Iso awarenee training dr. amsavel


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ISO 9001:2008 awarness

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Iso awarenee training dr. amsavel

  1. 1. <ul><li>MALLADI DRUGS & PHARMACEUTICALS LIMITED </li></ul><ul><li>QMS -ISO 9001:2008 </li></ul><ul><li>AWARNESS PROGRAMME </li></ul><ul><li>Dr. A. Amsavel </li></ul>
  2. 2. <ul><li>ISO Introduction </li></ul>
  3. 3. What is Quality <ul><li>Quality: </li></ul><ul><li>Degree to which a set of inherent characteristics fulfils requirements </li></ul><ul><li>System: </li></ul><ul><li>Set of interrelated or interactingelements </li></ul><ul><li>Quality Management: </li></ul><ul><li>Coordinated activities to direct and control an Organization with regard to Quality </li></ul>
  4. 4. Why Quality system is required? <ul><li>Quality has been widely accepted as the most powerful and sustaining factor </li></ul><ul><li>Inspection to assure quality of products and or services </li></ul><ul><li>In earlier days there is no single standard </li></ul><ul><li>Globalization: impacted on the need to develop International Standards for products and services. </li></ul>
  5. 5. What is ISO <ul><li>ISO : International Organization for Standardization: </li></ul><ul><li>ISO 9001 and ISO 14001 are among ISO's most well known standards ever. </li></ul><ul><li>The worldwide total of certificates to ISO 9001:2000 at the end of 2005 was 776 608 in 170 countries </li></ul><ul><li>This was increase of 18 % over 2004 when the total was 660 132 certificates. </li></ul><ul><li>They are implemented by some 887 770 organizations in 161 countries . </li></ul>
  6. 6. ISO An Introduction: <ul><li>ISO was formed in 1947 </li></ul><ul><li>Headquarters at Geneva, Switzerland, </li></ul><ul><ul><li>It is a part of UN </li></ul></ul><ul><li>ISO is a world-wide federation of standards bodies from more than 151 countries. </li></ul><ul><li>It’s mission is to promote the developments of standardization and related activities </li></ul><ul><li>ISO has so far development more than 17000 standards. </li></ul>
  7. 7. ISO An Introduction: <ul><li>Largest developer of Standards </li></ul><ul><li>Makes a positive difference not just to engineers and manufacturers but to society as a whole </li></ul><ul><li>Enables supply of products more efficient, safer and cleaner </li></ul><ul><li>Trade between countries more easier and fairer </li></ul><ul><li>Provide government with technical base for health, safety and environment legislations </li></ul><ul><li>Support transfer of technology to developing nations </li></ul><ul><li>Serve to safeguard consumers and users in general of products and services – make their lives simpler. </li></ul>
  8. 8. ISO 9000 Family standards <ul><li>ISO 9000 series first published in 1987 </li></ul><ul><ul><li>Second Edition -1994 </li></ul></ul><ul><ul><li>Third Edition -2000 </li></ul></ul><ul><ul><li>Fourth Edition 2008 (Published in 15 th Nov 2008) </li></ul></ul><ul><li>Current revision is ISO 9001:2008 will be enforced in 2010. </li></ul>
  9. 9. Other standards <ul><li>ISO 9000: 2005- QMS- Fundamentals and vocabulary </li></ul><ul><li>ISO 9001: 2008 - QMS - Requirements </li></ul><ul><li>ISO 9004: 2008 QMS Guidelines for performance improvements </li></ul><ul><li>ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing </li></ul><ul><li>ISO 10005:2005 : QMS- Guidelines for quality plans </li></ul><ul><li>ISO 10015:1999 : QMS- Guidelines for training </li></ul>
  10. 10. Evolution of 9001 <ul><li>QMS was focused on sorting good from bad & structured documentation in the begining, </li></ul><ul><li>Now it encompass the management of all activities that contribute to the business. </li></ul>Direction Quality management 2000 Prevention Quality Assurance 1994 Detection Quality control 1987 Focus Requirement Standard
  11. 11. Quality management . <ul><li>Quality refers to all those features of a product (or service) which are required by the customer. </li></ul><ul><li>Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements and </li></ul><ul><li>comply with any regulations applicable to those products or services. </li></ul><ul><li>Quality management also means what the organization does to </li></ul><ul><li>enhance customer satisfaction , and </li></ul><ul><li>achieve continual improvement of its performance. </li></ul>
