Basic ISO 9000 Information



Introduction

Welcome to a vital management tool for the next millennium. 

The 21st century will bring new challenges and new opportunities to corporations worldwide.  New markets have been intensely competitive and demand higher product quality standards from your company.  Managing and continuously improving existing quality assurance goals are essential for successful implementation of a quality management system. 

The intent of the ISO 9000 Series is consistent customer satisfaction through the timely supply of products or services that conform to the requirements and expectations of your customers.  The three new standards are:

ISO 9000:2000-Quality Management Systems-Fundamentals and Vocabulary- Describes quality management system fundamentals and terminology.  It cancels and replaces ISO 8402:1994 Quality Management and Quality Assurance-Vocabulary and ISO 9000-1:1994, clauses 4 and 5. 

ISO 9001:2000-Quality Management Systems-Requirements- Defines the requirements for quality management systems and is used to demonstrate an organization’s capability to provide products that meet customer and applicable regulatory requirements.  It cancels and replaces ISO 9001:1994, Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, ISO 9002:1994 Quality Systems-Model for Quality Assurance in Production, Installation, and Servicing and ISO 9003:1994 Quality Systems-Model for Quality Assurance in Final Inspection and Test.

ISO 9004:2000 Quality Management Systems-Guidance for Performance Improvement- Provides guidance on quality management systems and includes concepts for continual improvement processes that link to customer satisfaction.  It is intended to help organizations establish and improve their quality management systems, with an emphasis on performance improvement.  It cancels and replaces ISO 9004-1:1994 Quality Management and Quality System Elements-Guidelines.

The ISO Quality Management System monitors customer satisfaction, and can help an organization attract new customers.  An investment in a quality management system is also an investment in future sales success.

ISO 9000:2000 is not an external quality standard, nor is it subject to audit and certification as it is promulgated as a Quality Management Systems – Fundamentals and Vocabulary, and ISO 9004:2000 is promulgated as a Quality Management Systems – Guidelines for Performance Improvements.  ISO 9004:2000 is a useful quality systems model for many industries, including construction, software, hotels and other non-manufacturing services.  The primary difference in this standard is that ISO 9004:2000 is an internal guidance program and compliance does not guarantee or provide any assurance of product quality for external customers.

QS-9000, developed by the Big Three automakers, is another important ISO 9000 variant.  A separate package is available for companies developing a quality assurance system to the QS-9000 standard.  This specialized standard, based on the ISO 9000 Series, is used worldwide by the automotive industry and includes specific industry policies and procedures. 

A successful quality management system requires an unequivocal commitment from company management to support the program and its implementation.  With that support, and some technical assistance, anyone with effective computer and communication skills can customize this package to suit almost any company and industrial activity.  The result will be an effective ISO 9001:2000 Quality Management System that is both flexible and results-driven. 


Transition

The transition from the 1994 to the 2000 revisions is an important issue for industries, accreditation bodies and registrars.  This new organization makes ISO 9001 more compatible with the ISO 14001 (environmental) standard, and is consistent with ISO 9004’s Plan-Do-Check-Act improvement cycle.  It also corrects the unwarranted emphasis on the manufacturing industries that characterized previous editions.

The Plan-Do-Check-Act methodology is described as follows:

Plan:  Establish objectives and processes required to deliver results according to customer requirements and organization requirements.

Do:  Implement processes

Check-process and products should be continuously monitored against policies, objectives and requirements with recorded results.

Act:  Actions should be taken to continually improve process performance.

For organizations with a current 1994 ISO system in place, a smooth transition is possible with careful consideration and planning of documentation, training, auditing and management.  Organizations must first pay close attention to the implications of ISO 9001:2000’s Section 4, or outlined in the Quality Manual.  This outline stipulates that an organization must document their quality management system and address the best approach.  The Quality Manual help notes will assist you in referencing the 1994 requirements to the new requirements.

Transitioning will require your company to review your current Quality Manual to ensure that it is ISO 9001:1994 compliant.  This is critical to avoid existing nonconformance issues if you intend to use the old manual to edit and replace, where this is possible, within the new manual. 

Review all of the new requirements addressed in the Quality Manual located in this template.  This will introduce your company to the new requirements, and help you determine your plan of action.  It may be helpful to highlight the old documentation that you intend to keep and add to the new manual, which will typically be the forms, work instructions, interrelationships, and any specified methods your company is required to maintain.

Employees will need to be retrained and introduced to the new 2000 requirements.  Make sure your training is recorded. 

ISO: Short History

ISO has its roots in post-World War II Europe.  The need to rebuild infrastructure and retool industries also created the need to develop commonality among industry through standardization. 

In 1946, the International Organization for Standardization was founded.  Its stated purpose was to develop common manufacturing, trade, and communications standards.  Today for example, we accept without question, that sea and air containers can be handled worldwide.  Or, that the international telephone system will seamlessly connect any call from anywhere to anywhere. 

