ISO 9001

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KAMALJEET KAUR SIDDHU An overview of ISO 9001:2000 Quality Management System

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About ISO ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 161 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

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ISO's name Because "International Organization for Standardization" would have different acronyms in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), its founders decided to give it also a short, all-purpose name. They chose "ISO", derived from the Greek isos, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO.

Why standards matter : 

Why standards matter Standards make an enormous and positive contribution to most aspects of our lives. Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost. When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor quality, do not fit, are incompatible with equipment that we already have, are unreliable or dangerous. When products, systems, machinery and devices work well and safely, it is often because they meet standards. And the organization responsible for many thousands of the standards which benefit the world is ISO. When standards are absent, we soon notice.

What standards do : 

What standards do ISO standards: make the development, manufacturing and supply of products and services more efficient, safer and cleaner facilitate trade between countries and make it fairer provide governments with a technical base for health, safety and environmental legislation, and conformity assessment share technological advances and good management practice disseminate innovation safeguard consumers, and users in general, of products and services make life simpler by providing solutions to common problems

Whom standards benefit : 

Whom standards benefit ISO standards provide technological, economic and societal benefits. For businesses, the widespread adoption of International Standards means that suppliers can develop and offer products and services meeting specifications that have wide international acceptance in their sectors. Therefore, businesses using International Standards can compete on many more markets around the world. For innovators of new technologies, International Standards on aspects like terminology, compatibility and safety speed up the dissemination of innovations and their development into manufacturable and marketable products. For customers, the worldwide compatibility of technology which is achieved when products and services are based on International Standards gives them a broad choice of offers. They also benefit from the effects of competition among suppliers. For governments, International Standards provide the technological and scientific bases underpinning health, safety and environmental legislation.

What standards do : 

What standards do For trade officials, International Standards create "a level playing field" for all competitors on those markets. The existence of divergent national or regional standards can create technical barriers to trade. International Standards are the technical means by which political trade agreements can be put into practice. For developing countries, International Standards that represent an international consensus on the state of the art are an important source of technological know-how. By defining the characteristics that products and services will be expected to meet on export markets, International Standards give developing countries a basis for making the right decisions when investing their scarce resources and thus avoid squandering them. For consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability. For everyone, International Standards contribute to the quality of life in general by ensuring that the transport, machinery and tools we use are safe. For the planet we inhabit, International Standards on air, water and soil quality, on emissions of gases and radiation and environmental aspects of products can contribute to efforts to preserve the environment.

The ISO brand : 

The ISO brand Democratic Every full member of ISO has the right to take part in the development of any standard which it judges to be important to its country's economy. No matter what the size or strength of that economy, each participating member in ISO has one vote. Each country is on an equal footing to influence the direction of ISO's work at the strategic level, as well as the technical content of its individual standards. Voluntary ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce the implementation of its standards. ISO does not regulate or legislate. However, countries may decide to adopt ISO standards - mainly those concerned with health, safety or the environment - as regulations or refer to them in legislation, for which they provide the technical basis. In addition, although ISO standards are voluntary, they may become a market requirement, as has happened in the case of ISO 9001 quality management systems, or of dimensions of freight containers and bank cards.

ISO itself does not regulate or legislate. : 

ISO itself does not regulate or legislate. Market-driven ISO only develops standards for which there is a market requirement. The work is mainly carried out by experts from the industrial, technical and business sectors which have asked for the standards, and which subsequently put them to use. Consensus ISO standards are based on international consensus among the experts in the field. Consensus, like technology, evolves and ISO takes account both of evolving technology and of evolving interests by requiring a periodic review of its standards at least every five years to decide whether they should be maintained, updated or withdrawn. In this way, ISO standards retain their position as the state of the art. Globally relevant ISO standards are technical agreements which provide the framework for compatible technology worldwide. They are designed to be globally relevant - useful everywhere in the world. ISO standards are useful everywhere in the world.

How to recognize an ISO standard : 

How to recognize an ISO standard In paper form, an ISO standard is published in A4 format - which is itself one of the ISO standard paper sizes. It may be anywhere between a four-page document and one several hundred pages' long. ISO standards are also available as electronic downloads and many are available as part of a collection on CD or in handbook. An ISO standard carries the ISO logo and the designation, "International Standard".

