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ISO 9001 Policies Procedures Manual
Based on ISO 9001:2008
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Procedures Manual Sections:
ISO 9000:2000 Standard
In this Section:
- Plan-Do-Check-Act
- Quality Management Principles
- ISO 9000:2000 Key Changes
- ISO 9000:2000 Standards
- Copies of the ISO Standards
Other Introductory Sections:
- Introduction to ISO
- ISO Standards
- ISO 9000:2000 Standard
- ISO Quality Management Systems
- ISO Certification Process
- ISO_definitions.html
ISO 9000 describes the fundamentals of a quality management system and the definitions of terms used in ISO 9000, 9001, and 9004. The philosophy, intended purpose and general nature of the elements of the quality management system are also discussed. As with any requirements document, whether legal, regulatory, or voluntary, the definitions are a very important part of the document. Through these definitions, the scope and intent of the specific requirement are defined.
The 2000 version of the standard focuses more on management, the customer, and continuous improvement. This version establishes a management system model that is intended to continually improve customer satisfaction and the effectiveness of the management system. It is based on eight Quality Management Principles to be used by management as a guide towards improving performance. The principles were derived from the experience of experts on the technical committees and represent the main elements that a good quality system must have.
The official changes to the ISO 9000 standard took effect on December 15th, 2000. The basic tenants of quality remain the same, but the philosophy has shifted to the "Plan-Do-Check-Act" improvement cycle used in ISO 14000 standards.
Plan-Do-Check-Act
The quality management system structure is now viewed as a series of processes versus the 20 required elements as described in ISO 9001:1994. The process-based structure is based on the "Plan-Do-Check-Act" improvement cycle used in ISO 14000 standards.
Plan: First, start with a plan. Develop assumptions about the desired outcome and determine what resources will be needed, how they will be applied, and ensure that the plan is feasible. Make sure you have "measurable goals" or "effectiveness criteria" so others will know when the goal has been acheived.
Do: Then implement the plan. Deploy the resources and execute the plan.
Check: Evaluate the results. Every good plan must have built-in checkpoints or effectiveness criteria to ensure that the results are as planned. If the results are NOT as planned then STOP and fix the plan.
Act: Communicate the "lessons learned". Act on the data gathered from the "check" phase and go back to the first step and update the plan with this new information to ensure that you are moving forward as planned. Most importantly, communicate the information to others to improve the process.
This process-based structure uses an improvement cycle to ensure that outcomes are as planned or else the trajectory is adjusted so that you will eventually reach the desired outcome. It sounds simple but how many times does the lack of time drive the process and the result becomes... READY - FIRE! - AIM...
The ISO process is designed so that you "say what you are going to do" and then you "do what you said".
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Eight Quality Management Principles
1. Customer Focus
Organizations depend on their customers and therefore have to understand their current and future customer needs, meet their customer's requirements and strive to exceed their customer's expectations.
2. Leadership
Leaders establish a unity of purpose and the direction of the organization. They need to create and maintain an internal environment in which people can become fully involved in achieving the organization's objectives.
3. People Involvement
People at all levels are the essence of an organization. Their full involvement creates opportunities for their abilities to be used for the organization's benefit.
4. Process Approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
5. Systems Approach to Management
Identifying, understanding and managing interrelated processes as a system define the organization's effectiveness at achieving its objectives.
6. Continual Improvement
Continuous overall performance improvement is the objective of a successful long-term organization.
7. Factual Approach to Decision-making
Effective decisions are based on solid information and objective data analysis.
8. Mutually Beneficial Supplier Relationship
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
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ISO 9000:2000 Key Changes
The major reasons for the year 2000 revisions of the standards include:
- Emphasizing the need to monitor customer satisfaction,
- Meeting the need for more user-friendly documents,
- Assuring consistency between quality management system requirements and guidelines,
- Promoting the use of generic quality management principles by organizations, and enhancement of their compatibility with ISO 14001.
Extensive surveys have been performed on a worldwide basis to understand the needs of all users of the quality management system standards. The new revisions take into account previous experience with quality management system standards (1987 and 1994 editions) and emerging insights into generic management systems. They result in a closer alignment of quality management systems with the needs of organizations to better reflect the way organizations run their business activities. ISO's rules of procedure (the ISO/IEC Directives) also specify that standards be periodically revised to ensure that those standards are current and satisfy the needs of the global community.