  12. 12. ISO 9000: THIRD PARTY REGISTRATION <ul><li>Once Quality system implemented, certification agency verify the system for effective implementation and certifies. </li></ul><ul><li>Our organization has been certified by LRQA </li></ul><ul><li>OTHER ACCREDITED CERTIFYING AGENCIES: ( in India) </li></ul><ul><ul><li>BVQI SGS </li></ul></ul><ul><ul><li>KPMG BSI-QA </li></ul></ul><ul><ul><li>NQA UL </li></ul></ul><ul><ul><li>DNV Germanize Lloyd’s </li></ul></ul><ul><ul><li>TUV KEMA (Netherlands) </li></ul></ul><ul><ul><li>SA-QAS RINA (Italy) </li></ul></ul><ul><ul><li>IRQS Q-Cert </li></ul></ul>
  13. 13. ADVANTAGES OF ISO 9000 <ul><li>A passport to Global market / Advantage for exporters </li></ul><ul><li>Sets a base line for ultimate TQM </li></ul><ul><li>Reduces time consuming audits by customers and Regulating bodies commitment is assured </li></ul><ul><li>Improves efficiency, reduces scrap and network. Hence, the profitability is higher </li></ul><ul><li>Increased profitability is conducive to job security. </li></ul><ul><li>Improves the communication across the organization (IQA/MRM) </li></ul><ul><li>Gives International recognition of ability </li></ul><ul><li>Improves the Quality costs, removes uncertainty about quality and improves work culture </li></ul>
  14. 14. ISO 9001:2000 Survey . ( 2005 -776 608 )
  15. 15. Definition: <ul><li>Management system: </li></ul><ul><li>System to establish policy and objectives and to achieve those objectives </li></ul><ul><li>QMS: </li></ul><ul><li>Management system to direct and control an organization with regard to quality </li></ul><ul><li>Document: </li></ul><ul><li>Information and its supporting medium </li></ul><ul><li>Eg; specification, SOPs, drawing, report, standard. The medium can be paper, electronic, photograph etc. </li></ul><ul><li>Record : </li></ul><ul><li>Documents stating results achieved or providing evidence of activities performed. </li></ul>
  16. 16. Definition: <ul><li>Quality: </li></ul><ul><li>Degree to which a set of inherent characteristics fulfils requirements </li></ul><ul><li>Requirement: </li></ul><ul><li>Need or expectations that is stated , generally implied or obligatory </li></ul><ul><li>Process: </li></ul><ul><li>Set of interrelated or interacting activities which transforms inputs into outputs </li></ul><ul><li>Product: is a result of a process </li></ul>
  17. 17. Definition: <ul><li>Measurement process: </li></ul><ul><li>Set of operations to determine the value of a quantity </li></ul><ul><li>Continual improvement: </li></ul><ul><li>Recurring activity to increase the ability to fulfill requirements. </li></ul><ul><li>Non Conformity: </li></ul><ul><li> Non fulfillment of a requirement </li></ul><ul><li>Defect: </li></ul><ul><li>Non fulfillment of a requirement related to an intended or specified use </li></ul>
  18. 18. Definition: <ul><li>Correction: </li></ul><ul><li>Action to eliminate a detected non conformity </li></ul><ul><li>Corrective action: </li></ul><ul><li>Action to eliminate the cause of a detected nonconformity or other undesirable situation </li></ul><ul><li>Preventive action: </li></ul><ul><li> Action to eliminate the cause of a potential nonconformity or other undesirable potential situation </li></ul>
  19. 19. <ul><li>Quality management </li></ul>
  20. 20. 8 Principles of the ISO Standard Based on eight quality management principles. Leadership Process approach Involvement of people System approach to Management Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus
  21. 21. Set realistic and challenging goals provides resources and give people the tools, opportunities and encouragements to contribute the continual improvement of the processes. Continual improvement: Continual improvement of the organization’s overall performance should be permanent objective of the organization. 6 Create personnel ownership of the organizations target and goals by using the people’s knowledge and experience and through training achieve involvement in operational decisions and process improvement. Involvement of people: People at all levels are essence of an organization and their full involvement enables and their abilities to be used for the organization’s benefit. 3 Understand current and future customer needs and expectations. Measure customer satisfaction and act it. Customer focus: Organizations depend on the customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations 1 APPLICATION QUALITY MANAGEMENT PRINCIPLE #
