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ISO 9001:2015 QUALITY MANAGEMENT SYSTEM STANDARD REQUIREMENTS TRAINING.

TRAINING AGENDA. 3. INTRODUCTION (TRAINEE & TRAINER) WHAT IS MANAGEMENT SYSTEM ? ISO 9001 HISTORY ISO 9000 FAMILY ISO 9001:2015 TRANSITION TIME LINE ISO 9001:2015 STANDARD GUIDE MAP TRAINING FEEDBACK/CASE STUDY/Q & A.

WELCOME TO PARTICIPANTS. 4. TRAINING PARTICIPANTS LEAD/CORE TEAM.

WHAT IS MANAGEMENT SYSTEM. 5. A well-designed and well-implemented quality management system can and should Eliminate Ineffectiveness Inefficiencies Problems Errors Variations Uncertainties Bad culture.

WHAT TRANSITION BRING. 6. What does the 2015 revision bring to the QMS? Better integration with other business activities Enhancement of the process approach and PDCA cycle Decentralization of the system and spread of responsibilities for the QMS throughout the organization Greater involvement of the top management in the QMS Introduction of risk-based thinking in the QMS Higher emphasis on performance monitoring.

WHAT IS QC, QA, QMS. 7. QUALITY CONTROL (PRODUCT FOCUS) QUALITY ASSURANCE(PROCESS FOCUS) QUALITY MANAGEMENT SYSTEM (PERFORMANCE FOCUS).

ISO 9001 HISTORY. 8. YEAR STANDARDS TITLE 1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS 1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS 1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE 1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING 1987 ISO 9001:1987 MODEL FOR QUALITY ASSURANCE IN DESIGN, DEVELOPMENT, PRODUCTION, INSTALLATION, AND SERVICING ISO 9002:1987 MODEL FOR QUALITY ASSURANCE IN PRODUCTION, INSTALLATION, AND SERVICING ISO 9003:1987 MODEL FOR QUALITY ASSURANCE IN FINAL INSPECTION AND TEST 1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE 2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS 2015 ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS.

ISO 9001 HSITORY. 9. History of Quality Management System Standards 1959 United States De artment of Defense -Q-9858 standard 1969 1974 BSI published the BS 5179 series of guidance standards 1979 1987 ISO published the ISO 9000 standard 2000 2008 Third revision of the ISO 9001 standard MIL-Q-9858 was revised BSIpub1ished the BS 5750 Second revision of the standard and merging of ISO 9002 and ISO 9003 into ISO 9001 1959 into the NATO AQAP series of standards 1974 series of standards and submitted them to ISO 1994 First revision of the ISO 9000 standard September 2015 Current version of the ISO 9001 standard 1980 1987 1990 1994 2000 2015.

ISO 9000 FAMILY. 10. ISO 9000 FAMILY ISO 9001:2015 (Quality Management Systems – Requirements) ISO 9000:2016 ( Fundamentals and vocabulary) ISO 19011:2016 (Guidelines for auditing management systems) ISO 9004:2009 (Managing for the sustained success of an organization — A quality management approach).

TRANSITION TIME LINE. 11. Proposal Stage May-June 2012 Preparatory Stage June-October 2012 Committee Stage (CD) June-September 2013 Enqui%tage May-October 2014 ISO 9001 revision Approval Stage (FINS) July 2015 Publication September 2015 CURRENT.

ISO 9001:2015 STANDARD CLAUSES. 12. 1-Scope 2-Normative References 3-Terms & Definitions 4-Context of Organization 5-Leadership 6-Planning 7-Support 8-Operation 9-Performance Evaluation 10-Improvement.

ISO 9001:2008 VS ISO 9001:2015 STANDARD CLAUSES. 13.

GENERAL COMPARISON 2008/2015. 14. Old 2008 revision 8 principles 8 clauses 6 mandatory procedures mandatory records New 2015 revision 7 principles 10 clauses 6 mandatory documents (not necessarily procedures) 26 mandatoryxecords.

