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Iso 9001 2008 awareness training-slides

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Iso 9001 2008 awareness training-slides

  1. 1. ISO 9001:2008 Awareness Training WelcomeWelcome ISO 9001:2008 Awareness Trainingg Issue: TUVME/QM 002/02 Date: 24.02.09 1TUV Middle East ISO 9001:2008 Awareness Training
  2. 2. ISO 9001:2008 Awareness Training Course Course Duration: 8 Hours IQBAL ALI Course Structure: Tutorials, Discussions, … etc. Issue: TUVME/QM 002/02 Date: 24.02.09 2TUV Middle East ISO 9001:2008 Awareness Training
  3. 3. ISO 9001:2008 Awareness Training Course Introd ction Delegates will be: • Able to understand concepts & historic evolution of quality; Course Introduction • Able to understand concepts & historic evolution of quality; • Able to understand Quality Management System (brief overview); • Able to understand requirements of ISO 9001:2008 QMS standard inAble to understand requirements of ISO 9001:2008 QMS standard in detail; Issue: TUVME/QM 002/02 Date: 24.02.09 3TUV Middle East ISO 9001:2008 Awareness Training
  4. 4. ISO 9001:2008 Awareness Training Concepts of Quality and Historic Evolution?Concepts of Quality and Historic Evolution? Definitions for Quality? Fitness for the Purpose Conformance to Requirements C S i f i /D li hCustomer Satisfaction /Delight ISO Definition: “Degree to which a set of characteristics fulfils requirements” Issue: TUVME/QM 002/02 Date: 24.02.09 4TUV Middle East ISO 9001:2008 Awareness Training
  5. 5. ISO 9001:2008 Awareness Training Concepts of Quality and Historic Evolution?Concepts of Quality and Historic Evolution? Which Car is of better Quality? Toyota - Camry or Toyota - Echo Category Grade Quality Issue: TUVME/QM 002/02 Date: 24.02.09 5TUV Middle East ISO 9001:2008 Awareness Training
  6. 6. ISO 9001:2008 Awareness Training Concepts of Quality and Historic Evolution?Concepts of Quality and Historic Evolution? Category is given to entities having same functional use but different requirements forfunctional use but different requirements for Quality. Grade is inherent in the product and may bep y altered by change in Specification. “ Whereas Quality is dependent upon how well the product satisfies the needs ” Issue: TUVME/QM 002/02 Date: 24.02.09 6TUV Middle East ISO 9001:2008 Awareness Training
  7. 7. ISO 9001:2008 Awareness Training Quality Management SystemQuality Management System Quality Assurance: “ All the Planned and Systematic activities implemented within the“ All the Planned and Systematic activities implemented within the Quality Management System and Demonstrated as needed to provide adequate confidence for an entity to fulfill requirements for Quality ” Two aspects of Quality Assurance are: 1. External - Quality Assurance provides Confidence to Customers. 2. Internal - Quality Assurance provides Confidence to The Management to understand the customer’s needs at all times and that they have established the capability to meet this requirements at lowest possible Issue: TUVME/QM 002/02 Date: 24.02.09 7 cost & time, thus making profit. TUV Middle East ISO 9001:2008 Awareness Training
  8. 8. ISO 9001:2008 Awareness Training Quality Management SystemQuality Management System Quality Control: “ Operational Techniques and Activities that are used to fulfill requirements for Quality ” Quality Control is Reactive in nature. Quality Assurance is Pro-active in nature. Quality Management System uses both Quality Control & Quality Assurance. Issue: TUVME/QM 002/02 Date: 24.02.09 8TUV Middle East ISO 9001:2008 Awareness Training
  9. 9. ISO 9001:2008 Awareness Training Quality Management SystemQuality Management System Quality Management System: “All activities of overall Management function that determine Quality Policy, Objectives & Responsibility, & Implement them by meansResponsibility, & Implement them by means of Quality Planning, Quality Control, Quality Assurance & Quality Improvement”. Issue: TUVME/QM 002/02 Date: 24.02.09 9TUV Middle East ISO 9001:2008 Awareness Training
  10. 10. ISO 9001:2008 Awareness Training Quality Management System Some of the elements of QMS are : A sustained Management commitment to Quality; Quality Management System A sustained Management commitment to Quality; Preventing defects rather than detecting them; A Continual Improvement approach; Focusing on customer requirements &Focusing on customer requirements & expectations; Quality is everyone’s responsibility; T k d Q litTeam work produces Quality; Root cause Corrective /Preventive action; Issue: TUVME/QM 002/02 Date: 24.02.09 10TUV Middle East ISO 9001:2008 Awareness Training
  11. 11. ISO 9001:2008 Awareness Training Quality Management SystemQuality Management System The effect of QMS in any organization is directly proportional to the profit Why QMS is prominent in any organization? and customer satisfaction. A good QMS will reduce deficiencies, which will bring down the cost (which will increase the profit) and increase customer satisfaction.(which will increase the profit) and increase customer satisfaction. Other reasons are: Competition; Ch iChanging customer; Availability of options; Product complexity; Higher Level of customer expectations; Issue: TUVME/QM 002/02 Date: 24.02.09 11 Higher Level of customer expectations; TUV Middle East ISO 9001:2008 Awareness Training
