The ISO 9000 Standards for Quality Management Systems

1 © Alan G. Robinson, 2001.

The ISO 9000 Standards for QualityManagement Systems

ISO stands for “International Standards Organization”

The source of ISO 9000 and more than 13,000 international standards for business government and society

A network of national standards institutes from 140 countries working in partnership with international organizations governments industry business and consumer representatives. A bridge between public and private sectors.

Note: ISO has an excellent website: http://www.iso.ch/Alan G Robinson@2002


The ISO 9000 Family

ISO 9000:2000 ISO/DIS 10012 ISO 9001:2000 ISO 10012-2:1997 ISO 9004:2000 ISO 10013:1995 ISO 19011 ISO/TR 10014:1998 ISO 10005:1995 ISO 10015:1999 ISO 10006:1997 ISO/TS 16949:1999

ISO 10007:1995


Standards and Guidelines Purpose

ISO 9000:2000 Quality management systems - Fundamentals and vocabulary

Establishes a starting point for understanding the standards and defines the fundamental terms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their use.

ISO 9001:2000 Quality management systems – Requirements

This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried.


Standards and Guidelines Purpose(Cont’d)

ISO 9001:2000 Quality management systems - Requirements

This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried.

ISO 9004:2000 Quality management systems - Guidelines for performance improvements

This guideline standard provides guidance for continual improvement of your quality management system to benefit all parties through sustained customer satisfaction.



ISO 19011 Guidelines on Quality and/or Environmental

Management Systems Auditing (currently under development) Provides you with guidelines for verifying the system's ability to achieve defined quality objectives. You can use this standard internally or for auditing your suppliers.

ISO 10005:1995 Quality management - Guidelines for quality plans

Provides guidelines to assist in the preparation review acceptance and revision of quality plans.



ISO 10006:1997 Quality management - Guidelines to quality in project management

Guidelines to help you ensure the quality of both the project processes and the project products.

ISO 10007:1995 Quality management - Guidelines for configuration management

Gives you guidelines to ensure that a complex product continues to function when components are changed individually.



ISO/DIS 10012 Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment

Give you guidelines on the main features of a calibration system to ensure that measurements are made with the intended accuracy.

ISO 10012-2:1997 Quality assurance for measuring equipment - Part 2: Guidelines for control of measurement of processes

Provides supplementary guidance on the application of statistical process control when this is appropriate for achieving the objectives of Part 1.



ISO 10013:1995 Guidelines for developing quality manuals

Provides guidelines for the development and maintenance of quality manuals tailored to your specific needs.

ISO/TR 10014:1998 Guidelines for managing the economics of quality

Provides guidance on how to achieve economic benefits from the application of quality management.



ISO 10015:1999 Quality management - Guidelines for training

Provides guidance on the development implementation maintenance and improvement of strategies and systems for training that affects the quality of products.

ISO/TS 16949:1999 Quality systems - Automotive suppliers

Particular requirements for the application of ISO 9001:1994 Sector specific guidance to the application of ISO 9001 in the automotive industry.


What Is A Quality System?

A system of MANAGEMENT which assures that PLANNING is carried out such that ALL staff know what is EXPECTED and HOW to achieve the SPECIFIED results.


The Purpose of A Quality System

The technical, administrative and human factors affecting the quality of (the company’s) products and services will be under control. All such control should be oriented towards the reduction, elimination and, most importantly, prevention of quality deficiencies ...... the quality management system (should) be appropriate to the type of activity and to the product or service being offered.”

ISO 9004


According to Ian Durand

“Less than 1 percent of the small and midsize companies in the U.S. presently have a quality system that comes close to satisfying the requirements of ISO 9001 or 9002.”

“In a survey of 600 companies, less than 10 percent of the cost of registration was spent on the registrars themselves.”

The cost is not for the registrars; it is for the internal work to put the system in place.


Who Is Getting Registered

Manufacturers Truckers

Hotels Software Houses (TickIt )

Banks Lawyers

Universities and Colleges Insurance Companies

Restaurants Travel-related Services

Air Freight Companies

The carrot and the stick


9000 And 14000: The Engines Are The Same

Management responsibilityDocument controlCorrective actionInternal auditing

SAC

Plan Do

Check Act

Audit


The Cost of Quality (COQ)

For most U.S. companies, COQ amounts to between 20% to 40% of sales. In most companies, the cost of poor quality is a large sum, frequently larger than the company’s profits.

Frank Gryna

COQ is comprised of:

Internal Failure Costs:

Scrap, rework, failure analysis, scrap and rework (suppliers), downgrading, 100% sorting inspection, reinsertions/retest, avoidable process losses.

