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Quality is the best business plan:
An overview of Quality Management
system with the Nitty Gritties of ISO
9001:2015
By
M....
M. Youssef K
Six Sigma Associates
M. Youssef K is an executive consultant & trainer with several qualifications. He is an
...
What is a Quality Management
System?
Policies,
Processes
Procedures
What is a Quality Management
System?
What is a Quality Management
System?Required for planning and executing
business processes
To meet customer requirements...
A Cultural Transition
A PHILOSOPHY
Change
It Requires …..
1. Leadership
2. Determination
3. Resilience
4. Commitment
5. Engagement
Requires Leadership
RESILIENCE
A Strategic Choice
 Effective Application of ISO 9000 QM
Principles = Financial & Economic benefits
 Financial benefit r...
ISO 9001 Management Principles
1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approa...
Derived Benefits of QMS
improved profitability, improved revenues, improved
budgetary performance,
reduced costs, improv...
Realization of Benefits
INPUTS OUTPUTSPROCESS
The Inputs
1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approach
6. Continual impr...
The Process
Assess requirements,
Plan activities,
Allocate appropriate resources,
Implement continual improvement
acti...
Out put = Increased Productivity
The new ISO 9001:2015
The ISO 9001:2015
The new ISO 9001:2015
Introduction
A short overview of ISO 9001 in the world
The new ISO 9001:2015Introduction
A short overview of ISO 9001 in the world
The new ISO 9001:2015Introduction
A short overview of ISO 9001 in the world
The new ISO 9001:2015Introduction
A short overview of ISO 9001 in the world
The new ISO 9001:2015
The Framework
Standardize and effectively develop standards
Enhance alignment and compatibility of...
The new ISO 9001:2015ISO 9001:2015
0. Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of...
The new ISO 9001:2015
Focus on risk based management
Senior management must be able to demonstrate an
understanding of bus...
The new ISO 9001:2015
Objectives and measurement
The requirements around quality objectives have also been
made more detai...
The new ISO 9001:2015
The organization must determine who will be responsible
for the delivery of the objectives, resource...
The new ISO 9001:2015
Communication and awareness
Clause 7.3 Awareness is now a clause in its own right:
people working un...
The new ISO 9001:2015
Which leads into Clause 7.4 Communication – internal
and external communications are now a requireme...
The new ISO 9001:2015
Fewer prescriptive requirements
Much will be made of the fact that the new version of the
standard h...
The new ISO 9001:2015
An organization must decide what information they wish to
retain, how these are updated and controll...
The new ISO 9001:2015
5. High Level Structure New Clause Numbers
1. Scope
2. Normative References
3. Terms and Definitions...
The new ISO 9001:20155. Leadership
5.1. Management commitment
5.2. Policy
5.3. Roles, Responsibility and Authority
6. Plan...
The new ISO 9001:2015
8. Operations
8.1. Operational planning and control
9. Performance evaluation
9.1. Monitoring, measu...
The new ISO 9001:2015
6. Some Requirements – Examples
4. CONTEXT OF THE ORGANISATION
4.1. Understanding the organization a...
The new ISO 9001:2015
4.2. Understanding the needs and expectations of
interested parties
The organization must determine ...
The new ISO 9001:2015
4.4. Quality management system
The organization must establish, implement, maintain and
improve a QM...
The new ISO 9001:20155.1. Leadership
Top management must demonstrate leadership and
commitment with respect to the quality...
The new ISO 9001:20156.1. Actions to address risks and opportunities
When planning for the QMS, the organization must
cons...
The new ISO 9001:2015
7.1. Resources
The organization must determine and provide the
resources needed for the OMS (establi...
The new ISO 9001:20158.1. Operational Planning and Control
The organization must plan, implement and control the
processes...
The new ISO 9001:2015
The organization must control planned and review the
consequences of unintended changes, taking acti...
The new ISO 9001:20158.4. Control of External Provision of Goods and
Services
The organization must ensure that externally...
The new ISO 9001:20159. PERFORMANCE EVALUATION
9.1. Monitoring, measurement, analysis and evaluation
9.2. Internal audit
9...
??
QUESTIONS
92-306-5252528
6sigmapk@gmail.com www.sixsigmaassociates.co.uk/sixsigma
https://pk.linkedin.com/in/projectman...
Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015
Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015
Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015
Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015
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Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015

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The webinar covers:
• How Process Based QMS enables the organizations to identify, measure, control and improve the various core business processes.
• How QMS integrates the several internal processes within the organization.
• Policies, processes and procedures required for planning and execution of QMS in an organization (development/production/service).

Presenter:
This webinar was presented by M. Youssef. K, an Executive Consultant & Trainer at Six Sigma Associates – SSA.