ISO 9001:2015 DEGREE OF CHANGE. 15. E MOST IMPORTANT AREAS Risks and opportunities Context of the organization Interested parties Control of extemally provided processes, products and services Quality objectives and plans for achieving them Design and development Performance evaluation Document management Production and service provision QMS sco e Quality Policy Leadership Competence, training and awareness Management review Internal audit Corrective action.

MAJOR COMPARISON OF 2015/2008. 16. New requirements in ISO 9001:2015 revision • Context of the organization (Clause 4) • Actions to address risks and opportunities (Clause 6.1) Requirements from ISO 9001:2008 revision that are gone • Quality Manual • Management representative • Preventive action.

TERMINOLOGY COMPARISON IN 2008/2015. 17. ISO 9001:2008 ISO 9001:2015 Products Products and Services Exclusions Not Used Management Representative Not Use, Similar responsibilities and authorities are assigned but no requirement for a single management representative Documentation, Quality Manual, documented Procedures, Records Documented Information Work Environment Environment for the Operation of Process Monitoring & Measuring Equipment Monitoring & Measuring Resources Purchased Product Externally Provided Product& Services Supplier External Provider.

ISO 9001:2015 STANDARD CLAUSE 1.0 ~ 4.0. 18. 1 Scope 2 Normative References 3 Terms & Definitions 4 Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of your quality management system 4.4 Quality Management System & its Processes.

GENERAL PROCESS FLOW CHART. 19. Customer Orders Customer Orders Requirements Review Production Capacity & Target Review Raw & Packing Materials Review Production & Planning Production Inspection & Testing Product Identification Packing & Shipping Shipped Products to Customer.

ISO 9001:2015 STANDARD CLAUSE 1.0 ~ 4.0. 20. Quality Management System 1.0 Scope 2.0 Normative Reference 3.0 Terms & Definition 4.0 Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of your quality management system 4.4 Quality Management System & its Processes.

INTERNAL INTERESTED PARTIES NEEDS/EXPECTATIONS. 21.

EXTERNAL INTERESTED PARTIES NEEDS/EXPECTATIONS. 22.

INTERESTED PARTIES INTERNAL ISSUES. 23. Structure of the organization, Roles within the organization Availability of reliable, qualified and competent workforce Stability of workforce, Staff retention & Staff training levels External providers competence and availability Culture within the organization Working hours & Staff morale ,Internal politics Governance, Policies, objectives Strategies, Capabilities, Resources, Knowledge General competence, Technologies Information systems, Decision making processes Relationships with interested parties like employee Perceptions/values of interested parties Standards, guidelines and models adopted Contractual relationships, Social customs, Management’s abilities Priorities, Database skills, Root cause analysis abilities Improvement tools and abilities to apply Project management expertise – new offices Understanding and experience in implementing ISO 9001 Co-operation of workforce.

INTERESTED PARTIES EXTERNAL ISSUES. 24. Contractual arrangements, Competitive environment Legislation, e.g. employment of non-nationals Regulation within the industry generally Overall competition within the recruitment sector Overall economic climate in the country Countries environmental requirements affecting products/service, Technology advances Standardization and certification within the industry Client consideration of bringing expertise in-house Client working environment other trades working alongside us, Client configuration changes during installation Relationships with external interested parties like customer, supplier, contractor Perceptions/values of external interested parties Workforce culture within the sector and country Construction delays, External inspections/audits Competitors ceases trading, Availability of raw materials Power cuts in countries Availability of external providers – machinery maintenance etc..

PROCESS APPROACH. 25. Process: “A series of actions or steps taken in order to achieve a particular end.” OR A process is a set of interrelated or interacting activities that transforms inputs into outputs..

PLAN(4,5,6,7),DO(8),CHECK(9),ACT(10) (PDCA)CYCLE.

ISO 9001:2015 STANDARD CLAUSE 5.0(5.1~5.3). 27. Leadership 5.1 Leadership & Commitment 5.1.1 General 5.1.2 Customer Focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles,responsibilities and authorities.

ISO 9001:2015 STANDARD CLAUSE 5.0. 28. 5.0 Leadership 5.1 Leadership & Commitment 5.1.1 General 5.1.2 Customer Focus 5.2 Policy 5.3 Organizational Roles, Responsibilities & Authorities 5.2.1 Developing the Quality Policy 5.2.2 Communicating the Quality Policy.