External Failure Costs:

Warranty costs, complaint adjustment, returned material, cost of concessions, liability, litigation.


The Cost of Quality (COQ) (cont’d)

Appraisal costs:

Receiving inspection and test, in-process inspection and test, final inspection and test, product quality audits, calibration of test equipment, evaluation of materials inventory.

Prevention costs:

Training, supplier quality evaluation, quality planning, new-products review, corrective action system, process planning and control.


The Cost of Quality (COQ) (Cont’d)

One local manufacturing has COQ in excess of 50% of sales.

A typical profile:

Failure costs .......... 80% of COQ

Appraisal costs …….. 15% of COQ

Prevention Costs .......... 5% of COQ

Do it right the first time!


Quality IS Productivity

There is a direct relationship between productivity and quality. As quality goes up, so does productivity. Quality and productivity are different aspects of the same thing.

W. Edwards Deming

Manpower is something that is beyond measurement. Capabilities can be extended indefinitely when every one begins to think.

Taiichi Ohno

ISO 9000 is really a process improvement standard. It will improve your quality and productivity at the same time.

COQ at world-class companies runs under 1%.

The medicine works ...

but only if the patient takes it!


[ Insert “Talk about the cost of quality!” ]from Chase + Aquilaro


A Quiz

1) If a company representative tells you that his company is ISO certified, is he telling you the whole story?

2) Can you be assured that products you buy from a company that is ISO 9000 certified are of the highest quality?

3) Will ISO 9000 certification become a requirement for doing business in Europe within the next year?

� Yes

� No

� Yes

� No

� Yes

� No


The Idea Behind The Standards

Malcolm Baldrige National Quality Award:

Get the process right and the results will follow.

ISO 9000:

Document your quality system and adhere to what you have documented. Improvement will follow.

You can’t hope to get the MBNQA or the Deming Prize if you are not implementing ISO 9000.

George LofgrenPresident

Registrar Accreditation Board


The Need For International Standards

Increasing emphasis on process, rather than product.

There’s no inspector half as effective as a well-controlled process. Increasing cost of customer audits:

sometimes more than 1 per week; all look for essentially same things, except for possible

difference in emphasis. Proliferation of alternative definitions of “quality management

systems” could raise costs, hamper production, and hinder trade.

MIL-Q-9858A, FDA Good Management Practices (GMPs), ANSI C1, ANSI Z1.15, AQAP-1, Malcolm Baldrige, European Quality Award, Shingo Prize, Deming Prize, Juran Prize, Ford Q101 criteria, GM Target for Excellence, JUSE TQM program.


Liability issues if damage occurs and your products are involved:

• need well-implemented quality assurance system in place to prevent defects;

need to be able to prove that was prudent and all reasonable measures were taken.

On the other hand: discovery can allow lawyers to see exactly what you were and

weren’t doing. (Still no established case law.)

A single set of worldwide standards would promote economic cooperation, and reduce protectionism and trade wars. A win-win situation for everyone.

Do it once, do it right, do it internationally.

Lawrence D. EicherISO Secretary General

June 1991


The International Standards Organization (ISO)

Founded in 1947. 143 member countries.

Purpose:

1) to develop, publish, and promote worldwide standards;

2) to facilitate exchange of goods and services;

3) to foster cooperation in intellectual, scientific, technological and economic areas.

Has staff of 665:

500 are production and services staff;

165 involved in coordination work.


ISO Members

143 national standards bodies, comprising

93 member bodies36 correspondent members14 subscriber members


ISO Member Bodies

United States: American National Standards Institute (ANSI)

Great Britain: British Standards Institution (BSI)

Japan: Japanese Industrial Standards Committee (JISC)

France: Association Francaise de Normalisation (AFNOR)

Russian Federation: Committee of the Russian Federation for Standardization (GOSTR)

India: Bureau of Indian Standards (BIS)

China: China State Bureau of Technical Supervision (CSBTS)

Jamaica: Jamaica Bureau of Standards (JBS)

Italy: Ente Nazionale Italiano di Unificazione (UNI)

Brazil: Associacao Brasileira de Normas Tecnicas (ABNT)

South Korea: Bureau of Standards (KBS)

Result: ISO is administering a system with 500,000 people in it.


