Lead Auditor / Auditor Course For Quality Management Systems ISO 9001:2008

Transcription

1 INSTITUTE OF QUALITY Lead Auditor / Auditor Course For Quality Management Systems ISO 9001:2008 Apr 2010 INTRODUCTION Apr

2 INTRODUCTION OF PARTICIPANTS Participants are requested to find a partner each. You are expected to find out professional information about your partner in 2 minutes. Also enquire his / her key expected learning from the programme. Please record your findings. Write down your name and the details collected from your partner Each participant would in turn introduce his partner to the group and his key expected learning. Hand over your recorded findings to the tutors. Duration : 30 Minutes Apr COURSE FORMAT FOR A DURATION OF FIVE DAYS COVERS THE REQUIREMENTS OF IRCA / NABET ENABLES SUCCESSFUL CANDIDATES TO REGISTER INCLUDES CLASSROOM SESSIONS, SYNDICATE WORKSHOPS, ROLE PLAY EXERCISES EXTENSIVE EXAMPLES AND CASE STUDIES BASED ON INDUSTRY SITUATIONS Apr

3 COURSE LEARNING OBJECTIVES PURPOSE OF QUALITY MANAGEMENT SYSTEM & 8 QUALITY MANAGEMENT PRINCIPLES STANDARDS ISO 9000, ISO 9001, ISO 9004, ISO & THEIR INTERRELATIONSHIPS. INTERPRETATION OF ISO 9001 IN CONTEXT TO THE AUDIT ROLES AND RESPONSIBILITIES OF AUDITORS AND LEAD AUDITORS. PLAN AND CONDUCT AN AUDIT, GATHER OBJECTIVE EVIDENCE VIA VARIOUS METHODS AND DETERMINE CONFORMITY TO THE REQUIREMENTS AUDIT REPORT WRITING AUDIT FOLLOW UP EVALUATING THE EFFECTIVENESS OF CORRECTIVE ACTION IMPLEMENTATION CERTIFICATION AND ACCREDITATION PROCESSES AUDITOR CERTIFICATION AND ROLE OF IRCA / NABET Apr COURSE PROGRAMME BLEND OF LECTURES, INTERACTIVE WORKSHOPS AND PRESENTATIONS ROLE PLAY ON OPENING AND CLOSING MEETINGS INCLUDES PRE-COURSE MATERIAL AND COURSE MATERIAL CONTINUOUS ASSESSMENT OF PARTICIPANTS COURSE EXAMINATION Apr

4 DELEGATE RESPONSIBILITIES COURSE IS INTENSIVE, HENCE FULL ATTENTION AND DILIGENCE IS REQUIRED TIME SCHEDULES ARE IMPORTANT BE ALERT, INTERACTIVE AND CO-OPERATIVE TAKING NOTES USE OF MOBILE PHONES PROHIBITED DELEGATES APPEAL AND COMPLAINT Apr EVALUATION PROCESS & CRITERIA CONTINUOUS ASSESSMENT SKILL BASED PRACTICAL WORK TUTOR MARKED PRESENTATION / ROLE PLAY QUIZZES DAILY ASSESSMENT CONTRIBUTION, QUESTIONING, COMMUNICATION, REPORTING, PARTICIPATION IN TEAM PERSONAL ATTRIBUTES: ATTITUDE, MANNER,SUITABILITY AS AUDITOR ATTENDANCE, PUNCTUALITY AND PARTICIPATION RESITTING THE EXAMINATION OR THE COURSE WRITTEN EXAMINATION Apr

5 ISSUE OF CERTIFICATES SUCCESSSFUL COMPLETION CERTIFICATE WHEN THE DELEGATE HAS PASSSED BOTH THE WRITTEN EXAMINATION AND CONTINUOUS ASSESSMENT ATTENDANCE CERTIFICATE WHEN THE DELEGATE HAS NOT PASSSED THE WRITTEN EXAMINATION BUT SATISFIES THE CONTINUOUS ASSESSMENT AND ATTENDANCE REQUIREMENT LETTER OF ATTENDANCE WHEN THE DELEGATE IS NOT MEETING ANY OF THE ABOVE BUT SATISFIES ATTENDANCE REQUIREMENT ONLY Apr SECTION 1 Introduction to QMS Apr

6 Learning Objectives By the end of the session successful students will be able to : Explain the purpose and business benefits of a quality management system. Explain the 8 principles of quality management. Explain the process approach to management systems. Apr Streamlining the systems Certification and recognition Purpose of QMS Benefits to stake holders Improvement in performance Enhanced market standing Apr

7 BENEFITS OF QUALITY MANAGEMENT CUSTOMER CONFIDENCE CONSISTENCY IN QUALITY REDUCTION IN WASTE AND REWORK EMPLOYEE PARTICIPATION REDUCTION IN LIABILITIES IMPROVEMENT IN PROFIT CONTINUAL IMPROVEMENT Apr Activity on understanding QMPs Group exercise :Relate the following QMPS with organizations with the attribute most identifiable to them Process Approach Factual decision making Customer Focus Continual improvement Systems Approach Supplier relationship Involvement of people Duration = 15 min. Leadership Apr

8 PRINCIPLES OF QUALITY MANAGEMENT TO LEAD AND OPERATE AN ORGANIZATION SUCCESSFULLY, IT IS NECESSARY TO DIRECT AND CONTROL IT IN A SYSTEMATIC AND TRANSPARENT MANNER MANAGING AN ORGANIZATION ENCOMPASSES QUALITY MANAGEMENT AMONGST OTHER MANAGEMENT DISCIPLINES EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEEN IDENTIFIED AND THEY FORM THE BASIS OF ISO 9001 : 2008 STANDARD Apr PRINCIPLES OF QUALITY MANAGEMENT QUALITY MANAGEMENT PRINCIPLE 1 CUSTOMER FOCUSED ORGANIZATION ORGANIZATIONS DEPEND ON THEIR CUSTOMERS AND THEREFORE SHOULD UNDERSTAND CURRENT AND FUTURE CUSTOMER NEEDS, MEET CUSTOMER REQUIREMENTS AND STRIVE TO EXCEED CUSTOMER EXPECTATIONS. QUALITY MANAGEMENT PRINCIPLE 2 LEADERSHIP LEADERS ESTABLISH UNITY OF PURPOSE AND DIRECTION OF THE ORGANIZATION. THEY CREATE THE INTERNAL ENVIRONMENT IN WHICH PEOPLE CAN BECOME FULLY INVOLVED IN ACHIEVING THE ORGANIZATION S OBJECTIVE Apr

9 PRINCIPLES OF QUALITY MANAGEMENT QUALITY MANAGEMENT PRINCIPLE 3 INVOLVEMENT OF PEOPLE PEOPLE OF ALL LEVELS ARE THE ESSENCE OF AN ORGANIZATION AND THEIR FULL INVOLVEMENT ENABLES THEIR ABILITIES TO BE USED FOR THE ORGANISATION S BENEFIT QUALITY MANAGEMENT PRINCIPLE 4 PROCESS APPROACH A DESIRED RESULT IS ACHIEVED MORE EFFICIENTLY WHEN RELATED RESOURCES AND ACTIVITIES ARE MANAGED AS A PROCESS Apr PRINCIPLES OF QUALITY MANAGEMENT QUALITY MANAGEMENT PRINCIPLE 5 SYSTEM APPROACH TO MANAGEMENT IDENTIFYING, UNDERSTANDING AND MANAGING A SYSTEM OF INTERRELATED PROCESSES FOR A GIVEN OBJECTIVE IMPROVES THE EFFECTIVENESS AND EFFICIENCY OF THE ORGANIZATION QUALITY MANAGEMENT PRINCIPLE 6 CONTINUAL IMPROVEMENT CONTINUAL IMPROVEMENT SHOULD BE A PERMANENT OBJECTIVE OF THE ORGANIZATION Apr