The scope of ISO's work : 

The scope of ISO's work ISO has more than 17500 International Standards and other types of normative documents in its current portfolio. ISO's work programme ranges from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, information and communication technologies, and to standards for good management practice and for services.

Examples of the benefits standards provide : 

Examples of the benefits standards provide Standardization of screw threads helps to keep chairs, children's bicycles and aircraft together and solves the repair and maintenance problems caused by a lack of standardization that were once a major headache for manufacturers and product users. Standards establishing an international consensus on terminology make technology transfer easier and safer. They are an important stage in the advancement of new technologies and dissemination of innovation. Without the standardized dimensions of freight containers, international trade would be slower and more expensive. Without the standardization of telephone and banking cards, life would be more complicated.

Examples of the benefits standards provide : 

Examples of the benefits standards provide A lack of standardization may even affect the quality of life itself: for the disabled, for example, when they are barred access to consumer products, public transport and buildings because the dimensions of wheel-chairs and entrances are not standardized. Standardized symbols provide danger warnings and information across linguistic frontiers. Consensus on grades of various materials gives a common reference for suppliers and clients in business dealings. Agreement on a sufficient number of variations of a product to meet most current applications allows economies of scale with cost benefits for both producers and consumers. An example is the standardization of paper sizes. Standardization of performance or safety requirements of diverse equipment makes sure that users' needs are met while allowing individual manufacturers the freedom to design their own solution on how to meet those needs.

Examples of the benefits standards provide : 

Examples of the benefits standards provide Standardized computer protocols allow products from different vendors to "talk" to each other. Standardized documents speed up the transit of goods, or identify sensitive or dangerous cargoes that may be handled by people speaking different languages. Standardization of connections and interfaces of all types ensures the compatibility of equipment of diverse origins and the interoperability of different technologies. Agreement on test methods allows meaningful comparisons of products, or plays an important part in controlling pollution - whether by noise, vibration or emissions. Safety standards for machinery protect people at work, at play, at sea... and at the dentist's. Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.

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EXPECTED QUALITYby the Customer PLANNED QUALITY by the Company PRODUCED QUALITY by the Company PERCEIVED QUALITY by the Customer Measurement of the Performance of the Company Measurement of the Client’s satisfaction The ISO 9000:2000 requirements

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Customer focus Leadership Empowerment Process approach Systemic approach Continuous improvement Decisions based on facts Relationship with suppliers mutually beneficiary The 8 principles of TQM …

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Quality Control Quality Management Past Future Detect faults Prevent errors Look for guilty persons Look for defaults in the processes Accuse Help, Moderate, Facilitate Punish Motivate Micro-management Systematic and systemic management Transition towards TQM The 8 principles of TQM …

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VOICE OF THE CUSTOMER VOICE OF THE MANAGEMENT VOICE OF THE PERSONNEL VOICE OF THE SOCIETY Empowerment? The 8 principles of TQM …

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Deming’s wheel (P.D.C.A.) ISO 9000 PLAN DO ACT CHECK Continuous Improvement Continuous improvement ? The 8 principles of TQM …

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5 sections of requirements to translate in practice The 8 principles of TQM 4- QUALITY MANAGEMENT SYSTEMS (QMS, documentation requirements) 5- MANAGEMENT RESPONSIBILITY (Management commitment, Customer focus, Quality Policy, Planning, Responsibility, Authority and Communication, Management Review) 6- RESOURCE MANAGEMENT (Provision of Resources, Human Resources, Infrastructure, Work Environment) 7- PRODUCT REALIZATION (Planning, Customer Related Processes, Design and Development), Purchasing, Service Provision, Control of Measuring Devices) 8- MEASUREMENT, ANALYSIS AND IMPROVEMENT (Monitoring and Measurement, Control of Non-conforming Product, Analysis of Data, Improvement) The ISO 9000:2000 requirements

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Continuous improvement of the Quality Management System CLIENT Product / Service Realization Management Responsibility Measurement, Analysis and Improvement Resource Management Input Data Product Service Output Data Requirements Satisfaction CLIENT Systemic approach ? The 8 principles of TQM …