ISO 9000 National Standards Cross Referenced

Australia AS 3901

Belgium NBN X 90-003

Canada CSA Z299.1-08

Finland SFS-ISO 9001

France NFX 90-131

India IS 10201 part 4

Norway NS 9001

European Community EN 29001

United Kingdom BS 5751


How New Standards Are Developed

Decision made to develop new standard

Technical Committee (TC) formed

TC develops the new standard, using input from Technical Advisory Groups (TAGs) of each participating member country

ISO administers voting process

ISO does editing and publishing

Any member countries may adopt standard directly


The ISO 9000 Standards

ISO

USTAG 176

ISO TC 176

ANSI

Your Comments


“Product”

A mixture of:

Hardware: tangible; discrete assembled product.

Processed material: tangible; bulk.

Software: intangible; intellectual in origin.

Service: intangible.

“Product” = all of above, so standard is much broader.

ISO 9000 now requires companies to manage much more than it used to!


Who you gonna call?

To get copies of U.S. standards, contact ASQC at:

(800) 248-1946, or http://www.asq.org/

or ANSI at:

(212) 642-4900 or http://www.ansi.org/

To get copies of ISO standards, call ISO at:

011-41-22-7490111

or call Global Engineering Documents at:

(800) 854-7179 or http://global.ihs.com/


DESIGN AND DEVELOPMENT (OLD ISO 9001)

Must use when innovative design services expressed in performance terms are directly part of the contract:

specific design

for customer

does not apply if you are selling only different configurations to customers:

furniture. automobiles;

Example:

If ask for washing machine with special sock-folder, and a trumpet announcement at end of cycle, then 9001 situation.

Supplier Purchaser


NOT DESIGN AND DEVELOPMENT (OLD 9002)

For use when selling items built to specifications or when manufacturing to external designs.

Supplier

PurchaserPurchaser Purchaser Purchaser

Off the shelf

For example, walk into washing machine store and

buy one from stock;

order one from catalog configured to your tastes.

Key: Can I ask for innovative custom design?


The Early Driving Force

Certification Options When Conforming to Harmonized Standards by Product Category:

Type of Product:Machinery: Non-dangerous machines

Manufacturer’s Options:Self-declaration

Type of Product: Machinery: Dangerous machines

Manufacturer’s Options:Submit a technical dossier to a notified body to certify

compliance with standard

or

Submit a model for type-examination by a notified body


The Early Driving Force (Cont’d)

Type of Product:Personal Protection Equipment: Simple designManufacturer’s Options: Self-declaration

Type of Product:Personal Protection Equipment: Complex designManufacturer’s Options:EC type-examinationor

Certification by a notified body of EC quality control system for the final product (EN 29002/ISO 9002)or

Certification by a notified body of system for ensuring EC quality of production by means of monitoring (EN 29003/ISO 9003)

EC adopted ISO 9000 standards word for word.


Broad EC Directives

Product Liability Directive:

A manufacturer of a product is liable, regardless of fault or negligence, if a person is harmed or an object is damaged by a faulty product.

Product Safety Directive:

Managers must permanently monitor the safety of their products throughout their foreseeable useful life.


Broad EC Directives (Cont’d)

Service Liability Directive:

1. The supplier of a service shall be liable for damage to the health and physical integrity of persons or the physical integrity of movable or immovable property, including the persons or property which were the object of the service, caused by a fault committed by him in the performance of the service.

2. The burden of proving the absence of fault shall fall upon the supplier of the service.

3. In assessing the fault, account shall be taken of the behavior of the supplier of the service, who, in normal and reasonably foreseeable conditions, shall ensure the safety which may reasonably be expected.


Removing Trade Barriers

There are two kinds of product: regulated and unregulated.Regulated products are those for which the EU has stepped in to

pass Europe-wide directives. They are products that the EU feels have significant and health, safety, or environmental issues associated with them.

According to U.S. Dept. of Commerce, regulated products make up some 50 percent of U.S. exports to Europe.

Unregulated products are those for which no specific European-wide directives have been made.

Trade barriers removed by EC laws requiring mutual acceptance and recognition of unregulated and regulated products that meet EU directives and/or the health, safety and environmental concerns of the receiving state.


Which Products Are Regulated

In cases where:

Member states have legitimately imposed technical requirements;

and

Conflicting national rules restrict the free movement of products within the EC;

then

A product directive is issued.

