Iso 9001 - Et - 251108

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WELCOME TO

By:

Ajay K Agarwal PMI, Noida


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Presentation Outlines
Introduction to ISO Introduction to Quality Management System, Quality Principles of QMS Requirements of ISO 9001:2000 Quality Audits Process of Registration for ISO 9001:2000

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Introduction to ISO

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Who ISO is
Network of the national standards institutes of 156 countries Central secretariat in Geneva, Switzerland ISO is a non-governmental organization Meets the requirements of businesses & the broader needs of society

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What ISO name means


Derived from the Greek isos, meaning equal Therefore ,whatever the country ,whatever the language, the short form is always ISO

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How it all started


International standardization began in the electrotechnical field The international Electro-technical commision(IEC) was established in 1906 In 1946,delegates from 25 countries met in London Decided to create a new international organization Objective was to facilitate the international coordination and unification of industrial standards New organization,ISO,began operations on 23 February 1947
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How ISO standards benefit society


Benefits to Businesses Customers/Consumers Governments Trade officials Developing countries Everyone planet

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The hallmarks of the ISO brand


Equal footing Voluntary Market-driven Consensus worldwide

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How ISO decides what standards to develop


Need for a standard is felt by an industry or business sector Communicates the requirement to one of the ISOs national members Proposes the new work item to ISO If accepted, work item is assigned to an existing/new technical committee Apart from TC,3 general policy development committees exist These committees Provide strategic guidance for the standards development work on cross-sectoral aspects Ensures that the specific technical work is aligned with broader market and stakeholder group interests
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Who develops ISO standards


ISO standards are developed by technical committees, comprising of Experts from industrial, technical & business sectors others with relevant knowledge can also join, like, government agencies, testing laboratories, consumer associations, environmentalists, academic circles and so on
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How ISO standards are developed


Technical committee prepares draft document Draft international standard is circulated to ISO members for comment & balloting If accepted, with eventual modifications, Final DIS is circulated to members If accepted, the document is published as international standard

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PDCA Cycle & ISO

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Demings Cycle
PLAN DO Establish performance objectives and standards. Measure the ACTUAL performance against planned arrangements. Compare PERFORMANCE against planned arrangements (i.e objectives and standards) Gap measurement. Take necessary action to close gap by undertaking improvements.

CHECK -

ACT

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Quality Management System Modal


Continual improvement of the quality management system

Management responsibility

Customers Customers Resource management Measurement, analysis and improvement Satisfaction

Input Requirements
Key

Product realisation
Value-adding activities Information flow

Product

Output

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Quality Management System (QMS)

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Quality
Quality is Conformance with requirements. Quality is fitness for purpose. Quality is fitness for use. Quality is user dependent. Quality is journey & not destination.

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Quality
Understand customer needs and expectations. and regulatory Understand applicable statutory requirements of the products.

Establish Policy and Objectives to meet the above. Design the processes and establish criteria to realize those objectives.

Provide adequate resources to realize and measure product and other quality objectives

Contd
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Quality (contd)
Ensure reliability of inputs purchased from suppliers. Realize product meeting criteria.

Measure realization of processes for effectiveness in meeting product needs and objectives satisfying customer and Interested parties. Provide Clear instruction manuals/ Customer needed Product information Adhere to safety, environmental and statutory requirements.

Contd
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Quality (Contd)
Provide suitable packaging. Ensure on-time delivery. Provide efficient back-up service. Use of feedback from customers and internal processes for continual improvement. Provide proper training to build on organisational learning and continual improvement To achieve consistency in output, it is Quality of everything that we do, which can be improved.
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Concept of Quality

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Quality
Degree to which a set of inherent characteristics fulfills requirements.

Requirements
Need or expectation that is stated, generally implied or obligatory.

ISO 9000 : 2000


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System
Set of interrelated or interacting elements/processes put in sequence

Management System
System to establish policy and objectives and to achieve those objectives.