Without agreed basic standards, chaos would quickly result.  Standards are the “nuts and bolts” connecting the global community.  International trade operates on the tacit assumption that everything fits together.  The international standardization that we now enjoy did not occur spontaneously.  Standards were generally established outside the arena of geopolitics; consensus did not always come easily but commonsense, in the interests of all nations, seems to have prevailed since the late 1940s.

ISO derives its name from the Greek word, isos, meaning equal.  The English prefix, iso (from the same Greek root), also means equal and is found in such words as isobar (a line on a weather map connecting places having the same or equal barometric pressure) and isostatic (under equal pressure from every side).  For anything to be equal it must contain uniform or standard characteristics. 

ISO is therefore both a (French language) acronym for the International Organization for Standardization and an accurate description of its purpose.  Now based in Geneva, Switzerland, ISO is comprised of over 100 member countries.  Each country is represented by its appointed member body.  This national body is the function that establishes and controls its own country’s national standards.  Each nation has a single vote despite the often vast disparities in size, population and level of economic development among member countries.  The United States is represented by The American National Standards Institute (ANSI). 

Member countries are not under any international legal obligation to adopt or locally enforce ISO standards.  However, many countries chose to adopt ISO standards as their own national standards.  Some do so only by key industries; others by wider mandates.  ISO develops universal standards for all industrial and commercial activities, except in the electrical and electronic engineering industries.  These are the responsibility of the International Electrotechnical Commission (IEC), also based in Geneva.  ISO and IEC work closely and cooperate on the development of common standards. 

From its early beginnings in 1946, ISO has responded to the awesome task of bringing the business world together through common standards.  Today, ISO standards are found in almost every industrial and commercial endeavor, from heavy manufacturing to world currency exchange rate calculations.  Quality Systems are only a small but nevertheless an important part of the global ISO commitment to standardization. 

The development of quality assurance standardization benefited from, and was hampered by the Cold War.  Many early national and international standards arose from quality control demands for military and civilian nuclear industry needs.  These standards were either quality system requirements to be used by contractors or specification requirements for purchasers and suppliers.  Most were also classified and therefore not available for wider industrial or commercial use.

The ISO 9000:2000 Series of Standards in use today is, in part, a direct descendant of the U.S.  Department of Defense MIL-Q-9858 quality assurance program adopted in 1959.  In 1968, The North Atlantic Treaty Organization, more widely known as NATO, adopted the principles and much of the content of the successful Department of Defense program under a series of standards, prefixed AQAP. 

The first broad civilian use of quality assurance systems came in 1979 when the British Standards Institute (BSI) issued standards for industrial and commercial use.  The development of the European Union was also a major catalyst in the logical growth of international quality assurance standards. 

The 1970’s brought rapid global improvements in information and transportation technology.  Computers, telecommunications satellites and wide body jets all changed the way the world did business.  The need for corresponding product quality requirements and guidelines became increasingly obvious.  Differing national quality standards were increasingly perceived to be serious barriers to global trade.  As trade was becoming more complex and potentially more costly, countries could no longer uphold that their standards as superior to other national standards.  The solution for export/import trade and domestic vendor/customer relationships was to provide product standards and quality system guidelines to companies worldwide.  Standards were now essential to facilitate world trade.

It was not until 1987 that an ISO Technical Committee finally agreed to a common set of quality standards and published the ISO 9000 Series.  The term ISO 9000 Family or Series refers to the comprehensive group of standards developed by Technical Committee 176 and published in its entirety as ISO/TC176.  The 2000 standards have been reviewed and revised as part of an on-going process to keep up with changes, responses and the needs of individual companies, trying to be flexible enough to introduce it to more industries, which create a uniform Quality Management System. Only ISO 9001:2000 is a quality standard.  The other ISO/TC176 documents are guideline standards.

ISO standards are always published in English and French, two of the three ISO official languages. The third official language, Russian, is also used extensively.  Any standard adopted by a member country must be translated and published in the official language of that country.


ISO Today

ISO 9001:2000 is now a vital part of the way the world does business.  It is a universal quality ideal that is widely understood and transcends language and cultural barriers. 

Many U.S. companies adopted an ISO standard through the loss of a key customer or on the mistaken assumption that ISO registration would be a requirement for doing business in Europe or Asia. 

Other companies have become convinced that ISO 9001:2000 registration is good for business and a valuable process management system.  Registration continues to skyrocket.  Tens of thousands of businesses in the U.S. are now registered.  Thousands more are in ISO compliance or are introducing ISO 9001:2000 quality management systems. 

Most ISO certification is in the manufacturing sector, but new ISO success stories in construction, service, healthcare, and even the hospitality (hotel) industry, demonstrate the flexibility and usefulness of ISO 9001:2000. 