Some directives have ISO 9001 as an option

Some directives require ISO 9001


More Examples

Construction products:

At a minimum, manufacturer’s certification of production quality assurance system (EN 29002 and EN 29003 equivalent)

Gas appliances:

EC type-examination

and

Quality assurance system certification

or

On-site checks of appliances


More Examples

Non-automatic weighing instruments (commercial scales):

EC type-examinationand

Quality assurance certification ( EN 29002)

or EC verification

Telecommunications terminal equipment:

EC type-examinationor

Declaration of conformity with full quality assurance (EN 29001)


More Examples

Medical devices:

Various options depending on risk level, ranging up to full quality assurance ( EN 29001)

or

EC type-examination

and

Production quality assurance ( EN 29002)


Adopted Product Directives That Reference ISO9000

Product Standards Referenced

Elevators 9001 or 9002

Equipment for use in Explosive Atmospheres

9001 or 9002

Recreational Craft 9001 or 9002

Construction Products 9002 or 9003

Gas Appliances 9002

Personal Protective Equipment

9002 or 9003

Non-Automatic Weighting Devices

9002


Adopted Product Directives That Reference ISO9000 (Cont’d)


Active Implantable Medical Devices

9001 or 9002

Medical Devices 9001 or 9002

Telecommunications Terminal Equipment

9001 or 9002

Pressure Equipment 9001 or 9002


Planned Product Directives


Flammability of Furniture 9002

Measuring and Testing Instruments

9001, 9002 or 9003

Cable Ways 9001

Amusement Park and Fairground Equipment

9003

Used Machinery Fasteners 9002


Important Point

Manufacturers may have to meet requirements of more than one directive

e.g. Air conditioners must meet 5 different directives:

machine safety; pressure vessels; construction products; electromagnetic compatibility; low voltage.

ISO 9000 registration may be a broader requirement than appears at first sight!


A Self-Spawning ProcessISO 9001 and 9002 require procedures to be in place for assuring

supplier quality:

It is recommended that ISO 9001, ISO 9002 or ISO 9003, as appropriate, be used when purchasing products or services.

ISO 9004-2

Guidelines for Service

Leads to requiring suppliers to be ISO registered.

Case:

Supplier 1: good price, good quality;

Supplier 2: good price, good quality, ISO 9000 registered.

ISO 9000 registered customer. Who gets the contract?


The Bottom line

Virtually every purchase agreement, contract and specification written by European industries, institutions, and governments will likely include a “boilerplate” requirement that mandates a contractors to demonstrate compliance with ISO 9000.

John J. Kendrick


Rough Implementation Profile 1. Set up a steering group 2. Review existing procedures against the appropriate

ISO9001-9003 standard requirements

3. Identify what needs to be done 4. Establish a program 5. Define and implement new procedures 6. Compile quality manual 7. Meet with assessment body 8. Submit manual for approval 9. Assessor’s visit10. Certification

Source: ISO 9000 Is Coming, Dupont Electronics.


Getting Registered

A product is certified, a quality system is registered.

When you receive registration, you cannot put the registrar’s logo on your products.

Choose your registrar carefully:

• caveat emptor;• not all registrars are accredited by appropriate bodies

for• your markets; • different registrars apply the criteria differently;• different registrars have different fees/polices.

Worldwide registration system is still disorganized.BIGGEST PROBLEM WITH REGISTRATION:

WHO PAYS THE REGISTRARS


The Registration System

Standards setting in U.S. performed mainly by private sector.

In the United States:

behind scenes fighting going on between NIST, ANSI and ASQC for control of registrar accreditation;

many U.S. labs or registrars are recognized in EC;

European registrars have established offices in U.S.;

The EC has done a masterful job of exploiting differences between the U.S. and European standard-setting systems and government-business relationships for its own advantage.


UK: All is Traceable to Crown

The Queen

Department of Trade and Industry

National Accreditation Council for Certified Bodies (NACCB)

36 Individual Registrars

Your Company


In United States: A Mess

ASQC DoD ANSI NIST

Registrar AccreditationBoard (RAB)

24 Individual Registrars

Your Company


What to Register

You decide the scope. For example:

9001: Sulzer Bingham Pumps, Canada

Design, development, manufacture and overhaul of

centrifugal pumps and pump equipment. 9002: LEGO System Inc.

Manufacture of construction toys. 9003: Lapp Insulator Company

Produce high voltage bushings.


Scope is Also Site Specific

Shell has registered 35 sites in Great Britain.

Strategy 1: Do each site separately.

Benefit: Safer Disadvantages: Multiple certificate fees

Strategy 2: Do all at once.

Benefit: only 1 certificate fee; Can say “whole company” is registered. Disadvantages: if one site fails, all will fail


Excessive Personal Bias (EPB)

Auditing vs. Consulting:

One registrar bounced first time round -- auditors were giving advice.

Many different ways to meet the standard:

Method 1 you do thisMethod 2 : :Method 100 auditor wants you to do this

EPB!“Where does it say to do that in the standards?” If it doesn’t, the

auditor has EPB.Must never hear “I think”, “I feel”, “In my opinion”.