"Understanding Context of Organisation Clause as per ISO 9001:2015 and ISO 14001:2015"

"Understanding Context of Organisation Clause as per ISO 9001:2015 and ISO 14001:2015" PMI, PMP, PMBOK and the PMI Registered Education Provider logo are registered marks of the Project Management Institute, Inc. 2016 3FOLD Education Centre. All rights reserved. online@3foldtraining.com. www.3foldtraining.com. 800 3FOLD

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Learning Outcomes QUALITY MANAGEMENT PRINCIPLES BRIEF ON ISO 9001:2015 BRIEF ON ISO 14001:2015 LIFE CYCLE ANALYSIS CONTEXT OF ORGANISATION INTERESTED PARTIES ANALYSIS NEEDS AND EXPECTATION OF INTERESTED PARTIES Q/A 01/09/2016 3 2016 3FOLD Education Centre. All rights reserved. online@3foldtraining.com. www.3foldtraining.com. 800 3FOLD

QUALITY MANAGEMENT PRINCIPLES

HIGH LEVEL STRUCTURE THE NEW STANDARD ADOPTS THE HIGH-LEVEL STRUCTURE AND TERMINOLOGY OF ANNEX SL (USED FOR THE DEVELOPMENT OF ALL NEW ISO STANDARDS) HIGH LEVEL STRUCTURE - IDENTICAL CORE TEXT AND COMMON TERMS AND CORE DEFINITIONS FOR USE IN ALL MANAGEMENT SYSTEM STANDARDS: PURPOSE - ENHANCE THE CONSISTENCY AND ALIGNMENT OF DIFFERENT MANAGEMENT SYSTEM STANDARDS ORGANISATIONS THAT INTEGRATE MULTIPLE STANDARDS (EG QMS, EMS, OHS) WILL SEE THE MOST BENEFIT USES SIMPLIFIED LANGUAGE AND WRITING STYLES TO AID UNDERSTANDING AND CONSISTENT INTERPRETATIONS OF REQUIREMENTS.

WHAT ARE THE CHANGES? NEW CONCEPTS ARE CONSIDERED - MORE RISK BASED THINKING A NEW COMMON ISO FORMAT HAS BEEN DEVELOPED FOR USE ACROSS ALL MANAGEMENT SYSTEM STANDARDS A SIGNIFICANT RE-ORDERING OF THE KEY CLAUSES.

COMMON STRUCTURE FOR MSS INTRODUCTION 1. SCOPE 2. NORMATIVE REFERENCES 3. TERMS AND DEFINITIONS 4. CONTEXT OF THE ORGANISATION 5. LEADERSHIP 6. PLANNING 7. SUPPORT 8. OPERATION 9. PERFORMANCE EVALUATION 10. IMPROVEMENT.

CLAUSE STRUCTURE (4-6) 4. CONTEXT OF THE ORGANISATION UNDERSTANDING THE ORGANISATION AND ITS CONTEXT UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES DETERMINING THE SCOPE OF THE XXX MANAGEMENT SYSTEM XXX MANAGEMENT SYSTEM 5. LEADERSHIP LEADERSHIP AND COMMITMENT POLICY ORGANISATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES 6. PLANNING ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES OBJECTIVES AND PLANS TO ACHIEVE THEM.

CLAUSE STRUCTURE (7-10) 7. SUPPORT RESOURCES COMPETENCE AWARENESS COMMUNICATION DOCUMENTED INFORMATION 8. OPERATION OPERATIONAL PLANNING AND CONTROL 9. PERFORMANCE EVALUATION MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION INTERNAL AUDIT MANAGEMENT REVIEW 10. IMPROVEMENT NONCONFORMITY AND CORRECTIVE ACTION CONTINUAL IMPROVEMENT.

CONTEXT OF ORGANISATION AS PER ISO 9000, THE DEFINITION OF CONTEXT OF THE ORGANIZATION IS BUSINESS ENVIRONMENT, COMBINATION OF INTERNAL AND EXTERNAL FACTORS AND CONDITIONS THAT CAN HAVE AN EFFECT ON AN ORGANIZATION S APPROACH TO ITS PRODUCTS, SERVICES AND INVESTMENTS AND INTERESTED PARTIES. THE NOTE STATES THAT THIS CONCEPT OF CONTEXT OF ORGANIZATION IS EQUALLY APPLICABLE TO NOT FOR PROFIT ORGANIZATION, PUBLIC SERVICE ORGANIZATION AND GOVERNMENTAL ORGANIZATION. ALSO IN NORMAL LANGUAGE THIS CONCEPT IS ALSO KNOWN AS BUSINESS ENVIRONMENT, ORGANIZATIONAL ENVIRONMENT OR ECOSYSTEM OF AN ORGANIZATION. 01/09/2016 1 2016 3FOLD Education Centre. All rights reserved. online@3foldtraining.com. www.3foldtraining.com. 800 3FOLD 0