  22. 22. Process Approach – Continual Improvements of All Processes PDCA Cycle Processes in terms Of Added Value DO Continual Improvements of Processes Based on Objective Measurements ACTION Measure Results of Process Performance and Effectiveness - Objective Measurements CHECK Understanding & Meeting the Requirements PLAN
  23. 23. ISO 9001:2000 – Process Model CUSTOMER’S CUSTOMER ISO 9001:2000 Quality Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8 . Measurement Analysis and Improvements Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product
  24. 26. Structure of the Standard 4 Quality Management System Requirements Provision of Resources Human Resources Infrastructure Work Environment 6 Resource Management General Requirements Documentation Requirements Planning Customer Related Processes Design & Development Purchasing Production & Service Provision Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority & Communication Management Reviews 5 Management Responsibility 8 Measurement Analysis & Improvements 7 Product Realization General Monitoring & Measurements Control of NCP’s Analysis of Data Improvements
  25. 27. 4.0 Quality Management System <ul><ul><li>4.1 General Requirements </li></ul></ul><ul><ul><li>Establish, document, implement, maintain and continually improve the QMS, </li></ul></ul><ul><ul><li>Documentation requirements to include </li></ul></ul><ul><ul><ul><li>Documented statement of policy and objectives </li></ul></ul></ul><ul><ul><ul><li>Quality manual and records </li></ul></ul></ul><ul><ul><ul><li>Documented procedures and records </li></ul></ul></ul><ul><ul><ul><li>Documented procedures mandated </li></ul></ul></ul><ul><ul><ul><li>Documents required for effective control of processes </li></ul></ul></ul><ul><ul><ul><li>4.2 Quality Manual </li></ul></ul></ul><ul><li>Establish and maintain a quality manual </li></ul>
  26. 28. <ul><li>Outsourced process : </li></ul><ul><li>QMS Organization's responsibility to ensure all the necessary processes are in place to meet all regulatory, mandatory and customer requirements. </li></ul><ul><li>Determine the extent of the external documentation that requires controlling to maintain and operate the management system </li></ul>
  27. 29. 4.0 Quality Management System <ul><ul><ul><li>4.2.3 Control of documents: </li></ul></ul></ul><ul><li>Documents required for the QMS shall be controlled </li></ul><ul><li>Approval, review, update and re-approval </li></ul><ul><li>Identify the current status/version </li></ul><ul><li>Ensure current version available at the point of use </li></ul><ul><li>Ensure legible, identifiable and retrievable </li></ul><ul><li>Distributions are controlled </li></ul><ul><li>Prevent unintended use of obsolete. </li></ul>
  28. 30. Documentation requirements <ul><li>Important pocedures </li></ul><ul><li>Control of Documents </li></ul><ul><li>Control of records </li></ul><ul><li>Control of Nonconforming products </li></ul><ul><li>Internal Audit </li></ul><ul><li>Corrective Action </li></ul><ul><li>Preventive action </li></ul>
  29. 31. 4.0 Quality Management System <ul><ul><ul><li>4.2.4 Control of Records. </li></ul></ul></ul><ul><li>Ensure that records are legible and readily identifiable and retrievable </li></ul><ul><li>Define the controls needed for identification, storage protection, retrieval, retention time and disposition of records. </li></ul><ul><ul><li>Where tractability is required organization shall control and record the unique identification of the product. </li></ul></ul>
