ISO 9001 Awareness Training

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ISO 9001

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ISO 9001:2008 QMS Awareness Training Presented by: Ashwin Varma | Principal Consultant m : 050 3097020 | e : ashwin@isys.ae 1 Worldwide Certification Services isys Consulting FZE PO Box 50970 Sharjah , UAE

Why do you need systems? Situations facing companies:

Why do you need systems? Situations facing companies The company is losing business because a competitor is providing better services A key staff has left the company and no one knows how to proceed with a project left midway Someone in the production line made a mistake and everyone has to redo their work 2

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What Customers Want Better Pricing Flexibility & Speed Exceptional Service Consistent Quality Product Innovation

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History of Quality:

History of Quality 5 Americans (re)discover quality Pioneered by Edward Deming and Joseph Juran in early 1900’s Quality goes to Japan Japanese culture conducive to quality Observe, copy and improve (reminds of China!) By 1970’s Japanese manufacturing was far superior Quality returns to America High cost of fix for microelectronics vs. cars

Why Quality?:

Why Quality? 6 If you make or do something right the first time, chances are it will not go wrong later Customers prefer goods that do not break, and really like goods that do what they want them to do. 85% of the reasons for failure are related to deficiencies in systems and processes (Deming, E)

What is quality?:

What is quality? 7 It is a journey, not a destination Quality is 90% attitude and 10% knowledge (Barry, T) Quality is fitness for use (Joseph Juran & Frank Gryna) Satisfaction with the outcome

According to ISO 9001 standard Defining Quality:

According to ISO 9001 standard Defining Quality Quality means fitness for purpose . Quality does not necessarily mean ‘excellence’ or ‘best product’. It simply means that the product or service meets the customer’s needs . 8

Dimensions of Quality:

Product Quality Service Quality Reliability Faultless Aesthetics Performance Serviceability Safety Durability Reliability Courtesy Communication Responsiveness Access Empathy Assurance 9 Dimensions of Quality

Process:

Process 10 Any activity that accepts inputs, adds value to these inputs for customers, and produces outputs for these customers (BS 7850) Customers may be internal or external to the organization Process Controls Resources Inputs Outputs

Process owner:

Process owner 11 The person responsible for performing and/or controlling the activity As customer Process owner As supplier As customer Process owner As supplier Input from supplier Process 1 Output Input Process 2 Output to customer

Identifying a process:

Identifying a process 12 All activities represent processes, but these could have harmful or beneficial effects. Not all processes add value to the product – eg. Cross-checking someone else’s work or rectifying an error. Non-value adding processes should be avoided or eliminated where ever possible.

ISO 9001 Quality Management System The Quality Management System:

ISO 9001 Quality Management System The Quality Management System

The ISO Approach The Management System Hierarchy:

The ISO Approach The Management System Hierarchy 14

Model of a Process based Quality Management System:

Model of a Process based Quality Management System Continual Improvement of the quality management system Product Product Realization Management Responsibility Resource Management Measurement , Analysis & Improvement C U S T O M E RS R E Q U I R E M E N T S C U S T O M E RS S A T I S F A C T I O N Input Output Value-adding activities Information flow

The ISO Approach Document, document, document:

The ISO Approach Document, document, document 16

The ISO Approach The 8 Management Principles:

The ISO Approach The 8 Management Principles CUSTOMER FOCUS: Customer needs must be understood and met with the aim of enhancing customer satisfaction. LEADERSHIP : Every organization must establish its strategic objectives and then create an environment to achieve its goals. INVOLVEMENT OF PEOPLE : Employees at all levels must be fully involved to achieve organizational goals. PROCESS APPROACH : Processes within the organization must be identified and managed effectively. SYSTEM APPROACH TO MANAGEMENT : The system approach views the organization as a collection of inter-related processes. FACTUAL APPROACH TO DECISION MAKING : Organizations must base their decisions on logical or intuitive data that has been analyzed. CONTINUAL IMPROVEMENT : Every activity can be improved MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS 17

ISO 9001 Quality Management System Key Clauses:

ISO 9001 Quality Management System Key Clauses

ISO 9001:2008 Clauses:

ISO 9001:2008 Clauses CLAUSE DESCRIPTION 1 SCOPE & APPLICATION 2 NORMATIVE REFERENCES 3 TERMS & DEFINITIONS 4 QUALITY MANAGEMENT SYSTEM REQUIREMENTS 5 MANAGEMENT RESPONSIBILITY 6 RESOURCE MANAGEMENT 7 PRODUCT REALIZATION 8 MEASUREMENT, ANALYSIS & IMPROVEMENT 19

What is it? Clause 4: Documentation Requirements:

What is it? Clause 4: Documentation Requirements Documentation requirements Quality manual Control of documents Control of records 20

ISO Requirements General Requirements:

Has the organisation documented key processes , work procedures and supporting documentation including records REMEMBER: If it is not documented, you are not doing it! ISO Requirements General Requirements 21

Mandatory Procedure 4.2.3 Control of Documents:

Do you approve documents prior to issue? Do you ensure that changes and the current revision status of documents are identified? Do you ensure that relevant versions of documents are available at points of use? Do you ensure that documents remain legible and readily identifiable? Mandatory Procedure 4.2.3 Control of Documents 22

Too much, is it?:

Too much, is it?

