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Iso 9000

Iso 9000

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Overview of ISO 9001 and ISO 14001

Defining Quality – What is quality?

What are some common definitions of quality, which will be helpful in this discussion.

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WHAT IS ISO 9000 • ISO is a „nickname‟ to “International Organization for Standardization”.


An international standard more than 100 countries
ISO is a non-governmental organization established in 1947 by International Standard Agency headquartered in Geneva. Principles are applicable to all organizations

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WHAT IS ISO 9000

ISO 9000 is a written set of standard which describe and define the basic elements/clauses of the quality system needed to ensure that an organization‟s products/or services meet or exceed customer needs and expectations

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Principles of ISO 9000
ISO 9000 is a standard for a quality system, not product. ISO 9000 is based on documentation and is premised on the following:- Document what you do; - Do what your document; - Prove it and improve it ISO 9000 emphasises prevention.

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ISO 9000 is a universal standard; the focus is on what needs to be done and not on how it is to be carried out

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ISO 9000 • to satisfy customers through a quality product to gain self confidence – we get what we planned • • • to achieve competitiveness in both the local and overseas markets.WHY QUALITY SYSTEM . as a blueprint for efforts to improve the quality system of the organization. 6 .

QUALITY SYSTEM = VEHICLE QUALITY MANAGEMENT = DRIVER QUALITY POLICY = ROAD MAP 7 .

ADVANTAGES OF ISO 9000 IMPLEMENTATION 8 .

The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing 9 .WHAT IS IT INTENDED FOR? This International Standard specifies quality system requirements for use where organization‟s capability to design and supply conforming product needs to be demonstrated.

maximize productivity and communication efficiency. minimize grey areas and possible resources wastage. 10 .. i.e.Well defined organization and responsibilities.BENEFITS OF ISO 9000 IMPLEMENTATION For the company:- .Standardize practice and establishment of proper communication channel.e. . i.

.Increase satisfaction and growth in confidence. increase profitability and market share.A greater degree of internal control. improve competitive position.BENEFITS OF ISO 9000 IMPLEMENTATION For the company:- . For the customer:- . 11 .Ultimately.

ISO 9001 Revision 2000 been developed by TC 176. after a great deal of research on Eight Quality Management Principles Eight Quality Management Principles • Customer .focused organization • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationship 12 .

analysis and improvement Satisfaction Product realization Output Product Information flow Value-adding activities 13 Reference: ISO 9001:2000 .QUALITY MANAGEMENT SYSTEM Continual improvement of the Quality management system Customers Management responsibility Customers Resource management Requirements Input Measurement.

DOCUMENTING THE SYSTEM 14 .

• Quality management system is a management system to direct and control an organization with regard to quality. • Quality manual is the document specifying the quality management system of an organization. document. ISO 9001:2000) • Documentation is a set of documents. (Clause 4. • Document is information (meaningful data) and its supporting medium. 15 . for example specifications and records.Quality Management System Documentation The organization shall establish.1. implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

DOCUMENTATION PYRAMID QUALITY/ POLICY MANUAL OPERATION PROCEDURES LEVEL 1 LOW LEVEL 2 DETAIL WORK INSTRUCTIONS LEVEL 3 FORMS. RECORDS. ETC. LABEL. LEVEL 4 HIGH A Purchasing Department B C Production Personnel Department Department D Quality Control E Stores 16 .

LEVEL 1: QUALITY MANUAL The quality manual as a highest level document at the peak of a pyramid outlining the quality system and acting as a directory for the documents and procedures below. It will outline the company‟s policy and commitment to quality. 17 .

8. 2. Describing and implementing an effective quality system. 6. 5. 3. Demonstrating compliance of the quality system with quality requirements 18 . procedures and requirements. Presenting quality system for external purposes. Communicating the organization‟s quality policy. 7. Providing continuity of the quality system and its requirements during changing circumstances.WHY NEED QUALITY MANUAL? 1. Providing the documented bases for auditing the quality system. Providing improved control of practices and facilitating assurance activities. Training personnel. 4.

Quality Policy Clause 5. as formally expressed by top management 19 .3 The overall quality intentions and direction of an organization related to quality.

LEVEL 2: OPERATION PROCEDURE A second tier set of departmental procedures detail how that commitment is applied to the company operations and lay down procedures for the management to control the system 20 .

Revise and issue procedure for acceptance 7. Implement 10. Review comments 6. Develop a draft procedure 4. Analyse current practice 3. Obtain approval 8. Review current practice 2.PROCEDURES DEVELOPMENT 1. Release draft for comment 5. Monitor and Review 21 . Issue for use 9.

6. 7. 3. 8. PURPOSE APPLICATION/SCOPE REFERENCE DOCUMENT DEFINITION RESPONSIBILITY QUALIFICATION OR TRAINING PROCEDURE RECORD ATTACHMENT 22 .SUGGESTED FORMAT 1. 4. 2. 9. 5.

LEVEL 3: WORK INSTRUCTIONS This third tier of work instructions details the day-today operating instructions to provide control of quality and being applied in the manner laid down in operation procedures. 23 .

or specific to product Frequently changed In details 24 .Work Instructions The written and /or spoken direction given with regard to what is to be done. services & equipment to be used Criteria to be satisfied Balance between instructions & training Usually departmental. What is to be done? How it should be done? Who should do it? When it should be done? Supplies. including the information given in training.

job cards. records. logs. labels. etc. tickets. registers. 25 .LEVEL 4: SUPPORTING DOCUMENTS Relates to all the forms. goods inwards notes. that are used to support the levels above. documents. purchase orders.