ISO/TC 176/SC 2/ N1282 The common structure and ISO 9001:2015 additions 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 10 Improvement 4.1 Understanding context 5.1 Leadership and commitment 6.1 Risks and opportunities 7.1 Resources 8.1 Operational planning and control 9.1 Monitoring, measurement, analysis and evaluation 10.1 General 4.2 Interested parties 5.2 Policy 6.2 Planning 7.2 Competence 9.2 Internal audit 10.2 Nonconformity and corrective action 4.3 Scope 4.4 QMS 5.3 Organizational roles, responsibilities and authorities 7.3 Awareness 7.4 Communication 9.3 Management review 10.3 Continual improvement 7.5 Documented information 12 Date: 12

ISO/TC 176/SC 2/ N1282 The common structure and ISO 9001:2015 additions 8 Operation 8.1 Operational planning and control 13 Date: 13

ISO/TC 176/SC 2/ N1282 4 Context of organization 5 Leadership Plan 6 Planning 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 9.2 Internal audit 9.3 Management review 7.5 Documented information 14 Date: 14

PROCESSES IN OPERATION OF QUALITY MANAGEMENT SYSTEM

0.4 PLAN-DO-CHECK-ACT MODEL 2004 Introduction

SECTION 4 CONTEXT OF THE ORGANISATION 2004 No direct equivalent

4 CONTEXT OF THE ORGANISATION THIS IS A NEW CLAUSE AND PROVIDES A KEY INSIGHT INTO THE ORGANISATION WHAT CONSTITUTES THE ORGANISATION S ENVIRONMENTAL MANAGEMENT SYSTEM. 2004 No direct equivalent

4 CONTEXT OF THE ORGANISATION 4.1 UNDERSTANDING THE ORGANISATION AND ITS CONTEXT 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 4.3 DETERMINING THE SCOPE OF THE ENVIRONMENTAL MANAGEMENT SYSTEM 4.4 ENVIRONMENTAL MANAGEMENT SYSTEM AND ITS PROCESSES DETERMINE EXTERNAL AND INTERNAL ISSUES RELEVANT TO THE EMS INCLUDING POSSIBLE ENVIRONMENTAL CONDITIONS. 2004 No direct equivalent

4 CONTEXT OF THE ORGANISATION 4.1 UNDERSTANDING THE ORGANISATION AND LIST CONTEXT 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 4.3 DETERMINING THE SCOPE OF THE ENVIRONMENTAL MANAGEMENT SYSTEM 4.4 ENVIRONMENTAL MANAGEMENT SYSTEM DETERMINE INTERESTED PARTIES RELEVANT TO THE EMS DETERMINE THEIR NEEDS AND EXPECTATIONS WHICH ONES ARE COMPLIANCE OBLIGATIONS. 2004 No direct equivalent

4 CONTEXT OF THE ORGANISATION 4.1 UNDERSTANDING THE ORGANISATION AND LIST CONTEXT 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 4.3 DETERMINING THE SCOPE OF THE ENVIRONMENTAL MANAGEMENT SYSTEM 4.4 ENVIRONMENTAL MANAGEMENT SYSTEM ESTABLISH SCOPE BY DETERMINING BOUNDARIES AND APPLICABILITY OF THE EMS CONSIDER EXTERNAL/INTERNAL ISSUES, COMPLIANCE OBLIGATIONS, FUNCTION AND PHYSICAL BOUNDARIES, ACTIVITIES, PRODUCTS AND SERVICES, ABILITY TO CONTROL SCOPE MUST BE DOCUMENTED AND AVAILABLE TO INTERESTED PARTIES. 2004 clause 4.1

4 CONTEXT OF THE ORGANISATION 4.1 UNDERSTANDING THE ORGANISATION AND LIST CONTEXT 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 4.3 DETERMINING THE SCOPE OF THE ENVIRONMENTAL MANAGEMENT SYSTEM 4.4 ENVIRONMENTAL MANAGEMENT SYSTEM SAME AS PREVIOUS VERSION BUT INTRODUCES INTERACTIONS BETWEEN PROCESSES EMS MUST INCLUDE EXTERNAL/INTERNAL ISSUES AND COMPLIANCE OBLIGATIONS. 2004 clause 4.1

INTERESTED PARTIES ORGANIZATIONS ARE RRQUIRED TO UNDERSTAND THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES. IT IS A MANDATORY REQUIREMENT OF THE MANAGEMENT SYSTEMS STANDARDS

INTERESTED PARTIES STAKEHOLDERS ARE REFERRED TO SYNONYMOUSLY AS INTERESTED PARTIES BY ISO MANAGEMENT SYSTEMS STANDARDS ISO 9000 STATES THEIR IMPORTANCE CLEARLY: ORGANIZATIONS ATTRACT, CAPTURE AND RETAIN THE SUPPORT OF THE RELEVANT INTERESTED PARTIES THEY DEPEND UPON FOR THEIR SUCCESS.