  30. 32. 5.0 Management Responsibility <ul><li>Management Commitment: </li></ul><ul><li>Top management shall provide evidence of its commitment to the devolopement and implementation of QMS </li></ul><ul><ul><li>Customer focus </li></ul></ul><ul><li>Top Management to ensure customer requirements are determined and met with the aim of enhancing customer satisfaction </li></ul><ul><li>Quality Policy & Objectives </li></ul><ul><ul><li>Measurable </li></ul></ul><ul><ul><li>Consistent with the quality policy </li></ul></ul><ul><ul><li>Include for functions and levels </li></ul></ul><ul><ul><li>Relate to requirements for the product </li></ul></ul>
  31. 33. 5.0 Management Responsibility <ul><ul><li>5.5 Responsibility Authority and Communication </li></ul></ul><ul><li>Responsibility and authority: </li></ul><ul><ul><ul><li>Responsibilities and authorities are defined and communicated within the organization. </li></ul></ul></ul><ul><li>Management representative: </li></ul><ul><ul><ul><li>Person from Organization to ensure the QMS followed </li></ul></ul></ul><ul><li>Internal communication: </li></ul><ul><ul><ul><li>Shall ensure, communication takes place within the organisation regarding the effectiveness of the QMS </li></ul></ul></ul>
  32. 34. 5.6 Management Review <ul><li>Top management shall review the QMS at planned intervals. </li></ul><ul><li>To ensure its continuing suitability, adequacy and effeteness. </li></ul><ul><li>Asses the opportunities for improvement, change needed in QMS, Quality policy & objectives. </li></ul>
  33. 35. 6.0 Resource Management <ul><ul><li>6.1 Provision of resources: </li></ul></ul><ul><li>Organization shall determine and provide resources needed </li></ul><ul><ul><li> Implement and maintain the QMS and continually improve its effectiveness </li></ul></ul><ul><ul><li> Enhance customer satisfaction by meeting customer requirements </li></ul></ul><ul><li>6.2 Human resources: </li></ul><ul><li>Personnel performing work affecting product quality to be competent on the basis of appropriate: </li></ul><ul><ul><li>Education, Training, Skills and Experience </li></ul></ul><ul><ul><li>6.2.1 Competence, awareness and training </li></ul></ul><ul><ul><li>Determine and provide the training </li></ul></ul><ul><ul><li>Evaluate the effectiveness of the action taken </li></ul></ul><ul><ul><li>Maintain the relevant records. </li></ul></ul>
  34. 36. 6.0 Resource Management <ul><ul><li>6.3 Infrastructure: </li></ul></ul><ul><ul><li>Determine, provide and maintain infrastructure needed </li></ul></ul><ul><ul><li>Building, workspaces and associated utilities </li></ul></ul><ul><ul><li>Processes equipment both hardware and software </li></ul></ul><ul><ul><li>Supporting services such as transport or communication </li></ul></ul><ul><ul><li>6.4 Work Environment: </li></ul></ul><ul><ul><li>Determine and manage the work environment needed: </li></ul></ul><ul><ul><li>Creative work method and opportunities for greater involvement </li></ul></ul><ul><ul><li>Safety rules and guidance, PPEs </li></ul></ul><ul><ul><li>Ergonomics, Workplace location, Social interaction, Facilities for people </li></ul></ul><ul><ul><li>Heat, humidity, light, sound, airflow </li></ul></ul><ul><ul><li>Hygiene, cleanliness, noise, vibration and pollution </li></ul></ul>
  35. 37. 7.0 Product Realization <ul><li>Planning of Product realization: </li></ul><ul><ul><li>Determine: Quality objectives and requirement for the product </li></ul></ul><ul><ul><li>Processes, documents and resources needed </li></ul></ul><ul><ul><li>Verification, validation, monitoring, inspection and test activities and acceptance criteria </li></ul></ul><ul><ul><li>Records needed for process & product </li></ul></ul>
  36. 38. 7.2 Customer related processes. <ul><li>Determination of requirements related to the product </li></ul><ul><ul><li>Determine the customer requirements stated and implied needs </li></ul></ul><ul><ul><li>Statutory and regulatory requirements </li></ul></ul><ul><ul><li>Review of requirements related to the product </li></ul></ul><ul><ul><li>Product requirements, resolve any differences </li></ul></ul><ul><ul><li>Customer communication: </li></ul></ul><ul><ul><li>Product information, enquiry, contracts or order handling, amendments </li></ul></ul><ul><ul><li>Customer feedback, including complaints : </li></ul></ul>