SUPPORT DOCUMENTATION 1. 3. 4. QUALITY PLAN CODES OF PRACTICE USER MANUAL TECHNICAL DOCUMENTATION 26 . 5.

• ISO 9001 helps organizations to implement quality management. • ISO 14001 helps organizations to implement environmental management.ISO 9001 and ISO 14001 in brief • ISO 9001 and ISO 14001 are among ISO's most well known standards ever. . • They are implemented by more than a million organizations in some 175 countries.

• Quality management means what the organization does to • ensure that its products or services satisfy the customer's quality requirements and • comply with any regulations applicable to those products or services. . • Quality refers to all those features of a product (or service) which are required by the customer.Quality management • ISO 9001 is for quality management.

) • Quality management also means what the organization does to • enhance customer satisfaction. . and • achieve continual improvement of its performance.Quality management (cont.

Environmental management • ISO 14001 is for environmental management. • to conform to applicable regulatory requirements. This means what the organization does to: • minimize harmful effects on the environment caused by its activities. and to • achieve continual improvement of its environmental performance. .

. a public administration. Generic means that the same standards can be applied: • to any organization. or a government department. large or small.Generic standards ISO 9001 and ISO 14001 are generic standards. • in any sector of activity. whatever its product or service. and • whether it is a business enterprise.

ISO 14001 gives the essential features. ISO 9001 gives the essential features • or if it wants to establish an environmental management system.) Generic also signifies that • no matter what the organization's scope of activity • if it wants to establish a quality management system.Generic standards (cont. .

Management systems • Management system means what the organization does to manage its processes. such as • satisfying the customer's quality requirements. or activities in order that • its products or services meet the organization’s objectives. or • meeting environmental objectives . • complying to regulations.

• Nothing important is left out. when.Management systems • To be really efficient and effective. . • Everyone is clear about who is responsible for doing what. • Management system standards provide the organization with an international. why and where. state-of-the-art model to follow. the organization can manage its way of doing things by systemizing it. how.

or ones with complicated processes.) • Large organizations. automobiles. • The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations. .Management systems (cont. could not function well without management systems. • Companies in such fields as aerospace. defence. or health care devices have been operating management systems for years.

not products • Both ISO 9001 and ISO 14001 concern the way an organization goes about its work. • They can be used by product manufacturers and service providers. • They are not service standards. • They are process standards. . • They are not product standards.Processes.

• ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services. • ISO 14001 gives the requirements for what the organization must do to manage processes affecting the impact of its activities on the environment. . not products (cont.Processes.) • Processes affect final products or services.

external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001). • ISO does not carry out certification and does not issue or approve certificates. • It means that an independent.Certification and registration • Certification is known in some countries as registration. .

and known as accredited certificates .that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors.an accreditation body .may be perceived on the market as having increased credibility.Accreditation • Accreditation is like certification of the certification body. . • Certificates issued by accredited certification bodies . • It means the formal approval by a specialized body . • ISO does not carry out or approve accreditations.

Certification not a requirement • Certification is not a requirement of ISO 9001 or ISO 14001. . • The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified. • The organization can implement them for the internal benefits without spending money on a certification programme.

• If it meets customer preferences • it is part of a risk management programme. .Certification is a business decision • Certification is a decision to be taken for business reasons: • if it is a contractual. or • if it will motivate staff by setting a clear goal. regulatory. or market requirement.

• ISO does not accredit. • ISO develops standards and guides to encourage good practice in accreditation and certification. approve or control the certification bodies. • ISO does not issue certificates. .ISO does not certify • ISO does not carry out ISO 9001 or ISO 14001 certification.

• ISO 9001:2008 is the latest. improved version. • There are 16 other standards in the family that can help an organization on specific .The ISO 9000 family • ISO 9001 is the standard that gives the requirements for a quality management system. • It is the only standard in the ISO 9000 family that can be used for certification.

improved version. • The ISO 14000 family includes 21 other standards that can help an organization specific aspects such as auditing. environmental labelling. life cycle analysis… . • ISO 14001:2004 is the latest.The ISO 14000 family • ISO 14001 is the standard that gives the requirements for an environmental management system. • It is the only standard in the ISO 14000 family that can be used for certification.

The ISO Survey .

• Certificates had been issued in 175 countries compared to 170 the previous year. . • This was increase of 6 % over 2006 when the total was 896 929 certificates.) • The worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 951 486.The ISO Survey (cont.

) .The ISO Survey (cont.

• Certificates had been issued in 148 countries compared to 140 the year before. .The ISO Survey (cont.) • The worldwide total of ISO 14001 certificates at the end of 2007 was 154 572. • This was an increase of 21 % over 2006 when the total was 128 211.

expert consensus on state-ofthe-art practices for quality and environmental management. • Model for continual improvement. • Increase efficiency and effectiveness. • Common language for dealing with customers and suppliers worldwide in B2B. .Benefits of ISO 9001 and ISO 14001 • International.

.) • Model for satisfying customers and other stakeholders.Benefits of ISO 9001 and ISO 14001 (cont. • Address environmental concerns of customers and public. and comply with government regulations. • Build quality into products and services from design onwards. • Integrate with global economy.

Benefits of ISO 9001 and ISO 14001 (cont.) • • • • Sustainable business Unifying base for industry sectors Qualify suppliers for global supply chains Technical support for regulations .

) • Transfer of good practice to developing countries • Tools for new economic players • Regional integration • Facilitate rise of services .Benefits of ISO 9001 and ISO 14001 (cont.

National Quality Award Models .

National Quality Award Models – India .

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