STEP 1 IDENTIFY RELEVANT INTERESTED PARTIES. USE THE EXAMPLES FROM THE ISO MANAGEMENT SYSTEMS STANDARDS, 6 MARKET MODEL AND CATEGORIZED LIST OF YOUR INTERESTED PARTIES. CREATE A TABLE WITH A COLUMN FOR INTERESTED PARTIES, ADD COLUMNS FOR NEEDS AND EXPECTATIONS, POWER/INTEREST AND OBJECTIVES.

6 MARKET MODEL

STEP 2 DETERMINE THEIR NEEDS AND EXPECTATIONS. USE DIFFERENT RESEARCH METHODS AS NECESSARY TO CONFIRM YOUR KNOWLEDGE OF EACH GROUP OR SIGNIFICANT STAKEHOLDER. SUMMARIZE THE FINDINGS AND ADD THEM TO THE RELEVANT COLUMN IN YOUR TABLE OF INTERESTED PARTIES.

STEP 3 RANK THEM IN TERMS OF POWER AND INTEREST: CONSIDER THEIR STRENGTH OF INTEREST AND LEVEL OF INFLUENCE OVER YOUR DECISIONS AND ACTIONS. PLOT THEM IN THE POWER/INTEREST MATRIX TO DETERMINE THEIR RANK. ADD THE RANK TO THE RELEVANT COLUMN IN YOUR TABLE OF INTERESTED PARTIES..

POWER V/S INTEREST POWER Keep Satisfied Manage Closely Monitor Keep Informed INTEREST POWER : HOW MUCH POWER OR INFLUENCE DO THEY HAVE OVER YOUR DECISIONS AND ACTIVITIES? THIS COULD BE INTERPRETED AS THEIR SIGNIFICANCE OR RISK. INTEREST : HOW MUCH INTEREST DO THEY HAVE IN YOUR DECISIONS AND ACTIVITIES? THIS COULD BE INTERPRETED AS THE STRENGTH OF THEIR RELEVANCE.

STEP 4 SET OBJECTIVES AND PRIORITIES. DEFINE WHAT RESULTS ARE NECESSARY TO DELIVER TO THOSE RELEVANT INTERESTED PARTIES TO REDUCE THE RISK THAT THEIR NEEDS AND EXPECTATIONS ARE NOT MET. SET SMART OBJECTIVES WHEREVER POSSIBLE AND DOCUMENT THEM IN THE TABLE OF INTERESTED PARTIES.

INTERESTED NEEDS AND PI RANK OBJECTIVES PRIORITY PARTY EXPECTATION CUSTOMERS QUALITY KEEP ACHIEVE HIGH PRODUCTS SATISFIED EXPECTED SALES

PESTLE ANALYSIS THE PESTLE ANALYSIS IS THE ANALYSIS OF THE ENVIRONMENT AS A WHOLE IN WHICH A BUSINESS OPERATES OR TENDS TO OFFER ITS TRADE. THESE ARE SYSTEMATIC FACTORS THAT ARE BEYOND ONES CONTROL. BUSINESSES NEED STRATEGIES KEEPING THE RESULTS IN VIEW TO PEACEFULLY COEXIST AND KEEP ON GAINING REVENUES DESPITE THE CONCURRENT SITUATION.

PESTLE ANALYSIS IT IS OF UTMOST IMPORTANCE TO UNDERSTAND IN DEPTH THE MEANING OF PESTLE AND HOW EVERY LETTER OF THE ACRONYM REPRESENTS AN IMPORTANT ASPECT OF THE ENVIRONMENT YOUR BUSINESS IS IN. PESTLE STANDS FOR:

PESTLE ANALYSIS P FOR POLITICAL E FOR ECONOMIC S FOR SOCIAL T FOR TECHNOLOGICAL L FOR LEGAL E FOR ENVIRONMENTAL

Upcoming Training Programs:- Workshop on IMS Internal Auditor ISO 9001:2015 QMS Lead Auditor Date: Feb 10, 2017 Time: 8 AM 2 PM One Friday Date: Feb 24 March 24, 2017 Time: 2 PM 8 PM 5 Fridays BS OHSAS 18001:2007 Lead Auditor Date: Feb 25 March 25, 2017 Time: 8 AM 2 PM 5 Saturdays Contact: Ashish Anand ashish@3foldtraining.com +971 50 9816618