Link of the recorded session published on YouTube: https://youtu.be/KBlubvbBE_Y

Publié dans : Formation

Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015

  1. 1. Quality is the best business plan: An overview of Quality Management system with the Nitty Gritties of ISO 9001:2015 By M.Youssef.K
  2. 2. M. Youssef K Six Sigma Associates M. Youssef K is an executive consultant & trainer with several qualifications. He is an accomplished expert with over 10 years’ experience in the field of risk management, project and program management, PRINCE 2, Agile, EVM, business process analysis and design, as well as operational and organizational excellence 92-306-5252528 6sigmapk@gmail.com https://pk.linkedin.com/in/projectmanagementpk www.sixsigmaassociates.co.uk/sixsigma
  3. 3. What is a Quality Management System? Policies, Processes Procedures What is a Quality Management System?
  4. 4. What is a Quality Management System?Required for planning and executing business processes To meet customer requirements Accredited to International Standards by a Registrar ISO 9001:2015 is an example
  5. 5. A Cultural Transition
  6. 6. A PHILOSOPHY
  7. 7. Change
  8. 8. It Requires ….. 1. Leadership 2. Determination 3. Resilience 4. Commitment 5. Engagement
  9. 9. Requires Leadership
  10. 10. RESILIENCE
  11. 11. A Strategic Choice  Effective Application of ISO 9000 QM Principles = Financial & Economic benefits  Financial benefit results from cost-effective management practices within the organization.  Economic benefit results from improvements in the overall worth and health of the organization.
  12. 12. ISO 9001 Management Principles 1. Customer Focus 2. Leadership 3. People Involvement 4. Process Approach 5. Systems Approach 6. Continual improvement 7. Factual Approach to Decision Making 8. Mutually Beneficial Supplier Relationships
  13. 13. Derived Benefits of QMS improved profitability, improved revenues, improved budgetary performance, reduced costs, improved cash flow, improved return on investment, increased competitiveness, improved customer retention and loyalty, improved effectiveness of decision making, optimized use of available resources, heightened employee accountability, improved intellectual capital, optimized, effective and efficient processes, improved supply chain performance, reduced time to market, enhanced organizational performance, credibility and sustainability.
  14. 14. Realization of Benefits INPUTS OUTPUTSPROCESS
  15. 15. The Inputs 1. Customer Focus 2. Leadership 3. People Involvement 4. Process Approach 5. Systems Approach 6. Continual improvement 7. Factual Approach to Decision Making 8. Mutually Beneficial Supplier Relationships
  16. 16. The Process Assess requirements, Plan activities, Allocate appropriate resources, Implement continual improvement actions, Measure results to determine effectiveness,
  17. 17. Out put = Increased Productivity
  18. 18. The new ISO 9001:2015 The ISO 9001:2015
  19. 19. The new ISO 9001:2015 Introduction A short overview of ISO 9001 in the world
  20. 20. The new ISO 9001:2015Introduction A short overview of ISO 9001 in the world
  21. 21. The new ISO 9001:2015Introduction A short overview of ISO 9001 in the world
  22. 22. The new ISO 9001:2015Introduction A short overview of ISO 9001 in the world
  23. 23. The new ISO 9001:2015 The Framework Standardize and effectively develop standards Enhance alignment and compatibility of standards Useful for organizations which pursue multiple standards Some standards already under Common Framework: ISO 22000, ISO 20001, ISO 50001 Under revision to the Common Framework: ISO 14001, ISO 27001, ISO 9001
  24. 24. The new ISO 9001:2015ISO 9001:2015 0. Introduction 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operations 9. Performance Evaluations 10.Improvement
  25. 25. The new ISO 9001:2015 Focus on risk based management Senior management must be able to demonstrate an understanding of business risks and how they could impact on the ability to meet customer requirements. An effective risk management process will be critical for successful certification to the new version. It must ensure the management system can achieve its intended outcomes and achieve continual improvement. Clause 6.1 Actions to address risks and opportunities, is where this is covered and it addresses the ‘what, who, how and when of risk management.
  26. 26. The new ISO 9001:2015 Objectives and measurement The requirements around quality objectives have also been made more detailed. They need to be consistent with the quality policy, measurable (if practicable), monitored, communicated, and updated as appropriate. They also have to be established at relevant functions and levels. Objectives should include plans on how to achieve them as well as how the results will be evaluated.
  27. 27. The new ISO 9001:2015 The organization must determine who will be responsible for the delivery of the objectives, resources required, what needs to be done and by when. So remember that when establishing quality objectives organization needs to demonstrate how they plan to achieve them. And remember that the objectives (results to be achieved) – can be technical, strategic or operational.
  28. 28. The new ISO 9001:2015 Communication and awareness Clause 7.3 Awareness is now a clause in its own right: people working under an organization’s control should be aware of the quality policy, objectives, their contributions to QMS, implications of non-conformities etc. There is an increased emphasis on awareness to ensure that everyone knows the implications of not conforming to the management system requirements.
