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ISO 9000 Policies and Procedures Manual

ISO 9001 Policies Procedures Manual

Based on ISO 9001:2008

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Weight: 5 pounds

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Procedures Manual Sections:

ISO Standards


 

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Other Introductory Sections:

ISO 9000 and ISO 14000

In 1987, the first ISO 9000 standard was released. But it was not until 1992, when trade throughout Europe began opening up and multinational companies in the U.S. had to meet ISO 9000 requirements in Europe, that the standard was finally implemented in the United States.

ISO 9000 has become synonymous with quality. ISO 9000 translates "quality management" into a continuously improving process designed to meet or exceed customer and regulatory requirements.

ISO 14000 has become synonymous with quality environmental matters. ISO 14000 translates "environmental management" into a continuously improving process designed to minimize harmful environment effects while improving environmental performance. The original set of ISO 14000 standards were published in 1997.

ISO 9000:1994 Series Overview

The original set of quality assurance standards, commonly known as ISO 9000, was published in 1987 by ISO. The standard was initially based on British Standard 5750 and modified as appropriate to address issues of all member nations. The ISO 9000 series of standards are translated into many different languages and must be equal in all languages. This has resulted in the wording of the standard to be somewhat awkward at times.

The purpose of the ISO 9000 standard initially (1987 & 1994 revisions) was to provide a company with the minimum requirements for a quality system to be effective in providing customers with products of a consistent quality that met their requirements. Certification or Registration (the terms are used interchangeably) to ISO 9001, 9002 or 9003 provided customer organizations with confidence that a supplier had implemented an appropriate quality system, therefore providing a more reliable quality of product. If problems with the quality of products should arise, the customer complaint and corrective action system would ensure correction of the problem and prevention of recurrence.

The standards were updated in 1994 (ISO9000:1994) and again in December 2000 (ISO 9000:2000). All companies certified to one of the earlier ISO9000:1994 standards are required to re-certify under the latest ISO9000:2000 standard by December 2003 in order to maintain certification. This section is provided for reference only.

The old ISO 9000:1994 Series was a set of five individual, but related, international standards on quality management and quality assurance. They are generic in nature and not specific to any particular product or service. These standards were developed with the goal of effectively documenting the quality system elements to be implemented in order to maintain an efficient quality system in a company. However, the standards themselves do not specify the means to be used for implementing the quality system elements.

ISO 9000 is the first standard in the series and is entitled "Quality Management and Quality Assurance Standards - Guidelines for Selection and Use." This section presents an overview of the whole set and guidelines for use of the rest of the series.

ISO 9001, 9002 and 9003 are quality system models for external quality assurance. These three models are actually successive subsets of each other.

ISO 9001 is the most comprehensive, which covers design, manufacturing, installation and service.

ISO 9002 covers production, installation and servicing.

ISO 9003 covers only final product inspection and testing.

Under ISO9000:1994, The company would have chosen one of the above "auditable" standards to measure its quality system against. It would serve as the guideline for an independent third party audit of company operations against the requirements of the appropriate standard.

ISO 9004 is the fifth in the series. It provides guidelines for internal use by a producer developing its own quality system to meet business needs and take advantage of opportunities.

QS-9000 and other Sector Requirements

Several industries have adopted their own requirements based on the ISO standards. The automotive industry created QS-9000, which incorporates ISO 9001 along with additional auto industry specific requirements. The aerospace industry created AS9000 and the telephone industry has created TL 9000.

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Transitioning from ISO 9000:1994 to ISO 9000:2000

The International Organization for Standardization is chartered to revise and update the standard approximately every five years. Considering the effort involved in revising, translating, and obtaining agreement from the various nations, it is no wonder that the revisions have taken six to seven years.

The changes to ISO 9000 were officially released 15 December 2000. All companies certified to one of the earlier ISO 9000:1994 standards have three years from the release date to re-certify under the latest ISO 9000:2000 standard in order to maintain certification.

There were 20 required elements included in the ISO 9001:1994 auditable standards which served as guidelines to personnel for ensuring complete and thorough quality assurance system development and documentation. The new ISO 9000:2000 standard is now formed around eight management principles that use a process cycle instead of discrete elements. Therefore, the 20 required elements have been replaced by new standards that resemble the old elements.

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ISO 9000:1994 to ISO 9000:2000 Gap

Are you struggling with the latest ISO 9000:2000 standard?  

All companies certified to one of the earlier ISO 9000:1994 standards have three years from the release date (15 December 2000) to re-certify under the latest ISO 9000:2000 standard in order to maintain certification.  That means companies certified to ISO 9000 must re-certify to ISO 9000:2000 by December 15, 2003.

What Steps Do You Need To Take To Re-Certify?

  1. Understand the new ISO9000:2000 Standard.
  2. Understand the key changes from the ISO 9000:1994 to the 2000 standard.
  3. Identify the gaps in your company ISO 9000:1994 Quality Management System (QMS) as compared to the new ISO 9001:2000 version of the International Standard.
  4. Identify the maturity or effectiveness of your company QMS, (the degree to which the organization QMS meets the needs of the business and its' customers).
  5. Identify the gaps, if any, in the organization technical skills and knowledge which may prevent the organization from successfully transitioning to the new ISO 9001:2000 version of the International Standard.
  6. Provide a MS Project plan outlining the phases, activities and tasks your company must take in order to achieve ISO 9001:2000 registration.
  7. Address the gaps and improve the effectiveness of your company QMS
  8. Optionally, identify and integrate new software tools that can be used to simplify the continuous process improvement required by the new standard.

Is There A Faster Way?

Yes.  If you are an ISO 9000:1994 registered organization looking for a simple, plain language explanation of how your existing ISO registered Quality Management System (QMS) meets the requirements of ISO 9001:2000, then the Bizmanualz Gap Analysis is for you.  It is an opportunity for your ISO registered company to objectively review the degree to which your QMS meets the everyday needs of your business and your customers. 

Next: ISO 9000:2000 Standard

 

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