LESSON 3

INTERNATIONAL STANDARD ORGANIZATION (ISO)

What is ISO?

What is Standard?

- is an object considered by an authority or by general consent as a basis of comparison.

- is also an approved model, anything, as a rule or principle that is used as a basis for judgment.

Note: Standard is an authoritative principle or rule that usually implies a model or pattern for guidance, by comparison, with which the quantity, excellence, correctness, of other things may be determined.

What is ISO?

What is ISO? The ISO 9000 Standard was developed in

Geneva, Switzerland by the International Organization for Standardization (ISO) and is an internationally recognized quality benchmark that can be applied to any business in any environment.

It was founded in 1946 to promote the development of international standard and related activities, including conformity assessment, to facilitate the exchange of goods, services, and to develop cooperation in intellectual, scientific, technological, and economic activity worldwide.

What is ISO?

Note: ISO’s work covers all areas except those related to electrical and electronic engineering, which are covered by the International Electrotechnical Commission (IEC). The results of ISO’s technical work are published as International standards or Guides.

ISO is made up of approximately 180 Technical Committees. Each technical committee is responsible for one or many areas of specialization ranging from asbestos to zinc.

What is ISO?

At present, it comprises the national standard bodies of 91 countries. The American National Standards Institute (ANSI) is the member body representing the United States.

There are two main variations of the Standard:ISO 9001 – for businesses which design their

own products/servicesISO 9002 – for all other businesses

What is ISO?

Note: Applying the ISO 9000 Standard promotes a focus on the quality of an organization’s business and management processes, with the result that improved consistency of product/service delivery is achieved.

What is ISO?

Concepts of Benchmarking A benchmark is a point of reference by which

performance is judged or measured. For quality, possible benchmarks go from the traditional to the unusual:

The specificationCustomer desiresCompetitionBest in our industryBest in any industry

What is ISO?

Note: For survival in the marketplace, the traditional benchmark (the product specification) must be supplemented by measuring quality relative to competition; for quality leadership the benchmark must be the “best”. Xerox, for example, defines competitive benchmarking as “the continuous process of measuring our products, services and practices against our toughest competitors or those companies renowned as leaders.”

What is ISO?

Thus a benchmark for a photocopier product would be the best competitor in the photocopier industry; a benchmark for the Xerox system of packing warehouse orders might be the performance of a company in any industry, e.g., a mail order firm selling consumer products.

What is ISO?

The initial benchmarking steps are: Determining the characteristics to be

benchmarked Determining the organizations from

which data will be collected Collecting and analyzing the data Determining the “best in class”

What is ISO?

What is ISO 9000? ISO 9000 is a series of Standards (published

ISO) which define a framework of minimum requirements for the implementation of quality systems to be used in contractual situations identical to the EN series of standards (EN29000) and other national series. It has been adopted worldwide as suitable criteria for assessment and registration of companies of independent accredited third-party organizations (Registrars).

What is ISO?

ISO 9000 standards provide a systematic approach to process management, requiring a detailed account of procedures and operation. This system includes documentation of the processes of how a company designs, produces, inspects and packages, and installs its products. Its structure focuses on the management of all processes that affect quality.

The ISO 9000 Standard Series is generic in scope. Each Standard addresses a different aspect of quality assurance, depending on the needs of the user.

What is ISO?

Who developed the ISO 9000 Series Standards?

ISO Technical Committee 176 (ISO/TC176) was formed in 1979 to harmonize the increasing international activity in quality management and quality assurance standards. Subcommittee 1 was established to determine common terminology. Subcommittee 2 was established to develop quality systems standards – the result being the ISO 9000 series, published in 1987 (revised 1994).

What is ISO?

The United States had input into this development process through membership in ISO via ANSI. This input was channeled through a Technical Advisory Group (TAG).

The ISO 9000 standards were intended to be advisory in nature and were developed primarily for use in two-party contractual situations for internal auditing.

The ISO 9000 Standard Series has been adopted in the United States as the ANSI/American Society for Quality Control (ASQC) Q90 Series (Soon to be changed to the ANSI/ASQC Q9000 series).

Statistics show that returns from ISO 9000 registration are both real and long lasting.

What is ISO?

ISO BenefitsIt will guide you to build quality into your product or

service and avoid costly after-the-fact inspections, warranty costs, and rework.

It will also reduce the number of audits customers perform on your operation.

