The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016 [Part 1]

It has been more than 6 years now that ISO 9001 has been using the High-Level Structure (HLS) as outlined in the ISO/IEC Directive, Part 1. There have not been any significant problems created by the divergence of the two standards. In this update we will discuss the current activities by both Technical Committees and other activities by the ISO organization and others that could be of significance.

While there are still many people that focus on the differences, it is clear that the standards continue to be used alongside each other without significant issues as there remains no direct conflict between the requirements.

The following is a summary of the primary differences between these two Quality Management standards.

Structure:

While there are obvious differences in the structures of the two revised standards, this does not lead to distinct differences in the requirements. ISO 9001:2015 uses the structure specified in the ISO/IEC Directive, Part 1 (Annex SL) while ISO 13485:2016 continues with the structure developed in the previous versions.

Scope:

One of the biggest differences between the two standards begins with the scope statements. The scope of ISO 9001 defines it as a general and generic standard for all quality management systems while the scope of ISO 13485:2016 is specific to the medical device sector and those related services.

Focus:

One big difference between the standards that is driven by the difference in scope is the primary focus of the results. The general nature and industries that use ISO 9001:2015 are driven by customer focus and making the correct risk-based decisions to drive customer satisfaction. Meanwhile, the focus of ISO 13485:2016 is primarily driven by the need to ensure that the medical devices placed on the market by organizations are safe and effective and meet regulatory requirements.

Required Processes:

While ISO 13485:2016 maintains the requirements to document key processes and the related documentation in a quality manual and other processes, ISO 9001:2015 has taken a distinctly more flexible approach of allowing an organization to determine the documented information required to be maintained to ensure consistent results without directly stating the required documented information.

Personal Identification:

The flexibility of ISO 9001:2015 allows top management to assign responsibilities and authorities without defining any required roles. This is similar in ISO 13485:2016 except the requirement to specifically identify a Management Representative is retained.

Product Realization:

ISO 13485:2016 continues the strong emphasis on design and development as a key process within product realization. However, ISO 9001:2015 shifts this emphasis to the identification of operational processes to deliver product.

Continual Improvement:

ISO 9001:2015 continues an emphasis on continual improvement to both enhance customer satisfaction and improve the processes of the organization. Meanwhile, ISO 13485:2016 maintains the need for organizations to focus improvement activities on the continuing suitability, adequacy and effectiveness of the quality management system and the safety and performance of the medical device.

Look our for part two of our discussion in the coming weeks where we discuss the similarities between the two Quality Management Standards and summarise our thoughts on the topic.