10 PRINCIPLES OF QUALITY MANAGEMENT QUALITY MANAGEMENT PRINCIPLE 7 FACTUAL APPROACH TO DECISION MAKING EFFECTIVE DECISIONS ARE BASED ON THE ANALYSIS OF DATA AND INFORMATION QUALITY MANAGEMENT PRINCIPLE 8 MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP AN ORGANISATION AND ITS SUPPLIERS ARE INTERDEPENDENT AND A MUTUALLY BENEFICIAL RELATIONSHIP ENHANCES THE ABILITY OF BOTH TO CREATE VALUE Apr PDCA APPROACH CONCEPT INTRODUCED BY DR.SHEWHART IN EARLY 40 S POPULARIZED BY DR. DEMING IN THE 1950 S BECAME KNOWN AS DEMING CYCLE PDCA STANDS FOR PLAN, DO, CHECK AND ACT PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHIN THE ORGANIZATION Apr

11 PDCA Cycle PDCA cycle can be applied at all levels within the organization Apr Group exercise Activity on PDCA Apply Plan, Do, Check and Act on common activities like Making Tea Organizing a Picnic Home budgeting Reaching Place of work Duration = 30 min. Apr

12 PROCESS SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH TRANSFORM INPUTS INTO OUTPUTS (ISO ) OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTS INTO OTHER PROCESSES, PROCESSES MAY BE INTERRELATED OR INDEPENDENT, OVERALL AIM IS TO ADD VALUE BY PLANNING AND CONTROLLING PROCESSES Apr BASIC PROCESS MODEL CONTROL / PROCEDURES CUSTOM ER MANAGEMENT DESIRED CUSTOM ER INPUT PROCESS ACTIVITIES ENABLERS OUTPUTS (RESULTS) SATISFACTION MONITORING MEASUREMENTS Apr

13 PRODUCT THE RESULT OF A PROCESS (ISO ) 4 GENERIC PRODUCT CATEGORIES HARDWARE TANGIBLE PRODUCTS PROCESSED MATERIAL SOFTWARE SERVICE MOST PRODUCTS ARE COMBINATION OF THESE Apr PROCESS AN ACTIVITY USING RESOURCES, AND MANAGED IN ORDER TO ENABLE THE TRANSFORMATION OF INPUTS INTO OUTPUTS, CAN BE CONSIDERED AS A PROCESS. OFTEN, THE OUTPUT FROM ONE PROCESS DIRECTLY FORMS THE INPUT TO THE NEXT PROCESS PROCESS APPROACH THE APPLICATION OF A SYSTEM OF PROCESSES WITHIN AN ORGANIZATION, TOGETHER WITH THE IDENTIFICATION AND INTERACTIONS OF THESE PROCESSES AND THEIR MANAGEMENT, CAN BE REFERRED AS THE PROCESS APPROACH Apr

14 DOCUMENTING A PROCESS DOCUMENTING A PROCESS INVOLVES : IDENTIFY THE PROCESS OWNER IDENTIFY INPUTS AND EXPECTED OUTPUTS / RESULTS DEFINE THE CHARACTERISTICS OF INPUTS AND OUTPUTS DEFINE THE BOUNDARIES OF THE PROCESS DETERMINE THE ACTIVITIES AND THE SEQUENCE IDENTIFY RESOURCES AND RESPONSIBILITIES DETERMINE THE CRITERIA AND METHODS TO ENSURE THE OPERATION AND CONTROL ARE EFFECTIVE (SOPs AND CHECKING POINTS) DETERMINE PROCESS PERFORMANCE MEASURES Apr QMS PROCESSES QMS TYPICALLY INCLUDES PROCESSES FOR MANAGEMENT ACTIVITIES PROVISION OF RESOURCES PRODUCT REALIZATION MEASUREMENT Processes are not restricted to production or service delivery activities only Apr

15 PROCUREMENT PROCESS Actions on vendor related quality problem Improvement project with vendor Training needs of dept. Personnel & vendors P Procure material as per required specs and at required date Improve quality of incoming material Improve turn over Optimise inventory Cost reduction Timely payment of vendors Review of pending payments beyond agreed time Review incoming material go rate w.r.t. goal (item wise) Chronic vendor problems Cost reduction achievement review Status of inventory item wise & reduction of prod. Lead Time. (item wise) Review of matl. With Material Requirement Planning % (MRP) delivery adherance Review inspection cycle time incoming (itemwise SRV) A C D Vendor selection and evaluation Cost reduction project allotment Procure products as per drg and tech specs. Periodic process audit and periodic Rating Processing of bill/invoice Inventory management Disposal of receipt rejection Apr EVALUATING A PROCESS WITHIN THE QMS INCLUDES AUDIT OF : PROCESS INPUTS, OUTPUTS & RESULTS PROCESS MEASURES, LINKAGE WITH QUALITY OBJECTIVES & MEASURES FOR CONTINUAL IMPROVEMENT THROUGH THE 4 BASIC QUESTIONS IS THE PROCESS IDENTIFIED & APPROPRIATELY DEFINED? ARE RESPONSIBILITIES ASSIGNED? ARE THE PROCEDURES IMPLEMENTED & MAINTAINED? IS THE PROCESS EFFECTIVE IN ACHIEVING THE REQUIRED RESULTS? PROCESSES MAY OR MAY NOT BE DEFINED BY DOCUMENTATION Apr

16 Activity on understanding and documenting Process Approach Team exercise Identify the inter-linkages of a tutor given Process of an organization with the other relevant processes Present on Flip Charts Duration = 30 min. Apr Storage Raw Material Planning Procurement Process Any other process Incoming Inspection Production Processes Apr

17 SECTION 2 Apr Learning Objective By the end of the session successful students will be able to : Explain the purpose, content & interrelationship of ISO 9000, ISO 9001 & ISO 9004 Apr

18 Session 2a Purpose, content & inter relationship of ISO 9000 family of Standards Apr Activity on identifying the Purpose of ISO 9000 Series of Standards Read section 0.1 of ISO 9000:2005 of Precourse reading material In your syndicate groups discuss and list down the purpose of ISO 9000 series of Standards for an organization Duration = 20 min. Apr

19 ISO 9000 Family ISO 9000:2005 ISO 9001:2008 ISO 9004:2009 Quality Management Systems - Fundamentals And Vocabulary Quality Management Systems - Requirements Managing for Sustained success of an organization a quality management approach ISO : 2002 Guidelines On Quality And / Or Environmental Management Systems Auditing Apr ISO 9004 ISO 9001 ISO 9001 Perspective Quality of product and customer satisfaction (effectiveness) ISO 9004 Perspective Wider focus on quality management than ISO Addresses the needs and expectations of all relevant Interested parties. Systematic and continual improvement of the organization's overall performance. Apr