  12. 12. ISO 9001:2008 Awareness Training ISOISO ISO (International Organization for Standardization) is a worldwide federation of national standards bodies from approximately 140federation of national standards bodies from approximately 140 countries (1 from each); ISO is a non-governmental organization established in 1947; Objective – is to promote the development of standardization in the world with a view to facilitate the international exchange of goods and services and to develop cooperation in the spheres of intellectualservices, and to develop cooperation in the spheres of intellectual, scientific, technological and economic activity; ISO’s name – came from the Greek word “ isos ” means “equal ”. Issue: TUVME/QM 002/02 Date: 24.02.09 12TUV Middle East ISO 9001:2008 Awareness Training
  13. 13. ISO 9001:2008 Awareness Training SOISO Origin International Electro-technical Commission (1906) International Federation of the National Standardizing Associations (1926International Federation of the National Standardizing Associations (1926 - 1942) -> Mech. Field I i l O i i f S d di i (1947)International Organization for Standardization (1947) Issue: TUVME/QM 002/02 Date: 24.02.09 13TUV Middle East ISO 9001:2008 Awareness Training
  14. 14. ISO 9001:2008 Awareness Training ISOISO Standard Purpose Remarks E t bli h th t ti p i t t ISO 9000:2008 Establishes the starting point to understand the standards and defines the fundamental terms and definitions used in the ISO 9000 family Only for reference ISO 9001:2008 This is the requirement standard used to assess the ability to meet customer and applicable regulatory requirements and there by address customer satisfaction Against which is the third party certification there by address customer satisfaction ISO 9004:2008 This provides guidelines for continual improvement of QMS to all benefit all parties through sustained customer Only for reference Issue: TUVME/QM 002/02 Date: 24.02.09 14 satisfaction TUV Middle East ISO 9001:2008 Awareness Training
  15. 15. ISO 9001:2008 Awareness Training ISO ISO 9000 is the most successful standard in ISO history and is accepted world wide. Nearly 400,000 registrations world-wide with registrants in over 150 countries from all continents Being applied in a wide variety of organizations Over 40 “sectors” or industry classifications l d b l t i l/ ti l i t t l d t t tiled by: electrical/optical equipment, metal products, construction, machinery, wholesale/retail trade but growing in acceptance by many others, including: engineering, information technology, health/social work, utilities, transportation, public Issue: TUVME/QM 002/02 Date: 24.02.09 15 information technology, health/social work, utilities, transportation, public administration, education, other services. TUV Middle East ISO 9001:2008 Awareness Training
  16. 16. ISO 9001:2008 Awareness Training ISOISO B i Vi iBusiness Vision Performance Excellence Malcolm Baldrige Criteria CompetitiveMalcolm Baldrige Criteria Performance Improvement ISO 9004:2008 Competitive Advantage Efficient Quality Management SystemISO 9004:2008 Baseline Performance: ISO 9001:2008 Quality Management System Effective Quality Management System Issue: TUVME/QM 002/02 Date: 24.02.09 16TUV Middle East ISO 9001:2008 Awareness Training
  17. 17. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles ISO 9000:2008 is developed based on 8 Quality Management Principles 1. Customer Focus 2. Leadership 3. Involvement of People 4. Process Approach 5. System Approach 6. Continual Improvement 7. Factual Approach to Decision Making 8 Mutually Beneficial Supplier Relationships Issue: TUVME/QM 002/02 Date: 24.02.09 17 8. Mutually Beneficial Supplier Relationships TUV Middle East ISO 9001:2008 Awareness Training
  18. 18. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Customer Focus Organizations depend on their Customers and therefore should: Understand current and future customer Needs; Meet customer Requirements andq Strive to exceed customer Expectations. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 18
  19. 19. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Leadership Leaders should: Establish unity of purpose and Direction of the organization & Create and maintain the internal environment in which people can become fully Involved in achieving the organization’s objectives. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 19
  20. 20. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Involvement of People People at all levels are the essence of an organization and Their full involvement enables their abilities to be used for the organization’s benefit.g Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 20
  21. 21. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Process Approach Organizations need to do more than simply monitor process outputs. (typically through inspection activities): They must also control all process inputs, (people, facilities, equipment, material & methods) & Th bli h i l h f iThey must establish appropriate controls over the transformation activities (if desired results are to be achieved consistently and efficiently). Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 21
  22. 22. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles What is a Process? Activity that transforms Input into Outputy p p Input Activity Outputp Activity p Resources: Results: People Facilities/Equipment Material M h d Products Services Performance Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 22 Methods
