The ISO 9000 Revision: Why It Matters

The terms are often used interchangeably, which is inappropriate. A customer may require that a product that has been returned fulfill requirements or simply that it works (even if it doesn’t match all of the original requirements). It’s appropriate here to pause and remember the basic mandate that forms the foundation for ISO 9001: “…needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements….” Therefore, if an organization doesn’t distinguish between rework and repair, it can easily fail to fulfill customer requirements and expectations.

They’re not requirements. Think of them as guiding stars. If a quality management system is effectively deployed, these characteristics will be manifest. They will be self-evident.

There’s a bit of a chicken-and-egg perception of ISO 9000 and ISO 9001, with many people assuming that ISO 9001 came first and that ISO 9000 is just a nice add-on feature. In reality, without ISO 9000, ISO 9001 lacks context. ISO 9001 provides all the “shalls.” ISO 9000 gives you the “whys.”

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.

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.

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.

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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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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.

So, it is most beneficial to ensure that the two documents are appropriately aligned. The revision of one has immediate impact for the other.

Management

The ISO 9000 Revision: Why It Matters

Without ISO 9000, ISO 9001 lacks context

Equally important but with considerably less ballyhoo, ISO 9000 has also embarked on its own revision process. Why is this important? What actually is ISO 9000, and why does it matter?

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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.

They answer the questions:
• What is it?
• Why does it matter?
• How does it benefit this organization?
• What should we consider doing?

Each QMP is formatted in the same way:
• Statement
• Rationale
• Key benefits
• Possible actions

While ISO 9000 does not enjoy the prestige of the flagship standard ISO 9001, it’s worth remembering that without the terms and fundamentals, ISO 9001 lacks the context that makes it such a powerful QMS model.

Let’s look at the assessment of requirements relating to individuals’ awareness of the quality management system (ISO 9001 subclause 7.3). An auditor might look for evidence of people engagement to see if the level of awareness is effective. Do people know about the quality objectives? Are they aware of the role they play in the fulfillment or improvement of any particular one? Are they engaged in the conversation or planning of things they can do to reduce scrap or to improve on-time delivery? Do they know anything about the customer?

The level of people engagement is directly relevant to the health and sustainability of the quality management system. A great example of the manifestation of this QMP might be a 5S project to reorganize a production cell. The operators and inspectors worked as a team to facilitate retrieval of raw material and tooling. Then they developed an in-process inspection routine that abbreviated the time inspectors consumed making sure they had the right gauges for a particular job. Finally, the team presented the results of their efforts and the data substantiating that their project contributed to an improved delivery performance by mitigating the amount of wasted time.

Another example is the manner in which the organization interacts with its suppliers. ISO 9000 enumerates the benefits to be derived from effective relationship management. It lists the following:
• Enhanced performance of the organization and its relevant interested parties through responding to the opportunities and constraints related to each interested party
• Common understanding of objectives and values among interested parties
• Increased capability to create value for interested parties by sharing resources and competence, and managing quality-related risks
• A well-managed supply chain that provides a stable flow of products and services

The real nuggets in ISO 9000 are found in the next section: Quality Management Principles.

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.

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.

The fundamentals describe a culture where behavior, attitudes, and processes are inculcated into the fiber of the organization to enable fulfillment of customer expectations. They include consideration of factors that can affect the organization and relevant interested parties. Those interested parties vary widely from one organization to the next, but ubiquitously include at the least customers, suppliers, and employees. This is one illustration of the concept of “risk-based thinking” found in ISO 9001. Without this contextual understanding of the relevance of various issues and interested parties, it’s difficult to decide what actions will generate the most benefit—and where failure to act engenders the most risk. It boils down to how best to allocate resources. This, in turn, can most basically be viewed as an assessment of where you’ll get the most bang for your buck.

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?

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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.”

Essentially, in order to fully understand the concepts, terms, and requirements that are found in ISO 9001, it’s important to understand how they are defined in ISO 9000. And, for the purpose of consistency and effectiveness, the terms need to be applied uniformly as they are defined.

There are seven quality management principles:
• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

Terms can have subtle nuances—for example, audit evidence vs. audit findings. The point is, it’s important to know what the terms mean and to use them as intended by the standards developers. The terms in ISO 9000 are the responsibility of ISO/TC176/SC1. This subcommittee defines the terms that are used in ISO 9001 and in dozens of other management system standards that cite it as their normative reference. The working groups in SC1 include dedicated terminologists who ensure that the definitions are correct and precise, and that they aren’t riddled with contradictions or ambiguities.

Think of those whys as the justification for top management to support and actively promote the implementation and maintenance of an effective quality management system. Without ISO 9000, you just have a lot of blah, blah, blah that’s imposed by a customer or some other external interested party. It lacks the foundation that transforms it from a capricious mandate into an elegant model for reliable performance that benefits both the organization and its customers.