Understanding - Iso 9000 Quality Management System
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UNDERSTANDING ‐‐ ISO 9000 UNDERSTANDING ISO 9000 Q QUALITY MANAGEMENT SYSTEM
Presented by Manikandan
WHAT IS ISO ? WHAT IS ISO ? • IInternational Organisation t ti lO i ti for Standardisation f St d di ti • Established in 1946 @Geneva, Switzerland • It is an association of National Standard Bodies of more than 150 countries • Primary objective is coordination & unification of Pi bj i i di i & ifi i f international standards. • It employs system of technical committees, sub It l t ft h i l itt b committees & working groups to develop international standards international standards.
Presented by Manikandan
Why ISO ? Why ISO ? • • • •
It controls quality. It saves money. It saves money. Customers expect it. And competitors use it.
Presented by Manikandan
Benefits from (ISO‐9001) Quality Management System • It is a passport for entry in international market. i f i i i l k • It increases the professional image of your organization. • It increased customer confidence. • It improves quality cut in costs reducing to rejection control. rejection control. • It shows clarity of responsibility and authority. • It increases consistent quality. It increases consistent quality • According to this better and defined system. Presented by Manikandan
Documents to be Prepared Documents to be Prepared • • • •
Quality Policy Manual Quality System Procedures (QSPs) Quality System Procedures (QSPs) Work Instructions (WIs) Records / Formats / Forms
Presented by Manikandan
ISO Document Levels ISO Document Levels Quality Manual Procedures
Work Instructions
Other Documentation Records
Presented by Manikandan
LEVEL 1 – defines approach & responsibility
LEVEL 2 – defines Who, What & When
LEVEL 3 – Answers how
LEVEL 4 – Promotes Evidences
QUALITY POLICY MANUAL QUALITY POLICY MANUAL • First level documentation, defines “ what will y be done and why” • The manual communicates the quality policy and objectives of an organisation and objectives of an organisation • It is a living document because it reflects the current system being followed in the organisation.
Presented by Manikandan
Quality System Procedures (QSPs) Quality System Procedures (QSPs) • Second level documentation defines who dl ld i d fi h should perform specific tasks, when the task should be done and where the documentation will be made. • It collectively defines the organisation’s p g q y operations from receiving an enquiry to delivering a completed product / service. • These are confidential documents and need These are confidential documents and need not be revealed to outsiders. Presented by Manikandan
Work Instructions (WIs) Work Instructions (WIs) • 3rd Level Documentation defines how individual work processes (Ex: machining, welding..etc) are carried out within a company. p y • It also specifies how the work should be done; who should undertake the work and what records who should undertake the work and what records are to be maintained. • It may be in the form of drawings, routing sheet, It may be in the form of drawings routing sheet photographs..etc • It is advisable that it should be written by the It is advisable that it should be written by the employee who performs the task. Presented by Manikandan
Records / Formats / Forms Records / Formats / Forms • These are the evidence of activity having been p performed in compliance with quality system p q y y procedure. • These are used to provide traceability of These are used to provide traceability of actions on specific product or batch of products. • “IN IN GOD WE TRUST FROM ALL OTHERS WE GOD WE TRUST FROM ALL OTHERS WE REQUIRE OBJECTIVE EVIDENCE” Presented by Manikandan
1.Scope p 1.1. General The Standard specifies requirements for QMS where an organisation needs to demonstrate its where an organisation needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements customer and applicable regulatory requirements. 1.2 Application All requriements of this standard are generic and ll f h d d d are intended to be applicable to all organisations regardless of type, size and product provided. dl f d d d d
Presented by Manikandan
2.Normative Reference ISO 9000:2000 ISO 9000:2000 – Quality Quality Management Systems – Fundamentals & Vocabulary Fundamentals & Vocabulary
Presented by Manikandan
3 Terms and Definitions 3.Terms and Definitions The term “Organisation” replaces the term supplier used in ISO 9001:1994 and refers to the unit to which the i international standard applies. i l d d li
Presented by Manikandan
4 Quality management system 4.Quality management system. 4.1General Requirements 4 1General Requirements The organisation shall a) Identify the processes needed for QMS and their application. b) Determine the sequence & interaction of these processes c) Determine criteria & methods needed to ensure the operation & & control of these processes are effective. t l f th ff ti d) Ensure availability of resources & information necessary to support the operation and monitoring processes. e) Monitor, measure & analyse these processes. f) Implement actions necessary to achieve planned results and continual improvement of these processes continual improvement of these processes. 4.2 Documentation Requirements. All four level documents as explained earlier. p Presented by Manikandan
5 Management Responsibility 5.Management Responsibility 5.1Management Commitment Top Management shall provide evidence of its commitment to the development & implementation of the QMS and continually improving its effectiveness by Establishing the Quality policy and Quality Objectives effectiveness by Establishing the Quality policy and Quality Objectives. 5.2Customer Focus Top Management shall ensure that the customer requirements are determined and are met with the aim of enhancing customer satisfaction. 5.3Quality Policy Top Management shall establish communicate review the continuing Top Management shall establish, communicate, review the continuing suitability of the Quality Policy 5.4Planning Top Management shall ensure that Quality objectives including those needed to meet the requirement of the products are established and the same shall be measurable & consistent with the Quality Policy same shall be measurable & consistent with the Quality Policy. Presented by Manikandan
5 Management Responsibility 5.Management Responsibility 5.5 Responsibility, Authority & Communication Top Management shall ensure that responsibilites and authorities are defined Top Management shall ensure that responsibilites and authorities are defined and communicated within the organisation. Top Management shall appoint a member of management who irrespective of other responsibilites shall have responsibility and authority that includes other responsibilites shall have responsibility and authority that includes a) Ensuring that processes needed for QMS are established, implemented & maintained. b) Reporting to top management on the performance of the QMS and any b) Reporting to top management on the performance of the QMS and any need for improvement c) Ensuring the promotion of awareness of customer requirements throughout the organisation the organisation 5.6 Management Review Top Management shall review the organisation’s QMS at planned intervals to ensure its continuing suitability adequacy and effectiveness ensure its continuing suitability, adequacy and effectiveness.
