Origin Of ISO 9000 Standards

The standard requires companies to write an ISO 9000 quality manual that defines how each requirement of the rather broad ISO 9001:2008 standard is applied at the company. In a sense, the ISO 9000 quality manual is a company specific version of the standard.

While writing the quality manual represents a big hurdle for most companies, the ISO 9001:2008 standard requires further details in form of ISO 9000 quality procedures, a quality policy and quality objectives. Most companies make the mistake of creating various different documents to meet these requirements; however, this usually is the beginning of a cumbersome and bureaucratic ISO 9000 quality system.
Tip: Combine the different documentation requirements (i.e., quality manual, procedures, corporate policy and objectives) as much as possible into one comprehensive manual. This reduces repetition and bureaucracy, and it saves time implementing the quality system.

Read more on ISO 9000 Standards at http://www.iso-9001-store.com

Create a Documented Implementation Plan In ISO 9000 Standards

Create a Documented Implementation Plan In ISO 9000 Standards

Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.

The implementation plan should be thorough and specific, detailing:

a. Quality documentation to be developed

b. Objective of the system

c. Pertinent ISO 9001:2008 section

d. Person or team responsible

e. Approval required

f. Training required

g. Resources required

h. Estimated completion date

These elements should be organized into a detailed chart, to be reviewed and

approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.

Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning.

ISO 9000 Standards Certification and Registration

ISO 9000 Standards Certification and Registration

The International Standards Organization is responsible for two major sets of requirements that relate to an overall quality management system to be used by businesses. The ISO 9000 family of standards is the primary set of requirements for most businesses.

Quality management by definition address that the organization does certain things to “fulfill the customer’s quality requirements and applicable regulatory requirements while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives”.
ISO 14000 address the environmental management to minimize harmful effects to the environment. Again, it is a quality management system designed to “achieve continual improvement of its environmental performance.

ISO certification 9000 is the most common. So, let’s take a look at what ISO certification entails and what it means. To become certified, a quality management system must be in place that meets the requirements of the ISO standard. This begins with the business recognizes the requirements and developing a quality system to meet their needs at the same time they meet the requirements.

ISO 9000 certification and ISO 9000 registration are two different entities, though they are often used interchangeably. To achieve ISO certification 9001 , an independent registrar is hired to audit the quality system for thoroughness and compliance to all the standards. When this is accomplished, the business is offered a certificate stating that the quality system conforms to standards within the particular standard.

ISO registration means that the certification has been recorded in its client register. Because most companies have been certified and in turn registered, the terms are offed interchanged in general use. While the term “certification” is the most widely used, “registration” used in North America. Both are completely acceptable, because the business has fulfilled the requirements set forth by ISO.

Origin Of ISO 9000 Standards

The story of ISO 9000 Standards is a story of standards, methods and regulation. The brief
history that follows is in no way comprehensive but is intended to illustrate
four things:
1. that ISO 9000 standards are an ancient concept that survived several millennia;
that a means of verifying compliance often follows the setting of
standards;
2. that the formalizing of working practices is centuries old and seen as a
means to consistently meet standards;
3. that market regulation (relative to the standard of goods and services) has
been around for centuries for the protection of both craftsmen and
traders.
4. ISO 9000 is a symptom of practices that were around centuries before anyone
coined the term quality management. It is in some respects a natural
progression that will continue to evolve. The story is told from a British
viewpoint.

ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997.
The history of ISO 9000 Standards dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments.
During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally.
In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.

ISO 9000 Standards – Conducting Management Reviews

ISO 9000 Standards – Conducting Management Reviews

The ISO 9000 standards requires that top management conduct

management reviews.

The term review is defined in ISO 9001 as an activity

undertaken to ensure the suitability, adequacy, effective-

ness and efficiency of the subject matter to achieve

established objectives. The addition of the term manage-

ment means that the management review can be

perceived as a review of management rather than a

review by management, although both meanings are conveyed in the standard.