20 ISO 9001 & 9004 : Relationship diagram Apr 2010 O 39 Auditing Standards (Guidelines) Guideline Standards originally published by ISO Quality Management ISO :1990 Guidelines for auditing quality systems -- Part 1: Auditing ISO :1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria for quality systems auditors ISO :1991 Guidelines for auditing quality systems -- Part 3: Management of audit programmes Environmental Management ISO 14010:1996 Guidelines for environmental auditing -- General principles ISO 14011:1996 Guidelines for environmental auditing -- Audit procedures -- Auditing of environmental management systems ISO 14012:1996 Guidelines for environmental auditing -- Qualification criteria for environmental auditors Now superseded by ISO Apr

21 ISO 19011:2002 Guidelines for Quality and/or Environmental Management Systems auditing Published in October 2002 jointly ISO/TC 176, Quality management and Quality Assurance and ISO/TC 207 Environmental Management Replaced ISO :1990, ISO :1991, ISO :1991, ISO 14010:1996,14011:1996,ISO 14012:1996 and combined all aspects into generic guidelines The standard is intended to act as a guide to all auditors, including those who audit internally within their own organization. Can be applied to Management systems other than QMS and EMS Apr α NATIONAL STANDARDS ISO 9000 SERIES EN ISO 9000 SERIES ISO 9000 ISO 9004 EN EN ISO , ISO , , ISO 9001 : 2000 ISO 9004 : 2000 ISO 9001 : 2008 (CONTRACTUAL) ISO 9000 : 2005 ISO 9004 : 2009 (NON-CONTRACTUAL) Apr

22 How is ISO Standard Revised International organization for standardization (ISO) is a federation of national standards bodies ISO works through technical committees. (TC 176 has the responsibility to issue and update ISO 9000 standards ) TC 176 is supported by Sub Committees and Working Groups (WG) The standard progresses from Preliminary Working Draft (PWD) Committee Draft (CD) Draft International Standard (DIS) Finalized Draft International Standard (FDIS) Published International Standard The standard is published only after positive votes from members Apr Activity on identifying differences between Auditable Standard (AS) & Guidance Documents (GD) Standard AS/ GD Why? ISO 9000 ISO 9001 ISO 9004 ISO Identify the auditable standards & the guidance documents from the table Discuss the rationale for this distinction in your syndicate group Duration = 20 min. Apr

23 Auditable Standards / Guidance Documents Auditable standard - ISO 9001:2008 Requirements for a QMS as specified Audits are carried out against the requirements of ISO Guidance documents ISO 9001:2008 Requirements ISO fundamentals & vocabulary ISO Managing for Sustained success of an organization a quality management approach Notes under requirement specified in ISO 9001 standard Apr Legal compliance vs conformance to ISO 9001(1) The statutory & regulatory requirements applicable to products, as specified by the controlling authorities are to be complied under all circumstances. Euro norms for the automobile vehicles Examples Safety for medical equipments Intrinsically safe equipment in gas dangerous zone FDA regulations for food products & medicines Apr

24 Legal compliance vs conformance to ISO 9001(2) Customer driven Vendor selection by corporate Conformance to QMS standard Voluntary decision Market image & entry into new markets Apr Session 2b QMS Terminology Apr

25 Activity on vocabulary Match the key phrases of the definitions with the vocabulary in the table provided within your respective teams List your points of doubt on the flip charts Duration = 30 min. Apr Definition Terminology 1. Quality 2. Grade 3. Customer Satisfaction 4. Quality Policy 5. Quality Objectives 6. Top Management 7. Quality Management 8. Quality Control 9. Quality Assurance 10. Quality Planning 11. Quality Improvement 12. Quality Management Systems 13. Conformity 14. Non Conformity 15. Defect 16. Document 17. Quality Plan 18. Quality Manual 19. Record 20. Effectiveness 21. Efficiency Definition A. Information and its supporting medium B... increasing the ability to fulfill quality requirements C.. who directs and controls an organization, at the highest level D. Document specifying the quality management system of an organization E...inherent characteristics fulfills requirements F. aimed for, related to quality G. Document specifying.. procedure and associated resources a specific project, product, process or contract H. Extent to which planned activities are realized and planned results achieved I. Management system to direct and control an organization. J. Co-ordinated activities to direct and control an Organization K. The non fulfillment of a requirement L. Document stating results achieved or providing evidence M. Part of quality management focused on providing confidence... N. Overall intentions and direction of an organization. O. Category or rank given. having the same functional use P. Relationship between the result achieved and resources used Q. Customer s perception customer s requirements have been fulfilled R. The non fulfillment of a requirement, related to an intended or specified use S. Part of quality management focused on Fulfilling quality requirements T. Part of quality management, focused on setting quality objectives and specifying necessary operational process and related resources to fulfill the quality objectives U. The fulfillment of a requirement Apr

26 QUALITY DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS GRADE CATEGORY OR RANK GIVEN TO DIFFERENT QUALITY REQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVING THE SAME FUNCTIONAL USE CUSTOMER SATISFACTION CUSTOMER S PERCEPTION OF THE DEGREE TO WHICH THE CUSTOMER S REQUIREMENTS HAVE BEEN FULFILLED Apr QUALITY POLICY OVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATION RELATED TO QUALITY, AS FORMALLY EXPRESSED BY TOP MANAGEMENT QUALITY OBJECTIVES SOMETHING SOUGHT OR AIMED FOR, RELATED TO QUALITY Apr

27 TOP MANAGEMENT PERSON OR GROUP OF PEOPLE WHO DIRECTS AND CONTROLS AN ORGANIZATION, AT THE HIGHEST LEVEL Apr QUALITY MANAGEMENT CO-ORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY QUALITY CONTROL PART OF QUALITY MANAGEMENT FOCUSED ON FULFILLING QUALITY REQUIREMENTS QUALITY ASSURANCE PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING CONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLED Apr

28 QUALITY PLANNING PART OF QUALITY MANAGEMENT, FOCUSED ON SETTING QUALITY OBJECTIVES AND SPECIFYING NECESSARY OPERATIONAL PROCESS AND RELATED RESOURCES TO FULFILL THE QUALITY OBJECTIVES QUALITY IMPROVEMENT PART OF QUALITY MANAGEMENT, FOCUSED ON INCREASING THE ABILITY TO FULFIL QUALITY REQUIREMENTS Apr QUALITY MANAGEMENT SYSTEMS MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY Apr

29 CONFORMITY THE FULFILLMENT OF A REQUIREMENT NON CONFORMITY THE NON FULFILLMENT OF A REQUIREMENT DEFECT THE NON FULFILLMENT OF A REQUIREMENT, RELATED TO AN INTENDED OR SPECIFIED USE Apr DOCUMENT INFORMATION AND ITS SUPPORTING MEDIUM QUALITY PLAN DOCUMENT SPECIFYING WHICH PROCEDURE AND ASSOCIATED RESOURCES SHALL BE APPLIED BY WHOM AND WHEN TO A SPECIFIC PROJECT, PRODUCT, PROCESS OR CONTRACT QUALITY MANUAL DOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF AN ORGANIZATION RECORD DOCUMENT STATING RESULTS ACHIEVED OR PROVIDING EVIDENCE OF ACTIVITIES PERFORMED Apr