  23. 23. ISO 9001:2008 Awareness Training 8 QM Principles Monitor & Measure the Process make sure the inputs are right, the transformation ti iti i t tl k d th d i d lt 8 QM Principles activities consistently work, and the desired results are achieved, then - improve the process as needed ActivityInput Output Right Resources: Desired Results: Qualified People Right Facilities/Equipment Correct Materials Desired Results: Quality Products Quality Services Customer Satisfaction Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 23 Proven Methods Customer Satisfaction
  24. 24. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles How is a Process Measured? Efficient N W Effective D i d R l A hi dNo Waste Desired Results Achieved Input Activity Output Right Resources: Desired Results: Qualified People Right Facilities/Equipment Correct Materials Proven Methods Quality Products Quality Services Customer Satisfaction Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 24
  25. 25. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles System Approach Organizations must understand a system is a set of interrelated processes, and the output of one process is the input to one or more subsequent processes, so ... it is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 25
  26. 26. ISO 9001:2008 Awareness Training 8 QM Principles System: Controls Controls 8 QM Principles Input Process A Output - A Process B Output - B Input B Output - A Process Controls Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 26 Process C Output - C
  27. 27. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective;objective; Improvement must be a planned activity if th iz ti d i t i llthe organization desires to improve overall performance and capabilities. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 27
  28. 28. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Improve Process through PDCA Cycle The QMS must be used for continual Plan Do improvement ... Results / Act Check Measure/Monitor Results Against Objectives - Improve Process and Change QMS as N d d t A hi nd S t in Improvement Objective QMS Baseline Performance Needed to Achieve and Sustain Desired Results Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 28
  29. 29. ISO 9001:2008 Awareness Training 8 QM Principles Factual Approach To Decision Making 8 QM Principles Effective decisions are: Based on the analysis of data and information. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 29
  30. 30. ISO 9001:2008 Awareness Training 8 QM Principles8 QM Principles Mutually Beneficial Supplier Relationship An organization and its suppliers are truly inter-dependent and A mutually beneficial relationship enhances the ability of both to create value. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 30
  31. 31. ISO 9001:2008 Awareness Training 6 Resource5 Management 8 Measurement4 Quality 7 Product6 Resource Management M t 5 Management Responsibility 8 Measurement Analysis & improvement 4 Quality Management System 7 Product Realization Provision of resources Human resources General requirements Documentation Requirements Planning Customer related processes Management Commitment Customer focus General Monitoring & measurement Infrastructures Work environment Design & development Purchasing Quality policy Planning Control of NCR Analysis of data Production & service provision Responsibility, authority & communication Management Improvements Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 31 Management Reviews
  32. 32. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 0 Introduction 0.1 General Strategic Decision; Standard can be used by internal & external parties;Standard can be used by internal & external parties; QM principles in ISO 9000 & ISO 9004 are taken in to consideration; 0.2 Process approachpp Promotes the adoption of process approach; Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 32
  33. 33. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 0.3 Relationship with ISO 9004 ISO 9001 & ISO 9004 – a consistent pair – complement each other; Same structure; 0 4 C ibili i h h0.4 Compatibility with other management systems Aligned with ISO 14001:1996 specially to enhance the compatibility for the user;; Integration of other management systems (EMS, OHSM, FM … etc) is possible; Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 33
  34. 34. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 34
  35. 35. ISO 9001:2008 Awareness Training ISO 9001 Standard 1 Scope Specifies requirements for QMS if an organization wants to: ISO 9001 Standard Specifies requirements for QMS, if an organization wants to: demonstrate its ability and enhance customer satisfaction. All requirements are generic and are applicable for all types of i tiorganizations. If not applicable, requirement (s) can be excluded – but is limited to the requirements within clause 7. 2 N rm ti R f r nc2 Normative References 3 Terms and definitions Supplier – Organization – Customer “ Product “ means “ service “ also. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 35 product intended for, or required by, a customer, any intended output resulting from the product realization processes.
