Evolution of Quality Concept and Origin of ISO 9000 : Evolution of Quality Concept: Inspection to TQM : from LSSGB 1950s : Up to 1950s Manufacturing Industry was using various Inspection Methods to confirm the quality of Products. Produce, Inspect, Accept OR Rectify as per the specified norms on drawing was the trend in field of Quality. There was neither any control being executed while the manufacturing of the product in Process nor thought whether the given specifications fulfill the customers need. During the two World wars a Huge % of Bullets and Bombs went off in the factories themselves during the course of manufacturing. Considering the consequences of failures of defense equipments and armaments UK Ministry of Defense (MOD) appointed their inspectors in the factory itself to supervise the production process.

Thus the earlier concept of Inspection turned into Quality Control. (the execution of control over quality while in Production itself)

In the USA, quality standards for military procurement were introduced at the end of the 1950s.

1960s : North Atlantic Treaty Organisation (NATO) introduced an Allied Quality Assurance Publications (AQAPS) to provide Quality Assurance to their Military Equipments and Armaments. UK Ministry of Defense (MOD) did not accept the (AQAPS) Allied Quality Assurance Publications (AQAPS) and introduced a series of Standards (MOD Standards) for MOD contracts. Later, Allied Quality Assurance Publications (AQAPS) aligned with the MOD Standards considering the need of involvement of Design elements viz. design reviews, FMEAs etc and a series of New Standards called Defence Standard published in consultation with the Industry.

1970s : Major Big organizations started to publish their own standards with an idea that confidence in a product could be gained from an approved quality management system and quality manuals.

The Canadian CSA Z 299 series of standards were issued in the mid-1970s ,USA issued ANSI/ASQC Z-1.15, In December 1979 ( Generic Guidelines for quality systems ) and the British standard BS 5750 was issued in 1979 inline with the Defense standards.)

The concept of Quality Control (the execution of control over quality while in Production itself) now begun towards Quality Assurance (application of management/statistic techniques on line to assure Quality of end product From 1948 to 1994 Whilst the General Agreement on Tariffs and Trade (GATT) stimulated the growth rates in international commerce; a variety of different national standards created a barrier to international trade.

Origin of ISO 9000:

The Agreement on Technical Barriers to Trade (the so-called GATT Standards Code) introduced in 1979 aiming at ensuring that regulations, standards, testing and certification procedures do not create unnecessary obstacles to trade. ISO grasped immediately the importance of the GATT Standards Code and actively promoted the value of ISOs International Standards to be used worldwide as instruments facilitating the elimination of unnecessary barriers to trade, and, whenever needed, as a suitable basis for technical regulations.

The ISO technical committee (TC) 176, Quality management and quality assurance, was therefore established in 1979 which in 1987 published a family of International standards ISO 9000 : a series of quality management systems (QMS) Standards which are not specific to products or services, but apply to the processes that create them. The Standards are generic in nature so that they can be used by both manufacturing and service industries. Approval to ISO 9001 demonstrates that the organization meets the minimum requirements of quality management.

ISO : What Is It ?

An "International Organization for Standardization" officially began operations on 23 February 1947 with an objective "to facilitate the international coordination and unification of industrial standards".

Network of the national standards institutes of more than 150 countries with one member per country , has a strategic partnership with the World Trade Organisation (WTO) and Central Office at Geneva, Switzerland.

World largest non-governmental standards developing organization , having no legal authority to enforce the implementation of its standards.

@245 Technical Committees (TC) for different standards :

viz: TC 44- Welding and allied process

TC 85 Nuclear Energy

TC 86 Refrigeration and Air Conditioning

TC 207 Environmental Management

TC 176 Quality Management and Quality Assurance and Subcommittees (SC) viz:

TC 176/SC1 Concepts and Terminology

TC 176/SC2 Quality Systems

TC 176/SC3 Supporting Tchnology More than 17500 standards published till date from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, to the newest information and communication technologies, and to standards for good management practice and for services

Viz: Automotive : ISO/TS 16949:2002 Education : IWA 2:2007 IWA 2:2007Energy PC 242, ISO 50001 Food safety : ISO 22000:2005 Information security : ISO/IEC 27001:2005 Medical devices ISO:13485:2003 Petroleum and gas :ISO 29001:2003 Supply chain security : ISO 28000:2007 More than 1000 new ISO standards are published every year

What ISO : Is not ?

Is not a product or service standard however it provides a set of generic requirements relating to the processes of development and production, and how they will be managed, reviewed and improved in order achieve customer satisfaction.

Not a Certifying Body and Not audit / assess or certifies on itself.

Why to adopt ISO 9000?

To comply with customers requirements for ISO 9000 To comply with European Union market directives 1991

Product / Service liability Global Approach to conformity certifications World wide recognition of ISO 9000

AS a primary step towards TQM

"International Organization for Standardization" : Then Why ISO not IOS ?