30 EFFECTIVENESS EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND PLANNED RESULTS ACHIEVED EFFICIENCY RELATIONSHIP BETWEEN THE RESULT ACHIEVED AND RESOURCES USED Apr Session 2c ISO 9001: 2008 QMS Requirements Apr

31 Continual improvement of the quality management system Management responsibility Customers Customers Resource management Measurement, analysis and improvement Satisfaction Requirements Input Product Realization Product Output Value adding activities Information flow Apr Scope and general 2. Normative references 3. Terms & definitions Clauses 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement, analysis and improvement Apr

32 Scope of ISO 9001 General This international standard specifies requirements for a quality management system where an organization Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory & regulatory requirements, and Aims to enhance customer satisfaction through the application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory & regulatory requirements. Note : 1a in this international standard, the term product applies only to the product intended for, or required by, a customer Apr Application Scope of ISO 9001 All requirements of this international standard are generic and are intended to be applicable to all organizations regardless of type, size and the product provided Where any requirements of the standard cannot be applied due to the nature of an organization and its products, this can be considered for exclusion. Exclusions are limited to requirements stated in clause 7. Permissible exclusions are those that do not affect the organization s ability or responsibility to provide product that meets customer and applicable statutory & regulatory requirements Apr

33 Justification of Exclusions When an organization limits the application of the requirements of the ISO 9001: 2008, this must be detailed and justified in the organization s quality manual. This must also be clear in any other publicly available document, such as certification/registration document or marketing material Apr Most Likely Exclusions Within clause 7 (product realization), the following are the most likely requirements, though not the only ones. 7.3 Design & development Most Likely Exclusions Customer property Identification & traceability (traceability may not be applicable) 7.6 Control of monitoring & measuring devices. Apr

34 Scope of Audit Extent and Boundaries Product Physical location Organizational units Activities/ Processes Apr Activity on Understanding ISO 9001 Requirements Refer to E01 of Work Book & Case Study Total Duration = 90 min. Individual Work = 30 min; Group Work= 30 min; Feedback from Exercise = 30 min Apr

35 4.0 Quality Management System 4.1 General Requirements 4.2 Documentation Requirement General Quality Manual Control of Documents Control of Records Apr General Requirements Organization shall establish, document, implement, maintain and continually improve the effectiveness of a quality management system. The organization shall: a. Determine the processes needed for quality management systems, and its application. b. Determine the sequence and interaction of these processes. c. Determine criteria and methods needed to ensure that both the operation and control of these processes are effective. d. Ensure the availability of resources and information necessary to support these processes. e. Monitor, measure where applicable and analyze these processes. f. Implement actions necessary to achieve planned results and continual improvements of these processes. These processes shall be managed by the organization in accordance with the requirements of this international standard. Where an organization chooses to outsource any process, then control the outsourced processes. Note : processes needed for the quality management systems referred to above, should include processes for management activities, provision of resources, product realization and measurement analysis & improvement Apr

36 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority And Communication 5.6 Management Review Apr Resource Management 6.1 Provision of Resources Training 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment Work Environment Apr

37 7.0 Product Realization 7.1 Planning of Product Realization 7.2 Customer Related Processes 7.3 Design And Development 7.4 Purchasing 7.5 Production & Service Provision 7.6 Control of Monitoring & Measuring Devices Apr Production & Service Provision Control of Production & Service Provision Validation of Processes For Production & Service Provision Identification & Traceability Customer Property Preservation of Product Apr

38 8.0 Measurement, Analysis & Improvement 8.1 General 8.2 Monitoring & Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement Apr Monitoring & Measurement Customer Satisfaction Internal Audit Monitoring & Measurement of Processes Monitoring & Measurement of Product Apr

39 Activity on identifying relationship between Quality Management Principles (QMPs( QMPs) ) & ISO 9001 In your syndicate groups identify the allocated QMPs to the relevant clauses & sub clauses and list down in the flip chart Total Duration = 60 min. Apr RELATIONSHIP BETWEEN THE QMPs AND ISO 9001 ISO 9001 Clauses P1 P2 P3 P4 P5 P6 P7 P The above relationship are indicative - not exhaustive LEGEND P1 Customer Focus P5 System Approach P2 Leadership P6 Continual Improvement Apr 2010 P3 People Involvement P7 Fact Based Approach 78 P4 Process approach P8 Supplier Relationship 39

40 Session 2d Documentation for QMS Apr Documentation Requirements ISO 9001: 2008 requires Documented statements of quality policy and quality objectives. A quality manual. Documented procedures & records required by the standard. Documents needed by the organization to ensure effective planning, operation and control of its processes. Apr

41 Activity on Documentation Read through of ISO 9001:2008 in your syndicate groups What differences would you expect to see in the documentation of A large scale industry A small scale industry What in your opinion are the reasons for these differences? Tutor lead discussion Duration 10 mins Apr Areas of differences Degree of Formality Content Number Issue procedures Hierarchy of documents Document numbering system Style of presentation Medium Distribution of responsibilities for document approval Apr

42 Typical Quality Management System Documentation Hierarchy Source: ls/lso/tr 10013:2001 Apr A Typical Quality Manual 1. Title and scope 2. Table of contents 3. Review, approval and revision 4. Quality policy and objectives 5. Organization, responsibility and authority 6. References 7. Quality management system description 8. Appendices Quality Manual Source: ls/lso/tr 10013:2001 Apr

43 Structure of a typical Documented procedure Text Flow charts, Tables A combination of the above, Or any other suitable method Source: ls/lso/tr 10013:2001 Apr Content of a typical Documented procedure Title Purpose Scope Responsibility and authority Description of activities Records Appendices Review, approval and revision Identification of changes Source: ls/lso/tr 10013:2001 Xmxmxmx mxm xmmxmm mmxmxm m Xm mxmmxm xmmxm mm Xmmmxmxmmmxmmmxm mmxm mmxmm X,xmxm mmxmxm mmxmm xmmmxm mm Xm mxm xmxmxm xmmm mxm m Xm mxm xmxmxmxm mx Apr

44 Work Instructions The structure, format and level of detail used in the work instructions should be tailored to the needs of the organization s personnel and depends on the complexity of the work Source: ls/lso/tr 10013:2001 Apr Value of Documentation Enables communication of intent and consistency of action Definition of roles for members Enhancement of understanding Control and measurement System becomes auditable Evaluation of the effectiveness and continuing suitability of QMS Information useful for training and competence building Provides confidence in the QMS Helps in continual improvement Provides repeatability and traceability Apr

45 SECTION 3 Auditing QMS Apr Section 3 LEARNING OBJECTIVES: By the end of the section, successful students will be able to : Understand the Audit process Explain the role of auditor to plan, conduct, report and follow up a QMS audit in accordance with ISO Understand audit responsibilities Develop the skills required to plan, prepare, conduct and report on audits Understand the certification / registration and accreditation processes IRCA / NABET Schemes for Auditor certification 45

46 Sessions Accreditation certificate and auditor certification (3 a) Role of IRCA / NRBPT and Auditor certification (3 b) Introduction to Auditing (3 c) Auditor responsibilities (3 d) Audit Programmes (3 e) Planning of Audits (3 f) Checklists (3 g) Conducting Audits Opening meeting (3 h) Onsite auditing and audit skills (3 i) Closing meeting (3 j) Audit reporting (3 k) Audit follow up (3 l) Section 3 Learning Objective Session 3 By the end of the session, successful students will be able to : Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO Apr