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“A COHERENT PAIR”: ISO 9001:2000 – Quality Management Systems: REQUIREMENTS (WHAT ?) ISO 9001 oriented effectiveness and certification, ISO 9004:2000 - Quality Management Systems: GUIDELINES FOR PERFORMANCE IMPROVEMENTS (HOW ...?) ISO 9004 oriented effectiveness and efficiency Presentation of ISO 9000:2000

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TWO OTHER PRIMARY NORMS: ISO 9000:2000 – Quality Management Systems: Fundamentals and vocabulary ISO 19011:2003 – Guidelines for quality and/or environmental management systems auditing. This standard replaced: ISO 10011-1:1990 ISO 10011-2:1991 ISO 10011-3:1991 ISO 14010:1996 ISO 14011:1996 ISO 14012:1996 Presentation of ISO 9000:2000

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And two technical support documents: ISO 1000x – Technical brochure - Selection & Use ISO 1000y - Principles and application of quality management Presentation of ISO 9000:2000

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The 9 criteria of the EFQM Model The percentages were established following a wide ranging survey to collect views We acknowledge here the key role of leadership, policy and strategy, the management of people and the management of partnerships and ressources.

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1- Have you defined in writing the Mission of your company? 2- Is it appropriately deployed in operational objectives and action plans? 3- Is there meetings between the personnel and the management on a regular basis? Not At All /Never Small / Sometimes Strong / Often Very Strong / Always Self- Assessment Tool Management system (sample)

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1- Are written procedures available? 2- Is there an internal quality audit system in place? 3- Are non-conformities formally recorded and corrected? Self- Assessment Tool Quality system (sample) Not At All /Never Small / Sometimes Strong / Often Very Strong / Always

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1- Is there job descriptions in place for all the personnel? 2- Is there a formal system in place for the yearly evaluation of performance? 3- Is the training of the personnel well adapted to the needs? Self- Assessment Tool Human Resources (sample) Not At All /Never Small / Sometimes Strong / Often Very Strong / Always

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1- Are you formally “listening”the voice of your customers on a regular basis? 2- Is there a system in place for the treatment of the complaints of your customers? 3- Do you measure the level of satisfaction of your customers? Self- Assessment Tool Customer focus (sample) Not At All /Never Small / Sometimes Strong / Often Very Strong / Always

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4- INTEGRATED QUALITY MANAGEMENT SYSTEM 4-1- General requirements 4-2- Documentation requirements 4-2-1- General 4-2-2- Integrated Quality Management Manual 4-2-3- Control of documents 4-2-4- Control of Records Headlines of the future WRTVC Standard compatible with ISO 9001:2000 ...

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5- MANAGEMENT RESPONSIBILITY 5-1- Management commitment 5-2- Stakeholder focus 5-3- Ethics & Policies 5-4- Planning 5-5- Responsibility, Authority and Communication 5-6- Management review 5-7- Vision, Values and Mission 5-8- Independence, Transparency & Pluralism 5-9- Corporate social investment Headlines of the future WRTVC Standard compatible with ISO 9001:2000 ...

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6- RESOURCE MANAGEMENT 6-1- Provision of resources 6-2- Human resources 6-2-1- General 6-2-2- Competence, awareness and training 6-2-3- Independence of journalists & producers 6-3- Infrastructure 6-2-1- General 6-2-2- Quality of equipment 6-2-3- Accessibility to the Media 6-4- Work environment Headlines of the future WRTVC Standard compatible with ISO 9001:2000 ...

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7- PROGRAMME PRODUCTION 7-1- Planning of programme production 7-2- Stakeholder - related processes 7-3- Innovation & Creation 7-4- Purchasing 7-5- Programme and service provision 7-6- Control of monitoring and measuring devices 7-7- Quality & diversity of contents 7-8- Participation, interactivity & citizen empowerment 7-9- Social relevance (including gender issues, religion, etc.) 7-10- Education 7-11- Minority representation and proximity 7-12- World perspective Headlines of the future WRTVC Standard compatible with ISO 9001:2000 ...

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8- MEASUREMENT, ANALYSIS AND IMPROVEMENT 8-1- General 8-2- Monitoring and measurement of audience satisfaction 8-3- Control of nonconforming product 8-4- Analysis of data 8-5- Improvement Headlines of the future WRTVC Standard compatible with ISO 9001:2000 ...