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The ISO 9001:2008 QMS

TRAINING ON UNDERSTANDING THE REQUIREMENTS OF THE ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM

ISO 9001:2008 Quality Management System

COURSE CONTENTS

SECTION 1 : OVERVIEW - Overview & background of the evolution of Quality Management Systems - The QMS development cycle, the benefits, the Certification process, terminology. SECTION 2 : - The requirements of the ISO 9001 standard SECTION 3 : The audit process & methodology.

ISO 9001:2008 QMS & IQA Training


Purpose of the training : - to impart an understanding of the requirements of the ISO 9001:2008 standard requirements, - why & how audits are conducted - the benefits an ISO 9001 certification brings to an organization. At the end of the training, you should be able to : - understand the ISO 9001 standard & its benefits - identify the elements needed for your organization / department - conduct & report on audits - identify areas for continuous improvement and be a change agent in your organization. - inculcate a culture of structured management work practices & ethics towards becoming and being a THINKING organization.

ISO 9001:2008 QUALITY MANAGEMENT SYSTEM

SECTION 1
1. 2. 3. 4. OVERVIEW & BACKGROUND OF ISO 9000 SERIES, BENEFITS OF ISO 9000 THE CERTIFICATION PROCESS TERMINOLOGY

SECTION 1: OVERVIEW & BACKGROUND OF ISO 9001

What is ISO 9000 Series A method of demonstrating quality assurance Drives continual improvement Enhances Customer Satisfaction Develops a structured & documented management system within an organization Internationally recognized

SECTION 1 continued

Revision of the ISO 9000 standard The revision of the ISO 9000 International Standard is carried out at least once every 5 years.
ISO/TC 176 established in 1976 ISO 9000 Series 1987 ISO 9000 Series 1994 ISO 9000 Series 2000 ISO 9000 Series 2008

SECTION 1 continued

Previous ISO 9000 series (superseded)


ISO 9000 Quality Management & Quality Assurance Standards Guidelines for Selection & Use. (Guidance) ISO 9001 Quality Systems Model for Quality Assurance in Design & Development, Production & Installation and Servicing
(compliance)

ISO 9002 Quality Systems Model for Quality Assurance Production, Installation and Servicing (compliance) ISO 9003 Quality Systems Model for Quality Assurance in Final Inspection & Test (compliance for Labs / Test Houses) ISO 9004 Quality Management and Quality System Element Guidelines (guidance standard)

The current ISO 9000 Series (ISO 9001:2008)

ISO 9000:2000 QMS Fundamentals & Vocabulary

ISO 9000 Quality Management System

ISO 9001:2008 QMS Requirements

ISO 9004:2000 QMS Guidelines for Performance Improvements

Why Revise?
To define the minimum quality assurance requirements from time to time. To keep current with evolving business practices as well as market & industry developments

FIELDS OF APPLICATION

All categories of products ( hardware, software, services, processed materials ) Combination of categories Organization of all types & sizes In all functions & areas in an organization that directly affects the product quality & the related results. All levels within the organization.

Benefits of ISO 9001 Certification

To make products / services more acceptable internationally. To enable a company to export to countries (eg Europe, USA, Japan) where ISO9000 certification is expected. To satisfy customer contractual requirements. Gives a competitive edge Reduces rejects & Customer complaints Assist & reduce multiple 2nd party audits Increase in quality awareness & teamwork Reduces waste Improves resource management & utilisation

THE CERTIFICATION PROCESS

Organization develops QMS Organization engages a Certification Body (CB) CB conducts Document review and /or Initial visit CB conducts Certification audit Issue of Certificate CB conducts periodic surveillance CB conducts Certification renewal audit

ACCREDITATION BODY & CERTIFICATION BODY

Registrar Management Committee (ISO umbrella of member countries)

Accreditation Body (AB ) (UKAS, DOS Msia, Registrar of Accreditation Bodies USA,RvA of Netherlands , JAB of Japan,
DAR of Germany, JAS-ANZ, etc)

Certification Body (CB)


(eg BVQI, SIRIM, Lloyds, DNV, RTUV)

Companies being audited

ACCREDITATION BODY & CERTIFICATION BODY

ACCREDITATION BODY (AB)


AB is an authoritative body that has vested powers to give formal competency recognition to an organization eg CB to carry out specific tasks such as ISO Certification, UL qualification etc.

CERTIFICATION BODY CB is a 3rd party company that is Engaged contractually to evaluate an organizations QMS to the requirements of the standards and recommend to the AB for registration. Once approved, will issue the certificate Of registration. Examples: 1. SGS 2. BVQI 3. SIRIM QAS 4. Lloyds 5. DNV

Examples: 1. Dept of Standards Msia 2. UKAS of UK 3. ANSI-RAB of USA 4. Standards Council of Canada 5. Japan Accreditation Board

What ISO's name means Because "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning "equal". Therefore, whatever the country, whatever the language, the short form of the organization's name is always ISO

DOCUMENTATION STRUCTURE

Quality Manual

Quality Procedures

Work Instruction, Forms, Customer Supplied, Method Statement, Standards, Drawings etc

Company functional description Management review Company Goals

COMPANY TOP MANAGEMENT

Quality Objective Vision Quality Policy Mission

DEPT

DEPT

HR&FIN.
Dept. organization chart Dept. Job description

DEPT

DEPT

Individual dept. Organization chart Individual employee job description Dept. overall function procedure. Dept. individual process procedure Individual department records

Dept. Functional Description procedure Dept. process activity procedure Dept. Records Dept. Document list

Individual dept. document list. ( E.g. Procedure / W.I / Records ) Individual dept. key process for measurement,analysis and improvement.

Dept. Key process

Value of Documentation

Repeatability & Traceability Able to evaluate for effectiveness & continuing suitability Be able to provide appropriate training Able to measure achievement of conformity to Customer / Product requirements and undertake improvement Able to provide objective evidence. Documentation depends on: 1. Size of organization 2. Product / operations complexity 3. Criticality 4. Level of employees skill & knowledge.

WHAT IS QUALITY ??

It is:
Conformance to Customer Specification Meeting Customer expectations Trouble-free No problems / zero defect Good service

Definition:
1. 2. Fitness for Purpose or Use - Juran The quality of a product is the minimum loss imparted by the product to the society from the time the product is shipped Dr. Taguchi The degree to which a set of inherent characteristics fulfills requirements ISO definition from Fundamentals & Vocabulary

3.

Common Terminology
(extracted from ISO 9000;2000 QMS Fundamentals & Vocabulary)

Customer Organization or person that receives a product or service (internal / external) Top Management Person/group of people who direct & control an organization at the highest level. Quality Assurance Part of quality management focused on providing confidence that quality requirements will be fulfilled. Quality Control Part of quality management focused on fulfilling quality requirements. Non conformity Non fulfillment of specified requirement. (deficiency, discrepancy, non compliance)

Quality Management System Management system to direct & control an organization with regard to quality Procedure Specified way to carry out an activity or a process Auditee the organization to be audited Auditor A person who has the qualification to perform the Quality audit Objective Evidence Qualitative or quantitative information based on facts, measurement, test etc & can be verified Observation A statement of fact made as part of the audit process & substantiated by objective evidence.

Q&A THE END OF SECTION 1

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