47 SESSION 3a CERTIFICATION AND ACCREDITATION CERTIFICATION ACCREDITATION REGISTRATION SCHEME FOR LEAD AUDITORS / AUDITORS PRINCIPLES OF AUDITING CONFIDENTIALITY CONFLICT OF INTEREST Apr ACCREDITATION BOARD APPLICATION FOR ACCREDITATION AUDIT AND SURVEILLANCE BY ACCREDITATION BOARD CERTIFICATION BODY (CB) APPLICATION FOR CERTIFICATION AUDIT AND SURVEILLANCE BY CB ORGANIZATION Apr

48 CONFORMITY ASSESSMENT IN UK DTI UKAS IRCA/CQI NAMAS LABORATORY ACCREDITATION QUALITY MANAGEMENT SYSTEM CERTIFICATION BODIES TRAINING COURSES REGISTRATION AUDITOR LEAD AUDITOR DTI : DEPARTMENT OF TRADE AND INDUSTRY NAMAS : NATIONAL MEASUREMENT ACCREDITATION SCHEME UKAS : UNITED KINGDOM ACCREDITATION SERVICES IRCA : INTERNATIONAL REGISTER OF CERTIFICATED AUDITORS CQI : CHARTERED QUALITY INSTITUTE PRINCIPAL AUDITOR PROVISIONAL AUDITOR INTERNAL AUDITOR Apr CONFORMITY ASSESSMENT IN INDIA Quality Council of India Secretariat NABCB NABET NABH NABL National Accreditation Board for Certification Bodies National Accreditation Board for Education & Training National Accreditation Board for Hospitals & Health services National Accreditation Board for Testing & Calibration Laboratories NBQP National Board for Quality Promotion QIES Quality Information & Enquiry Services Apr

49 ACCREDITATION ACCREDITATION OFFERS ASSURANCE TO THE CERTIFICATION PROCESS REFERENCE STANDARD FOR ACCREDITATION EN / ISO Apr CERTIFICATION CREDIBILITY OF QUALITY SYSTEM CERTIFICATION DEPENDS ON IMPARTIALITY WELL DEFINED SCOPE MAINTENANCE OF THE CERTIFICATE COMPETENCE OF THE AUDITORS CONSISTENCY OF APPROACH Apr

50 BENEFITS OF A CERTIFIED QMS CUSTOMER CONFIDENCE ENHANCED CREDIBILITY NATIONAL AND INTERNAL RECOGNITION ACCEPTANCE IN GLOBAL MARKET FACILITY OF INDEPENDENT EVALUATION AND FEEDBACK REDUCES NEED FOR MULTIPLE AGENCY / MULTIPLE PURCHASER EVALUATION Apr SESSION 3b ROLE OF IRCA / NABET AND AUDITOR CERTIFICATION REQUIREMENTS Apr

51 INTERNATIONAL REGISTRATION SCHEME FOR AUDITORS OF QUALITY SYSTEM THE BEST KNOWN & WIDELY USED METHOD TO DEMONSTRATE AUDITOR COMPETENCE INTERNATIONAL AUDITOR AND PERSONNEL CERTIFICATION ASSOCIATION (IPC) IRCA (UK,) EARA(UK), NABET (INDIA), RAB (USA) ARE MEMBERS OF IPC AUDITOR REGISTRATION IS CARRIED OUT BY SELECT MEMBERS OF IPC Apr REGISTRATION AS AUDITOR / LEAD AUDITOR DEPENDS UPON EDUCATIONAL QUALIFICATION WORK EXPERIENCE AUDIT EXPERIENCE 40 HOURS OF AUDITORS TRAINING AUDITOR COMPETENCE Apr

52 COMPETENCE AND EVALUATION OF AUDITORS A COMPETENT AUDITOR GENERIC KNOWLEDGE & SKILLS SPECIFIC KNOWLEDGE & SKILLS EDUCATION, WORK EXPERIENCE, TRAINING & AUDIT EXPERIENCE AUDITOR EVALUATION Apr A COMPETENT AUDITOR DEMONSTRATES PERSONAL ATTRIBUTES DEMONSTRATES ABILITY TO APPLY THE KNOWLEDGE & SKILLS TO CONDUCT SUCCESSFUL AUDITS & ACHIEVE THE AUDIT OBJECTIVES GAINS COMPETENCE THROUGH EDUCATION WORK EXPERIENCE AUDIT TRAINING AUDIT EXPERIENCE Apr

53 PERSONAL ATTRIBUTES ETHICAL OPEN-MINDED DIPLOMATIC OBSERVANT PERCEPTIVE VERSATILE TENACIOUS DECISIVE SELF RELIANT Apr GENERIC KNOWLEDGE & SKILLS FOR AUDITORS AUDIT PRINCIPLES, PROCEDURES & TECHNIQUES MANAGEMENT SYSTEM & REFERENCE DOCUMENTS ORGANIZATIONAL SITUATIONS APPLICABLE LAWS, REGULATIONS & OTHER REQUIREMENTS Ref : ISO 19011: 2002 Section Apr

54 SPECIFIC KNOWLEDGE & SKILLS FOR QMS AUDITORS QUALITY RELATED METHODS AND TECHNIQUES QUALITY TERMINOLOGY QUALITY MANAGEMENT PRINCIPLES & THEIR APPLICATION QUALITY MANAGEMENT TOOLS PROCESSES AND PRODUCTS INCLUDING SERVICES SECTOR SPECIFIC TERMINOLOGY TECHNICAL CHARACTERISTICS OF PROCESSES & PRODUCTS Ref : ISO 19011: 2002 Section Apr GENERIC KNOWLEDGE & SKILLS OF LEAD AUDITORS ABILITY TO PLAN THE AUDIT & MAKE EFFECTIVE USE OF RESOURCES REPRESENT THE AUDIT TEAM ORGANIZE & DIRECT THE TEAM DIRECT & GUIDE AUDITORS IN TRAINING LEAD AUDIT TEAM TO REACH AUDIT CONCLUSIONS PREVENT / RESOLVE CONFLICTS PREPARE AUDIT REPORT Apr

55 EDUCATION, WORK EXPERIENCE, TRAINING AND AUDIT EXPERIENCE OF AUDITORS EDUCATION TO PROVIDE GENERIC & SPECIFIC KNOWLEDGE & SKILLS WORK EXPERIENCE TO CONTRIBUTE TO THE DEVELOPMENT OF KNOWLEDGE & SKILLS IN QUALITY MANAGEMENT FIELD COMPLETION OF AUDITOR TRAINING AUDIT EXPERIENCE UNDER THE GUIDANCE OF A COMPETENT LEAD AUDITOR Apr EDUCATION, WORK EXPERIENCE, TRAINING AND AUDIT EXPERIENCE OF LEAD AUDITORS SHOULD HAVE ACQUIRED ADDITIONAL AUDIT EXPERIENCE TO DEVELOP THE REQUIRED KNOWLEDGE AND SKILLS THE ADDITIONAL EXPERIENCE IS FROM ACTING IN THE ROLE OF AN AUDIT TEAM LEADER UNDER THE GUIDANCE OF ANOTHER COMPETENT AUDIT TEAM LEADER Apr