  36. 36. ISO 9001:2008 Awareness Training ISO 9001 Standard 4 Quality management system 4 1 General requirements ISO 9001 Standard 4.1 General requirements The organization shall Determine the processes needed for the quality management system and their application throughout the organization,application throughout the organization, determine the sequence and interaction of these processes, determine criteria and methods needed to ensure that both the operation and control of these processes are effective,control of these processes are effective, ensure the availability of resources and information necessary to support the operation and monitoring of these processes and monitor, measure where applicable and analyze these processes, and Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 36 , pp y p , implement actions necessary to achieve planned results and continual improvement.
  37. 37. ISO 9001:2008 Awareness Training ISO 9001 Standard These processes shall be managed by the organization in accordance with the requirements of this International Standard; ISO 9001 Standard Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within thep ocesses. Co t o o suc outsou ced p ocesses s a be de t ed w t t e quality management system. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 37
  38. 38. ISO 9001:2008 Awareness Training ISO 9001 Standard 4.1 General requirements NOTE 3 E i l d d b l h ISO 9001 Standard NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as ) h i l i f h d h i i 'a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements, b) the degree to which the control for the process is shared,) g p , c) the capability of achieving the necessary control through the application of 7.4. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 38
  39. 39. ISO 9001:2008 Awareness Training ISO 9001 Standard 4.2 Documentation requirements ISO 9001 Standard 4.2.1 General a) quality policy and quality objective; b) quality manual; c) documented procedures required;c) documented procedures required; d) other documents needed; and e) records. 4 2 2 Q li l4.2.2 Quality manual a) the scope & and justification for any exclusions; b) procedures, or reference to them; and c) interaction between the processes. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 39 c) interaction between the processes.
  40. 40. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 4.2.3 Control of documents A documented procedure required:A documented procedure required: • approve; • review and update; h d h i i• changes and the current revision status are identified; • relevant versions are available at points of use; • documents remain legible and readily id tifi blidentifiable; • documents of external origin are identified and their distribution controlled; and • to prevent the unintended use of obsolete d t Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 40 documents.
  41. 41. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 4.2.4 Control of records R d h ll b t bli h d d i t i d tRecords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system; Records shall remain legible, readily identifiable and retrievable; A doc mented proced re shall be establishedA documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 41
  42. 42. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5 Management responsibility 5.1 Management commitment a) communicate the importance of meeting customer as well as statutory and regulatorycustomer as well as statutory and regulatory requirements; b) establish the quality policy; c) ensure that quality objectives are established; d) d i dd) conduct management reviews; and e) ensure the availability of resources. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 42
  43. 43. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 43
  44. 44. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.3 Quality policy a) appropriate; b) commitment to comply and continually improve; c) provides a framework for establishing and reviewing quality objectives; d) communicated and understood; and) ; e) reviewed. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 44
  45. 45. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.4 Planning 5 4 1 Quality objectives5.4.1 Quality objectives a) establish quality objectives at relevant function & levels; and b) these shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planningQ y g y p g a) planning of the QMS is carried out in order to meet the requirements as well as the quality objectives; and b) integrity of the QMS is maintained Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 45 b) integrity of the QMS is maintained.
