The QMPs provide a useful approach for auditors to employ when they are conducting an audit. Auditors are focused on the fulfillment of a requirement—on gathering the evidence that allows them to conclude that a requirement is fulfilled. This is the primary mandate. But, auditors also need to be able to assess whether a requirement is effectively fulfilled. Is a requirement applied in such a manner as to yield the intended result? Does it manifest a particular management principle?
Due to the criticality of products in some industries, the risk of failing to differentiate the two terms can have life-threatening consequences. Conversely, there could be a case in which it is cost-prohibitive and unnecessary to do a complete rework to the originally defined specifications and requirements.
The standards developers of ISO 9000 will use multiple inputs in their deliberations. They’ll look at global changes and technological advances, and consider whether the wording is still relevant or whether it needs to be revised to accommodate these changes. The working groups will review feedback from the user community. They’ll seek to correct any perceived ambiguities and to clarify text. And, there’ll be liaison with the developers of ISO 9001 to see whether they believe new terms need to be introduced.
For example, ISO 9000 defines both rework and repair. These are two different activities. Rework is defined as “action on a nonconforming product or service to make it conform to the requirements. By contrast, repair is defined as “action on a nonconforming product or service to make it acceptable for the intended use.”
Terms are only half of what’s found in ISO 9000. The standard also contains the fundamentals. Included are the quality management system fundamentals, the quality management principles (QMPs), and guidance on developing a quality management system using the fundamentals and the QMPs.
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ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.
There are seven quality management principles:
• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management
So, it is most beneficial to ensure that the two documents are appropriately aligned. The revision of one has immediate impact for the other.
They answer the questions:
• What is it?
• Why does it matter?
• How does it benefit this organization?
• What should we consider doing?
When you look back to the benefits—particularly the last bullet—you can see why this quality management principle would resonate with the organization’s leadership. The need for a “stable flow of products and services” is the cornerstone of a company. Without stable flow of resources in and products out, there’s no revenue stream. There’s no money.
If there is objective evidence that the organization’s processes result in these benefits, then it is appropriate for the auditor to conclude that the activities relating to “control of externally provided processes, products, and services” conform to requirements.
ISO 9000 discusses the management and interaction of processes and resources required to achieve desired results. It goes on to mention the need “…to identify actions to address intended and unintended consequences in providing products and services.” All of this facilitates understanding the rationale for the ISO 9001 requirements relating to the “context of the organization.” It also makes the case for understanding and determining the required resources (e.g., people, infrastructure) without which no company can function. In this way, it makes the connection between the QMS and the budget. Resources cost money. If there’s no clear mandate, the funding is unjustified. Again, the fundamentals speak to top management about the benefits to be derived from an effective QMS.
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Let’s say that a customer is requesting repair of a large piece of equipment used in a highly corrosive environment. The initial requirement probably included an expectation for the machine to be delivered with shiny red paint and gleaming chrome. Two years later, the need for a functioning unit would probably not include the specified requirements for a shiny, pretty thing. The unit won’t be reworked (to original requirements); it will be repaired.
Rather than thinking of ISO 9000 as a subordinate document that serves ISO 9001, it’s more appropriate to view it as informing ISO 9001. It gives the why that makes the shall palatable—and even desirable.