56 LEVELS OF EDUCATION, WORK EXPERIENCE, AUDITOR TRAINING & AUDIT EXPERIENCE APPROPRIATE FOR AUDITORS CONDUCTING CERTIFICATION OR SIMILAR AUDITS. HIGHER OR LOWER LEVELS ARE APPROPRIATE DEPENDING ON THE AUDIT PROGRAMME Ref TABLE 1 of ISO Apr Table 1 Example of levels of education, work experience, auditor training ng and audit experience for auditors conducting certification or similar r audits Parameter Education Total work experience Work experience in quality or environmental management field Auditor training Audit experience 5 years Auditor Secondary education At least 2 years of the total 5 years 40 h. of Audit training Four complete audits for a total of at least 20 days of audit experience as an auditor in- training under the direction & guidance of an auditor competent as an audit team leader The audits should be completed within the last 3 consecutive years Auditor in both disciplines Same as for Auditor Same as for Auditor 2 years in the second discipline 24 h. of training in the 2 nd discipline Three complete audits for a total of at least 15 days of audit experience in the 2 nd discipline under the direction & guidance of an auditor competent as an audit leader in the 2 nd discipline. The audits should be completed within the last two consecutive years. Audit team leader Same as for Auditor Same as for Auditor Same as for Auditor Same as for Auditor Three complete audits for a total of at least 15 days of audit experience acting in the role of an audit team leader under the direction & guidance of an auditor competent as an audit team leader. (Contd..) Apr 2010 O

57 MAINTENANCE & IMPROVEMENT OF COMPETENCE OF AUDITOR CONTINUAL PROFESSIONAL DEVELOPMENT MAINTENANCE OF AUDITING ABILITY Apr AUDITOR COMPETENCE EVALUATION INITIAL EVALUATION OF AUDITORS WHO WISH TO BECOME AUDITORS AS PART OF THE AUDIT TEAM SELECTION PROCESS CONTINUAL EVALUATION OF AUDITOR PERFORMANCE TO IDENTIFY NEEDS FOR MAINTENANCE & IMPROVEMENT OF KNOWLEDGE & SKILLS Apr 2010 O

58 RELATIONSHIP BETWEEN THE STAGES OF EVALUATION Criteria not met Development of Competence Initial Evaluation Continual Evaluation of Performance Criteria met Auditor Criteria met Criteria not met Not Selected Audit Team Selection Maintenance & Improvement of Competence Auditing Apr 2010 O 115 COMPETENCE EVALUATION PROCESS IDENTIFY PERSONAL ATTRIBUTES, KNOWLEDGE & SKILLS SET EVALUATION CRITERIA (WORK EXPERIENCE, EDUCATION, NUMBER OF AUDITS, HOURS OF AUDIT TRAINING) SELECT APPROPRIATE EVALUATION METHODS (REVIEW OF RECORDS, FEEDBACK, INTERVIEW, OBSERVATION, TESTING, POST AUDIT REVIEW) CONDUCT EVALUATION Apr 2010 O

59 CONFLICT OF INTEREST AUDITORS SHOULD ENSURE THAT THERE IS NO CONFLICT OF INTEREST DURING THE AUDIT. CONFLICT OF INTEREST CAN OCCUR IF AN AUDITOR IS AN INTERESTED PARTY OF THE ORGANIZATION. CONFLICT OF INTEREST CAN ALSO OCCUR IF AUDITOR OR HIS ORGANIZATION HAS PROVIDED ADVICE, GUIDANCE OR CONSULTANCY DURING THE RECENT PAST TO THE AUDITEE ORGANIZATION. Apr WITNESSING OF AUDITORS COVERAGE OF THE STANDARD KEEPING TO THE PROGRAMME KNOWLEDGE OF THE CLIENT S QUALITY SYSTEM RELEVANCE OF AUDITOR S EXPERIENCE QUESTIONING SKILLS PROCESS OF SAMPLE SELECTION HANDLING UNFORESEEN OR DIFFICULT SITUATIONS RAISING NCRs NUMBER OF COMPANY STAFF INTERVIEWED Apr

60 SESSION 3c INTRODUCTION TO AUDITING WHY AND WHAT OF AUDITS AUDIT TERMINOLOGY TYPES OF AUDITS STAGES OF AUDITS PROCESS APPROACH TO AUDITS Apr WHY AUDIT? TO DETERMINE THE HEALTH OF THE UNIT TO CHECK COMPLIANCE TO A STANDARD AND / OR CONTRACTUAL REQUIREMENTS TO DETERMINE THE EFFECTIVENESS OF THE QUALITY SYSTEM TO IDENTIFY AND PRIORITISE AREAS FOR IMPROVEMENT TO ASSESS AN EXISTING OR A POTENTIAL SUPPLIER TO CHECK READINESS FOR CERTIFICATION Apr

61 PRINCIPLES OF AUDITING ETHICAL CONDUCT (TRUST, INTEGRITY, CONFIDENTIALITY, DISCRETION) FAIR PRESENTATION (TRUTHFUL & ACCURATE REPORTING) DUE PROFESSIONAL CARE (DILIGENCE & JUDGMENT IN AUDITING) INDEPENDENCE (INDEPENDENT, FREE FORM BIAS & CONFLICT OF INTEREST OBJECTIVES) EVIDENCE BASED APPROACH (RELIABLE & REPRODUCIBLE AUDIT CONCLUSIONS BASED ON VERIFIABLE EVIDENCE & APPROPRIATE SAMPLING) Apr AUDIT TERMINOLOGY AUDIT SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR OBTAINING AUDIT EVIDENCE AND EVALUATING IT OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH AUDIT CRITERIA ARE FULFILLED AUDIT EVIDENCE RECORDS, STATEMENTS OF FACT OR OTHER INFORMATION WHICH ARE RELEVANT TO THE AUDIT CRITERIA AND VERIFIABLE. AUDIT CRITERIA SET OF POLICIES, PROCEDURES OR REQUIREMENTS, USED AS REFERENCE Apr

62 AUDIT FINDINGS RESULTS OF THE EVALUATION OF COLLECTED AUDIT EVIDENCE AGAINST AUDIT CRITERIA AUDIT CONCLUSION OUTCOME OF AN AUDIT PROVIDED BY THE AUDIT TEAM AFTER CONSIDERATION OF THE AUDIT OBJECTIVES & ALL AUDIT FINDINGS Apr AUDIT PROGRAMME SET OF ONE OR MORE AUDIT PLANNED FOR A SPECIFIC TIME FRAME & DIRECTED TOWARDS A SPECIFIC PURPOSE AUDIT PLAN DESCRIPTION OF THE ACTIVITIES & ARRANGEMENTS FOR AN AUDIT AUDIT SCOPE EXTENT & BOUNDARIES OF AN AUDIT Apr