The new requirements and the format of the ISO 9001:2000 standard communicate the systems nature of the standard. The emphasis on planning and top management involvement establishes it as a true management system. Product and service quality are included, but they are not the only aspect of the customer's experience. Understanding and improving the customers' perception of how well you meet their requirements is a requirement of the new standard. This must be established at the top levels of management and communicated throughout the whole organization.
In addition to new requirements, the standard itself was simplified by merging 9001, 9002, and 9003 into a single 9001 standard. Organizations will no longer have to choose which standard to certify to now that all will certify to a single standard - 9001:2000.
Some areas were revised or updated in order to bring them in line with changes that have occurred in other areas of the standard.
- ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 were merged into a single ISO 9001:2000 standard.
- ISO 8402 and part of ISO 9000-1 were combined into a new ISO 9000:2000 standard.
- ISO 9004-1 was revised into a new ISO 9004:2000 standard.
- ISO 10011 (Parts 1, 2 and 3) were combined with ISO 14010, ISO 14011 and ISO 14012 into a new guideline standard for quality and environmental management system auditing (to be numbered ISO 19011).
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ISO 9000:2000 Standards
The 2000 version of the standard focuses more on management, the customer, and continuous improvement. This version establishes a management system model that is intended to continually improve customer satisfaction and the effectiveness of the management system.
ISO 9000:2000
ISO 9000 describes the basic fundamentals of a quality management system and the definitions of terms used in ISO 9000, 9001, and 9004. The philosophy, intended purpose and general nature of the elements of the quality management system are discussed. As with any requirements document, whether legal, regulatory, or voluntary, the definitions are a very important part of the document. Through these definitions, the scope and intent of the specific requirement are defined.
ISO 9001:2000
The ISO 9001 document establishes the requirements of the quality management system. According to the Introduction to ISO 9001:2000,
"This International Standard may be used by internal and external parties including certification bodies to assess the organization's ability to meet customer, regulatory, and the organization's own requirements."
In other words, this is the requirements document for a company wanting to Register or Certify to ISO 9001.
Notice that the only standard discussed here is ISO 9001. That is because the 2000 revision replaced ISO 9002 and ISO 9003 with ISO 9001. Organizations that are currently registered to ISO 9002 or 9003 may take exception to the non-applicable clauses of ISO 9001 in accordance with section 1.2 of the standard.
For an organization to claim an exception to a clause or element in ISO, the element must truly be not applicable based on the nature of the organization and its product. The exclusions are limited to paragraphs within clause 7 and must not
"affect the organization's ability or responsibility, to provide product that meets the customer and applicable regulatory requirements".
Basically, this means that if you have activities that are necessary in any way to provide your product or service to the customer, these activities must be included in your system. If you outsource any activity that affects product conformity, you are also responsible for ensuring control of these outsourced processes and the controls identified in your quality system.
For instance, a company that was registered to ISO 9002 thereby excluding the Design organization from the scope of its quality management system would no longer be able to exclude design under the 2000 revision. Any exclusions an organization takes must be documented in the Quality Manual.
ISO 9004:2000
ISO 9004 provides guidance on implementing a quality management system and addresses a broader approach than ISO 9001. Objectives related to overall performance and efficiency are included. ISO 9004 should not be viewed as a requirements document, but rather a guidance document for companies wishing to move beyond the requirements of ISO 9001.
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Copies of the ISO Standards
American Society for Quality - ASQ
A copy of the ANSI/ISO/ASQ Q9000 (U.S. version of ISO 9000:2000) series standard is available for a small charge from ASQ either in print or for electronic download from their website.
Contact ASQ at:
The American Society for Quality - ASQ600 North Plankinton Avenue
Milwaukee, WI 53203
Internet: www.asq.org
Phone: 800-248-1946 or 414-272-8575
Fax: 414-272-1734
American National Standards Institute - ANSI
The ISO 9000 or ISO 14000 series standards are available (for a small charge) from ANSI either in print or for electronic download from their website. The ANSI website store contains the complete collection of ISO published standards. The collection is organized into 43 new categories, based on the International Classification for Standards (ICS) developed by ISO.
Contact ANSI at:
The American National Standards Institute (ANSI)
1819 L Street
NW, Washington, DC 20036
Internet: www.ansi.org
Phone: 202-293-8020
Fax: 202-293-9287
Next: What is a Quality System?