  46. 46. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.5 Responsibility, authority & communication 5 5 1 Responsibilit and a thorit5.5.1 Responsibility and authority a) define; and b) communicate.) 5.5.2 Management representative Top management shall appoint a member of the organization's management who irrespective of other responsibilities shall havemanagement who, irrespective of other responsibilities, shall have responsibility and authority that includes; a) ensure QMS is established, implemented & maintained; b) report to top management on the performance & need for improvement; and Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 46 improvement; and c) promote awareness of customer requirement.
  47. 47. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.5.3 Internal communication a) top management shall ensure that appropriate communication processes are established; and b) that communication takes place regarding the effectiveness of the QMS. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 47
  48. 48. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.6 Management reviewg 5.6.1 General 1 T t h ll i QMS t l d i t l t it1. Top management shall review QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. 2. Maintain records. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 48
  49. 49. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.6.2 Review input a) customer feedback; b) process performance and product conformity; c) status of preventive and corrective actions; d) f ll i f i id) follow-up actions from previous management reviews; e) change that could affect the quality management system; f) recommendation for improvements; and g) results of audit.g) Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 49
  50. 50. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 5.6.3 Review output The output from the management review shall include any decisions and actions related to: a)impro ement of the effecti eness of the QMS and its processes;a)improvement of the effectiveness of the QMS and its processes; b)improvement of product related to customer requirements; and c)resource needs. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 50
  51. 51. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 6 Resource management 6.1 Provision of resources a) to implement and maintain the QMS and continually improve its effectiveness; and b) to enhance customer satisfactionb) to enhance customer satisfaction. 6.2 Human resources 6.2.1 General Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 51 p
  52. 52. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 6.2.2 Competence, training and awareness 1. determine the competence; 2. Where applicable, provide training or take other actions to satisfy these needs; 3. evaluate the effectiveness of the actions3. evaluate the effectiveness of the actions taken; 4. ensure that its personnel are aware of the relevance & importance of their activities & how they contribute to the achievement ofy the quality objectives; and 5. maintain appropriate records of education, training, skills and experience. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 52
  53. 53. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 6.3 Infrastructure a) buildings, workspace and associated utilities; b) process equipment (both hardware and software); and ) i i ( hc) supporting services (such as transport or communication or information system). 6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 53
  54. 54. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7 Product realization 7.1 Planning of product realization a) quality objectives and requirements; b) the need to establish processes and documents, and provide resources; c) required verification, validation, monitoring, measurement, inspection) q , , g, , p & test activities & the criteria for acceptance; and d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 54 g p q ( )
  55. 55. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product a) requirements specified by the customer; b) requirements not stated by the customer but necessary for specified or intended use, where known; c) statutory and regulatory requirements applicable to the product ; and d) any additional requirements considered necessary by the organization. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 55
  56. 56. ISO 9001:2008 Awareness Training ISO 9001 Standard 7.2.2 Review of requirements related to the product a) product requirements are defined; ISO 9001 Standard a) product requirements are defined; b) contract or order requirements differing from those previously expressed are resolved; and c) the organization has the ability to meet the defined requirements. maintain records of review. if no documented statement of requirements, then confirm before acceptance. if product requirements are changed, ensure that relevant documents are amended and that relevant personnel are made aware. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 56 p
  57. 57. ISO 9001:2008 Awareness Training ISO 9001 Standard 7.2.3 Customer communication ISO 9001 Standard The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information; b) enquiries, contracts or order handling, including d t damendments; and c) customer feedback, including customer complaints. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 57
  58. 58. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.3 Design and development 7.3.1 Design and development planning The organization shall plan and control the design and development of product. a) the design and development stages; b) the review verification & validation that are appropriate to each design &b) the review, verification & validation that are appropriate to each design & development stage; and c) responsibilities & authorities for design & develop. Manage the interfaces between different groups involved in design & developmentManage the interfaces between different groups involved in design & development to ensure effective communication & clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 58 progresses.