  37. 39. 7.3 Design and development: <ul><li>7.3.1 Design and development planning </li></ul><ul><li>7.3.2 Design and development inputs </li></ul><ul><li>7.3.3 Design and development outputs </li></ul><ul><li>7.3.4 Design and development review </li></ul><ul><li>7.3.5 Design and development verification </li></ul><ul><li>7.3.6 Design and development validation </li></ul><ul><li>7.3.7 Control of design and development changes </li></ul>
  38. 40. 7.4 Purchasing: <ul><ul><ul><li>Purchasing process </li></ul></ul></ul><ul><ul><li>Criteria for selection, evaluation and re-evaluation to be established, including service provider, sub-contracting activities. </li></ul></ul><ul><ul><ul><li>Purchasing information </li></ul></ul></ul><ul><ul><ul><li>Specification </li></ul></ul></ul><ul><ul><ul><li>Verification of purchased product </li></ul></ul></ul><ul><ul><ul><li>Testing </li></ul></ul></ul>
  39. 41. 7.5. Production and service provision: <ul><li>Control of production and service provision </li></ul><ul><ul><li>GMP: MI, BPR, SOPs, Specification, Equipments & Instruments, Cleaning, Testing etc </li></ul></ul><ul><li>Validation of processes for production and service provision </li></ul><ul><ul><li>Process, Equipments, personal, test methods, etc </li></ul></ul><ul><li>Identification and traceability </li></ul><ul><li>Customer property </li></ul><ul><li>Preservation of product: </li></ul><ul><li>Identification, handling, packaging, storing etc . </li></ul><ul><li>Damage or lose of customer property shall be reported. </li></ul>
  40. 42. 7.6 Control of monitoring and measuring devices <ul><li>Calibration of monitoring and measuring devices to ensure the conformity of product. </li></ul><ul><li>Standards used should traceable to national & international measurement standard </li></ul><ul><li>Status, records. </li></ul>
  41. 43. 8.0 Measurement Analysis, and Improvement <ul><li>General: </li></ul><ul><ul><li>Monitoring, measuring, analysis and improvement processes to be planned and implemented to: </li></ul></ul><ul><ul><ul><li> Demonstrate conformity of product </li></ul></ul></ul><ul><ul><ul><li> Ensure conformity to the QMS </li></ul></ul></ul><ul><ul><ul><li> Continually improve effectiveness of the QMS </li></ul></ul></ul><ul><ul><li>Monitoring and Measurement: </li></ul></ul><ul><ul><li>Customer satisfaction </li></ul></ul><ul><ul><li>Monitor information relating to the customer’s perception of how well requirements were fulfilled. </li></ul></ul><ul><ul><li>Method of obtaining and using this information to be determined </li></ul></ul>
  42. 44. 8.0 Measurement Analysis, and Improvement <ul><ul><ul><li>Internal Audit </li></ul></ul></ul><ul><li>Periodic audits to be performed at planned intervals to determine whether the QMS </li></ul><ul><ul><li>Conforms to ISO-9001 and planned arrangements </li></ul></ul><ul><ul><li>Is effectively implemented and maintained </li></ul></ul><ul><li>Audits to be objective and impartial-auditors shall not audit their own work </li></ul>
  43. 45. Internal Audits <ul><li>Internal Audits </li></ul><ul><ul><li>Effectiveness & Efficiency of Processes </li></ul></ul><ul><ul><li>Opportunities for Improvements </li></ul></ul><ul><ul><li>Use of Data / Information </li></ul></ul><ul><ul><li>Effective & Efficient Use of Resources </li></ul></ul><ul><ul><li>Adequacy, Accuracy and Performance of Measurements </li></ul></ul>
  44. 46. 8.0 Measurement Analysis, and Improvement <ul><ul><ul><li>8.2.3 Monitoring and Measurement of processes: </li></ul></ul></ul><ul><ul><li>Suitable methods to be used to monitor and measure the quality management system processes to ensure conformity of product </li></ul></ul><ul><ul><li>8.2.4 Monitoring and Measurement of product </li></ul></ul><ul><ul><li>Product characteristics to be monitored and measured to verify conformity </li></ul></ul><ul><ul><li>Evidence and acceptance criteria to be documented </li></ul></ul><ul><ul><li>Authority for product release to be documented </li></ul></ul>