Mandatory Procedure 4.2.4 Control of Records:

Are records legible, readily identifiable and retrievable? Has a documented procedure been established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? Mandatory Procedure 4.2.4 Control of Records 24

How to implement? Clause 4: Documentation Requirements:

How to implement? Clause 4: Documentation Requirements PROCEDURES Control of Document Procedure Control of Records Procedure FORMS Quality Management System Manual External Documents Register Document Control Register Document Creation, Revision And Deletion Form Work Procedures Register Management Records Chart 25

What is it? Clause 5: Management Responsibility:

What is it? Clause 5: Management Responsibility Management commitment Customer focus Quality policy Quality objectives Quality management system planning Responsibility, authority and communication Management representative Management review 26

ISO Requirements 5.1 Management Commitment:

Has a Quality Policy been established? Does management communicate the importance of meeting customer as well as regulatory requirements? Does management conduct management reviews ? Does management ensure the availability of resources ? ISO Requirements 5.1 Management Commitment 27

What is the moral of this story?:

What is the moral of this story? This is a story about four people named Everybody, Somebody, Anybody, and Nobody. There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody's job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn't do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have done! 28

How to implement? Clause 5: Management Responsibility:

How to implement? Clause 5: Management Responsibility PROCEDURES Management Review Procedure Customer Complaint & Feedback Procedure FORMS Organization Chart Individual Responsibilities and Authorities Form Customer Complaints Form and Log Quality Policy & Objectives Management Review Form Management Review Minutes 29

What is it? Clause 6: Resource Management:

What is it? Clause 6: Resource Management Human resources Competence, training and awareness Infrastructure Work environment 30

ISO Requirements 6.2 Human Resources:

Are personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience? Does the organisation provide training or take other actions to satisfy these needs? ISO Requirements 6.2 Human Resources 31

ISO Requirements 6.3 Infrastructure:

Does the organisation determine, provide and maintain building , workspace , equipment and supporting services needed to achieve conformity to product requirements? ISO Requirements 6.3 Infrastructure 32

How to implement? Clause 6: Resource Management:

How to implement? Clause 6: Resource Management PROCEDURES Competence, Training and Awareness Procedure FORMS New Employee Induction Form Training Enrolment Form Training Attendee List Training Evaluation Form 33

What is it? Clause 7: Product Realization:

What is it? Clause 7: Product Realization Planning of product realization Customer-related processes Determination of requirements related to the product Customer communication Design and development Purchasing Purchasing information Verification of purchased product 34

What is it? Clause 7: Product Realization:

What is it? Clause 7: Product Realization Production and service provision Control of production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment 35

ISO Requirements 7 Product Realization:

Does the organisation plan and develop the processes needed for product realisation? Does the organization determine and review customer requirements ? Does the organisation plan and control the design and development of product? ISO Requirements 7 Product Realization 36

ISO Requirements 7 Product Realization:

Are processes in place to ensure that purchased products conform to specified purchase requirements ? Does the organisation plan and carry out production and service provision under controlled conditions ? Does the organisation monitor and calibrate plant and equipment ? ISO Requirements 7 Product Realization 37

How to implement? Clause 7: Product Realization:

How to implement? Clause 7: Product Realization PROCEDURES Vendor Selection and Assessment Procedure Procedure for procurement Sales and Contract Review Procedure Plant and Equipment Procedure FORMS Vendor Assessment Form Approved Vendor Register Contract Review Authorisation Log Key Equipment Asset Register Test Equipment Calibration Register 38

What is it? Clause 8: Measurement, Analysis & Improvement:

What is it? Clause 8: Measurement, Analysis & Improvement Customer satisfaction Internal audit Monitoring and measurement of processes & product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action 39

ISO Requirements 8.2.1 Customer Satisfaction:

Does the organisation monitor information relating to customer perception as to whether the organisation has met customer requirements ? ISO Requirements 8.2.1 Customer Satisfaction 40

Mandatory Procedure 8.2.2 Internal Audits:

Does the organisation conduct internal audits at planned intervals? Does management responsible for the area being audited ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes? Mandatory Procedure 8.2.2 Internal Audits 41

Mandatory Procedure 8.3 Control of Non Conforming Products:

Do you ensure that products which do not conform to product requirements are identified and controlled to prevent unintended use or delivery ? Mandatory Procedure 8.3 Control of Non Conforming Products 42

Mandatory Procedure 8.5 Continual Improvement:

Does the organisation continually improve the effectiveness of the QMS? Mandatory Procedure 8.5 Continual Improvement 43

Mandatory Procedure 8.5.2 Corrective Action:

Do you take action to identify, review and eliminate the cause of non-conformities? Mandatory Procedure 8.5.2 Corrective Action 44

Mandatory Procedure 8.5.3 Preventive Action:

Do you take action to prevent re-occurrence of non-conformities? Mandatory Procedure 8.5.3 Preventive Action 45

How to implement? Clause 8: Measurement, Analysis & Improvement:

How to implement? Clause 8: Measurement, Analysis & Improvement PROCEDURES Internal Audit Procedure Control of Non-Conformance Procedure Corrective and Preventive Action Procedure FORMS Customer Satisfaction Survey Audit Schedule Audit Attendee List Non Conformance Form Internal Audit Report Opportunity for Improvement 46

Enjoy doing quality ,not everywhere:

Enjoy doing quality ,not everywhere A company chairman was given a ticket for a performance of Schubert's unfinished Symphony. Since he was unable to go, he passed the invitation to the company's Quality Assurance Manager. The next morning, the chairman asked him how he enjoyed it, and, instead of a few plausible observations, he was handed a memorandum which read as follows "For a considerable period, the oboe players had nothing to do. Their number should be reduced, and their work spread over the whole orchestra, thus avoiding peaks of inactivity. "All twelve violins were playing identical notes. This seems unnecessary duplication, and the staff of this section should be drastically cut. If a large volume of sound is really required, this could be obtained through the use of an amplifier. "No useful purpose is served by repeating with horns the passage that has already been handled by the strings. If all such redundant passages were eliminated, the concert could be reduced from two hours to twenty minutes. "In light of the above, one can only conclude that had Schubert given attention to these matters, he probably would have had the time to finish his symphony. ” 47

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