Clause 7 Explained | 7.1.1, General | ISO 9001 Version 2015 Quality Management System | ISO 9001
Clause 7 explained - 7.1.1, General. In the previous video, we reviewed the contents of clause 7 of ISO 9001 2015 standard – Support. This element includes five main sub-clauses:
• Resources
• Competence
• Awareness
• Communication, and
• Documented information
Let's start from the first, Resources section 7.1, and focus first on subclause 7.1.1, General. The standard tells us that:
• The organization shall determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the QMS considering:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
To address these requirements, we have to consider two stages;
• The establishment and implementation of a system, and,
• The maintenance of an existing QMS.
Both stages require consideration of the organization's capabilities – can we do it? Constraints on the internal resources – what stops us from making it happen, and consideration of external service providers, if we do not have sufficient staff or it is just more economical at this time to outsource the process. So, we start with capabilities. Let's say we need to establish a QMS, and Jessica implemented one in her previous job. It looks like we have qualified internal resources to implement the QMS. But now constraints come – we spoke with Jessica about the QMS, and she said that it was a great idea, but she did not have time. Now it's time to consider external service providers. Can we hire a consultant to establish and implement our QMS? This approach appears to be a good option for resolving internal constraints to get the job done, so, clause 7 explained
We should apply the same considerations to the maintenance stage when the system is established. One of the triggers for the evaluation of resource needs is the Management Review. It is a requirement of the standard. Resource needs also can come from business reviews, customer and internal audits, and other inputs. Speaking of audits, not long ago, I audited a company that was two years late with its internal audit schedule. When I asked why it happened, the answer was that they lost their internal auditor and did not replace her. In this situation, the company did not provide sufficient resources to maintain its QMS, which is a non-conformity. Now, the question is, against which clause should we document this non-conformity? Of course, the first thought is against the internal audit clause – the company did not follow the audit schedule. But what if you observed other instances of insufficient resources? In this case, the better element for the non-conformity would be 7.1.1, which requires that the organization shall … provide the resources needed for the … maintenance … of the QMS.
To summarize, we have covered clause 7 explained - 7.1.1, General
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