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ISO 9001:2000 Marks ‘Quality’ Supplements

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ISO 9001:2000 Marks ‘Quality’ Supplements
by Alan Bryden

Executives in the nutraceutical industry inherently understand the importance of quality standards, since their products impact people’s health and well being. In fact, many companies in the industry undoubtedly already apply company and industry standards, and meet state and federal regulations relevant to this business sector.

ISO (International Organization for Standardization) is the world’s largest developer of voluntary standards for business, government and industry with a current portfolio of more than 15,000 International Standards offering benefits for almost every sector of activity and technology. These include a substantial number of standards for different aspects of health care addressed by at least 15 of 190 ISO technical committees.

There is a great deal of discussion in the nutraceutical industry about ISO certification. The vast majority of ISO’s standards are highly specific to a particular product, material or process. However, ISO 9001:2000 is a “generic quality management system standard.”

“Generic” means the same standard can be applied to any organization, large or small, whatever its product—including whether its “product” is actually a service—in any sector of activity, and whether it is a business enterprise, a public administration or a government department.

“Management system” refers to what the organization does to manage its processes or activities to ensure the products or services meet the objectives it has set itself, in particular:

  • satisfying the customer’s quality requirements, and
  • complying to relevant regulations.

In a very small organization, there is probably no system, as such, just “our way of doing things,” which may not even be written down, but all in the owner’s head. The larger the organization, and the more people involved, the greater the likelihood that there are some written procedures, instructions, forms or records. These help ensure everyone is not just doing his or her own thing, and that the organization goes about its business in an orderly and structured way so time, money and other resources are utilized efficiently.

To be really efficient and effective, the organization can manage its way of doing things by systemizing it. This ensures nothing important is left out and everyone is clear about who is responsible for doing what, when, how, why and where.

Management system standards provide the organization with a model to follow in setting up and operating the management system. This model incorporates features that experts in the field have reached a consensus on as representing the international state of the art. A management system that follows the model—“conforms to the standard”—is thus built on a firm foundation of state-of-the-art practices.

Large organizations, or ones with complicated processes, could not function well without management systems, although they may have been called by some other name. Companies in such fields as aerospace, automobiles, defense or health care devices have been operating management systems for years. ISO 9001:2000 now makes these successful practices available for all organizations when it comes to meeting quality objectives.

It should be clear ISO 9001:2000 concerns the way an organization goes about its work, and not directly the result of this work. In other words, it applies to processes, not products. Nevertheless, the way in which organizations manage processes certainly affects final products. Obviously, the efficient and effective management of processes is a substantial part of doing everything possible to ensure a product or service satisfies the customer’s quality requirements.

The underlying philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system, the requirements of such a system are stated in ISO 9001:2000. However, the standard does not dictate how the requirements should be fulfilled in any particular organization because this will be specific to its business activity and context. If a product is simple, such as elastic bands, for which the technology is long established, the company would have a different management system than a leading edge designer/developer and producer of new dietary ingredients that may be linked into global supply chains and has to deal with regulatory oversight.

In brief, a quality management system conforming to the requirements of ISO 9001:2000 is a powerful management tool for identifying customer requirements, setting the organization’s objectives, assigning responsibilities, managing the organizational processes along with the human and material resources, realizing the organization’s products and services, and monitoring the output of the system, including customer satisfaction, with a view to continual improvement.

ISO 9001:2000 is one of an ISO 9000 family that includes standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system conforms to the standard). In particular, ISO 9001:2000 was developed as one half of a team, with ISO 9004:2000 providing guidance for performance improvements. It is a bridge to “excellence” models like the Malcolm Baldrige Award and the EFQM model.

One of the difficulties of many quality approaches is that in being based on the words of a “quality guru,” they are open to many interpretations. ISO 9001:2000 is a transparent, documented set of requirements developed by international consensus on the basis of user feedback on past experience, future requirements and developments in the field of quality. It is not quality for quality’s sake, but quality for successful business in the real world.

ISO 9001:2000 is the only standard in the ISO family against which an organization can be certified (or “registered”, as it is often referred to in North America). However, companies can implement ISO 9001:2000 without seeking to have their management systems audited and certified as conforming to the standard by an independent, external certification/registration body.

Like all ISO standards, ISO 9001:2000 is a voluntary standard. Organizations can implement it solely for its internal benefits such as increased effectiveness and operation efficiency, without incurring the investment required in a certification program. Undertaking an independent audit of the system to confirm it conforms to the standard is a decision to be taken on business grounds.

A major impetus for companies to be ISO certified is the growth of international trade and global supply chains. This creates more opportunities for business partnerships between suppliers and customers located in different countries. In this context, ISO 9001:2000 is being used as an international “business card” to establish initial confidence, or even to select partners in the supply chain.

Striving to achieve certification can also be a powerful element of internal motivation for the staff to fulfill the requirements. Finally, certification may be a positive and reassuring argument for economic partners, such as bankers, investors, insurance companies and shareholders.

A point that should be noted in this connection is that ISO is responsible for developing, maintaining and publishing the ISO 9000 family of standards; but ISO does not itself audit or assess the management systems of organizations and ISO does not issue ISO 9001:2000 certificates. The auditing and certification of management systems is carried out independently of ISO by more than 750 certification bodies active around the world. ISO has no authority to control their activities, although it does develop voluntary standards and guidelines to encourage good practice worldwide in this field, which is known as conformity assessment.

To conclude, consider the question: “What kind of benefits can I expect if my organization implements ISO 9001:2000?”

There are important internal and external benefits. Internally, implementing ISO 9001:2000 can be expected to increase the efficiency and effectiveness of the processes that realize and deliver the organization’s products and services according to the quality requirements of the customer. Externally, this can lead to enhanced customer satisfaction, which can translate into sales, profits, market share and reputation. In addition, ISO 9001:2000 certification may serve as a “business card” to introduce the organization on new markets and to new business partners.

Finally, specific product and service standards and the ISO 9001:2000 quality management standard are complementary. The former address what the organization does (e.g., products, services) and the latter addresses how it does things (e.g., processes, activities). Organizations that implement both types of standard in combination may provide greater confidence for customers, users and regulators. And managers in the dietary supplements sector probably know better than most that confidence is, after all, the ultimate business resource.

Since 2003, Alan Bryden has served as the secretary general of the International Organization for Standardization (ISO). Prior to his appointment, he served as director general of the French national standards body (AFNOR) and director general of the French national testing laboratory. He began his career in metrology, notably with the U.S. National Bureau of Standards, and has a strong background in the fields of quality and the rational use of energy. To learn more about ISO, visit www.iso.org.

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