Presented by Manikandan
6.Resource Management g 6.1
Provision of resources The organisation shall determine and provide the resources needed to implement & maintain the QMS and contin all impro e its effecti eness continually improve its effectiveness. 6.2 Human resources P Personnel performing work affecting product quality shall l f i k ff ti d t lit h ll be competent on the basis of appropirate education, training, skill and experience skill and experience 6.3 Infrastructure – Buildings, transport, communication devices ..etc 6.4 Work Environment – work space, ventilation ..etc
Presented by Manikandan
7 Management Responsibility 7.Management Responsibility 7.1
Planning of Product Realisation A document specifying the processes of QMS and the resources to be applied to a specific product referred as quality plan resources to be applied to a specific product referred as quality plan 7.2 Customer– related Process Requirements specified by the customer for delivery and post Requirements specified by the customer for delivery and post delivery activities / requirements not stated by the customer but necessary for specified or intended use 7.3 Design & Development 7.4 Purchasing 7.5 Production & service provision d & 7.6 Control of monitoring and measuring devices Presented by Manikandan
8.Measurement, Analysis & Improvement 81 8.1
Generall G The organisation shall plan & Implement the applicable methods, including statistical techniques li bl h d i l di i i l h i and continually improve the effectiveness of the QMS. QMS 8.2 Monitoring & Measurement 821C 8.2.1 Customer Satisfaction S if i 8.2.2 Internal Audit 8.2.3 Monitoring & measurement of Processes 8.2.4 Monitoring & measurement of Product Presented by Manikandan
8.Measurement, Analysis & Improvement 8.3 Control of nonconforming product (a) by taking action to eliminate the detected nonconformity (b) by authorising its use, release or acceptance under concession by relevant authority and where applicable by the customer. customer 8.4 Analysis of data – with data from customer satisfaction, conformity of product requirement suppliers etc conformity of product requirement, suppliers..etc 8.5 Improvement – The Organisation shall continually improve the effectiveness of the QMS through the use of the improve the effectiveness of the QMS through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive actions Presented by Manikandan
ISO 9000 family a review ISO 9000 family a review ISO 9001 – for QA in design, development, production, installation and servicing (Module H in ISO 9001 : 2000) ISO 9002 – for QA in Production and installation ( (Module D in ISO 9001: 2000) ) ISO 9003 – for QA in final inspection & test (Module E in ISO 9001:2000) E in ISO 9001:2000) ISO 9004 – for Quality Management and system elements guidelines (Converted as QMS in ISO elements guidelines (Converted as QMS in ISO 9001:2000) Presented by Manikandan
Benefits on implementing QMS as per ISO standards • • • • • • • •
“Users” experience clearly indicates the several significant “U ” i l l i di h l i ifi improvements in the following areas : Improved employee involvement (Avg gain 100%) Improved employee involvement (Avg gain 100%) Improved House Keeping (Avg.gain 140%) Improved Decision making based on facts & data (Avg.gain Improved Decision making based on facts & data (Avg.gain 95%) Improved Customer Satisfaction (Gain 55%) Improved safe working area (Gain 45%) Reduced Customer Complaints (about 40%) Reduced inspection efforts (about 45%) Reduced Quality Cost (about 50%) Presented by Manikandan
List of Changes in ISO 9001: 2008 & likely impact on QMS • Refer the text matter attached 3 pages
Presented by Manikandan
ALL THE BEST THANK U THANK U
Presented by Manikandan
Presented by Manikandan
WHAT IS ISO ? WHAT IS ISO ? • IInternational Organisation t ti lO i ti for Standardisation f St d di ti • Established in 1946 @Geneva, Switzerland • It is an association of National Standard Bodies of more than 150 countries • Primary objective is coordination & unification of Pi bj i i di i & ifi i f international standards. • It employs system of technical committees, sub It l t ft h i l itt b committees & working groups to develop international standards international standards.
