There should be no uncertainty about what resources are required to be determined and provided in implementing the requirements of ISO 9001. Unfortunately, there is considerable uncertainty on the subject as I reveal as I examine the clauses of ISO DIS 9001 .
The first mention of resources in the standard is in clause 0.4 where in explaining the P in PDCA, it is suggested we “establish the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies”. Nothing wrong here except this is not a requirement as the clause simply explains a methodology.
The next mention of resources is in clause 0.6 where it states “processes for support, including resources, people and information” implying that people and information are not resources but we’ll treat this as a minor quibble. Clause 3.05 tells us that top management has the power to delegate authority and provide resources within the organization implying it doesn’t have authority to provide resources to customers or suppliers but we’ll also treat this as a minor quibble. Clause 3.36 tells as that a resource is an object and therefore we can substitute ‘object’ for ‘resource’ in the definition of quality and get ” degree to which a set of inherent characteristics of a resource fulfils requirements”. This is useful because it’s legitimate to refer to the quality of resources, the quality of people and the quality of information or even the quality of ISO 9001 when using ISO 9001.
The first use of the term ‘resource’ among the requirements is in 4.4d) where it requires we determine the resources needed …..for the processes needed for the QMS. This is an ambiguous statement because we are required to “establish a QMS in accordance with the requirements of this International Standard” rather than to achieve a certain objective such as “to deliver results in accordance with customers’ requirements and the organization’s policies” as in 0.4 or to “provide product or service that meets customer and applicable statutory and regulatory requirements, and enhance customer satisfaction” as in clause 1. As a process is defined as “set of interrelated or interacting activities which transforms inputs into outputs” are we to assume therefore that the resources needed for the processes are those resources needed to transform inputs into outputs or are they also to include the resources needed to manage these processes?
So understanding which processes and hence which resources are being referred to rather depends on what a QMS is perceived to be and this will differ depending on the readers preconceptions because the definitions don’t help all that much. Just look at the definition of a management system and we find that not only are policies, objectives and processes not elements of the system but neither are resources, which brings us to the next mention of resources.
In clause 5.1.1f) we are told that top management demonstrate leadership and commitment to the QMS by “ensuring that the resources needed for the quality management system are available”. This is fine as long as top management know what a QMS is. If they think its a set of rules (because they are told in clause 0.1 to adopt a QMS) they may interpret this as the resources to produce and maintain a set of rules, or put another way, maintain a set of documents such as a quality manual. I have witnessed consultants and auditors refer to the quality manual as the QMS so my claim is not inconceivable.
The next mention of resources is in clause 6.2.1 where it tells us to “determine what resources will be required “to achieve the quality objectives”. We have already determined the resources needed for QMS processes and assuming these are the same as the resources needed to transform inputs into outputs, are the resources needed to achieve quality objectives different or is the standard duplicating a requirement here? It’s fair enough in 6.3 to consider the availability of resources when planning to change the QMS as they may be tied up doing other things, but then in 7.1.1 it tells us to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. Again this depends on knowing what a QMS is. It would have been far better had the standard restated the objective to be achieved.
In 7.1.5 we are advised to “determine the resources needed to ensure valid and reliable monitoring and measuring results”. Unlike the other statements, this one is really useful because it gives us a reason, an objective and thus makes a response less dependant on knowing what a QMS is. In 8.1 there is another example where we are given an objective when we are told to “determine the resources needed to achieve conformity to product and service requirements”. Then in 8.3.3 we are required to determine the internal and external resource needs for the design and development of products and services without being given an objective but in 8.5.1, we are required to use suitable measuring and monitoring resources but there is no requirement to determine the internal and external resource needs for the production and delivery of products and services. This sort of inconsistency really does make the standard appear incoherent. Now are these resources different to the ones we have determined so far or is this another example of duplication?
Are all the following saying the same thing and just expressing it in different ways?
- Determine the resources needed for the processes needed for the QMS.
- Determine what resources will be required” to achieve the quality objectives.
- Determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
- Determine the resources needed to achieve conformity to product and service requirements.
Having specified a general requirement for the determination of resources it should not be necessary to also include specific requirements as it undermines the integrity of the standard when a specific requirement for resources is omitted as in clauses 9 and 10 where there is not requirement to determine resources for evaluating performance and reviewing the QMS. It almost appears as though these additional requirement exist for auditors so they can catch us out.
In clause 9.3, trends and indicators for the adequacy of resources required for maintaining an effective quality management system are required. Once again depending on your view as to what a QMS is, this might result in a variety of interpretations e.g. would these include or exclude resources for achieving conformity to product and service requirements?
It is interesting to note that in B.5 in explaining the rationale for the process approach, we are told that “The quality management system is composed of interrelated processes and understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance”. This is an unbounded statement which implies the resources relevant to ISO 9001 are all the organization’s resources, that there are no limits.
There is no definitive statement in ISO DIS 9001 as what the output of a QMS is intended to be. Figure 1 of ISO 9001 implies the output is products and services but that is in doubt in 5.1.1 where it requires QMS requirements to be integrated into the organization’s business processes. Is it QMS processes or business processes that produce products and services and if it’s the latter what indeed is the output of the QMS?
Now to another bombshell. Clauses 3.14 and 8.4.2 place outsourced processes within the scope of the management system and therefore indirectly invoke 4.4d thus bringing the resources of an external organization into the QMS. So is it the intention that the resources for both operating and managing outsourced processes come within the scope of the QMS?
I hope that between now and March 2015 TC 176 resolve these and many more uncertainties otherwise the user community will not be best pleased with ISO 9001:2015.
Bio:
After a period in aircraft production and development following which I qualified as a Chartered Engineer, I spent the next 20 years in quality management with British Aerospace and Ferranti International. For the next 15 years I operated as a management consultant and guided large and small companies through their ISO 9000 programmes, delivered quality management and auditor training courses throughout the world, set up my own consultancy business, Transition Support Ltd, and published several books on quality management many of which have been translated into Japanese, Spanish and Italian. A member of the IQA (Now CQI) since 1974, I was elected Fellow in 1988 and have served on and chaired several committees. In 2005 I took early retirement due to sudden sight loss but continue my interest in quality management. My Quality Systems Handbook first published in 1992 is now in its 6th edition and this particular piece on resources, I developed as I undertake my research for a major revision to align with ISO 9001:2015.