understanding context of organisation clause as per iso...

"Understanding Context of Organisation

Clause as per ISO 9001:2015 and

ISO 14001:2015"

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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 . [email protected] . 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.



LIFE CYCLE ANALYSIS




12

Date:

ISO

/TC

17

6/S

C 2

/ N

12

82

12

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

4.2 Interested parties

4.3 Scope

4.4 QMS

5.1 Leadership and commitment

6.1 Risks and opportunities

6.2 Planning

7.1 Resources

9.1 Monitoring, measurement, analysis and evaluation

10.1 General

10.3 Continual improvement

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence 9.2

Internal audit

9.3 Management review

8.1 Operational planning and control

5.2 Policy

5.3 Organizational roles, responsibilities and authorities

10.2 Nonconformity and corrective action

13

Date:

ISO

/TC

17

6/S

C 2

/ N

12

82

13

8 Operation

8.1 Operational planning and control

The common structure and ISO 9001:2015 additions

14

Date:

ISO

/TC

17

6/S

C 2

/ N

12

82

14

Do Check Act Plan 4

Context of organization

5 Leadership

6 Planning

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

6.1 Actions to address risks

and opportunities

6.2 Quality objectives and

planning

9.1 Monitoring,

measurement, analysis and evaluation

10.2 Nonconformity and corrective action

10.3 Continual improvement

5.3 Organizational roles, responsibilities and

authorities

9.2 Internal audit

9.3 Management review

8.1 Operational planning

and control

5.2 Policy

6.3 Planning of changes

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational knowledge

10.1 General

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.



• 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.



• 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.



• 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


• 4.1 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. .

Keep Satisfied

Manage Closely

Monitor Keep

Informed

POWER V/S 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.

POWER

INTEREST

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 PARTY CUSTOMERS

NEEDS AND EXPECTATION QUALITY PRODUCTS

PI RANK KEEP SATISFIED

OBJECTIVES ACHIEVE EXPECTED SALES

PRIORITY HIGH

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

PESTLE ANALYSIS

Clarification… If any?




Upcoming Training Programs:-

Workshop on IMS Internal Auditor Date: Feb 10, 2017 Time: 8 AM – 2 PM One Friday

ISO 9001:2015 QMS Lead Auditor 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 [email protected] +971 50 9816618


Please return the feedback form at the reception!

END OF THE SESSION




understanding context of organisation clause as per iso...

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