Quality Management System


Management System to direct and control an organisation with regard to quality.
ISO 9000:2000
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Quality Management Principles


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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QUALITY MANAGEMENT PRINCIPLES

CUSTOMER FOCUS
Organizations depend on customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations

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QUALITY MANAGEMENT PRINCIPLES


LEADERSHIP Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.

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QUALITY MANAGEMENT PRINCIPLES

INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit

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QUALITY MANAGEMENT PRINCIPLES

PROCESS APPROACH
A desired result is achieved more efficiently when activities and related resources are managed as a process

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QUALITY MANAGEMENT PRINCIPLES

SYSTEM APPROACH TO MANAGEMENT


Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives

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QUALITY MANAGEMENT PRINCIPLES

CONTINUAL IMPROVEMENT
Continual improvement of the organizations overall performance should be a permanent objective of the organization

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QUALITY MANAGEMENT PRINCIPLES

FACTUAL APPROACH TO DECISION MAKING


Effective decisions are based on the analysis of data and information

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QUALITY MANAGEMENT PRINCIPLES

MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS


An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value

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Process Approach
Process approach to quality Management is encouraged by ISO 9000 standards, as a means to enhance customer satisfaction by meeting customer requirements. Introduces and explains process model as conceptual presentation of specified QMS requirements. The application of a system of processes within an organisation together with the identification and interactions of these processes and their management can be referred to as process approach.

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All Work is accomplished by a Process


Method (Procedure, documented or not)

INPUT (includes resources)

PROCESS

OUTPUT Product (Result of the process) Examples of output: - A cup of tea. - Computing software. - Liquid fuel. - Banking service - Intermediate product.

Examples of resources: - Materials (Raw materials, parts). - Manpower (Competent). - Machinery (Infrastructure). - Measurement (Testing equipment). - Environment (Work environment).

A value-adding transformation, involving people and other resources.

Monitoring and measurement opportunities before, during and after the process.

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Interaction of Processes

Process A

Process C

Process B

Process D

Input

Output

Controls

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Model of the process approach


Continual improvement of the quality management system

Management responsibility

Customers Customers Resource management Measurement, analysis and improvement Satisfaction

Input Requirements
Key

Product realisation
Value-adding activities Information flow

Product

Output

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Quality Management Systems Approach


Determining the needs and expectations of the customer and other interested parties; Establishing the quality policy and quality objectives of the organisation ; Determining the processes and responsibilities necessary to attain the quality objectives;

Determining and providing resources necessary to attain the quality objectives; Contd
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Quality Management Systems Approach (Contd)


Establishing methods to measure the effectiveness and efficiency of each process; Applying these measures to determine the effectiveness and efficiency of each process; Determining means of preventing nonconformities and eliminating their causes; Establishing and applying a process for continual improvement of the quality management system.
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Perceived Benefits of Process Approach


Provides a structure for QMS of an organisation addressing all organisational aspects from identification of customer needs to realization of desired results. Applicable to any size and type of organisation. Directing attention to both people and products. Highlights process ownership and responsibility for CAPA providing a basis for improvement.

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Quality Control
It is focused on providing confidence that Quality requirements will be fulfilled. It is essentially a control loop based on monitoring, feedback and corrective action.

Quality Assurance
It is an anticipation & prevention of unfavorable events by the task performers.

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TERMINOLOGY
CONTINUAL IMPROVEMENT Recurring activity to increase the ability to fulfill requirements EFFECTIVENESS
Extent to which planned activities are realized and planned results achieved

EFFICIENCY Relationship between results achieved and resources used

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TERMINOLOGY
PRODUCT Result of a Process

CORRECTION Action taken to eliminate a detected Non conformity.