Benefits of Implementing the ISO 9000 StandardImproved management efficiency, internal

communications and problems solving abilitiesLess duplication and wasteImproved product/service quality, customer satisfaction

and customer focusEnhanced company imageProvides a framework for other improvement initiatives

such as TQM and Benchmarking

What is ISO?

Cost Vs BenefitsCompanies paid $245,000 on average for costs

associated with registration, including auditing fees and internal expenses. Remember the costs are much lower for companies that have some form of quality system in place.

Companies saved an average of $179,000 annually after registration.

Eighty percent of the registered companies say ISO 9000 registration influences their choice of supplier.

Almost 83% of the registered companies say they encourage some supplier to seek registration and 34% encourage all suppliers to seek registration.

More than 80% of the registered companies say they use ISO 9000 registration as a criterion for selecting suppliers.

What is ISO?

ISO 9000 Series BreakoutISO 9000-1 (ANSI/ASQC Q90), Quality Management and

Quality Assurance Standards – Guidelines for Selection and Use.

This standard explains fundamental quality concepts; defines key terms; and provides guidance on selecting, using, and tailoring series and helps in the selection and use of the standards in the ISO 9000 family.

ISO 9001-1 (ANSI/ASQC Q91), Quality Systems – Model for Quality Assurance in Design/Development, Production, Installation and Servicing.

This is the most comprehensive standard. It addresses all elements in the including design. The 1994 edition of the standard improved the consistency of the terminology and clarified or expanded the meaning of some of the standard’s clauses. Several new requirements, such as that for the quality planning, were

What is ISO?

ISO 9002 (ANSI/ASQC Q92), Quality Systems – Model for Quality Assurance in Production and Installation, and Servicing.

Model for quality assurance in production, installation, addresses the prevention, detection and correction of the problems during production and installation. It is identical with ISO 9001, except that it does not include design requirements. The 1994 edition added servicing requirements to the 1987 edition.

What is ISO?

ISO 9003 (ANSI/ASQC Q93), Quality Systems – Model for Quality Assurance in Final Inspection and Test.

This is the least comprehensive standard. It addresses the detection and control of problems during final inspection and testing. The 1994 edition added additional requirements including: contract review; control of customer supplied product; corrective action; and internal quality audits

What is ISO?

ISO 9004-1 (ANSI/ASQC Q94), Quality Management and Quality System Elements – Guidelines.

This standard provides guidance in developing and implementing an internal quality system and in determining the extent each quality system element is applicable. It is intended to assist a supplier in improving internal quality management procedures and practices – it is not intended for use in contractual, regulatory or registration applications. The 1994 edition contains new guidance and clarification of the guidance contained in the 1987 edition.

What is ISO?

Cost of Certification First think of ISO 9000 series certificate of registration in

terms of the benefits. The benefits you get depend on your industry and your particular business but they can’t be sizable. Some facilities recoup the cost associated with ISO 9000 in as little as 9 months.

Total costs do vary on the size of your plant and your industry but there are some ballpark figures for a company of modest size:

Total consulting fees, based on fees of $1,000 per day, might fall between $25,000 to $80,000

What is ISO?

The fees to the registrar you select are $1,000 per day plus travel and expenses for a minimum of 10 days. At very least, a registrar will bill you for one or two days for the initial visit, a two or three preliminary audit and a three to five day registration audit. Thus total registrar fees may range from $10,000 to $30,000.

What is ISO?

Your total cost (consulting and registrar) will range anywhere from $35,000 to $110,000 plus. The smaller the firm, normally the lower the total cost.

Note: Remember, certification to an ISO 9000 series standard requires your firm to undergo surveillance audit about every six months and an entire re-audit every three years.

What is ISO?

Span of Time in Undertaking Certification

The amount of time it takes you to certify to one of the ISO standards depends on the current state of your quality system and documentation:

If your company uses a quality system framework such as Category 5 of the Baldrige Criteria (Management of Process Quality) or MIL-Q-9858A, you may search ISO 9000 series conformance in less than 12 months with a minimum of consulting help.

If your company has sketchy procedures or is relatively unsophisticated in the application of the quality methods and procedures you might reach ISO 9000 series conformance from 12 to 15 months.

What is ISO?

If your company is starting a quality system from scratch and you have less than a full commitment from your senior leadership, it will take you up to and beyond 24 months to reach ISO 9000 level quality.

Another rate of criterion: Research on certification shows an initial ISO 9000 series failure rate about 60% for companies that try to prepare without outside consulting help.