September, 2001 Newsletter Articles

Quick Reference and Tips

Sep 12, 2001 in Newsletter | 0 comments

We have a two-page quick reference for all the ISO 9001:2000 sub-clauses with simple one line descriptions of the requirements. You can refer to our “Ten Tips for Moving to ISO 9001:2000” in the June, 2001 newsletter Next month, we will publish the first part of our new “Ten Tips for Auditing to ISO 9001:2000” guidance...

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Frequently Asked Questions

Sep 12, 2001 in Newsletter | 0 comments

The guidance document on Frequently Asked Questions includes 48 questions and answers. This list was developed from experts and users based on seminars and presentations around the world. These questions are reviewed and updated on a regular basis to maintain their accuracy and to include new questions as appropriate. A sampling of questions that may be of interest are: 10. Will we have to rewrite all our documentation? 13. What are the benefits of the revised standards? 14. What are the main changes to the standards? 15. What new requirements...

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Transition Planning

Sep 12, 2001 in Newsletter | 0 comments

The Transition Planning Guidance document explains that we are now in phase 2, the co-existence period for the 1994 and 2000 standards. Guidance is provided for current users of the ISO 9001:1994 and ISO 9002:1994 standards, as well as, new users of ISO 9001:2000. The document also shares guidance for registrars, training companies, and consultants. A large part of the guidance is devoted to summarizing the key ISO 9001:2000 enhancements compared to ISO 9001:1994. To see the transition planning guidance, go to:...

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Process Approach

Sep 12, 2001 in Newsletter | 0 comments

The process approach is one of the eight quality management principles incorporated by the ISO 9001:2000 family of standards. Since a process is simply a set of interrelated or interacting activities which transform inputs to outputs, the process approach refers to the systematic identification and management of these processes. The Process Approach guidance describes the concept and intent of the process approach. It also explains the difference between efficiency (results achieved versus resources used) and effectiveness (ability to achieve...

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Terminology Guidance

Sep 12, 2001 in Newsletter | 0 comments

The Terminology guidance document lists 164 important words and terms. In 77 cases, it refers you to the ISO 9000:2000 Fundamentals and Vocabulary document for the official definitions. However, it repeats the ISO 9000:2000 definitions for four “difficult” entries: Continual Improvement, Customer Satisfaction, Quality Improvement, and Requirement. The guidance includes dictionary definitions for 83 entries that are not covered in ISO 9000:2000. For example, the word “integrity” is used in ISO 9001:2000 and is defined by...

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Documentation Requirements

Sep 12, 2001 in Newsletter | 0 comments

The Guidance on the Documentation Requirements of ISO 9001:2000 explains why there has been a reduction in the required documentation with the new standard. The primary reason is to allow more flexibility in the way an organization chooses to document its quality management system. This means you can develop the minimum amount of documentation needed to show effective planning, operation, and control of your processes, as well as, the continual improvement of the system. The guidance points out that ISO 9001 has always required a...

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Clause 1.2, Application

Sep 12, 2001 in Newsletter | 0 comments

The scope of your quality management system should be based on the nature of your products and realization processes, as well as, the result of risk assessment, commercial considerations, and contractual, statutory, and regulatory requirements. If you choose to implement a system with limited scope, this should be clearly defined in your quality manual and other publicly available documents to avoid confusing or misleading customers. If you have overall responsibility for product realization, the fact that a specific process such as design or...

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Quality Management Principles

Sep 12, 2001 in Newsletter | 0 comments

The Quality Management Principles document introduces the eight principles upon which the ISO 9000:2000 family of standards were based: 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships The guidance describes the benefits of adopting these principles and the management actions necessary to apply them for improved organizational performance. To read about the eight quality...

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Selection and Use

Sep 12, 2001 in Newsletter | 0 comments

The brochure on Selection and Use of the ISO 9000:2000 Family of Standards is actually a collection of several documents at the ISO web site. The first part of the brochure explains its purpose and identifies the contents of the rest of the sections. You can see the opening section of the brochure at: <http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/selection_use.html>. The ISO 9000 Family portion of the brochure lists the standards, guidelines, and technical reports that make up the family. Go...

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