Presented by Manikandan
Why ISO ? Why ISO ? • • • •
It controls quality. It saves money. It saves money. Customers expect it. And competitors use it.
Presented by Manikandan
Benefits from (ISO‐9001) Quality Management System • It is a passport for entry in international market. i f i i i l k • It increases the professional image of your organization. • It increased customer confidence. • It improves quality cut in costs reducing to rejection control. rejection control. • It shows clarity of responsibility and authority. • It increases consistent quality. It increases consistent quality • According to this better and defined system. Presented by Manikandan
Documents to be Prepared Documents to be Prepared • • • •
Quality Policy Manual Quality System Procedures (QSPs) Quality System Procedures (QSPs) Work Instructions (WIs) Records / Formats / Forms
Presented by Manikandan
ISO Document Levels ISO Document Levels Quality Manual Procedures
Work Instructions
Other Documentation Records
Presented by Manikandan
LEVEL 1 – defines approach & responsibility
LEVEL 2 – defines Who, What & When
LEVEL 3 – Answers how
LEVEL 4 – Promotes Evidences
QUALITY POLICY MANUAL QUALITY POLICY MANUAL • First level documentation, defines “ what will y be done and why” • The manual communicates the quality policy and objectives of an organisation and objectives of an organisation • It is a living document because it reflects the current system being followed in the organisation.
Presented by Manikandan
Quality System Procedures (QSPs) Quality System Procedures (QSPs) • Second level documentation defines who dl ld i d fi h should perform specific tasks, when the task should be done and where the documentation will be made. • It collectively defines the organisation’s p g q y operations from receiving an enquiry to delivering a completed product / service. • These are confidential documents and need These are confidential documents and need not be revealed to outsiders. Presented by Manikandan
Work Instructions (WIs) Work Instructions (WIs) • 3rd Level Documentation defines how individual work processes (Ex: machining, welding..etc) are carried out within a company. p y • It also specifies how the work should be done; who should undertake the work and what records who should undertake the work and what records are to be maintained. • It may be in the form of drawings, routing sheet, It may be in the form of drawings routing sheet photographs..etc • It is advisable that it should be written by the It is advisable that it should be written by the employee who performs the task. Presented by Manikandan
Records / Formats / Forms Records / Formats / Forms • These are the evidence of activity having been p performed in compliance with quality system p q y y procedure. • These are used to provide traceability of These are used to provide traceability of actions on specific product or batch of products. • “IN IN GOD WE TRUST FROM ALL OTHERS WE GOD WE TRUST FROM ALL OTHERS WE REQUIRE OBJECTIVE EVIDENCE” Presented by Manikandan
1.Scope p 1.1. General The Standard specifies requirements for QMS where an organisation needs to demonstrate its where an organisation needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements customer and applicable regulatory requirements. 1.2 Application All requriements of this standard are generic and ll f h d d d are intended to be applicable to all organisations regardless of type, size and product provided. dl f d d d d
Presented by Manikandan
2.Normative Reference ISO 9000:2000 ISO 9000:2000 – Quality Quality Management Systems – Fundamentals & Vocabulary Fundamentals & Vocabulary
Presented by Manikandan
3 Terms and Definitions 3.Terms and Definitions The term “Organisation” replaces the term supplier used in ISO 9001:1994 and refers to the unit to which the i international standard applies. i l d d li
Presented by Manikandan
4 Quality management system 4.Quality management system. 4.1General Requirements 4 1General Requirements The organisation shall a) Identify the processes needed for QMS and their application. b) Determine the sequence & interaction of these processes c) Determine criteria & methods needed to ensure the operation & & control of these processes are effective. t l f th ff ti d) Ensure availability of resources & information necessary to support the operation and monitoring processes. e) Monitor, measure & analyse these processes. f) Implement actions necessary to achieve planned results and continual improvement of these processes continual improvement of these processes. 4.2 Documentation Requirements. All four level documents as explained earlier. p Presented by Manikandan
5 Management Responsibility 5.Management Responsibility 5.1Management Commitment Top Management shall provide evidence of its commitment to the development & implementation of the QMS and continually improving its effectiveness by Establishing the Quality policy and Quality Objectives effectiveness by Establishing the Quality policy and Quality Objectives. 5.2Customer Focus Top Management shall ensure that the customer requirements are determined and are met with the aim of enhancing customer satisfaction. 5.3Quality Policy Top Management shall establish communicate review the continuing Top Management shall establish, communicate, review the continuing suitability of the Quality Policy 5.4Planning Top Management shall ensure that Quality objectives including those needed to meet the requirement of the products are established and the same shall be measurable & consistent with the Quality Policy same shall be measurable & consistent with the Quality Policy. Presented by Manikandan
5 Management Responsibility 5.Management Responsibility 5.5 Responsibility, Authority & Communication Top Management shall ensure that responsibilites and authorities are defined Top Management shall ensure that responsibilites and authorities are defined and communicated within the organisation. Top Management shall appoint a member of management who irrespective of other responsibilites shall have responsibility and authority that includes other responsibilites shall have responsibility and authority that includes a) Ensuring that processes needed for QMS are established, implemented & maintained. b) Reporting to top management on the performance of the QMS and any b) Reporting to top management on the performance of the QMS and any need for improvement c) Ensuring the promotion of awareness of customer requirements throughout the organisation the organisation 5.6 Management Review Top Management shall review the organisation’s QMS at planned intervals to ensure its continuing suitability adequacy and effectiveness ensure its continuing suitability, adequacy and effectiveness.
