ISO 9001 is the world’s most-respected and commonly-used set of standards for quality management systems (QMS). It is a tool that most companies use as a guideline to define best practices that will allow them to best serve their customers. Adopting ISO 9001 standards is not required, but it has become the definitive way to communicate to the outside world that a company holds itself to a high level of professionalism in terms of quality.
With the release of ISO 9001:2015, many are wondering what the primary differences are between the two sets of standards. Because EVS Metal recently began the process of moving from ISO 9001:2015 to the new ISO 2015 standards, we’ve had to take a close look at the differences between the two versions.
The Seven Principles of Quality Management
To begin, it’s important to understand why the ISO standards were created in the first place. In brief, they exist to assist companies in implementing quality management practices so that they may consistently meet company, employee and customer needs. The standards (also called “clauses”) are based on the seven principles of quality management:
- Customer focus
- Engagement of people
- Process approach
- Evidence-based decision making
- Relationship management
ISO principles and ISO standards are not the same thing. The principles outline the “whys” of implementing a quality management system (QMS), while the standards give companies actionable “hows” in order to help them reach their quality management goals, and if desired, gain ISO certification.
ISO 9001:2008 vs ISO 2015: Changes and Updates to Clauses
One of the biggest changes for ISO 9001:2015 is that there are two new clauses, bringing the total to ten up from eight; this is likely the most significant update overall. While the first clauses (0-3) remain the same, after that, things look quite different, due to the additions of sections and name changes of several of the clauses to be more precise about what they cover. ISO has stated that this was done due to the use of the Annex SL template, and that all future management system standards (MSS) will use this layout for the sake of consistency. Here’s what the new clauses look like when laid out next to the old:
|ISO 9001:2008 Standards||ISO 9001:2015 Standards|
|4. Quality management system||4. Context of the organization|
|5. Management responsibility||5. Leadership|
|6. Resource management||7. Support|
|7. Product realization||8. Operation|
|8. Measurement, analysis and improvement||9. Performance evaluation|
The first change can be found under clause number four, what used to be “Quality Management System” but is now called “Context of the Organization.” The biggest change here is that the standard now expects you to understand your organization’s “context” before proceeding with anything else. By “context,” ISO means the big picture for your company — its values, its place in the industry, its culture, etc. because until you can define these things, it will be impossible to implement a QMS that is effective and results-oriented for your organization and all of its moving parts. This could no doubt be difficult for some companies, but if it’s viewed as an opportunity to make a difference instead of with dread or exasperation, getting a better grasp of organizational context can be hugely impactful in terms of a business’ future viability, especially in competitive markets and industries like EVS’.
The second has to do with a change between ISO 9001:2015 section 1.2 and section 4.3 of the 2015 standards 1.2/2008 states that companies can choose to ignore product realization requirements, as long as this doesn’t affect quality outcomes or break the law. However, the ISO 9001:2015 standard takes it step farther, saying that while any requirement may be excluded, if you choose to do so, you will need to be able to explain and justify why this choice has been made. In other words, the new standard requires more responsibility and accountability over the choice to not implement certain requirements within the organization.
Changes to Definitions and Terms in ISO 9001:2015
Besides changes to the clauses, ISO 9001:2015 also updates the way certain terms are defined. The first covers a shift in the way the word “object” can be used, and ultimately broadens its applicability. “Object” used to be reserved solely to describe a tangible thing, such as a product. The new standards differ in that “object” can now be used to describe a range of different things, including those that are strategic/non-concrete, like quality, innovation and design.
Another change is to how the term “continual improvement” is used. It is now used to describe the goal of getting continuously better results, rather than simply striving to consistently fulfill the requirements of the ISO standards. Additionally, the new standards take a more accommodating approach to defining monitoring and measuring activities, asking companies to use the term “resources,” rather than “equipment,” when describing how they effectively carry out activities related to quality. ISO is taking the step here of recognizing that not all MM exercises are completed with tools or machines. There has also been a significant change to the standard around the use of the word “product.” ISO 9001:2015 now refers to products as “outputs,” also grouping “services” into this category, so that it covers items that are not necessarily physical/concrete.
Additional Changes to the ISO 9001:2015 Standards
- Formerly, a “service” was a type of “product.” It has been replaced by “products and services” to acknowledge that ISO standards can be applied outside of pure manufacturing environments.
- There are three terms that have disappeared completely from the new standards. They are: Product Realization, Management Representative, and Preventative Action (replaced by Risk-Based Thinking).
- The definition of “customer property” has been broadened to include all processes, products and services that may be provided externally, and companies are expected to control the quality and take responsibility for of all of the above it is included in their product or service.
While adopting ISO 9001 standards is not required, it has become the definitive way to communicate to the outside world that a company holds itself to a high degree of professionalism in terms of quality. As a precision metal fabricator, EVS Metal is absolutely committed to quality at every level and we believe converting to the new ISO 9001:2015 standards is one of the best ways we have to assure our customers that we have their best interests front of mind with every project we take on.