Description
The presentation describes details of stakeholders of international standardization, detailed stages of the development of international standards, ISO 9000 standards, quality system requirements, quality management syatem advantages of ISO 9000 certification.
International Organization for Standardization
About ISO
?
?
?
?
?
World's largest developer and publisher of International Standards. Established in 1947 to develop common international quality standards ISO is a network of the national standards institutes of 163 countries. Bureau of Indian Standards (BIS) is the Indian representative to ISO Non-governmental organization that forms a bridge between the public and private sectors.
Stakeholders in international standardization
? ? ? ? ?
Industry and industry/trade associations Science and academia Consumers and consumer associations Governments and regulators Societal and other interests
ISO standards are developed through…
• Public access • Consensus • Voting • Appeals
Detailed stages of the development of International Standards
International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a six-step process Stage 1: Proposal stage Stage 2: Preparatory stage Stage 3: Committee stage Stage 4: Enquiry stage Stage 5: Approval stage Stage 6: Publication stage
? ? ? ? ?
?
What standards do
?
? ?
? ? ?
?
Make the development, manufacturing and supply of products and services more efficient, safer and cleaner Facilitate trade between countries and make it fairer Provide governments with a technical base for health, safety and environmental legislation, and conformity assessment Share technological advances and good management practice Disseminate innovation Safeguard consumers, and users in general, of products and services Make life simpler by providing solutions to common problems
Who benefit from standards??
?
ISO standards provide technological, economic and societal benefits. • Businesses • Innovators • Customers • Governments • Trade officials
ISO 9000 Standards
?
1987 version
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing • ISO 9002:1987 Model for quality assurance in production, installation, and servicing • ISO 9003:1987 Model for quality assurance in final inspection and test
?
1994 version
• Emphasis on quality assurance via preventive actions
?
2000 version
• Emphasis on Process Management
?
2008 version
QUALITY SYSTEM REQUIREMENTS
EARLIER
ISO 9000 :1994 standard specified 20 sections of quality systems requirements. They were:
Quality system elements.
1
Define and document commitment, policy and objectives, responsibility and authority, verification resources and personnel. Appoint a management representative and conduct regular reviews of the system 2 Quality system Establish and maintain a documented quality system ensuring that products conform to specified requirements 3 Contract Review Ensure that customer's contractual requirements are evaluated and met 4 Design Control Requires procedures for controlling & verifying product design to ensure that specified requirements are being met. 5 Document control System for control and identification of all documents regarding quality, e.g. procedures, instructions, and specifications 6 Purchasing Ensure that purchased products conform to specified requirements 7 Product Identif ica- System to identify and control traceability of product at all stages from raw tion & traceability materials through production to the final product as delivered to the customer 8 Process control Ensure and plan the control of production which directly effects quality by documented work instructions, monitoring and control of processes 9 Inspection and Inspect and test incoming products, intermediate and final product; testing establish product conformance to specified requirements and identify nonconforming pro- ducts; maintain inspection and test records 10 Inspection, and test Selection and control of equipment to ensure reliability and accuracy in equipment measuring data
Quality System Requirements Management responsibility
Contents
11 Inspection and test status 12 Control of non-conforming products 13 Corrective actions
For the whole process the products shall be identified and clearly marked concerning test status, including indication of conformance or non-conformance Identification, documentation, evaluation, isolation (if possible) and disposition of non-conforming products Prevention of reoccurrence of failures (non-conforman- ce)
14 Handling, storage Protection of the quality of the product during hand- ling, storage, packaging and delivery packaging and delivery 15 Quality records Records, including those which demonstrate that the specified requirements have been met, shall be control- led and maintained
16 Internal Quality Audits Regular, planned internal audits shall be carried out, documented and recorded to verify the effectiveness of the quality system 17 Training 18 Purchaser Supplied Product 19 Servicing
20
Training requirements at all levels shall be identified and the training planned, conducted and recorded Requires procedures for verification, storage, & maintenance of purchased product Requires procedures for performing servicing to be carried out by competent personnel
Requires procedures for identifying the use of ST in process, product & service.
Statistical Techniques
PRESENT
8 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 relationship
Quality Management System
? ? ? ?
To meet the principles/requirements you must:
Document what you do
Continually Improve Effectiveness Use corrective action to improve your service to your customers
? ? ?
Implement or ‘Do’ what you wrote down Maintain Show evidence that you are doing what you said you were doing
ISO Certification Process
?
? ?
Certification to International Standards
The Registration Audit Surveillance Audits
Advantages of ISO 9000 Certification
?
?
? ? ?
?
? ? ? ?
Improves & maintains product quality Improves customer service & satisfaction Improves employee’s productivity & efficiency Meets international standard Improves Company’s market Image Provides competitive edge to the company Marketing Easier Increases Exports Increased profitability Top line growth & bottom line improvement
CONCLUSION
•
Management’s perspective on quality and commitment to ISO is the key to its successful implementation. Management must initiate and take responsibility for the necessary changes and should employ policies that encourages innovation and recognize employee’s motivation and competencies to make ISO a real success
•
Thank You!!
doc_561457598.ppt
The presentation describes details of stakeholders of international standardization, detailed stages of the development of international standards, ISO 9000 standards, quality system requirements, quality management syatem advantages of ISO 9000 certification.