Presented by Manikandan
6.Resource Management g 6.1
Provision of resources The organisation shall determine and provide the resources needed to implement & maintain the QMS and contin all impro e its effecti eness continually improve its effectiveness. 6.2 Human resources P Personnel performing work affecting product quality shall l f i k ff ti d t lit h ll be competent on the basis of appropirate education, training, skill and experience skill and experience 6.3 Infrastructure – Buildings, transport, communication devices ..etc 6.4 Work Environment – work space, ventilation ..etc
Presented by Manikandan
7 Management Responsibility 7.Management Responsibility 7.1
Planning of Product Realisation A document specifying the processes of QMS and the resources to be applied to a specific product referred as quality plan resources to be applied to a specific product referred as quality plan 7.2 Customer– related Process Requirements specified by the customer for delivery and post Requirements specified by the customer for delivery and post delivery activities / requirements not stated by the customer but necessary for specified or intended use 7.3 Design & Development 7.4 Purchasing 7.5 Production & service provision d & 7.6 Control of monitoring and measuring devices Presented by Manikandan
8.Measurement, Analysis & Improvement 81 8.1
Generall G The organisation shall plan & Implement the applicable methods, including statistical techniques li bl h d i l di i i l h i and continually improve the effectiveness of the QMS. QMS 8.2 Monitoring & Measurement 821C 8.2.1 Customer Satisfaction S if i 8.2.2 Internal Audit 8.2.3 Monitoring & measurement of Processes 8.2.4 Monitoring & measurement of Product Presented by Manikandan
8.Measurement, Analysis & Improvement 8.3 Control of nonconforming product (a) by taking action to eliminate the detected nonconformity (b) by authorising its use, release or acceptance under concession by relevant authority and where applicable by the customer. customer 8.4 Analysis of data – with data from customer satisfaction, conformity of product requirement suppliers etc conformity of product requirement, suppliers..etc 8.5 Improvement – The Organisation shall continually improve the effectiveness of the QMS through the use of the improve the effectiveness of the QMS through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive actions Presented by Manikandan
ISO 9000 family a review ISO 9000 family a review ISO 9001 – for QA in design, development, production, installation and servicing (Module H in ISO 9001 : 2000) ISO 9002 – for QA in Production and installation ( (Module D in ISO 9001: 2000) ) ISO 9003 – for QA in final inspection & test (Module E in ISO 9001:2000) E in ISO 9001:2000) ISO 9004 – for Quality Management and system elements guidelines (Converted as QMS in ISO elements guidelines (Converted as QMS in ISO 9001:2000) Presented by Manikandan
Benefits on implementing QMS as per ISO standards • • • • • • • •
“Users” experience clearly indicates the several significant “U ” i l l i di h l i ifi improvements in the following areas : Improved employee involvement (Avg gain 100%) Improved employee involvement (Avg gain 100%) Improved House Keeping (Avg.gain 140%) Improved Decision making based on facts & data (Avg.gain Improved Decision making based on facts & data (Avg.gain 95%) Improved Customer Satisfaction (Gain 55%) Improved safe working area (Gain 45%) Reduced Customer Complaints (about 40%) Reduced inspection efforts (about 45%) Reduced Quality Cost (about 50%) Presented by Manikandan
List of Changes in ISO 9001: 2008 & likely impact on QMS • Refer the text matter attached 3 pages
Presented by Manikandan
ALL THE BEST THANK U THANK U
Presented by Manikandan
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