Issue 21 – Clause 7.1: Resources
Clause 7.1: Resources
What’s new in Clause 7.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 20) we discussed the topic of “planning QMS changes”, and now here in Clause 7.1 we move into Element 7.0 (Support) and address the first Clause within it, dealing with “resources”.
Note A: This Clause does include a requirement for “documented information” BUT only in sub-clause 7.1.5.
Note B: The content for these Newsletters comes from working in the field with my Clients, and with their ISO Certification Bodies. I gain a lot of hands-on experience from conducting numerous gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. Combining a Gap Audit with ISO 9001 Essentials Training, has become our most popular request from our Newsletter readers (…more details on this, as well as other training, can be found below).
The new numbering format…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Clause 7.1 Resources consists of six (6) Sub-Clauses as listed below:
7.1.4 Environment for the Operation of Processes
7.1.5 Monitoring and Measuring Resources
7.1.6 Organizational Knowledge
Sub-Clause 7.1.1 General – The requirements within this sub-clause are very similar to the requirements in the old 2008 version, essentially asking the organization to allocate sufficient resources to implement and maintain its Quality Management System (QMS). One thing that was left out in this new version (that was included in 2008), was the requirement that resources be provided to enhance Customer satisfaction. They did however add parts [a] and [b] within this sub-clause which asks organizations to consider how much internal resources they have and what, if any, external resources will be needed. Using outside assistance when needed to help operate the business was always likely part of the decision making process, so I doubt this will cause much change in current QMS practices.
Sub-Clause 7.1.2 People – Basically the requirement in this sub-clause is for the organization to provide the necessary number, and type, of people to ensure the QMS and its processes are effectively implemented and running properly.
Sub-Clause 7.1.3 Infrastructure – Basically the requirement in this sub-clause is to provide the necessary infrastructure (buildings; equipment; technology; utilities; etc) to ensure its processes are effectively implemented, and for achieving conformity of the products AND services being supplied to Customers. Think macro when looking at what is needed to run the business.
Sub-Clause 7.1.4 Environment for the Operation of Processes – The requirement in this sub-clause is to provide the necessary environment (human and physical factors) to ensure its processes are effectively implemented, and for achieving conformity of the products AND services being supplied to Customers. Think micro when looking at what is needed to run the business.
They have included a “NOTE” at the end of this sub-clause but first of all keep in mind that “NOTES” are not “shall” requirements. Secondly, this particular “NOTE” has caused a lot of consternation to some readers due to the words used within it. I suggest you approach Sub-Clause 7.1.4 in the same manner that you addressed the old “work environment” clause because the requirements are essentially unchanged.
Sub-Clause 7.1.5 Monitoring and Measuring Resources – This sub-clause contains two distinct sections within it: 22.214.171.124 (General) and 126.96.36.199 (Measurement Traceability). The first change you will notice here is the use of the word “resources” instead of “equipment”, which serves to expand the nature and type of devices that organizations need to “calibrate”. This goes hand-in-hand with the inclusion of “and services” in this sub-clause. They’ve introduced new wording in this sub-clause “fitness for purpose” however the intent remains the same… pick the right method/device/equipment/resource, for what you are trying to measure. With respect to “traceability” they’ve added new wording to allow organizations more flexibility to decide when, or if, measurement traceability is in fact required. Keep in mind that this is the only sub-clause that requires documented information as per the ISO 9001:2015 Standard.
Sub-Clause 7.1.6 Organizational Knowledge – This is a brand new sub-clause in this Standard. I believe one primary reason for adding this sub-clause was to get organization’s to do a better job of preserving corporate/business knowledge before it retires and walks out the door. Lessons learned databases, comprehensive training materials/programs and succession planning are just a few of the ways a business currently tries to capture its corporate knowledge. The intent here is to ensure that Customer products and services can be consistently delivered without being affected by the departure of key personnel. In its most basic form, the QMS itself represents a repository of documented instructions on how to ensure that Customers consistently receive what they ordered. Keep in mind that this organizational knowledge can be based on both internal and external sources. Additionally, this sub-clause wants organizations to consider any knowledge gaps that will arise in the future, and then to take actions to close them.
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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The two (2) day Internal Process Auditing for ISO 9001:2015 Session (also covers requirements in ISO 19011) is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed. PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event. This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.
Q: How do you perform a gap audit for Clause 7.1 of ISO 9001:2015?
A: For Clause 7.1, a Gap Audit checklist should cover these areas:
– When determining resource needs, has the organization considered its internal capabilities?
– Has the organization considered what constraints there are on its internal resources?
– Has the organization considered what needs to be obtained from external providers?
– Has the organization provided the necessary persons to operate and control its processes?
– Has the organization provided the necessary infrastructure to operate and control its processes?
– Has the organization provided the necessary environment to operate and control its processes?
– Has the organization provided the necessary (and fit for purpose), monitoring and measuring resources to verify conformity of products/services? Is this documented?
– Does the organization provide measurement traceability where required? Is this documented?
– Has the organization maintained the knowledge necessary to operate its processes, and to achieve product/service conformity?
– How does the organization acquire any new knowledge necessary to operate its processes, and to achieve product/service conformity?
(Make sure to interview more than one person and obtain examples for the items listed above)
Until next time…
Helping Business Professionals Reduce Risk and Remove Waste!