63 TYPES OF AUDIT INTERNAL AUDITS FIRST PARTY AUDIT AN AUDIT PERFORMED WITHIN AN ORGANIZATION BY THE ORGANIZATION S OWN AUDITING RESOURCES. EXTERNAL AUDIT SECOND PARTY AUDIT AN AUDIT OF CONTRACTORS / SUPPLIERS UNDERTAKEN BY OR ON BEHALF OF A PURCHASING ORGANIZATION. THIS MAY INCLUDE THE AUDIT OF COMPANIES OR DIVISIONS SUPPLYING GOODS OR SERVICES TO OTHERS WITHIN THE SAME GROUP. (ALSO REFERRED TO AS SUPPLIER AUDIT) THIRD PARTY AUDIT AN AUDIT OF AN ORGANIZATION PERFORMED BY A BODY THAT IS INDEPENDENT OF THE ORGANIZATION BEING AUDITED CERTIFICATION BODY OR REGISTRAR.) Apr Auditor roles First, Second and Third party audits Common To conduct audit in a professional and unbaised manner Finding evidence against defined criteria Determining effectiveness of processes and systems Varying First party to determine opportunities for improvements Can give suggestions in the reports Second party to determine capability of auditee s systems to supply products / services Can mutually agree on improvements specific to contract Third Party to determine capability to meet and enhance satisfaction of all customers Apr 2010 O

64 Auditee roles First, Second and Third party audits Common To provide for time and resources for the audit to be conducted Varying Objectives First party To develop internal audit criteria and ensure its implementation To plan and schedule audits based on importance of activities To provide competent and independent internal auditors To take follow up actions on internal audit reports and review findings in management review Second and third party To agree on audit dates, audit plans and auditors To provide guides during audits To agree on improvement actions if non conformances are raised To take follow up actions and report to audit client Apr 2010 O 127 First, Second and Third party audits Audit Client role Common To establish and inform to auditee and auditors Audit criteria which may include statutory / regulatory requirements Expectations from audits Audit procedure and manner of reporting Varying First party Top Management is Audit Client To review audit findings during management review and take decisions for improvements Second party To inform auditee of any contract specific audit criteria To receive a specific evaluation report from the audit team in respect of the terms of contract and / or regulatory requirements To base business decisions on the report findings Third Party To receive a report from the audit team with recommendations To inform decisions on certification or approval as relevant Apr 2010 O

65 STAGES OF AUDIT INITIATING THE AUDIT STAGE 1 AUDIT STAGE 2 AUDIT ONSITE AUDIT ACTIVITIES REPORTING ON THE AUDIT AUDIT COMPLETION AUDIT FOLLOW UP Apr STAGE 1 AUDIT The stage 1 audit shall be performed to audit the client's management system documentation to evaluate the client's location and site-specific conditions to determine the preparedness for the stage 2 audit; to review the client's status and understanding regarding requirements of the standard, to collect necessary information regarding the scope, processes and location(s) of the client, and related statutory and regulatory aspects to review and agree with the client the allocation of resources for stage 2 audit to evaluate if the internal audits and management review are being planned and performed, to estimate the client is ready for the stage 2 audit. Apr

66 STAGE 2 AUDIT To evaluate on site, the implementation, including effectiveness, of the client's management system which includes evidence about conformity to all requirements of ISO 9001 performance monitoring, measuring, reporting and reviewing against key quality objectives and targets compliance to regulatory requirements related to product operational control of the client's processes; internal auditing and management review; management responsibility links among all of the above Apr STAGE 1 TYPICAL STAGES OF AUDIT I. DOCUMENTATION REVIEW REVIEW OF RELEVANT MANAGEMENT SYSTEM DOCUMENTS AND RECORDS, IF REQUIRED, AND DETERMINATION OF THEIR ADEQUACY II. VERIFICATION OF PREPAREDENESS OF AUDITEE (OFF SITE + ON SITE) III. ON-SITE AUDIT CONDUCTING OPENING MEETING COLLECTING AND VERIFYING INFORMATION (COLLECTING AUDIT EVIDENCE) IDENTIFYING AUDIT FINDINGS COMMUNICATION DURING THE AUDIT AUDIT CONCLUSIONS PREPARATION FOR CLOSING MEETING CONDUCTING CLOSING MEETING STAGE 2 Apr

67 AUDITING QMS DOCUMENTATION USE CHECK LIST / MATRIX. CAN BE DONE OFF-SITE BUT ON-SITE REVIEW PREFERRED. SHOULD COVER ALL THE LEVELS OF QUALITY SYSTEM DOCUMENTS; MAY BE RESTRICTED TO QUALITY MANUAL, INITIALLY, IN THIRD PARTY AUDITS FOR CONFIDENTIALITY REASONS. LOOK FOR CLARITY IN UNDERSTANDING AND INTERACTION OF THE PROCESSES ALSO. RAISE NON-CONFORMANCE REPORTS, WHERE REQUIRED Apr PURPOSE OF DOCUMENT AUDIT TO ENSURE THAT THE QMS DOCUMENTATION PROVIDES ADEQUATE CONFIDENCE AND PROVIDES SCOPE FOR CONTINUAL IMPROVEMENT TO HELP IN PLANNING FOR ON-SITE AUDIT TO IDENTIFY SHORT-COMINGS AND INADEQUACIES IN THE QMS AND THE QMS DOCUMENTATION TO IDENTIFY THE LOGISTICS DURING THE ON-SITE AUDIT TO TAKE INTO CONSIDERATION THE SIZE, NATURE AND COMPLEXITY OF ORGANIZATION BASED ON THE SCOPE OF THE AUDIT Apr

68 DOCUMENTATION REVIEW MATRIX I SO 9001 REQUIREM EN TS 5.1 MANAGEMENT COMMITMENT 5.2 CUSTOM ER FOCUS 5.3 QUALI TY POLI CY 5.4 PLANNING 5.5 RESPONSI BI LI TY, AUTHORITY AND COMMUNICATION D OCUM EN TATION THAT ADD RESSES THI S RQUIREM ENT QUAITY M AN UAL PROCED URE OTHERS Apr O PROCESS APPROACH TO AUDITING AUDIT PLAN includes all activities applicable to the scope of audit and ISO 9001 enables audit trails to be established from top level policy to all relevant functions and levels enables links to be established between policy, objectives, targets, monitoring and continual improvement. reflects the structure, sequence and interrelationship of processes is sufficiently flexible enables objective evidence to be gathered to verify activities and results. reflects the organization's goals and priorities. Apr 2010 O

69 PROCESS APPROACH TO AUDITING Conducting the audit Verify that the purpose, inputs, outputs, controls and resources for each process are clear. links are established between processes and high level and local quality objectives. outputs are compared with purpose, desired outcomes and specific quality objectives of the process. steps in the process and associated responsibilities are determined, where necessary. inter relating processes are identified and process measures are identified. evidence of continual improvement is available needs of internal and external customers are clear. Apr 2010 O 137 SESSION 3d AUDIT RESPONSIBILITIES Roles and responsibilities of the auditor, auditee, client, lead auditor, guides and observers, in accordance with ISO Management responsibilities of the Lead Auditor Effective communication with the auditee Auditor confidentiality. The IRCA code of conduct Apr

70 WHO ARE INVOLVED IN AN AUDIT AUDITOR : A PERSON WITH THE COMPETENCE TO CONDUCT AN AUDIT AUDITEE : ORGANIZATION BEING AUDITED AUDIT CLIENT : ORGANIZATION OR PERSON REQUESTING AN AUDIT Apr WHO ARE INVOLVED IN AN AUDIT (Continued( Continued) AUDITOR : A PERSON WHO IS COMPETENT AND IS AUTHORISED TO PERFORM ALL OR ANY PORTION OF QUALITY SYSTEM AUDIT LEAD AUDITOR : AN AUDITOR WHO IS COMPETENT AND IS AUTHORIZED TO MANAGE A QUALITY SYSTEM AUDIT Apr