Different countries have different languages and obviously different acronyms for ISO in different languages

Eg: "IOS" for ( "International Organization for Standardization" ) in English, "OIN" for ( Organisation internationale de normalization ) in French, So it was decided to give it a short, all-purpose name as "ISO", derived from the Greek isos, meaning "equal". The always equal short form ISO of the organization's name for any country, and any language.

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The Journey : ISO 9000: 1987 to ISO 9000: 2008

ISO standards are periodically reviewed (usually once in 5 Years) to take account both of evolving technology and of evolving interests and to decide whether they should be maintained, updated or withdrawn

Year 2008 Family Of Standards

Consists of four Core Standards :

A CONSISTENT PAIR: ISO 9001:2008 ANSD ISO 9004:2000* (UNDER Revision) designed to complement each other, but can also be used independently have different scopes but similar structure in order to assist to use as A CONSISTENT PAIR

ISO 9001:2008 QMS: REQUIREMENTS (WHAT ?)

The only part of the ISO 9000 family against which an organization can become certified

ISO 9004:2000* - QMS: GUIDELINES FOR PERFORMANCE IMPROVEMENTS ( HOW ...?)

The requirements statements in ISO 9001 may be seen sometimes as a little brief and it rarely, if ever, tells the user 'how' to achieve compliance with it.

ISO 9004 takes the basic requirement and expands on it. It gives options for the organization to consider if they wish to progress beyond basic compliance and into excellence particularly for Continual improvement. Please Note: ISO 9004 is not a guide on how to implement ISO 9001, rather a guide on how to improve on the basic requirements that ISO 9001 specifies

ISO 9000:2005 - Fundamentals and vocabulary

ISO 9000 is an introduction to the philosophy of quality management and also contains the definitions used in ISO 9001 and ISO 9004.

ISO 19011:2002 Guidelines for Quality and/or environmental management systems auditing.

Benefits of ISO 9001:2008:

Helps to improve the quality of all of the organisations management activities, which has the potential to result in some substantial overall organisational improvement.

Improved capability to consistently provide the product performance and service due to Improved quality awareness, Boost in morale and job satisfaction of employees.

Recognition/Publicity in Market , increased marketing and sales opportunities

Increased customer satisfaction levels.

Cost reductions through improved productivity and efficiency

8 sections of ISO 9001:2008:

1. Scope

2. References

3 .Terms and definitions

4. Quality management system

5. Management responsibility

6. Resource management

7. Product realization

8. Measurement, analysis and improvement

1. Scope

ISO 9001:2008 specifies requirements for a quality management system where an organization

needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and

aims to enhance customer satisfaction through the effective application

of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicablestatutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can beconsidered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

2. References

ISO 9000:2005 - Fundamentals and vocabulary

3 .Terms and definitions

All the terms and definitions given in ISO 9000 apply for ISO 9001:2008

4- QUALITY MANAGEMENT SYSTEM4.1- General requirements4.2- Documentation requirements

4.2.1- General4.2.2- Quality Manual

4.2.3- Control of documents4.2.4- Control of Records

5- MANAGEMENT RESPONSIBILITY

5.1- Management commitment

5.2- Customer focus

5.3- Quality Policy

5.4- Planning

5.4.1- Planning for Quality Objective

5.4.2- Quality Management System Planning

5.5- Responsibility , Authority and Communication

5.5.1- Responsibility and Authority

5.5.2- Management Representative

5.5.3- Internal Communication

5.6- Management review

5.6.1- General

5.6.2- Review Input

5.6.3- Review Output

6 - RESOURCE MANAGEMENT

6.1- Provision of resources

6.2- Human resources

6.2.1- General

6.2.2- Competence, training and awareness

6.3- Infrastructure

6.4- Work environment

7- PRODUCT REALIZATION

7.1- Planning of product realization

7.2- Customer - related processes

7.2.1- Determination of requirements related to product

7.2.2- Review of requirements related to product

7.2.3- Customer Communication

7.3- Design and Development

7.3.1- Design and development Planning

7.3.2- Design and development inputs

7.3.3- Design and development outputs

7.3.4- Design and development review

7.3.5- Design and development verification

7.3.6- Design and development validation

7.3.7- Control of design and development changes

7.4- Purchasing

7.4.1- Purchasing Process7.4.2- Purchasing Information

7.4.3- Verification of purchased product

7.5- Production and service provision

7.5.1- Control of production and service provision

7.5.2- Validation of processes for production and service provision

7.5.3- Identification and traceability

7.5.4- Customer Property

7.5.5- Preservation of product

7.6- Control of monitoring and measuring devices

8- MEASUREMENT, ANALYSIS AND IMPROVEMENT8.1- General8.2- Monitoring and measurement 8.2.1- Customer Satisfaction8.2.2- Internal Audit

8.2.3- Monitoring and measurement of processes

8.2.4 - Monitoring and measurement of product

8.3- Control of nonconforming product

8.4- Analysis of data

8.5- Improvement

8.5.1- Continual Improvement

8.5.2- Corrective Action

8.5.3- Preventive Action