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TERMINOLOGY
CORRECTIVE ACTION Action to eliminate the cause of a detected non conformity or other undesirable situation. PREVENTIVE ACTION Action to eliminate the cause of a potential situation.
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TERMINOLOGY
VERIFICATION confirmation through the provision of objective evidence that specified requirements have been fulfilled. VALIDATION confirmation, through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled.
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Background
To help expand world trade, provide confidence to the customers on the quality of products / services they buy, and help the industry to remain competitive by continual improvement, ISO published ISO 9000 series of standards for the first time in 1987. These standards are reviewed and revised periodically. The phase-I revision of ISO 9000 series of standards took place in July 1994. The phase-II revision took place in December 2000.

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REVISION OF ISO 9000 SERIES


Second revision of ISO 9000 series was published by ISO on 15 Dec 2000 This revision brought out based on feedback received from various member countries 3 years time was given for change over from 1994 version to 2000 version To remove technical barrier-ISO 9001:2000 replaces the old versions viz. ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 To introduce process approach concept
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REASONS FOR REVISION


To restructure standard as per P-D-C-A cycle To introduce quality management principles in formulation of this revised series To make it more business oriented rather than document oriented To reduce the volume of documentation To make it more user friendly To give more emphasis on regulatory requirements, customer satisfaction and continual improvement
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REASONS FOR REVISION


To change terminology as under Subcontractor-supplier-customer To Supplier-organization-customer To bring alike activities under the same clause -thus earlier 20 clauses rearranged in 5 processes To give more emphasis on the role of top management
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REASONS FOR REVISION


To make quality objectives documented, measurable at relevant functions and levels and also consistent with the quality policy To evaluate the effectiveness of training or other actions taken w.r.t. Resources To make it compatible with other management system standards like EMS To give emphasis on analysis of data to verify the performance of QMS and to decide on improvement of QMS
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Year 2000 Family of Standards


In the ISO 9000:2000 Series, 1994 family of standards have been reduced to 4 core standards:
1 2 3 4 ISO 9000:2000 Fundamentals and vocabulary ISO 9001:2000 Requirements ISO 9004:2000 Guidelines for performance improvements ISO 19011:2002 Guidelines for Auditing Quality and/ or Environmental Management Systems Auditing

ISO 9000:2000 & ISO 9004:2000 are intended as guidelines only & can not be used as ref. Standards to audit the adequacy of QMS. Contd
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ISO 9000 STANDARDS


ISO 9000:2000

ISO 9001:2000

ISO 9004:2000

ISO 19011:2002

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FAMILY OF REVISED ISO 9000 STANDARDS


ISO 9000 : 2000 QMS Fundamentals and vocabulary ISO 9001 : 2000 QMS Requirements ISO 9004 : 2000 QMS Guidelines for performance improvement ISO 19011 : 2002 Guidelines for auditing of QMS and/or EMS
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DIFFERENCE BETWEEN ISO 9001 AND ISO 9004


ISO 9001:2000 ISO 9004:2000 Certification possible Certification not possible
Emphasis on effectiveness Emphasis on efficiency as well as effectiveness Emphasis on meeting customer as well as regulatory Emphasis on meeting requirements requirements of all interested parties

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Year 2000 Family of Standards (contd)


Other Standards ISO 10005:1995* ISO 10006:2003 ISO 10007:2003 ISO 10012:2003 ISO 10018*: ISO 10019*: Technical Reports ISO/TR 10013:2001 ISO/TR 10014:1998* ISO/TR 10015:1999* ISO/TR 10017:2003 Documentation. Economics of quality. Training. Statistical techniques.
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Quality Plans. Project Management. Configuration Management. Measurement Control System. Complaints handling. Selection of QMS consultants and use of their services.

FAMILY OF REVISED ISO 9000 STANDARDS


ISO 9000 : 2000 QMS Fundamentals and vocabulary ISO 9001 : 2000 QMS Requirements ISO 9004 : 2000 QMS Guidelines for performance improvement ISO 19011 : 2002 Guidelines for auditing of QMS and/or EMS
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DIFFERENCE BETWEEN ISO 9001 AND ISO 9004


ISO 9001:2000 ISO 9004:2000 Certification possible Certification not possible
Emphasis on effectiveness Emphasis on efficiency as well as effectiveness Emphasis on meeting customer as well as regulatory Emphasis on meeting requirements requirements of all interested parties

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Year 2000 Family of Standards (contd)


Technical Specifications ISO/TS 16949:2002 ISO/TS 29001:2003 ISO/IEC 17025:1999* ISO 15161:2001 QS - Automotive suppliers. QS - Petroleum, petrochemical and natural gas industry QS - Testing and calibration labs. QS - Food and drink industry.