71 WHO ARE INVOLVED IN AN AUDIT (Continued( Continued) AUDIT TEAM : ONE OR MORE AUDITORS CONDUCTING AN AUDIT SUPPORTED IF NEEDED BY TECHNICAL EXPERTS TECHNICAL EXPERT : A PERSON WHO PROVIDES SPECIFIC KNOWLEDGE OR EXPERTISE TO THE AUDIT TEAM: Does not act as auditor Apr ROLE OF LEAD AUDITOR LEAD THE THE TEAM OF AUDITORS REPRESENT THE AUDIT CLIENT (CERTIFICATION BODY) MANAGE THE AUDIT ACTIVITIES REPORT AUDIT FINDINGS TO AUDIT CLIENT Apr

72 MANAGEMENT RESPONSIBILITIES OF LEAD AUDITOR NEGOTIATE THE AUDIT SCOPE SELECTION OF AUDIT TEAM DIRECT THE AUDIT TEAM MEMBERS PLANNING THE AUDIT & MAKE EFFECTIVE USE OF RESOURCES REPRESENTING THE AUDIT TEAM MANAGING THE AUDIT REVIEW OF AUDIT TEAM S WORK PREVENT & RESOLVE CONFLICTS TO LEAD THE AUDIT TEAM TO REACH AUDIT CONCLUSIONS PREPARATION OF THE REPORT CONTROL OF THE OPENING AND CLOSING MEETINGS SUBMISSION OF THE REPORT Apr ROLE OF AUDITOR COMMUNICATING AUDIT REQUIREMENTS TO THE AUDITEE CONDUCTING AUDIT DOCUMENTING OBSERVATIONS WITH EVIDENCE VERIFYING THE EFFECTIVENESS OF THE QUALITY SYSTEM REPORTING RESULTS TO THE LEAD AUDITOR CO-OPERATING WITH AND ASSISTING LEAD AUDITOR Apr

73 ROLE OF AUDITEE PRE - AUDIT DURING THE AUDIT POST AUDIT Apr ROLE OF AUDITEE PRE - AUDIT 1. SELECT AUDITING AGENCY, BASED ON EXPERIENCE, ACCREDITATION IN COUNTRIES OF INTEREST AND REPUTATION. 2. LIASE WITH AUDITING / CERTIFYING AGENCY TO PROVIDE REQUIRED INFORMATION (VERBAL AND WRITTEN) 3. AGREE ON SCOPE FOR AUDIT AND THE NOMINATED TEAM. 4. AGREE ON SUITABLE DATES FOR THE AUDIT ACTIVITY AND SITES TO BE VISITED. 5. AGREE TO PROVIDE LOGISTIC ASSISTANCE DURING AUDIT 6. DECIDE ON THOSE WHO WILL ATTEND THE OPENING AND CLOSING MEETINGS 7. INFORM ALL STAFF REGARDING THE AUDIT Apr O 73

74 DURING THE AUDIT ROLE OF AUDITEE 1. PROVIDE OFFICE FACILITIES FOR OPENING AND CLOSING MEETINGS, AND ALSO FOR LIASION MEETINGS OF AUDITORS 2. PROVIDE GUIDES 3. SEEK CLARIFICATIONS, IN CASE OBSERVATIONS, ATTRIBUTIONS OR EXPLANATIONS OF THE AUDITORS ARE NOT CLEARLY UNDERSTOOD 4. ENSURE RELEVANT PEOPLE FROM MANAGEMENT ARE PUNCTUAL FOR ALL MEETINGS 5. INFORM MANAGEMENT OF ANY MAJOR NON-CONFORMITY OBSERVED BY THE AUDITORS 6. COOPERATE WITH THE AUDITORS, AGREE TO NON-CONFORMITIES AND COMMIT TO TIMELY CORRECTIVE ACTIONS Apr ROLE OF AUDITEE POST AUDIT 1. IDENTIFY CAUSES FOR THE NON-CONFORMITY. 2. IDENTIFY THE CORRECTIVE ACTION ON THE CAUSES OF THE NON-CONFORMITY. 3. PROPOSE TIME-BOUND CORRECTIVE ACTIONS, AND SEEK AGREEMENT WITH AUDITORS (IN CASE REQUIRED). 4. IMPLEMENT THE CORRECTIVE ACTION 5. VERIFY THE EFFECTIVENESS OF THE ACTIONS, THROUGH INTERNAL AUDITS, INFORM AUDITORS ABOUT SATISFACTORY COMPLETION OF CORRECTIVE ACTIONS Apr 2010 O

75 ROLES & RESPONSIBILITIES OF GUIDES SHOULD ASSIST THE AUDIT TEAM SHOULD ACT ON REQUEST OF THE LEAD AUDITOR OTHER RESPONSIBILITIES : ESTABLISH CONTACTS &TIMINGS FOR INTERVIEWS ARRANGE VISITS TO SPECIFIC SITES ENSURE RULES CONCERNING SAFETY ARE FOLLOWED BY AUDITORS WITNESS THE AUDIT ON BEHALF OF AUDITEE IF REQUIRED PROVIDE CLARIFICATION OR ASSIST IN COLLECTING INFORMATION GUIDES & OBSERVERS MAY ACCOMPANY THE AUDIT TEAM BUT ARE NOT PART OF IT Apr GUIDE TO THE GUIDE MUST HAVE GOOD KNOWLEDGE ON THE STANDARD MUST HAVE GOOD KNOWLEDGE OF QMS, IN THE AREA OF AUDIT MUST HAVE OVERALL UNDERSTANDING OF QMS OF THE COMPANY MUST BE TACTFUL AND COURTEOUS ACKNOWLEDGE NOT KNOWING AN ANSWER MUST BUILD RAPPORT WITH AUDITOR WITNESS TO THE OBSERVATION MUST BE BRIEF AND PRECISE SHOULD HELP THE AUDITOR IN FACILITIES NOT TO ARGUE WITH THE AUDITOR NOT TO VOLUNTEER OPINIONS AUDITORS SHOULD FIND THE NON-CONFORMANCES; IT IS NOT FOR THE GUIDES TO PROVIDE THEM Apr

76 COMMUNICATION WITH AUDITEE DURING AUDITS, TEAM LEADER SHOULD COMMUNICATE TO THE AUDITEE PROGRESS & CONCERNS EVIDENCE SUGGESTING SIGNIFICANT RISKS ISSUES OUTSIDE AUDIT SCOPE WHERE AUDIT OBJECTIVES ARE UNATTAINABLE REPORT REASONS TO AUDITEE & CLIENT RECONFIRM / MODIFY AUDIT PLAN CHANGE AUDIT OBJECTIVES, SCOPE OR TERMINATE AUDIT Apr CONFIDENTIALITY AUDITORS HAVE TO ENSURE THAT THE INFORMATION RECEIVED OR REVIEWED BY ANY MEANS DURING THE AUDIT SHALL NOT BE DISCLOSED TO ANY PARTY OR PERSON NOT RELATED TO THE AUDIT UNLESS AGREED TO BY THE PARTIES CONCERNED. THIS IS ESSENTIAL SINCE CONFIDENTIAL AND SENSITIVE INFORMATION MAY BECOME ACCESSIBLE TO THE AUDITORS DURING THE AUDIT Apr