ISO9001:2000 Articles

Over the years, ISO Champions have come to realize that there are common threads in their ISO success stories. This article reviews and analyzes these successes and provides practical suggestions for those who want to get their ISO project off to the right start. The three magic pills to achieve genuine value from ISO are what we call "ISO Done Right"... more

ISO 9000 (more formally ISO 9001:2000) is an international quality standard that defines minimum requirements for a company's Quality Management System (QMS). A company's QMS comprises the organization's policies, procedures and other internal requirements that ensure customer requirements are met with consistency resulting in customer satisfaction. Some of the areas of the company within the scope of ISO 9000 include... more

As many of you who have worked with the ISO 9000 standards know, the standards are periodically updated. The last revision of the ISO 9001 standard was in the year 2000 (hence the title ISO 9001:2000). The next revision (technically an amendment) is scheduled to be released by the end of 2008, probably around October... more

Since the release of ISO 9001:2000, all ISO certified companies have wrestled with the practical application of the Process Approach that was introduced in the current version of the standard. In fact, other than the reduction of the number of required (i.e. prescribed) documents, the shift to the Process Approach was the most significant change from older editions of ISO 9001... more

Ensuring that ISO 9001:2000 remains a vital, relevant tool for your top management to improve business performance is often of concern by those responsible to oversee the ISO program within your organization. If your organization has struggled to show measurable and sustainable improvements in performance for your customers or toward top-priority management goals, then... more

A quality manual is a document stating the company management's intentions for operating the quality system. It includes policies for all areas of the business affecting or affected by the quality system. These policies authorize department managers to implement procedures within the boundaries specified in the quality manual. They also serve to provide a measure for procedures, processes and results... more

A cornerstone of the quality management system (QMS) is the control of documents. While not a particularly glamorous activity, document control is an essential preventive measure ensuring that only approved, current documentation is used throughout the organization. Inadvertent use of out-of-date documents can have significant negative consequences on quality, costs and customer satisfaction... more

Record keeping is one of the most painstaking, and important, requirements in the ISO 9001:2000 standard. Painstaking, because records must be identified, filed, protected and controlled throughout their lifecycle. Important, because they contain the history of how your quality management system (QMS) is functioning. The energy, effort and expense of keeping up your quality records are ongoing investments in building a reference-base for analysis, compliance and improvement... more

The new ISO 9001 standard (2000) substantially raised the expectations for top management leadership and involvement to provide guidance to the overall quality management system. In fact, nearly 15% of the standard's text is devoted to the subject of top management responsibility. Clearly, the designers of the standard have realized the imperative for the perspective and authority that top management must bring to ensure effective operation of the system... more

Being clear about an organization's intentions and goals is the first step toward effectiveness and results. This information, if it is well communicated and monitored in the organization, forms the basis for directed progress. The ISO 9001:2000 standard identifies the techniques of policies (for stating intentions for how we will operate) and objectives (for stating goals for what we want to achieve) as primary tools of top management to direct the organization toward it's quality goals for the products and processes of the company... more

To some, the point of ISO 9000 registration is a certificate. While important to convince customers that certain procedures are in place, a certificate can be a very expensive piece of paper if that is the only benefit realized by the organization. To others, the point of ISO 9000 is measured performance improvement for the organization, and the certificate is merely a confirmation of an effective quality management system (QMS). This results-focused view of ISO 9001:2000 is confirmed by the growing number of companies pursuing "compliance through self-certification" instead of a formal registrar-certification of their QMS... more

Leadership. Direction. Coordination. Communication. Coaching. All terms that could describe the critical role of the Management Representative (MR) in an ISO 9001:2000 quality management system. Just as the point guard on a basketball team is responsible for setting up plays for his teammates, the MR is an enabler of the quality system. But, don't confuse responsibility for enabling the quality management system with developing and implementing the quality management system. The ISO 9001:2000 standard clearly places the latter responsibilities with top management... more

It seems that dealing with people issues must have been a hot topic of discussion during the development of the new ISO 9001:2000 standard. While the 1994 version (ref. 4.18) said we needed to identify training needs, deliver the training and keep records, the 2000 version (ref. 6.2.2) introduces terms such as competence and effectiveness. The somewhat obvious implication in the new requirement is that we have to deal with the people issues in a way that actually works, not just to go through the motions... more

The Purchasing requirements in the ISO 9001 standard help to ensure that products and services you purchase from various suppliers fully meet your needs so that you can, in turn, satisfy your customers. The disruption and cost to your organization stemming from supplier problems can impact your customers and your own bottom-line. So, having processes in place that prevent problems and provide consistency within your supply chain is a key focus of your ISO quality management system (QMS)... more

The internal auditor role is normally staffed by a number of experienced employees from throughout the organization. The purpose of the internal audit is to confirm that the company's documentation meets requirements (e.g. ISO 9001, OSHA, etc.) and that day-to-day operations follow the documentation. So, the internal auditor must serve as... more