ISO 13485:2016 and ISO 9001:2015: Are They Aligned?

September 13, 2016

Decades ago, the concept of alignment didn’t arise often. There were not enough widely adopted industry standards to worry about alignment. But today we are moving in the right direction with the widespread – often required – use of global standards. Now we need to consider alignment when we compare revised versions of standards against their predecessors or related standards.

What do we mean by alignment?

A traditional dictionary definition of alignment is “the proper positioning or state of adjustment of parts … in relation to each other” (Merriam-Webster). When we talk about the alignment between different quality system standards, the parts may include their intent, structure, and/or contents.

Are ISO 9001:2015 and ISO 13485:2016 aligned?

Short answer: No. Longer answer: From a high-level perspective, the standards now differ in intent, content, and structure.

A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016

Intent: Not fully aligned

The standards share one ultimate goal: Both ISO 9001:2015 and ISO 13485:2016 specify quality management system (QMS) requirements by which an organization must demonstrate that it can consistently provide products and services that meet customer and statutory/regulatory requirements.

ISO 9001, however, adds enhancing customer satisfaction and continual improvement as goals. As ISO 13485 has matured, it has moved way beyond ISO 9001. For the 2016 version, one objective of the working group that developed the new standard was to ensure ISO 13485 would better support the global alignment of regulatory requirements for medical devices.

Content: Not fully aligned

ISO 9001 specifies requirements that are generic so that any organization, regardless of the products or services it provides, can use the standard. ISO 13485 specifies requirements for organizations involved in one or more stages of the medical device life cycle. To a large extent, ISO 13485 keeps the fundamentals of quality management systems we see in ISO 9001, adding or subtracting, where appropriate, requirements that are/are not relevant to medical devices.

Both standards now feature more robust Introductions that clarify topics relevant to their respective users. As an example, ISO 9001 addresses the new risk-based approach to the QMS, while ISO 13485 notes factors that can influence the design and implementation of a QMS, such as an organization’s objectives or the products it provides. Of particular importance is the “Clarification of Concepts” section of the Introduction to ISO 13485. It includes a statement that says “when a requirement is qualified by the phrase ‘where appropriate,’ it is deemed to be appropriate unless the organization can justify otherwise.”

There are also more definitions in ISO 13485, which makes sense when you consider that ISO 13485 serves a distinct, high-risk industry: medical devices.

Structure: Somewhat aligned

While ISO 13485:2016 maintains the same structure of its prior version (based on ISO 9001:2008), the new structure of ISO 9001:2015 has an entirely fresh look and feel.

ISO 9001:2015 is based on Annex SL, which is intended to provide a uniform frame for writers to use when developing or revising standards. One goal of Annex SL is to support consistency in the writing of standards to make it easier to integrate multiple systems (e.g., quality, environmental, or safety).

The 2016 edition of 13485 does not follow the Annex SL structure, but it is possible that future editions of ISO 13485 may do so.

Below, a visual comparison between the two structures:

Source: Oriel STAT A MATRIX

The use of different structures eliminated the need to use italicized text in ISO 13485 to identify additional requirements beyond ISO 9001. The former “ISO 9001 + additional requirements” approach is replaced by a “stand-alone” approach. This independence is appropriate considering the difference in context between the two standards, as the 2016 edition of 13485 wants to facilitate the global alignment of regulatory requirements.

We maintain that ISO 9001:2015 and ISO 13485:2016 are not as aligned as you may have heard. Organizations holding certifications to both standards need to identify and address these differences as they upgrade to the most current versions of the standards.

Oriel STAT A MATRIX is available to assist organizations of all sizes in addressing the risk requirements, needed documentation, and regulatory compliance necessary for transitioning to ISO 13485:2016.

Interested in learning more about ISO 13485? Consider our ISO 13485 and FDA’s Fundamentals training class – choose from virtual instructor-led or in person deliveries.

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