The rationale for this is that the examples given in ISO 9000 such as design

review and nonconformity review clearly indicate it is design and non-

conformity that is being reviewed. If the system was to be reviewed then the

action should be called a system review. It is no doubt unintentional in the

standard but, if the management system is perceived as the way in which the

organization’s objectives are achieved, a review of management is in fact a

review of the way achievement of objectives is being managed because the

organization exists to achieve objectives and so both meanings are correct.

Top management will not regard the management review as important unless

they believe it is essential to running the business. The way to do this is to treat

it as a business performance review. This is simpler than it may appear. If the

quality policy is now accepted as corporate policy and the quality objectives

are accepted as corporate objectives, any review of the management system

becomes a performance review and no different to any other executive

meeting. The problem with the former management reviews was that they

allowed discussion on the means for achieving objectives to take place in other

management meetings leaving the management review to a review of errors,

mistakes and documentation that no one was interested in anyway. The

management system is the means for achieving objectives therefore it makes

sense to review the means when reviewing the ends so that actions are linked to

results and commitment secured for all related changes in one transaction.

The requirement emphasizes that top management conduct the review – not

the quality manager, not the operational manager – but top management – those

who direct and control the organization at the highest level. In many ISO 9000

registered organizations, the management review is a chore, an event held once

each year, on a Friday afternoon before a national holiday – perhaps a cynical

view but nonetheless often true. The reason the event has such a low priority

is that management have not understood what the review is all about. Tell

them it’s about reviewing nonconformities, customer complaints and internal

audit records and you will be lucky if anyone turns up. The quality manager

produces all the statistics so the others managers are free of any burden. By

careful tactics, these managers may come away with no actions, having

delegated any in their quarter to the quality manager.

In order to provide evidence of its commitment to conducting management

reviews, management would need to demonstrate that it planned for the

reviews, prepared input material in the form of performance results, metrics

and explanations, decided what to do about the results and accepted action to

bring about improvement.

The ISO 9000 standards requires that top management conduct management reviews.

The term review is defined in ISO 9000 Standards as an activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject matter to achieve established objectives. The addition of the term management means that the management review can be perceived as a review of management rather than a review by management, although both meanings are conveyed in the standard.

The rationale for this is that the examples given in ISO 9000 Standards such as design review and nonconformity review clearly indicate it is design and non-conformity that is being reviewed. If the system was to be reviewed then the action should be called a system review. It is no doubt unintentional in the standard but, if the management system is perceived as the way in which the organization’s objectives are achieved, a review of management is in fact a review of the way achievement of objectives is being managed because the organization exists to achieve objectives and so both meanings are correct.

Top management will not regard the management review as important unless they believe it is essential to running the business. The way to do this is to treat it as a business performance review. This is simpler than it may appear. If the quality policy is now accepted as corporate policy and the quality objectives are accepted as corporate objectives, any review of the management system becomes a performance review and no different to any other executive meeting. The problem with the former management reviews was that they allowed discussion on the means for achieving objectives to take place in other management meetings leaving the management review to a review of errors, mistakes and documentation that no one was interested in anyway. The management system is the means for achieving objectives therefore it makes sense to review the means when reviewing the ends so that actions are linked to results and commitment secured for all related changes in one transaction.

The requirement emphasizes that top management conduct the review – not the quality manager, not the operational manager – but top management – those who direct and control the organization at the highest level. In many ISO 9000 registered organizations, the management review is a chore, an event held once each year, on a Friday afternoon before a national holiday – perhaps a cynical view but nonetheless often true. The reason the event has such a low priority is that management have not understood what the review is all about. Tell them it’s about reviewing nonconformities, customer complaints and internal audit records and you will be lucky if anyone turns up. The quality manager produces all the statistics so the others managers are free of any burden. By careful tactics, these managers may come away with no actions, having delegated any in their quarter to the quality manager.

In order to provide evidence of its commitment to conducting management reviews, management would need to demonstrate that it planned for the reviews, prepared input material in the form of performance results, metrics and explanations, decided what to do about the results and accepted action to bring about improvement.