All about ISO 9000:1994 Standards

(This document does not cover ISO 9000:2000 standards)

What are standards?

Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose.

International Standards thus contribute to making life simpler, and to increasing the reliability and effectiveness of the goods and services we use.

What is ISO?

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country.

ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity.

ISO's work results in international agreements which are published as International Standards.

Why is international standardization needed?

The existence of non-harmonized standards for similar technologies in different countries or regions can contribute to so-called "technical barriers to trade". Export-minded industries have long sensed the need to agree on world standards to help rationalize the international trading process. This was the origin of the establishment of ISO.

International standardization is well-established for many technologies in such diverse fields as information processing and communications, textiles, packaging, distribution of goods, energy production and utilization, shipbuilding, banking and financial services. It will continue to grow in importance for all sectors of industrial activity for the foreseeable future.

What fields are covered?

The scope of ISO is not limited to any particular branch; it covers all technical fields except electrical and electronic engineering, which is the responsibility of IEC. The work in the field of information technology is carried out by a joint ISO/IEC technical committee.

What is the difference between ISO 9001, 2 and 3?

If you have heard of ISO 9000, then it is most probably through ISO 9001, ISO 9002 or ISO 9003, the three quality assurance models against which organizations can be certified. At some stage, you have probably wondered what the difference between them is. The answer is that the difference is simply one of scope. It works like this:

ISO 9001 sets out the requirements for an organization whose business processes range

all the way from design and development, to production, installation and servicing;

for an organization which does not carry out design and development, ISO 9002 is the appropriate standard, since it does not include the design control requirements of ISO 9001 - otherwise, its requirements are identical;

ISO 9003 is the appropriate standard for an organization whose business processes do not include design control, process control, purchasing or servicing, and which basically uses inspection and testing to ensure that final products and services meet specified requirements.

So, an organization chooses that its quality system be certified against ISO 9001, ISO 9002 or ISO 9003 according to the business processes covered by the quality system. There is no difference of quality ranking between the three standards.

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The Standards that make up the ISO 9000 family :

(Note that standards are constantly being added and revised, so this list can quickly become out of date. )

ISO 9000-1: 1994 Quality management and quality assurance standards-Part 1: Guidelines for selection and use.

ISO 9000-2:1993 Quality management and quality assurance standards-Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003.

ISO 9000-3:1991 Quality management and quality assurance standards-Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software.

ISO 9000-4:1993 Quality management and quality assurance standards -- Part 4: Guide to dependability program management

ISO 9001:1994 Quality system-model for quality assurance in design, development, production, installation and servicing.

ISO 9002:1994 Quality system-model for quality assurance in production, installation and servicing.

ISO 9003:1993 Quality Systems-Model for quality assurance in final inspection and test.

ISO 10011-1: 1990 Guidelines for auditing quality systems. Part 1: Auditing.

ISO 10011-2: 1991 Guidelines for auditing quality systems. Part 2: Qualification criteria for quality systems auditors.

ISO 10011-3: 1991 Guidelines of auditing quality systems. Part 3: Management of audit programs.

ISO 10012-1: 1992 Quality assurance requirements for measuring equipment-Part 1: Metrological confirmation system for measuring equipment.

ISO 10013 Guidelines for developing quality manuals.

ISO/TR 13425 Guidelines for the selection of statistical methods in standardization and specification.

ISO 8402:1994 Quality management and quality assurance-Vocabulary

*Additional Info :______________________________________________________________________

How does the ISO 9000 family of standards work?

The requirements for a quality system have been standardized - but most of us like to think our business is unique. So how does ISO 9000 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration?

The answer is that ISO 9000 lays down what requirements your quality system must meet, but does not dictate how they should be met in your organization - which leaves great scope and flexibility for implementation in different business sectors and business cultures...as well as different national cultures.

So, the ISO 9000 family includes standards that give organizations guidance and requirements on what constitutes an effective quality management system. ISO 9004-1 (and the other parts of ISO 9004) are the standards giving guidelines on the elements of quality management and a quality system.

The family also includes models against which this system can be audited to give the organization and its clients assurance that the system is operating effectively. The three quality assurance models are ISO 9001, ISO 9002 and ISO 9003.

Lastly, the family includes a standard on terminology, and other standards, which can be described as "supporting tools", that give guidance on specific aspects, such as auditing quality systems.

Why should my organization implement ISO 9000?

To keep customers - and to keep them satisfied - your product (which may, in fact, be a service) needs to meet their requirements. ISO 9000 provides a tried and tested framework for taking a systematic approach to managing your business processes (your organization's activities) so that they consistently turn out product conforming to the customer's expectations. And that means consistently happy customers!

How are ISO standards developed?

ISO standards are developed according to the following principles:

ConsensusThe views of all interests are taken into account: manufacturers, vendors and users, consumer groups, testing laboratories, governments, engineering professions and research organizations.