LEADERSHIP APPROACH. 29. Leadership Communications Strategy People = Traction Customers = Focus Feedback Coaching: Directs, Boss, Team Engagement Course: Vision, Mission, Core Values, Key Objectives, RRATE Expectations Accountability = Em-POWER-ment.

ISO 9001:2015 STANDARD CLAUSE 6.0(6.1~6.3). 30. 6 Planning 6.1 Actions to address risks and Opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes.

ISO 9001:2015 STANDARD CLAUSE 6.0. 31. 6.0 Planning 6.1 Actions to address risks and Opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes.

QUALITY RISKS. 32. RAW MATERIALS WORKERS MACHINES OTHER PROBLEMS.

HSE RISKS. 33. Hazards Fire Explosion • Natural hazards • Hazardous materials • spill or release Terrorism • • Workplace violence Pandemic disease • • Utility outage • Mechanical breakdown Supplier failure • Cyber attack Hazard Identification Assets at Risk People • Property including • buildings, critical infrastructure Supply chain • • Systems/equipment Information Technology • Business operations • Reputation of or • confidence in entity Regulatory and • contractual obligations • Environment Vulnerability Assessment Impacts Casualties • • Property damage Business interruption • Loss of customers • Financial loss • Environmental • contamination Loss of confidence in • the organization Fines and penalties • Lawsuits • Impact Analysis.

RISK ANALYSIS FOR INTERNAL ISSUES. 34. ISSUES (INTERNAL) EXPECTED RESULTS UNCERTAINTY RISK(-VE) H/M/L OPPORTUNITIES Availability of reliable, qualified, competent and multi-skilled workforce Work force is Competent Existing Workforce not all skilled M Opportunity to multi-skilled installation teams — impact on installation times Culture within the organization – work quality Work force is motivated Unacceptable quality of work H Opportunity for top Managers to lead. Work Force retention- Wage Work force are loyal to the organization Work force leaving for better paid work H Opportunity to benchmark our Competitors wages.

RISK ANALYSIS FOR EXTERNAL ISSUES. 35. ISSUES (EXTERNAL) EXPECTED RESULTS UNCERTAINTY RISK (-VE) H/M/L OPPORTUNITIES Client working environment – other trades working alongside us Integrated is protected Damage to our installation H Opportunity to place barriers, floor markers, signs for clear identification Standardization and certification within the industry – not conforming Being upto date and informed on standards Code of practices are changing all the time L Opportunity for designers to attend free update trade body conference Client Consideration – bringing expertise in-house Work force remain loyal to the organization Workforce for managed on-site contracts being employed direct by clients H Opportunity for new contract clause prohibiting employment (time-bound).

QUALITY OBJECTIVES. 36. Quality Objectives -Achievement Plan S.No Strategy for Achievement Responsibility Target Date Completion Date 1 Approval from Business Unit Head for establishment of Quality Enhancement Cell (QEC). Quality Council Members 2 Preparation, Selection and Communication of Quality Council Members (QCM) List. Quality Council Members 3 Functioning of Quality Council Members (QCM) Quality Council Members 4 Reviewing of Existing Quality Management System Quality Council Members 5 Suggestions/Recommendations to improve the Quality Management System Quality Council Members 6 Compilation of data Quality Council Members 7 Incorporation of data in Quality Management System. Quality Council Members 8 Issuance & Implementation of Recommended data. Quality Council Members 9 Evaluation of Recommended data. Quality Council Members.

ISO 9001:2015 STANDARD CLAUSE 7.0(7.1). 37. 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring & measuring resources 7.1.5.1 General 7.1.5.2 Measurement Traceability 7.1.6 Organizational Knowledge.

ISO 9001:2015 STANDARD CLAUSE 7.0(7.2~7.5). 38. 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.5.1 General 7.5.2 Creating & Updating 7.5.3 Control of Documented Information.

