Issue 7 – Element 7.0: Support
Element 7.0 – Support
What’s new in Element 7.0?… We covered the “planning” activities in my last Newsletter (ISO 9001:2015 Newsletter Issue 6), and these “plans” now require support to implement them, which is the focus of Element 7.0 (Support). This Element combines a number of topics from the previous 2008 version with the biggest change being the concept of “organizational knowledge” to address the potential loss of knowledge which could impact Customer satisfaction, as well as the ability to run the business effectively.
The new Clause numbering…
Section 4 – Context of the organization
Section 5 – Leadership
Section 6 – Planning
Section 7 – Support
Section 8 – Operation
Section 9 – Performance evaluation
Section 10 – Improvement
Element 7.0 Support consists of five (5) Clauses as listed below:
7.5 Documented Information
Clause 7.1 Resources – This Clause contains six (6) sub-clauses:
Sub-Clause 7.1.1 (General) is as the name implies “general” regarding the need for resources to ensure the QMS functions properly. It also asks the organization to take into consideration the impact on internal resources as well as the need to use external providers.
Sub-Clause 7.1.2 (People) is a straight-forward requirement to make sure you put “round pegs into round holes”. Note that this applies to any person who performs activities outlined within the QMS, whether they be management, front-line, full-time, part-time, hourly, salary, union, non-union, contract, temporary, summer student, intern, virtual worker, etc.
Sub-Clause 7.1.3 (Infrastructure) contains the same requirements as we had in the past with very little changes to it.
Sub-Clause 7.1.4 (Environment for the operation of processes) is essentially the same as “work environment” in the previous version, however they have included social and psychological factors to be considered within the accompanying “Note”. They use terms like “non-confrontational” and “emotionally protective” which should make trying to audit this requirement quite a challenge.
Sub-Clause 7.1.5 (Monitoring and measuring resources) is the new “calibration” clause and it repeats many of the same requirements found in the 2008 version.
Sub-Clause 7.1.6 (Organizational Knowledge) – As I mentioned earlier this is one of the new changes found within Element 7.0 and it addresses the risk of knowledge walking out the door with the possible negative impact on Customer orders. Keep in mind that although this is a new requirement in 2015, it had been partially addressed by asking organizations to create documented procedures in the 2008 version (and likewise with work instructions). These types of documents are one way to capture knowledge embedded within the organization and preserve it over time.
Clause 7.2 Competence: This Clause contains very few changes from the previous 2008 version.
Clause 7.3 Awareness: This Clause has a couple of changes within it, namely it is asking organizations to make it clear to their employees the impact on the business if they improve their performance, as well as the impact if they perform poorly.
Clause 7.4 Communication: This Clause combines requirements found in the previous 2008 version however it takes it a step further by being very prescriptive by asking “what”, “when”, “who” and “how” the organization will communicate both internally and externally.
Clause 7.5 Documented Information – This Clause contains three (3) sub-clauses, Sub-Clause 7.5.1 (General), Sub-Clause 7.5.2 (Creating and Updating) and Sub-Clause 7.5.3 (Control of documented information). This is the new Clause combining the old “control of documents” and “control of records”. The requirements appear to be much the same and it is not clear what they’ve accomplished by combining these two concepts, except perhaps confusion in the user community.
Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…
PS: Don’t forget to look at the Q&A section below for some final thoughts…
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Q: How should we address this new term called “documented information” and has there been a reduction in documentation requirements in this new revision?
A: Let me start with the second part of the question. In the previous edition (2008) they asked for 1 Quality Manual, 6 areas requiring a documented procedure and 19 records. In this new revision they have used the term “documented information” 34 times. I just don’t see where they’ve reduced the requirements for documentation. As always, it’s up to you to decide how much, or how little, documentation you will create to satisfy yourself and your Customers that you have an effectively functioning QMS… period. With respect to addressing “documented information” I would suggest that if your current method of “controlling documents” and “controlling records” works, then leave it as is and don’t change it. Of course if it needs fixing then get on with repairing it for the good of your business and not just because a revision was made to the ISO 9001 Standard.
Until next time…
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