International Organization for Standardization
About ISO
?
?
?
?
?
World's largest developer and publisher of International Standards. Established in 1947 to develop common international quality standards ISO is a network of the national standards institutes of 163 countries. Bureau of Indian Standards (BIS) is the Indian representative to ISO Non-governmental organization that forms a bridge between the public and private sectors.
Stakeholders in international standardization
? ? ? ? ?
Industry and industry/trade associations Science and academia Consumers and consumer associations Governments and regulators Societal and other interests
ISO standards are developed through…
• Public access • Consensus • Voting • Appeals
Detailed stages of the development of International Standards
International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a six-step process Stage 1: Proposal stage Stage 2: Preparatory stage Stage 3: Committee stage Stage 4: Enquiry stage Stage 5: Approval stage Stage 6: Publication stage
? ? ? ? ?
?
What standards do
?
? ?
? ? ?
?
Make the development, manufacturing and supply of products and services more efficient, safer and cleaner Facilitate trade between countries and make it fairer Provide governments with a technical base for health, safety and environmental legislation, and conformity assessment Share technological advances and good management practice Disseminate innovation Safeguard consumers, and users in general, of products and services Make life simpler by providing solutions to common problems
Who benefit from standards??
?
ISO standards provide technological, economic and societal benefits. • Businesses • Innovators • Customers • Governments • Trade officials
ISO 9000 Standards
?
1987 version
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing • ISO 9002:1987 Model for quality assurance in production, installation, and servicing • ISO 9003:1987 Model for quality assurance in final inspection and test
?
1994 version
• Emphasis on quality assurance via preventive actions
?
2000 version
• Emphasis on Process Management
?
2008 version
QUALITY SYSTEM REQUIREMENTS
EARLIER
ISO 9000 :1994 standard specified 20 sections of quality systems requirements. They were:
Quality system elements.
1
Define and document commitment, policy and objectives, responsibility and authority, verification resources and personnel. Appoint a management representative and conduct regular reviews of the system 2 Quality system Establish and maintain a documented quality system ensuring that products conform to specified requirements 3 Contract Review Ensure that customer's contractual requirements are evaluated and met 4 Design Control Requires procedures for controlling & verifying product design to ensure that specified requirements are being met. 5 Document control System for control and identification of all documents regarding quality, e.g. procedures, instructions, and specifications 6 Purchasing Ensure that purchased products conform to specified requirements 7 Product Identif ica- System to identify and control traceability of product at all stages from raw tion & traceability materials through production to the final product as delivered to the customer 8 Process control Ensure and plan the control of production which directly effects quality by documented work instructions, monitoring and control of processes 9 Inspection and Inspect and test incoming products, intermediate and final product; testing establish product conformance to specified requirements and identify nonconforming pro- ducts; maintain inspection and test records 10 Inspection, and test Selection and control of equipment to ensure reliability and accuracy in equipment measuring data
Quality System Requirements Management responsibility
Contents
11 Inspection and test status 12 Control of non-conforming products 13 Corrective actions
For the whole process the products shall be identified and clearly marked concerning test status, including indication of conformance or non-conformance Identification, documentation, evaluation, isolation (if possible) and disposition of non-conforming products Prevention of reoccurrence of failures (non-conforman- ce)
14 Handling, storage Protection of the quality of the product during hand- ling, storage, packaging and delivery packaging and delivery 15 Quality records Records, including those which demonstrate that the specified requirements have been met, shall be control- led and maintained
16 Internal Quality Audits Regular, planned internal audits shall be carried out, documented and recorded to verify the effectiveness of the quality system 17 Training 18 Purchaser Supplied Product 19 Servicing
20
Training requirements at all levels shall be identified and the training planned, conducted and recorded Requires procedures for verification, storage, & maintenance of purchased product Requires procedures for performing servicing to be carried out by competent personnel
Requires procedures for identifying the use of ST in process, product & service.
Statistical Techniques
PRESENT
8 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 relationship
Quality Management System
? ? ? ?
To meet the principles/requirements you must:
Document what you do
Continually Improve Effectiveness Use corrective action to improve your service to your customers
? ? ?
Implement or ‘Do’ what you wrote down Maintain Show evidence that you are doing what you said you were doing
ISO Certification Process
?
? ?
Certification to International Standards
The Registration Audit Surveillance Audits
Advantages of ISO 9000 Certification
?
?
? ? ?
?
? ? ? ?
Improves & maintains product quality Improves customer service & satisfaction Improves employee’s productivity & efficiency Meets international standard Improves Company’s market Image Provides competitive edge to the company Marketing Easier Increases Exports Increased profitability Top line growth & bottom line improvement
CONCLUSION
•
Management’s perspective on quality and commitment to ISO is the key to its successful implementation. Management must initiate and take responsibility for the necessary changes and should employ policies that encourages innovation and recognize employee’s motivation and competencies to make ISO a real success
•
Thank You!!
doc_561457598.ppt