  29. 29. The new ISO 9001:2015 Which leads into Clause 7.4 Communication – internal and external communications are now a requirement. It’s up to the organisations to decide what/who/when and how they are communicating. Communication is important for both internal and external stakeholders and an organization must develop a communication plan. It is important to decide who will own the communication and ensure that they have the appropriate authority, competencies and knowledge. The communication plan can include a variety of mediums including briefings, meetings, seminars, conferences and newsletters.
  30. 30. The new ISO 9001:2015 Fewer prescriptive requirements Much will be made of the fact that the new version of the standard has no requirements for procedures but it does have requirements for documentation. Clause 7.5 Documented Information deals with documented information and is split into 3 sub-clauses – general, creating and updating and control.
  31. 31. The new ISO 9001:2015 An organization must decide what information they wish to retain, how these are updated and controlled and adequately protected Clause 8 Operations includes: Requirements for customer communication (from information on products to contracts and invoicing) Review of design and development changes Information for external providers Identification and traceability Release of products and services now part of operational controls Non-conforming processes, outputs and product and services
  32. 32. The new ISO 9001:2015 5. High Level Structure New Clause Numbers 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of the Organization 4.1. Understanding the Organization and its context 4.2. Needs and expectations 4.3. Scope 4.4. Management system
  33. 33. The new ISO 9001:20155. Leadership 5.1. Management commitment 5.2. Policy 5.3. Roles, Responsibility and Authority 6. Planning 6.1. Actions to address risks and opportunities 6.2. Objectives and plans to achieve them 7. Support 7.1. Resources 7.2. Competence 7.3. Awareness 7.4. Communications 7.5. Documented Information
  34. 34. The new ISO 9001:2015 8. Operations 8.1. Operational planning and control 9. Performance evaluation 9.1. Monitoring, measurement, analysis and evaluation 9.2. Internal audit 9.3. Management review 10. Improvement 10.1. Nonconformity and corrective action 10.2. Continual improvement
  35. 35. The new ISO 9001:2015 6. Some Requirements – Examples 4. CONTEXT OF THE ORGANISATION 4.1. Understanding the organization and its context The organization must determine external and internal issues relevant to its purpose and that affect its ability to achieve the intended outcome(s) of its QMS.
  36. 36. The new ISO 9001:2015 4.2. Understanding the needs and expectations of interested parties The organization must determine interested parties relevant to the QMS, and the requirements of these interested parties List of interested parties the organization must consider: Direct customers End users Suppliers, distributors, retailers or others involved in the supply chain Regulators, and Any other relevant interested parties
  37. 37. The new ISO 9001:2015 4.4. Quality management system The organization must establish, implement, maintain and improve a QMS, including the processes needed and their interactions, in accordance with the requirements of this standard "Process approach" is maintained, and it will be embedded in all ISO management system standards.
  38. 38. The new ISO 9001:20155.1. Leadership Top management must demonstrate leadership and commitment with respect to the quality management system, by ... Ensuring the integration of the QMS requirements into the organization's business processes, Promoting awareness of the process approach, Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. Top management must demonstrate leadership and commitment with respect to customer focus.
  39. 39. The new ISO 9001:20156.1. Actions to address risks and opportunities When planning for the QMS, the organization must consider the issues... in 4.1 and the requirements ... in 4.2 and determine the risks and opportunities that need to be addressed to: Assure the QMS can achieve its intended outcome(s) Prevent or reduce undesired effects Achieve improvement The organization must plan: Actions to address these risks and opportunities, and how to: • Integrate and implement the actions into its OMS processes and • Evaluate the effectiveness of these actions
  40. 40. The new ISO 9001:2015 7.1. Resources The organization must determine and provide the resources needed for the OMS (establishment, implementation, maintenance and improvement of the OMS). Resources may include: Infrastructure (7.1.2 ) Process environment (7.1.3) Monitoring (7.1.4 ) Knowledge (7.1.5)
  41. 41. The new ISO 9001:20158.1. Operational Planning and Control The organization must plan, implement and control the processes needed to meet requirements and to implement the actions determined in 6.1, by: Establishing criteria for those processes Implementing the control of the processes in accordance with the criteria Keeping sufficient documented information to demonstrate the processes have been carried out as planned
  42. 42. The new ISO 9001:2015 The organization must control planned and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization must ensure the operation of a function or process of the organization by an external provider is controlled (outsourcing ).
  43. 43. The new ISO 9001:20158.4. Control of External Provision of Goods and Services The organization must ensure that externally provided goods and services satisfy the specified requirements. Note: These include outsourcing.
  44. 44. The new ISO 9001:20159. PERFORMANCE EVALUATION 9.1. Monitoring, measurement, analysis and evaluation 9.2. Internal audit 9.3 Management review
  45. 45. ?? QUESTIONS 92-306-5252528 6sigmapk@gmail.com www.sixsigmaassociates.co.uk/sixsigma https://pk.linkedin.com/in/projectmanagementpk THANK YOU

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