Brochures Quality Management Principles. Selection and use. Hand book for small businesses. * Under revision/preparation
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Generic Product Categories


Hardware Software Processed Materials Services

The terms product can comprise elements belonging to different generic product categories. Throughout, the Standard, wherever the term product occurs, it can also mean service

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ISO 9001:2000
Requirements Quality Management System Management Responsibility Resource Management Product Realization Scope General requirements, Documentation requirements. Commitment, Customer Focus, Quality Policy, Objectives, Planning, Responsibility, Authority and communication, Management review. Provision of resources: Human resources, Infrastructure and Work environment. Planning of product realization ,Customer related processes , Design & development, Purchasing, Production and service provision, Control of measuring & monitoring devices. Monitoring and measurement, Control of nonconforming product, Analysis of data, Improvement.

Measurement, Analysis and Improvement

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ISO 9001:2000
REQUIREMENTS - CL.4 THE DESCRIPTION OF QMS - IDENTIFICATION, CONTROL, IMPROVEMENT OF PROCESSES INCLUDING THOSE
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ISO 9001:2000
THE DESCRIPTION OF QMS(CONTD.) REFERENCE FOR IMPLEMENTATION DOCUMENTS, CONTROL EVIDENCE FOR IMPLEMENTATION RECORDS, CONTROL
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ISO 9001:2000
THE DESCRIPTION OF QMS(CONTD.) Cl. 4.2.2: Quality Manual- contains regulatory requirements, Quality policy, Introduction of company (nature of work- marketing/manufacturing etc.), Justification of any exclusion of clause Any manual must consists the following: 1. Title 2. (i) Scope & Field of application, (ii) Structure i.e. level 3. Table of contents 4. Abbreviation list

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ISO 9001:2000
REQUIREMENTS CL. 5 MANAGEMENT RESPONSIBILITY - EVIDENCE - COMMITMENT: POLICIES; OBJECTIVES; EVIDENCE AKA_PMI_TAJ

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5.3 QUALITY POLICY


Top management shall ensure that the quality policy: a) is appropriate to the purpose of the organization; b) includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system; c) provides a framework for establishing and reviewing quality objectives; d) is communicated and understood within the organization and ; e) is reviewed for continuing suitability.

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QUALITY POLICY
CHARACTERISTICS:
BASED ON BUSINESS PHILOSOPHY OF PROMOTERS HAVE VISION, MISSION & STRATEGY EASY TO REMEMBER: COINCISE & SIMPLE LANGUAGE AIM AT ERROR FREE PERFORMANCE CUSTOMER ORIENTED GUIDE SETTING OF PERFORMANCE STANDARDS SIGNED BY CHIEF EXECUTIVE OBJECTIVES FOR VISION

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ISO 9001:2000
REQUIREMENTS CL. 6 RESOURCE MANAGEMENT - PROVISION - COMPETENCE (HUMAN RESOURCES) - INFRASTRUCTURE
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ISO 9001:2000
REQUIREMENTS CL. 7 PRODUCT REALISATION (PROCESSES) - PLANNING - CUSTOMER RELATED (INCLUDING CUSTOMER
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ISO 9001:2000
REQUIREMENTS CL. 7 (CONTD.) DESIGN AND DEVELOPOMENT - PLANNING TO VALIDATION - CHANGES
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ISO 9001:2000
REQUIREMENTS CL. 7.4 PURCHASING - PRODUCT CONFORMITY - EXTENT OF CONTROLS - PURCHASING INFORMATION
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ISO 9001:2000
REQUIREMENTS CL. 7.5 PRODUCT AND SERVICE PROVISIONS - PRODUCT REQUIREMENTS(INFORMATION)
- PROCESS REQUIREMENTS, WIs

