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TRAINING ON UNDERSTANDING THE REQUIREMENTS OF THE 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.
SECTION 1
1. 2. 3. 4. OVERVIEW & BACKGROUND OF ISO 9000 SERIES, BENEFITS OF ISO 9000 THE CERTIFICATION PROCESS TERMINOLOGY
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
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)
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.
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
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 (AB ) (UKAS, DOS Msia, Registrar of Accreditation Bodies USA,RvA of Netherlands , JAB of Japan,
DAR of Germany, JAS-ANZ, 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
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.
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.