BRIG PK HOOGAN (RETD)

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ISO Central Secretariat 1, rue de Varembe, Case postale 56 CH-1211 Geneve 20, Switzerland
Tel. + 41 22 749 01 11 fax: + 41 22 733 34 30

web: www.iso.org
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ISO
International Organisation for Standardisation - central secretariat located in Geneva, Switzerland. ISO- responsible for publication of international standards. Work ranges for standards from agriculture, construction, mechanical engineering, medical, IT etc
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ISO Established on 23 February 1947. An association of approximately 150 National Standards Bodies each representing their country. Employs a system of Technical Committees, Subcommittees and Working Groups to develop International Standards. ISO published about 15 000 International Standards.
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1. 2. 3. 4.

We will discuss Concepts & terminology of ISO9000:2000 Requirements of ISO 9001:2008. A general understanding of the performance improvement guidelines of ISO 9004:2000 5. Familiarity with auditing guidance standard ISO 19011:2002.

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ISO 9000:2000 Quality Management Systems Fundamentals & Vocabulary.

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ISO 9000: 2000

Supersedes ISO 9000-1:1994 & ISO 8402: 1994

ISO 9000 describes fundamentals of quality management systems and specifies terminology for quality management systems. It has three clauses only. 1. Scope 2. Fundamentals of QMS 3. Terms and Definitions.
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2. Fundamentals of QMS
2.1 Rationale for QMS 2.2 Requirements for QMS & Requirements for Products. 2.3 QMS Approach 2.4 Process Approach

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Model of Process based Quality Management System

Continual Improvement of the quality management system
R E Q U I R E M E N T S

C U S T O M E R

Management responsibility

Resource management

Measurement, analysis & improvement

Product realization

C U S T O M E R

Product

S A T S F A C T I O N
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2.5 Quality policy and quality objectives Role of top management 2.7 Documentation 2.8 Evaluating QMS 2.9 Continual improvement 2.10 Role of statistical techniques 2.11 Role of QMS and other management systems 3 Terms and definitions
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QMS Principles
1. 2. 3. 4. 5. 6. 7. 8. Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships.
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IPIMAI model
To adopt "process approach" an organization should apply following steps: Identify processes of organization, Plan processes, Implement and measure processes, Analyse processes, Improve processes.

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ISO 9001:2008 Quality Management SystemsRequirements

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ISO 9001 structure

1. 2. 3. 4. 5. 6. 7. 8. Scope Normative Reference Terms and Definitions Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement
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4.QMS
General requirements Document requirements
Quality manual-scope of qms,procedure Control of document Control of records

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5.MANAGEMENT RESPONSIBILITY
Management commitment Customer focus Quality policy Quality planning
Quality objectives QMS planning

Responsibility, authority and communication Management review

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6.RESOURCE MANAGEMENT
Provision of resources Human resources-competence, training Infrastructure-building ,equipment , tpt, com Work environment

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7.PRODUCT REALISATION
Planning of product realisation Customer related processes-requirements , delivery
Customer communication

Design and development-input, output, design review, verification Purchasing-verification of products, identification and traceability Control of monitoring and measuring devices
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MEASUREMENT ,ANALYSIS AND IMPROVEMENT

Monitoring and measurement Internal audit Control of non conforming products Analysis of data Improvement
Continual improvement Corrective action Preventive action
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 ISO does not award certificates. Registration body awards certificates. Registration body charges a nominal fee for registration service. Certification is for QMS of organisation as covered in scope. Scope may be limited to any one department/ unit of an organisation. However generally it is for entire QMS of Organisation.
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 ISO Certificate is valid for 3 years. Each registration body has its own register. QMS certification is distinct from product certification. Organization QMS certification against ISO 9001 demonstrates its capability to meet customer and applicable statutory and regulatory requirements.

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ISO 9004:2000 Quality management systemsGuidelines for performance improvements

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 ISO 9004 gives guidance on a wide range of objectives of a quality management systems than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001 in pursuit of continual improvement of performance.
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 ISO 9004 standard has 8 clauses. Sub-Clauses of clause 4, 5,6,7, 8 have built-in box that contains corresponding ISO 9001:2008 subclause. Annex A guidelines for selfassessment. Annex B Process for continual improvement.
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ISO 19011:2002 Guidelines for Quality and/or Environmental management systems Auditing
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Importance of Auditing
Auditing is an important management tool for monitoring and verifying effective implementation of an organization's quality policy. Audits are also essential part of conformity assessment activities such as an external certification/registration and supply chain evaluation and surveillance.
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ISO 19011:2002 has seven clauses. Clause 4 describes Principles of auditing-

1. 2. 3. 4. 5.

Ethical conduct Fair presentation Due professional care Independence Evidence based approach

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 Clause 5 provides guidance on managing audit programmes and covers such issues as assigning responsibility for managing audit programmes, establishing the audit programme objectives, coordinating audit activities and providing sufficient audit team resources.

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 Clause 6 provides guidance on conducting audits of quality and/or environmental management systems, including the selection of audit teams. Clause 7 provides guidance on competence needed by an auditor and describes a process for evaluating auditors.

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Quality Council of India

Institution of Engineers Building, IInd Floor, Bahadur Shah Zafar Marg New Delhi - 110 002, India
Tel./Fax: 91-11-2337 9321, 2337 9621

www.qcin.org
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QCI is setup as an Autonomous body by the Government of India, (Ministry of Commerce & Industry, Department of Industrial Policy & Promotion being the nodal Ministry) to establish and operate National Accreditation Structure for conformity assessment bodies.
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 Objectives of QCI : To establish National Accreditation Boards suitable for country and in accordance with relevant international standards and guidelines.

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 NABCB is an associate member of the Pacific Accreditation Cooperation (association of Accreditation Bodies in the Asia-Pacific Region) and International Accreditation Forum (Association of Accreditation Bodies worldwide). NABCB is also a signatory to the IAF MLA (Multi lateral Arrangement for Mutual Recognition). This status has been achieved after undergoing an assessment by our peers from other countries.

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NABCB Policy

NABCB will provide service to satisfaction of its customers in accordance with the national and international norms. It is committed to provide equal opportunity to all applicants with highest regard to transparency, integrity and confidentiality.
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International Register of Certificated Auditors 12 Grosvenor Crescent London SW1X 7ZL United Kingdom
Tel: +44 (0) 20 7245 6833 Fax: +44 (0) 20 7245 6755

WEB : WWW.IRCA.ORG

IRCA was formed in 1984 as part of the UK government's enterprise initiative. Over 26,000 auditors have been awarded certification since 1984 and more than 105 countries are represented on the IRCA register.
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Secretariat: B-4/B-5/B-6 Apartments, Qutab Hotel, New Mehrauli Road, New Delhi - 110 016. www.nabl-india.org
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Thank You
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