- MONITORING PROVISION

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ISO 9001:2000
REQUIREMENTS CL. 7.5 (CONTD.) - SPECIAL PROCESS VALIDATION IDENTIFICATION/TRACEABILIT
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ISO 9001:2000
REQUIREMENTS CL. 7.6 CONTROL OF MONITORING AND MEASURING DEVICES - CALIBRATION, VERIFICATION - TRACEABILITY - STATUS (FOR USE)
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REQUIREMENTS CL. 8

ISO 9001:2000

MEASURE, ANALYSE AND IMPROVE FOR MONITORING AND MEASUREMENT (CL.8.2) - CUSTOMER SATISFACTION - IQA - PROCESSES - INSPECTION AND TESTING
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ISO 9001:2000
REQUIREMENTS CL. 8 (CONTD.) - ANALYSIS OF DATA (CL.8.4)OBTAINED - IMPROVEMENT (CONTINUAL IMPROVEMENT) CORRECTIVE ACTION

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Permissible Exclusions in ISO 9001:2000


Where any requirement(s) of the standard can not be applied due to the nature of organisation and its product, this can be considered for exclusion. Exclusions are limited to requirements within clause 7, and such, exclusions should not affect the organisations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

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Typical Structure of Documentation


ISO/TR 10013 : 2001
Document contents A : Describes the QMS in accordance with the stated quality policy and objectives. B : Describes the interrelated processes and activities required to implement the QMS C: Consists of detailed work documents. D: Evidences to audit.

Quality Manual (Level A) Quality Management System Procedures (Level B) Work instructions , process maps and other documents for QMS (Level C) Forms and Records (Level D)
Note 1: The numbers and levels may be adjusted to meet the organisations needs. Note 2: Forms may be applicable at all levels of the hierarchy.
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List of Mandatory Documented Procedures


1. 2. 3. 4. 5. 6. Control of Documents (4.2.3). Control of Records (4.2.4). Internal Audit (8.2.2). Control of Nonconforming product (8.3). Corrective Action (8.5.2). Preventive Action (8.5.3).

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List of Records
Results of management reviews (5.6.1). Records of education, experience, training and qualifications (6.2.2e). Records to provide evidence that realisation process and resulting product meet requirement (7.1d). Results of customer requirement reviews and actions arising from reviews (7.2.2). Design and development input relating to product requirement (7.3.2). Records of design and development reviews (7.3.4) Contd...
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List of Records (contd)


Results of design and development verification and any necessary actions (7.3.5). Results of design and development validation and necessary actions (7.3.6). Results of the review of design and development changes and any necessary actions (7.3.7). Results of evaluation of suppliers and any necessary actions arising from the evaluation (7.4.1). Evidence of validated processes (7.5.2d). Traceability (where it is requirement) (7.5.3). Contd
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List of Records (contd)


Records of customer property loss/ damage/ otherwise found unsuitable (7.5.4). Results of calibration and verification (7.6). Records of internal audit (8.2.2). Records of product conformity with acceptance criteria indicating authority responsible for release of product (8.2.4). Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained (8.3). Records of results of corrective actions taken (8.5.2e). Records of results of preventive actions taken (8.5.3d).

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Quality Audit
WHY DO AUDITS? 1. To ensure compliance with the standards 2. Check of current status 3. Facilitate improvement 4. Enhance quality awareness 5. Increased interdepartmental understanding & cooperation

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AUDIT PROCESS: What Audit is?

