This is a 52 week discussion of the proposed 2015 revision of ISO9001. We challenge you to follow us each week, and review your QMS from top to bottom with us. Each week, we discuss a specific clause of the proposed ISO9001:2015 standard in detail and look for ways to trim the fat from our quality management systems. By year end 2015, you can have your QMS upgraded and ready for the 2015 revision! (It is strongly recommended that you purchase a copy of the ISO9001:2015 Revision for reference).
The proposed revision of ISO9001:2015 begins with the usual explanation of “Scope”, “Normative References” and “Terms and Definitions”. Let’s break them down one-at-a-time.
1 Scope – the ISO standard takes a moment to introduce itself and explain the potential applicability to a business. It clearly states what “it IS” and what “it IS NOT”. It explains that it is generic and intended to be universally applicable to many different types of organizations. We should keep this in mind as we will be tasked later with identifying the scope of our own quality management system. We will have to clearly define what it DOES and DOES NOT apply to within the context of our businesses. We can take a cue from the ISO 1 Scope statement – define the boundaries or draw a line around the QMS.
2 Normative References – this is easy – there ARE no normative references in ISO9001:2015, therefore there are no significant changes. This was added simply as a number alignment so that all ISO standards will eventually have similar numbering.
3 Terms and Definitions – there are 69 terms and definitions included in the standard! And it is critical that EVERYONE associated with the design, development, implementation, maintenance, continual improvement and auditing of your QMS clearly understand each of these terms and definitions. These terms are provided to establish a framework of communication so that all parties have a common understanding of the requirements and criteria.
THIS WEEK’S HOMEWORK – Read carefully through the “Terms and Definitions”. Review your QMS and ask yourself – are these terms clearly understood by everyone? Are they specifically taught as part of our training? Does our internal audit team clearly understand these terms? Does our team and our external auditing team communicate well and understand these terms together? What improvements should I make to ensure these terms and definitions are a solid underpinning to our QMS?
Use this week to make whatever changes are necessary to ensure the Terms and Definitions are understood throughout your organization.
How can I help? Reach out if you need support in training or clarifying these terms with your team.
69 Terms and Definitions is about 60 too many. If we are going to demystify and simplify, this would be a good place to start. I work in design and construction and use an ISO-compliant quality management tool, but I seldom reveal that it’s so, because folks panic and run from the room. Even grouping definitions (e.g., all the audit details) would be an improbement.
You nailed it! ISO9001 for most people is either completely simple or completely perplexing with nothing in between.