  59. 59. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.3.2 Design and development inputs Inputs relating to product requirements: a) functional and performance requirement; b) applicable statutory and regulatory requirements;b) applicable statutory and regulatory requirements; c) where applicable, information derived from previous similar designs; and d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 59
  60. 60. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.3.3 Design and development outputs Th f d i d d l h ll b i f i bl fThe output of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. D i d d l h llDesign and development outputs shall: a) meet the input requirements for design and development; b) provide appropriate information for purchasing, production and for) p pp p p g, p service provision; c) contain or reference product acceptance criteria; and d) specify the characteristics of the product that are essential for its safe and proper use. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 60 p p
  61. 61. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.3.4 Design and development review a) to evaluate the ability of the results of design and development to meeta) to evaluate the ability of the results of design and development to meet requirements; and b) to identify any problems and propose necessary actions. P i i h ll i l d i f f i d R dParticipants shall include representatives of functions concerned. Records shall be maintained. 7.3.5 Design and development verification7.3.5 Design and development verification a) planned arrangements; b) have met the design and development input; and ) d h ll b i i d Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 61 c) records shall be maintained.
  62. 62. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.3.6 Design and development validation ) l da) planned arrangements; b) product is capable of meeting the requirements for the specified application / intended use; c) validate prior to the delivery / implementation; and d) records shall be maintained. 7.3.7 Control of design and development changes a) identified and records maintained; and b) reviewed, verified and validated, as appropriate, and approved before implementation. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 62
  63. 63. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.4 Purchasing 7 4 1 Purchasing process7.4.1 Purchasing process • ensure purchased product conforms to specified requirements; and • apply control on the supplier and purchased product dependents on h ff f h h d d d li i h fi l pp y pp p p p the effect of the purchased product on product realization or the final product • evaluate and select suppliers based on their ability;pp y • criteria for selection, evaluation and re-evaluation shall be established; and • maintain records. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 63
  64. 64. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.4.2 Purchasing information a) requirements for approval of product. procedures, processes and equipment; b) requirements for qualification of personnel; and c) quality management system requirements.c) quality management system requirements. 7.4.3 Verification of purchased product ) bli h d i l h i i h i i i fa) establish and implement the inspection or other activities necessary for ensuring; and b) verification at the supplier premises. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 64
  65. 65. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.5 Production & service provision 7.5.1 Control of production and service provision Plan and carry out production and service provision under controlled conditionsconditions. a) information that describes the characteristics; b) the availability of work instructions, as necessary; c) the use of suitable equipment; d) the availability and use of monitoring and measuring equipment; e) the implementation of monitoring & measurement; and f) the implementation of product release, delivery and post-delivery Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 65 f) the implementation of product release, delivery and post delivery activities.
  66. 66. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.5.2 Validation of processes for production and service provision Validation shall demonstrate the ability of these processes to achieveValidation shall demonstrate the ability of these processes to achieve planned results. a) defined criteria for review and approval; b) approval of equipment and personnel; c) use of specific methods and procedures; d) requirements for records; and e) revalidation. 7.5.3 Identification and traceability. Where appropriate shall identify & trace the product by suitable means Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 66 Where appropriate, shall identify & trace the product by suitable means throughout product realization .
  67. 67. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.5.4 Customer property Exercise care with customer property while it is under the organization’s control or being used by the organization. identify; ifverify; protect; and safeguard If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer. maintain records. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 67 maintain records.
  68. 68. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.5.5 Preservation of product identification; handling; packaging; delivery;y; storage; and protection Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 68 protection.
  69. 69. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 7.6 Control of monitoring and measuring equipment d i h i i d b d kdetermine the monitoring and measurement to be undertaken; determine monitoring and measuring equipment needed; and establish processes to ensure that monitoring and measurement are consistent with requirements. a) be calibrated or verified or both at specified intervals, or prior to use; b) be identified to enable the calibration status to be determined: c) be safeguarded from adjustments that would invalidate thec) be safeguarded from adjustments that would invalidate the measurement result; and d) be protected from damage and deterioration during handling, maintenance and storage. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 69
  70. 70. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8 Measurement, analysis and improvement 8.1 General 1 to demonstrate conformity of product requirements;1. to demonstrate conformity of product requirements; 2. to ensure conformity of the QMS; and 3. to continually improve the effectiveness of the quality management system. • determine applicable methods. 8.2 Monitoring and measurement8.2 Monitoring and measurement 8.2.1 Customer satisfaction Monitor information relating to customer perception as to whether the Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 70 organization has met customer requirements.
