Download - Qms for Iipm
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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
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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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