Issue 49 – Clause 7.1: Resources
ISO 9001:2015…
Clause 7.1: Resources
What’s the intent of Clause 7.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 48) we discussed the topic of “changes to your QMS”, and now here in Clause 7.1 we move into Element 7.0 (Support) and address the first Clause within it, dealing with “resources”. The intent of this Clause is make sure you have sufficient resources in place to make good on your promise to fulfill Customers orders (covered under Clause 8.2), while maintaining a “system for managing Quality” (QMS) at a level that your Customers expect. Think of resources as time, people, money, equipment, information, with all of these included, or implied, within this Clause.
Note A: This Clause DOES include requirements 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 training workshops, gap audits and internal audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. A popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit. On that note, some organizations are opting to use an outside resource to assist with their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions we offer, 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:
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
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 essentially asking the organization to allocate sufficient resources to establish a QMS, to implement that QMS, to maintain that QMS and to drive improvement of that QMS. They then went further by adding items [a] and [b] within this sub-clause, which asks organizations to consider the capability, and constraints, on their existing internal resources they have and what, if any, external resources will be needed. In most cases, the budget process allows for the use of outside assistance (when needed) to help operate the business and this was always likely part of the decision making process, so I doubt this will cause much change in current QMS practices. The budget process will be the simplest way to address the requirements in this sub-clause, and if you are worried about exposing this information to an auditor, keep in mind there is no requirement here for “documented information”!
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. As some of you would have heard me say this in training sessions that I have delivered, this sub-clause is asking you to “put round pegs into round holes”. Many companies incorrectly assume that when it says “…provide the persons…”, that this means only your full-time permanent employees. Not so. This sub-clause applies to any “persons” that are carrying out an activity defined within the scope of your QMS. This includes, full-time, part-time, permanent, temporary, union, non-union, salary, hourly, contract, interns, co-ops, summer students, agency personnel, retirees and telecommuters… in other words, anyone who completes an activity defined within your “system for managing Quality” (QMS) should be a “round peg in a round hole”. Naturally, you will use different methods for “qualifying” these various “persons” depending on the type of human resource they represent. Try approaching it this way… if you were a Customer should you have to worry about how your Supplier decides to fill the many jobs/positions it has? Whether the Supplier decides to use many different and flexible employment practices should be irrelevant to you the Customer, should it not?
Sub-Clause 7.1.3 Infrastructure – Basically the requirement in this sub-clause is to provide the necessary infrastructure (buildings; equipment; utilities; technology; logistics) needed 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 this sub-clause with what is needed to run the overall business. This is where the Maintenance and IT departments connect into ISO 9001 (in case they didn’t think they were part of making Quality happen inside a company!).
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. If you wanted to insert a link to your whole safety management system, then this is where many organizations tend to do it.
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, “NOTE a) & b)” have caused a lot of concern to some readers due to the words used within it that are impossible to properly assess as an Auditor. Thirdly, “NOTE c)” is where I recommend you focus your attention on (physical factors – e.g. temperature, heat, humidity, light, airflow, hygiene, noise). 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 from 2008.
Sub-Clause 7.1.5 Monitoring and Measuring Resources – Let me start by saying this is the “calibration” section of the ISO 9001 Standard, in case you didn’t immediately recognize it. This sub-clause contains two distinct sections within it: 7.1.5.1 (General) and 7.1.5.2 (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 use to measure their processes, and that need to be “calibrated”. 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 within Clause 7.1 that requires “documented information”. I often get asked, what devices need to be calibrated and which ones don’t. The way I suggest you approach this is by starting with the requirements stated by the Customer (plus any other requirements that you must adhere to). For each requirement agreed to, there should be a corresponding way to measure whether you have met it… and if you use a device to measure it then you want to periodically check to make sure this device is working right so you don’t provide a defective product or service to your Customer. For example if you a sell product by weight then you would use a weigh-scale to validate that this requirement has been met… which means that the weigh-scale should be periodically calibrated to ensure it continues to function correctly. By building a list of all of the devices you use to verify that the requirements you agreed to were met, then this list becomes the minimum listing of what needs to be calibrated… after that it’s a business decision whether there is justification to calibrate additional devices.
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 who hold key information in their heads. 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. Bottom line is that you need to look at your current practices of how you retain business operating knowledge and then use that to address the requirements within this sub-clause. At it’s most basic level, you could offer up your entire “documented” QMS, along with your “document” revision process as evidence for an Auditor to assess compliance here.
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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ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
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Documentation Development Training Workshop for ISO 9001:2015
This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator. This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame. If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part). Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it. A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant. As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.
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Internal Process Auditor Training for ISO 9001:2015
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session 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.
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ISO 9001:2015 Essentials + Gap Audit
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.
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Q: How do you perform an audit for Clause 7.1 of ISO 9001:2015?
A: For Clause 7.1, an Audit Checklist should cover these areas:
– Does the organization have an annual budgeting process? How does it work?
– When determining resource/budget 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? Does this include all persons who affect quality?
– 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 devices/resources to verify conformity of products? Conformity of 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…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!