  71. 71. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.2.2 Internal audit To determine whether the QMS: a) conforms to the requirements of this standard and to the QMS requirements established; and b) is effectively implemented and maintainedb) is effectively implemented and maintained. An audit program shall be: planned - consider the status and importance; criteria, scope, frequency & methods shall be defined; and auditors and conduct of audits shall ensure objective and impartiality of the audit process. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 71
  72. 72. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard Define in a procedure: • Responsibilities;• Responsibilities; • requirements for planning; • requirements for conducting; • requirements for reporting; and • maintain records. Ensure that actions are taken without undue delay . Follow-up activities shall include: • verification of the actions taken; and h i f ifi i l Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 72 • the reporting of verification results.
  73. 73. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.2.3 Monitoring & measurement of processes h d f i i QMS• methods for monitoring QMS processes; • measurement of the QMS processes ; • demonstrate the ability of the processes to achieve planned results; • when planned results are not achievedwhen planned results are not achieved, correction and corrective action shall be taken; and • maintain records. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 73 maintain records.
  74. 74. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.2.4 Monitoring & measurement of product methods for monitoring product;methods for monitoring product; measurement of the product ; demonstrate the ability of the processes to achieve planned results; when planned results are not achieved, correction and corrective action shall be taken; and; maintain records. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 74
  75. 75. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.3 Control of nonconforming product identify and control to prevent its unintended use or delivery responsibilities and authorities for dealing with nonconforming product shall be defined Deal with NCP : 1. by taking action to eliminate the detected non-conformity; 2 d i b l h i d h li bl b h2. under concession by a relevant authority and, where applicable, by the customer; 3. by taking action to preclude its original intended use or application. 4. by taking action appropriate to the effects, or potential effects, of the f i h f i d i d d f d li Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 75 g pp p p nonconformity when nonconforming product is detected after delivery or use has started.
  76. 76. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard Maintain records; When nonconforming product is corrected, it shall be subject to re- verification; and When nonconforming product is detected after delivery or use hasWhen nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects of the nonconformity. Procedure requiredProcedure required. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 76
  77. 77. ISO 9001:2008 Awareness Training ISO 9001 Standard 8.4 Analysis of data ISO 9001 Standard Determine, collect & analyze data – to demonstrate the suitability & effectiveness of QMS. Collect data from monitoring & measurement of processes. This shall provide information relating to: • Customer satisfaction; • Conformity to product requirement; • Characteristics and trend of processes; and • Suppliers. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 77
  78. 78. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.5 Improvement 8 5 1 C ti l i t h h8.5.1 Continual improvement - through • quality policy; • quality objectives;quality objectives; • audit result; • analysis of data; • corrective and preventive actions; and • management review. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 78
  79. 79. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.5.2 Corrective action T k ti t li i t th f f iti i d t tTake action to eliminate the causes of nonconformities in order to prevent recurrence. A documented procedure shall be established to define requirements for:p q 1. reviewing nonconformities; 2. determining the cause of nonconformities; 3. evaluating the need for action;g ; 4. determining and implementing action needed; 5. records of the results of action taken; and 6. reviewing the effectiveness of the corrective action taken Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 79
  80. 80. ISO 9001:2008 Awareness Training ISO 9001 StandardISO 9001 Standard 8.5.3 Preventive action Determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Establish procedures to define requirements for:Establish procedures to define requirements for: 1) determining potential non-conformities and their causes; 2) evaluating the need for action to prevent occurrence of non-conformities; 3) d i i d i l i i d d3) determining and implementing action needed; 4) records of results of action taken; and 5) reviewing the effectiveness of the preventive action taken. Issue: TUVME/QM 001/02 Date: 24.02.09 TUV Middle East ISO 9001:2008 Awareness Training 80
  81. 81. ISO 9001:2008 Awareness Training To meet the requirements you must: Continually Improve Effectiveness Use corrective action to improve your service to your customers. Continually Improve Effectiveness Use corrective action to improve your service to your customers. Maintain Show evidence that you are doing what you said you were doing. Maintain Show evidence that you are doing what you said you were doing. DocumentDocument Implement Do what you wrote down. Implement Do what you wrote down. Document Write down what you do. Document Write down what you do.

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