  45. 47. Criteria for Measurements System Performance <ul><li>Internal Audits </li></ul><ul><ul><li>Effectiveness & Efficiency of Processes </li></ul></ul><ul><ul><li>Opportunities for Improvements </li></ul></ul><ul><ul><li>Use of Data / Information </li></ul></ul><ul><ul><li>Effective & Efficient Use of Resources </li></ul></ul><ul><ul><li>Adequacy, Accuracy and Performance of Measurements </li></ul></ul><ul><ul><li>Relationships with customers/ suppliers/ other interested parties </li></ul></ul><ul><li>Financial Measurements </li></ul><ul><ul><li>Prevention cost </li></ul></ul><ul><ul><li>Non conforming / failure cost </li></ul></ul><ul><ul><li>Lifecycle cost </li></ul></ul>Self Assessment <ul><li>Satisfaction Surveys for customers and other interested parties </li></ul><ul><ul><li>Feedback on products </li></ul></ul><ul><ul><li>Customer & market requirements </li></ul></ul>
  46. 48. Criteria for Measurements Products Processes <ul><ul><li>Inspection and testing of incoming, in process and final products </li></ul></ul><ul><ul><li>Product verification </li></ul></ul><ul><ul><li>Product validation </li></ul></ul><ul><ul><li>Process Capability / Process validation </li></ul></ul><ul><ul><li>Reaction time </li></ul></ul><ul><ul><li>Cycle time / throughput (Capacity) </li></ul></ul><ul><ul><li>Utilization of new technology </li></ul></ul><ul><ul><li>Waste reduction </li></ul></ul><ul><ul><li>Cost reduction </li></ul></ul>
  47. 49. 8.3 Control of non-conforming product <ul><li>A documented procedure shall define the control and recording of non-conforming product including </li></ul><ul><li> Take action to eliminate the detected non- conformity </li></ul><ul><li> Action to preclude original intended use and to eliminate the non-conformity </li></ul><ul><li> Authorize use by concession by relevant authority </li></ul><ul><li> Corrected non-conforming product to be re-verified </li></ul>
  48. 50. 8.4 Analysis of data <ul><li>Collect and analyze data to determine suitability and effectiveness of the QMS and identify improvements from sources including : </li></ul><ul><ul><ul><li> Customer satisfaction </li></ul></ul></ul><ul><ul><ul><li> Conformance to product requirements </li></ul></ul></ul><ul><ul><ul><li> Characteristics of processes, products and their trends </li></ul></ul></ul><ul><ul><ul><li> Suppliers </li></ul></ul></ul>
  49. 51. 8.5 Improvement <ul><ul><ul><li>8.5.1 Continual Improvement: </li></ul></ul></ul><ul><ul><li>The organisation to continually improve the effectiveness of the QMS through the use of the Quality Policy, Quality objectives, audit results, analysis of data, corrective and preventive action and management review </li></ul></ul>
  50. 52. 8.5.2 Corrective action <ul><ul><ul><li>Eliminate the cause of non-conformity and prevent recurrence </li></ul></ul></ul><ul><li>A documented procedure to define requirements for: </li></ul><ul><li> Reviewing non-conformities and customer complaints </li></ul><ul><li> Determining causes of non-conformity </li></ul><ul><li> Evaluating need for and determining and implementing actions </li></ul><ul><li> Recording results action taken </li></ul><ul><li> Reviewing actions taken </li></ul>
  51. 53. 8.5.3 Preventive action <ul><ul><ul><li>Eliminate the cause of potential non-conformity to prevent occurrence </li></ul></ul></ul><ul><li>A documented procedure to define requirements for : </li></ul><ul><li> Determining potential non-conformities and their causes </li></ul><ul><li> Evaluating need for action to prevent occurrence </li></ul><ul><li> Determining and implementing action needed </li></ul><ul><li> Recording results of action taken </li></ul><ul><li> Reviewing actions taken </li></ul>
  52. 54. cGMP Vs ISO standards <ul><li>  ISO-9000 cGMP </li></ul><ul><li>  </li></ul><ul><li>1 Business Covered All Pharmaceutical </li></ul><ul><li>2 Focus Quality Mgmt Safety and efficacy </li></ul><ul><li>3. Legal basis No Yes  </li></ul><ul><li>4. Business processes Yes No </li></ul><ul><li>5. Product quality Not specified Specified </li></ul><ul><li>6. Continual Improvement Yes No </li></ul><ul><li>7. Customer Focus Satisfaction Protection </li></ul>
  53. 55. More information <ul><li>ISO 9000/ISO 14000 section on ISO Web site : </li></ul><ul><li> </li></ul><ul><li>ISO Management Systems magazine </li></ul><ul><li> </li></ul><ul><li>IMS Alerts free electronic newsletter </li></ul><ul><li> </li></ul>