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AUDIT PROCESS
SEEKS ANSWERS TO THREE BASIC QUESTIONS AT MOST, ANYTIME, ANYWHERE
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AUDIT PROCESS
THE THREE BASIC QUESTIONS: QUESTION 1. TO WHAT EXTENT IS THE QMS DOCUMENTED?
ADEQUACY OF QMS DOCUMENTS

VIS--VIS REQUIREMENTS IN THE STANDARD


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AUDIT PROCESS
QUESTION 2. TO WHAT EXTENT IS THE DOCUMENTED QMS IMPLEMENTED?
COMPLIANCE OF QMS DOCUMENTS

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AUDIT PROCESS
QUESTION 3. TO WHAT EXTENT IS THE QMS PUT INTO PRACTICE IS EFFECTIVE? STATED OTHERWISE ARE THE STATED OBJECTIVES OBTAINED? CONCLUSIONS OF AUDIT
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AUDIT PROCESS
WHAT AUDIT IS? DEFINITION FROM ISO 9000:2000 SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR OBTAINING EVIDENCE AND EVALUATING IT OBJECTIVELY TO

DETERMINE

THE EXTENT TO WHICH AUDIT

CRITERIA ARE FULFILLED


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WHY AUDITS ?
IT IS REQUIREMENT OF IS/IS0 9001:2000(CLAUSE 8.2.2) IT IS REQUIREMENT BY A CERTIFICATION BODY FOR THE PURPOSES OF CERTIFICATION IT IS AN EFFECTIVE MANAGEMENT TOOL TO KNOW, MONITOR AND IMPROVE ITS MANAGEMENT SYSTEMS

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WHY AUDITS ?
TWO QUESTIONS THAT NEED ANSWERS ARE :
ARE WE DOING THINGS RIGHT ? ARE WE DOING THE RIGHT THINGS ?

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LEVELS OF AUDITS
AUDITS ARE CARRIED OUT AT TWO LEVELS
1) TO EVALUATE IF THE PRESENT PROCEDURES ARE SUITABLE FOR ACHIEVING ORGANIZATIONAL GOALS AND OBJECTIVES 2) TO EVALUATE COMPLIANCE TO EXISTING PROCEDURES/CRITERIA

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TYPES OF AUDIT
First Party

ADEQUACY AUDIT
Second Party

COMPLIANCE AUDIT
Third Party

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Certification Bodies
An impartial body either governmental or non governmental, possessing the necessary competence and reliability to operate a certification system. BIS, NQA-QSR, STQC, LRQA, TUV, DNV, BVQI, KPMG, IRQS, SGS, QAS, UAL, ICL
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Accreditation Body
A national body which evaluates the competence of certification body. UKAS- United Kingdom Accreditation Services RAB- Registrar Accreditation Board in USA. RvA- RAAD VOOR ACCREDITATIE- Dutch Council JAS-ANZ- Joint Accreditation Services of Australia & NewZealand NACQS (Belgium), InMetro (Brazil), SCC (Canada), DAR PGA (German), SINCERT (Italy), SAS (Switzerland) INN (Chilly)
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Advantages
To Customers Product conforming to the requirements. Dependable and reliable product. Improved supply. Less noncompliance. Competitive pricing. Favorable response to changes.

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Advantages
To Organisation Reduced rejection rate Improved operational results Consistency in output Improved customer satisfaction Increased market share Increased return on investment

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Advantages
To Employees Defined roles & responsibilities. Increased job satisfaction. Improved morale. Better working conditions. Involvement. Pride.

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Advantages to Supplier and Partners


Stability Growth Partnership and mutual understanding

Advantages to Society
Fulfillment of legal & regulatory requirements Improved health and safety Reduced environmental impact

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10 Step Plan for Registration of a Company for ISO 9001


Establish steering groups. Develop a strategic plan, which describes Quality policy, mission, & goals Establish a training plan Review the existing Quality system Select appropriate ISO standard Define, develop and implement the new QMS Develop a Quality Manual, Establish procedure and Work Instructions Develop self assessment capability Make application for certification. Submit manuals for approval Final assessment & certification
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vision,

Thank You !!!


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Management Systems Requirements


Policy Structure, Roles & Responsibilities Objectives Processes Procedures Operational Control Monitoring, Checking, Audits and Reviews Improvement Training
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