The Big Three automakers (Ford, Chrysler and General Motors) have their own quality system for their suppliers.  QS-9000 includes most of the elements of ISO 9001:1994 with additional automotive manufacturing standards for use by the thousands of suppliers in the auto and truck manufacturing industries.  American-made autos have largely overcome many of the disastrous quality image problems that plagued the auto industry in past decades.  Japanese auto manufacturers now use the American developed QS-9000 standards for many of their own global operations. 

ISO 9001:2000 works.  Companies voluntarily use ISO 9001:2000 Quality Management Systems requirements.  There are no Federal or State laws requiring ISO compliance.  (The U.S.  Federal government encourages its departments to adopt voluntary consensus standards and a 1995 law requires those departments that do not do so to provide a written explanation.) 

They key to its global success is its flexibility.  One size does not fit all.  ISO 9001:2000 is essentially a five-clause program (4-8), with portions of clause seven (design), flexible for modification and changes enabling desired company behavior.  Each company has the ability to build on the key principles contained in their ISO 9001:2000 standard with procedures that meet their specialized needs.

The principles of ISO quality assurance work equally as well in Indiana as they do in India.


The Future of ISO 9000

ISO 9000 is here to stay.  It has proven its worth worldwide and is accepted as not just “another management fad” ‑ it is a gateway to new markets and customers.  ISO 9000 will continue to grow as a vital global trading requirement. 

It will also continue to strengthen the domestic production capabilities of successful companies.  As the world grows smaller through new technology, and as more non-stop flights connect major foreign cities, quality management will become a basic tenet for business success.  Companies that cannot convince their customers of ISO quality management will inevitably lose business to their new competitors.  As tariff barriers continue to fall, those new competitors may not be across town, but on a different continent, possibly speaking a different language.  Tomorrow’s customers may regard the ability to delivery conforming product before location and national loyalties. 

As the world grows seemingly smaller with the advancements in communication carried into the 21st century, ISO 9001:2000 will continue to succeed in bringing customers closer to suppliers.  It will also bring competitors closer to traditional customers and markets.

Understanding Quality Standards

“Quality” is an easy concept to understand but difficult to define.  Most contemporary definitions are subjective in nature.  In the context of an ISO 9000 standard, “Quality” is defined as:

“The totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.”

Simply put, “quality” is the sum total of all the parts of an entity that directly or indirectly affects its actions or ability to meet the goals or expected result.  Quality is therefore not only the result itself; it is also all the activities that lead up to that result.  (Note: An “entity” in this definition can be a process, a product, a company or organization, a system, a person, or any combination thereof.)

Understanding the accepted and narrower product (or service) definition of “quality” is nevertheless important.  It is usually defined as “fitness for use” or “fitness for purpose.”  A manufacturer that consistently produces product that is unfit for use is unlikely to stay in business.  Most manufacturers base production activities on agreed technical standards so as to produce a standard result.  Specifications are often technically complex, and production well managed, leading some executives to question the need for additional ISO 9000 Quality Management Systems requirements. 

However, ISO 9004:2000 (the basic guidance document in the ISO 9001:2000 Series) states, “Specifications may not in themselves guarantee that a customer’s requirements will be met consistently.” It is important to recognize that “quality” under ISO guidelines is not exclusively the result of product standards and/or technical specifications.  Quality is also a separate but an interconnected result of an effective quality management system. 

ISO 9001:2000 standards are founded on the principle that consistent product quality is achieved by the parallel applications of a quality system and product standards.  The latter provides the technical standards under which the production process operates to produce the desired result.  However, a quality system is not related to the any particular technical standard.  It is a method under which your company uses ISO 9000 standards to identify and empower the management systems needed to design, produce, deliver and support products that conform to customer expectations. 

Product standards are specific to that product.  The Quality System enhances every activity, irrespective of the specific product.  “Quality,” under the ISO definition, is therefore achieved through the control of two types of standards: technical and behavioral.  Both are equally important but neither is overly reliant on the other.  Managing technical quality has historically relied on inspection “after the fact.” Managing human error has traditionally relied on the apportionment of blame, sometimes with disciplinary consequences.  ISO 9000 principles seek to move past these traditional approaches by systemizing quality control and reducing negative quality events.  It is a system of total process overview with the ability to quickly intervene when quality problems arise. 

ISO 9000-1 bases effective quality control on eight quality management principles:

  • Customer focus

  • Leadership

  • Involvement of people

  • Process approach

  • System approach to management

  • Continual improvement

  • Factual approach to decision making

  • Mutually beneficial supplier relationships

 The first two fundamentals rely on product standards and technical specifications.  The others rely primarily on the quality system.  An effective quality management system program essentially contains an equal commitment to product specifications and human production processes. 

