Qms for Iipm

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30 July 2012 PKH 1

BRIG PK HOOGAN (RETD)


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ISO Central Secretariat

1, rue de Varembe, Case postale 56CH-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 forStandardisation - central secretariat

located in Geneva, Switzerland.

ISO- responsible for publication of

international standards.

Work ranges for standards fromagriculture, 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, Sub-

committees and Working Groups to develop

International Standards.

ISO published about 15 000 International

Standards.


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1. We will discuss -

2. Concepts & terminology ofISO9000:20003. Requirements ofISO 9001:2008.

4. A general understanding of the

performance improvement guidelines ofISO 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 specifiesterminology for quality managementsystems.

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 qualitymanagement system

Product

Product

realization

Managementresponsibility

Resource

management

Measurement,

analysis &

improvement

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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 managementsystems

3 Terms and definitions

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QMS Principles

1. Customer focus2. Leadership

3. Involvement of people

4. Process approach

5. System approach to management

6. Continual improvement

7. Factual approach to decision making

8. Mutually beneficial supplier relationships.


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IPIMAI model

To adopt "process approach" an organizationshould 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 Systems-

Requirements


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ISO 9001 structure

1. Scope2. Normative Reference

3. Terms and Definitions

4. Quality Management System5. Management Responsibility

6. Resource Management

7. Product Realization8. 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 devices30 July 2012 PKH 18


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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 feefor 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 ISO9001 demonstrates its capability to meet

customer and applicable statutory and

regulatory requirements.


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ISO 9004:2000

Quality management systems-

Guidelines for performanceimprovements


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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 thecontinual 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 inpursuit ofcontinual improvement of

performance.


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ISO 9004 standard has 8 clauses.

Sub-Clauses of clause 4, 5,6,7, 8 havebuilt-in box that containscorresponding ISO 9001:2008 sub-

clause. Annex A guidelines for self-

assessment.

Annex B Process for continualimprovement.


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ISO 19011:2002

Guidelines for Qualityand/or Environmental

management systemsAuditing


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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 chainevaluation and surveillance.


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ISO 19011:2002 has seven clauses.

Clause 4 describes Principles of auditing-

1. Ethical conduct

2. Fair presentation

3. Due professional care4. Independence

5. Evidence based approach


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Clause 5 provides guidance on managing

audit programmes and covers such issuesas 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 environmentalmanagement systems, including the

selection of audit teams.

Clause 7 provides guidance on competenceneeded 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, IndiaTel./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 conformityassessment bodies.


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Objectives of QCI : -

To establish National Accreditation

Boards suitable for country and in

accordance with relevant internationalstandards and guidelines.


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NABCB is an associatemember of the PacificAccreditation 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 (Multilateral Arrangement for Mutual Recognition).

This status has been achieved after undergoingan assessment by our peers from other

countries.


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NABCB Policy

NABCB will provide service tosatisfaction of its customers inaccordance with the national and

international norms.It is committed to provide equalopportunity to all applicants withhighest regard to transparency,integrity and confidentiality.


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IRCA was formed in 1984 as part of the UK government'senterprise initiative. Over 26,000 auditors have been awarded

certification since 1984 and more than 105 countries are

represented on the IRCA register.

International Register of Certificated Auditors

12 Grosvenor Crescent

London SW1X 7ZL

United KingdomTel: +44 (0) 20 7245 6833 Fax: +44 (0) 20 7245 6755

WEB : WWW.IRCA.ORG


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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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