What ?Why ?How ?
ISO 9000 - WHAT ? 1946- Standardization Movement - Formation of International Organisation for Standardization - ( I.O.S. >>> ISO)- Purpose is to develop uniform guidelines on quality management system 1982- Formation of ISO Technical Committee (TC 176) at UK - Purpose is to design Standards & Guidelines
ISO 9000 - WHAT ?
1987- Standards born- ISO 9000 - Fundamentals- ISO 9001 - Design- ISO 9002 - Manufacturing- ISO 9003 - Service- ISO 9004 - Guidelines1994, 2000 & 2008 - Standards revised
ISO 9001:2008 - Result orientation [ System > System + Results] - Quality Policy [No Structure > Structure ] - Quality Objectives [ No Structure > SMART ones] - Documentation [ Large > Meaningful] - Improvement focus [ Continuous > Continual] - Approach [ No Model > Now Process Model ]
SIMPLE TO USE - A GOOD TOOL FOR ORGANISATION DEVELOPMENT
ISO 9001 STANDARDSpecifies Requirements Quality Management System
Scope of ISO 9001:2008The ISO 9001:2008 standard specifies requirements for a QMS where an organisation:
1. needs to demonstrate its ability to consistently provide product / service that meets customer and applicable regulatory requirements, and
2. aims to enhance customer satisfaction through effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
S T R U C T U R E O F I S O 9 0 0 0 S E R I E S O F S T A N D A R D SThe ISO 9000 series of standard contains4 core standards:ISO 9000:2005 QMS: Fundamentals and Vocabularyb) ISO 9001:2008 QMS : Requirementsc) ISO 9004:2000 QMS : Guidelines for performance improvementsd) ISO 19011:2002 Guidelines for quality and environmental auditing
Quality Management Principles Eight quality management principles have been identified that can be used by top management in order to lead the organisation towards improved performance:
Customer Focus LeadershipInvolvement of people Process Approach System approach to Management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships
PROCESSAn organisation functions through a series of activities linked to each other to deliver a service.Each activity or a set of activities takes certain inputs and converts them into outputs.Such activity or a set of activities which transform inputs into outputs is called Process.
Measure Why measure: What cannot be measured cannot be monitored.
Measure what: Those parameters which influence efficiency & effectiveness of the process.
Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows:Plan:Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.
Do:Implement the processes.
Check:Monitor and measure processes and product against policies, objectivesand requirements for the product and report the results.
Act:Take actions to continually improve processes performance.
Quality Management System Requirements
Quality Management System- General requirements and Documentation requirements.
Management Responsibility- Management commitment, Customer focus, Quality policy, Quality objectives, Planning, Responsibility, authority & communication, and Management review.
Resource Management- Provision of resources, Human resources, Infrastructure and Work environment.
Product Realization- Planning, Customer requirements, Design & development, Purchasing, Production & service provision and Control of monitoring & measuring equipments.
Measurement, Analysis and- Monitoring and measurement, Control of Improvement non - conforming product, Analysis of data & Continual improvement.
Documents and Records
Records are special type of documents and are established and maintained to provide evidence of conformity to requirements and of effective operations of the quality management system.
The list of mandatory records as per standard is:Results of management reviews.Records of education, experience, training and qualifications.Records to provide evidence that realization process and resulting product meet requirement.Results of customer requirement reviews and actions arising from reviews.Design and development input relating to product requirement.Records of design and development reviews.Results of design and development verification and any necessary actions.Results of the review of design and development changes and any necessary actions.Results of evaluation of suppliers and any necessary actions arising from the evaluation.Evidence of validated processes.Traceability (where it is requirement).Records of customer property loss/ damage / otherwise found unsuitable.Results of calibration and verification.Records of internal audit.Records of product conformity with acceptance criteria indicating authority responsible for release of product.Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.Records of results of corrective actions taken.Records of results of preventive actions taken.Mandatory Records Required by Standard
Clause No. 4 Q.M.S [Quality Management System]4.1 General Requirements4.2 Documentation Requirements
4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records
Clause No. 5 Management Responsibility5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning 5.4.1 Quality Objectives 5.4.2 QMS Planning
5.5 Responsibility, Authority & Communication
5.5.1 Responsibility & Authority 5.5.2 Management Representative 5.5.3 Internal Communication
5.6 Management Review 5.6.1 General 5.6.2 - Review Input 5.6.3 Review Output
Clause No. 6 Resource Management6.1 Provision of resources6.2 Human Resources
6.2.1 General 6.2.2 - Competence, Training & Awareness
6.3 Infrastructure6.4 Work Environment
Clause No. 7Product Realization7.1 Planning of product realization7.2 Customer related processes
7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer Communication
7.3 Design & Development
7.3.1 D & D planning 7.3.2 D & D inputs 7.3.3 D & D outputs 7.3.4 D & D review 7.3.5 D & D verification 7.3.6 D & D validation 7.3.7 Control of D & D Changes
7.4.1 Purchasing process 7.4.2 - Purchasing information 7.4.3 Verification of purchased product
7.5 Production and Service provision
7.5.1 - Control of production & service provision 7.5.2 - Validation of processes for production and service provision 7.5.3 - Identification & traceability 7.5.4 - Customer property 7.5.5 - Preservation of product
7.6 Control of monitoring and measuring equipment
Clause No. 8 Measurement, Analysis & Improvement8.1 General8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring & Measurement of Processes 8.2.4 Monitoring & Measurement of Products
8.3 Control of Non Conforming Product8.4 Analysis of data8.5 Improvement
8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action
ISO 9000 - HOW ? VISION, MISSION, QUALITY POLICY & OBJECTIVESDOCUMENTATION - QUALITY MANUAL How do we comply to QMS requirements ? - PROCESS MANUAL How do our processes perform ? How do we perform our operations ?TRAINING - AWARENESS + SYSTEM + AUDITIMPLEMENTATION INTERNAL QUALITY AUDIT + MGMT. MTG.PRE-AUDIT + CERTIFICATION AUDIT + PERIODIC / SURVEILLANCE AUDIT
Building Systems The Right Approach An approach to developing and implementing a quality management system consists of several steps including the following:
determining the needs and expectations of customers 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 the resources necessary to attain the quality objectives;
Building Systems The Right Approach establishing methods to measure the effectiveness and efficiency of each process;
applying these measures to determining the effectiveness and efficiency of each process;
determining means of preventing nonconformities and eliminating the causes;
establishing and applying a process for continual improvement of the quality
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