The frequently used term, “Quality Management System,” is not necessarily interchangeable with “Quality.”  Quality is the end result of effective Quality Management Systems efforts.  Quality Management System is defined as:

“To establish policy and objectives, through directly controlling a group of people and facilities with an arrangement of responsibilities, authorities and relationships with regard to the degree to which a set of inherent distinguishing features fulfills the needs or expectations that are stated, generally implied or obligatory.”

The intent of your quality management system is to prevent problems.  By preventing problems, you reduce and hopefully eliminate, the production of nonconforming product that does not meet the expectations of your customers (or “conform” to specifications). 

To prevent problems from recurring within your quality management system, it is critical that you are able to detect them when they do occur.  You must then identify the cause, remedy the cause, and prevent recurrence.  If you do not, you do not have a true quality management system.  Without the ability to identify and correct nonconforming events (quality failures), all other quality activities will be jeopardized.

The successful introduction of a viable quality management system for your company can only be accomplished by embracing the totality of the ISO 9000 philosophy.  Elements of the systems may be progressively introduced in a timely manner but there also needs to be a clear commitment to the total concept of quality management at all company levels. 

The ISO Standard Explained

The original ISO Series, issued in 1987, was revised and reissued in 1994 and again in 2000.  The external Quality Management Systems Requirements, ISO 9001, contain specific elements that a company’s quality system must contain for compliance and subsequent certification.  However, the standards do not specify how a company is required to implement the essential elements.  The requirements are generic and broadly suited to any industrial or economic activity. 

ISO standards are not intended to enforce a worldwide uniform quality management systems method.  Companies are encouraged to adopt the standard best suited to their needs and then adapt a quality management system that complies with the essential ISO elements but which is also consistent with the individual requirements of each company.  A flexible quality system is intended to conform to the company’s processes and not to force company to change its basic production methods. 

There are three basic ISO quality standards groups.  These are defined as:

·        Primary Standards for external quality systems in response to customer requirements and/or internal quality system used by management as an independent control tool (also known as Conformance Standards);

·        Secondary Standards to provide guidance in the selection and applicability of primary standards (also known as Guidance Standards); and

·        Support Standards to provide technological support in the development of a quality system.  Support standards are generally issued under the ISO10000 Series and not under the ISO 9000 numbering system. 

Reference

ISO QUALITY SERIES

Type

ISO 9000:2000

Quality Management Systems ‑ Fundamentals and Vocabulary

Specifies the terminology for (9000:2000) quality management systems.

Support

ISO 9001:2000

Quality Management Systems– Requirements

Outline requirements (9001:2000) which exhibits where an organization must evidence a focus on customer service and demonstrate its ability to provide products that meet customer and applicable regulatory requirements.

Primary

IS0 9004:2000

Quality Management System– Guidelines for performance improvements

*ISO (9004:2000) is not a Conformance Standard.  It is an internal quality management standard.  Its elements are not intended for external quality assurance systems.  The aim of this standard is to monitor the effectiveness and efficiency of the quality management system, focusing on overall performance, improvement, and customer satisfaction.

Secondary*

ISO 10005

Quality Management – Guidelines for quality plans ................ (1995)

Support

ISO 10007

Guidelines for configuration management

Support

ISO 10011

Guidelines for configurations management

Part 1:   Auditing.............. (1990/reissue 1993)
Part 2:   Qualification criteria for quality system auditors................ (1991/reissue 1993)

Support

ISO 10012

Quality assurance requirements for measuring equipment

Part 1:   Management of measuring equipment

Support

ISO 10013

Guidelines for development quality manuals

Support

ISO 19011

Guidelines for auditing quality and environmental management systems.

Support

ISO 9001:2000 System Element Requirements Quick Reference

Section Standard Requirements Clause

5

Management Responsibility

5.1

Management Commitment

5.2

Customer Focus

5.3

Quality Policy

5.4

Planning

5.5

Responsibility, Authority, and Communication

5.6

Management Review

6

Resource Management

6.1

Provision of Resources

6.2

Human Resources

6.3

Infrastructure

6.4

Work Environment

7

Product Realization

7.1

Planning or Product Realization

7.2

Customer-related Processes

7.3

Design and Development

7.4

Purchasing

7.5

Production and Service Provision

7.6

Control of Monitoring and Measuring Devices

8

Measurement, Analysis and Improvement

8.1

General

8.2

Monitoring and Measurement

8.3

Control of Nonconforming Product

8.4

Analysis of Data

8.5

Improvement

Please note:  Organizations can only reduce the scope of Clause 7, Product or Service Realization, (which excludes requirements for Design and Development), when the reduction does not affect the organization’s ability to provide conforming product.  All reductions of scope must be clearly identified and documented in the Quality Manual.