7.5.1)
• Qualification of Infrastructure (7.5.2)
• Installation Activities

Apart from these, there are many other document requirements in ISO 13485, which are not mandatory in ISO 9001:2008.

1. Customer Satisfaction

ISO 9001:2008 emphasizes the assessment of customer requirements and satisfaction while ISO 13485 insists on monitoring the data to show that customer requirement is met. However, customer requirement is of immense importance both in these two ISO standards.

1. Continuous Improvement

ISO 9001:2008 attaches great importance to achieving continuous improvement while ISO 13485:2016 focuses on maintaining the achieved improvement. Achieving a height of success is good, but it is challenging to retain that level. Therefore, meeting the requirements of ISO 13485 sounds more challenging in comparison to the ISO 9001:2015 requirements related to the continuous improvement.

A Final Takeaway

It is true that ISO has introduced all of its standards to elevate the quality of products, boost the risk-mitigation approach, and maintain the overall performance of an organization. Still, they do have differences. From the above discussion, it is clear that ISO 9001:2008 and ISO 13485:2016 have differences in more than one issue. Therefore, it would be wrong if you take the medical device-manufacturing standard simply as an extension of ISO 9001:2008. The biggest difference is the industries. ISO 9001:2008 is a generalized standard. Any business, regardless of what is its size or industry, can adapt this standard. ISO 13485:2008, on the other hand, is a generic standard. It can be adapted only by the organizations that need to deal with medical device manufacturing or supplying.