ISO 9001:2015 STANDARD CLAUSE 7.0. 39. 7.0 Planning 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for Operation of Process 7.1.5 Monitoring& Measuring Resources 7.1.6 Organizational Knowledge 7.5.1 General 7.5.2 Creating & Updating 7.5.3 Control of Documented Information 7.1.5.1 General 7.1.5.2 Measurement Traceability.

DOCUMENTED INFORMATION PLANNING. 40. 7.5.2 Creating Documentation.

ISO 9001:2015 GENERAL FORMS USE TIPS. 41. NEW DOCUMENT REQUEST FORM This form will be used if you want to create/define new document DOCUMENT CHANGE FORM This form will be used if you want to change in existing document NON-CONFORMITY FORM This form will be used if any violation/non-conformity in system QUALITY OBJECTIVE FORM This form will be used if you have not access/facility in success factor(optional) INTERNAL AUDIT CORRECTIVE ACTION FORM This form will be used if any non-conformity in internal quality audit QUALITY RISK ASSESSMENT FORM This form will be used to define the quality risks of your respective department TRAINING NEED ASSESSMENT FORM This form will be used if you want to conduct training need assessment TRAINING EVALUATION FORM This form will be used after training effectiveness verification TRAINING ATTENDANCE FORM This form will be used if you record the internal training attendance CUSTOMER COMPLAINT FORM This form will be used for customer complaints.

ISO 9001:2015 STANDARD CLAUSE 8.0,8.1 & 8.2. 42. 8 Operations 8.1 Operational Planning & Control 8.2 Requirements for Products & Services 8.2.1 Customer Communication 8.2.2 Determining the requirements related to Product & Services 8.2.3 Review of requirements related to Products & Services 8.2.4 Changes to Requirements for Products & Services.

ISO 9001:2015 STANDARD CLAUSE 8.2. 43. 8.2 Requirements of Product/Service 8.2.1 Customer Communication 8.2.2 Determining Requirement related to Product/Service 8.2.3 Review of Requirement related to Product/Service 8.2.4 Changes to Requirement for Product/Service.

ISO 9001:2015 STANDARD CLAUSE 8.3. 44. 8.3 Design & Development of Products & Services 8.3.1 General 8.3.2 Design & Development Planning 8.3.3 Design & Development Inputs 8.3.4 Design & Development Controls 8.3.5 Design & Development Outputs 8.3.6 Design & Development Changes.

ISO 9001:2015 STANDARD CLAUSE 8.3. 45. 8.3 Design & Development of Product/Service 8.3.1 General 8.3.2 Design & Development Planning 8.3.3 Design & Development Inputs 8.3.4 Design & Development Control 8.3.5 Design & Development Output 8.3.6 Design & Development Changes.

ISO 9001:2015 STANDARD CLAUSE 8.4~8.7. 46. 8.4 Control of externally provided Processes, Products, And Services 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers 8.5 Production & service provision 8.5.1 Controls of production and service provision 8.5.2 Identification & traceability 8.5.3 Property belonging to customer or external providers 8.5.4 Preservation 8.5.5 Post delivery activities 8.5.6 Control of changes 8.6 Release of products & services 8.7 Control of non-conforming outputs.

ISO 9001:2015 STANDARD CLAUSE 8.4. 47. 8.4 Control Externally Provided Processes, Products/Services 8.4.1 General 8.4.2 Type & Extent of Control 8.4.3 Information for External Providers.

ISO 9001:2015 STANDARD CLAUSE 8.5. 48. 8.5 Production & Services Provision 8.5.1 Controls of production and service provision 8.5.2 Identification & traceability 8.5.3 Property belonging to customer or external providers 8.5.4 Preservation 8.5.5 Post delivery activities 8.5.6 Control of changes.

ISO 9001:2015 STANDARD CLAUSE 9.0(9.1 ~ 9.3). 49.

ISO 9001:2015 STANDARD CLAUSE 9.0. 50. 9.0 Performance Evaluation 9.1 Monitoring, Measurement, Analysis & Evaluation 9.1.1 General 9.1.2 Customer Satisfaction 9.2 Internal Audit 9.3 Management Review 9.1.3 Analysis & Evaluation 9.3.1 General 9.3.2 Management Review Inputs 9.3.3 Management Review Outputs.