Industry-wideGlobal solutions to satisfy industries and customers worldwide.

VoluntaryInternational standardization is market-driven and therefore based on voluntary involvement of all interests in the market-place.

The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. The latter proposes the new work item to ISO as a whole. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. This phase is usually carried out in working groups which comprise technical experts from countries interested in the subject matter.

Once agreement has been reached on which technical aspects are to be covered in the standard, a second phase is entered during which countries negotiate the detailed specifications within the standard. This is the consensus-building phase.

The final phase comprises the formal approval of the resulting draft International Standard (the acceptance criteria stipulate approval by two-thirds of the ISO members that have participated actively in the standards development process, and approval by 75 % of all members that vote), following which the agreed text is published as an ISO International Standard.

How it all started ?

International standardization began in the electrotechnical field: the International Electrotechnical Commission (IEC) was created in 1906. Pioneering work in other fields was carried out by the International Federation of the National Standardizing Associations (ISA), which was set up in 1926. The emphasis within ISA was laid heavily on mechanical engineering.

ISA's activities ceased in 1942, owing to the Second World War. Following a meeting in London in 1946, delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards". The new organization, ISO, began to function officially on 23 February 1947.

The first ISO standard was published in 1951 with the title, "Standard reference temperature for industrial length measurement".

20 Clauses in ISO :

Each model is comprised of clauses. There are a total of 20 clauses that apply to one or more of the ISO quality models. Some models share clauses, and others may pertain to only one specific model. The quality manual will document and incorporate those clauses that apply to the organization's function(s). Listed below is a brief description of each ISO clauses :

4.1 Management Responsibility.

This clause requires that management be committed to establishing and maintaining a quality management system. Management must appoint a Management Representative (MR) to oversee the quality system. The MR should possess appropriate rank and authority in the organization to establish, implement and maintain the quality system. The MR is responsible for coordinating responses to ISO standards, for initiating action to prevent nonconformity in the quality system, for identifying and recording quality problems, for initiating and recommending solutions to quality issues, for auditing ISO compliance, and for serving as a liaison between management and the ISO registrar.

4.2 Quality System.

The organization must prepare a quality manual that documents the development and implementation of policies, procedures, and work instructions that relate to the ISO standards. The front of the manual will include an outline on the enclosed documentation.

4.3 Contract Review.

This clause mandates that prior to accepting a contract that customer requirements must be documented, roles of all contract parties will be understood, resources will be available, and contract performance must be within the organization's capabilities.

4.4 Design Control.

This clause requires the establishment and maintenance of documented procedures that verify and control the design process to ensure that products satisfy the customer's requirements.

4.5 Document and Data Control.

This clause standard requires the establishment of procedures to ensure that the organization uses only current documentation and data for producing quality products and services. Documentation should address the quality manual, referenced procedures, operating instructions, and design documents.

4.6 Purchasing.

This clause requires procedures that specify what is being purchased, ensures that suppliers can deliver the required product or service, and verifies that what is delivered by the supplier conforms to applicable procurement requirements.

4.7 Control of Customer-Supplied Product.

Documented procedures are required to protect customer provided supplies from theft or destruction.

4.8 Product Identification and Traceability.

This clause requires that the organization have an audit trail for its products during any stage of the production, delivery, or installation process.

4.9 Process Control.

The organization must have documented controls for business practices that affect quality. Practices include: detailed procedures, work instructions, personnel assignments, and equipment used.

4.10 Inspection and Testing.

This clause requires that the organization establish acceptance criteria for work to ensure that customer product requirements are met.

4.11 Control of Inspection, Measuring and Test Equipment.

Procedures are required to ensure that equipment used to inspect, test, and measure products and services are properly calibrated and maintained.

4.12 Inspection and Test Status.

This clause requires testing (pass/fail) the status of products throughout the production process.

4.13 Control of Nonconforming Product.

The organization must be able to identify products that do not comply with the customers' requirements. This identification will take place before the product is delivered to the customer.

4.14 Corrective and Preventive Action.

This clause mandates that steps be in place to detect nonconformity, and to implement corrective and preventive actions.

4.15 Handling, Storage, Packaging, and Delivery.

The organization must protect the product and service from damage or deterioration.

4.16 Control of Quality Records.

This clause requires documentation on the collection, indexing, accessing, filing, maintenance, disposal, and storing of materials that address quality records.

4.17 Internal Quality Audits.

The organization shall document the audits of its quality process to identify nonconformity thus ensuring compliance with the standard.

4.18 Training.

The organization shall train their employees on ISO to ensure that duties are carried out consistently to support the objectives of the quality system. The organization will maintain the records of employees that receive training.

4.19 Servicing.

The organization will document those services provided on customer products, and verify that products provided comply with the customer's requirements.

4.20 Statistical Techniques.

The organization will draft procedures that implement and control the use of statistical techniques for the quality system.