ISO 9001:2015 Revision Overview: part 2

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ISO 9001:2015 Revision Overview: part 2

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1. DQS-ULManagementSystemsSolutions© 1 DIS ISO9001:2015 Overview Welcome Sections 1-5 Revisions & Impact 2. DQS-ULManagementSystemsSolutions© 2 Jawaid.Mansour@us.dqs-ul.com Joe Mansour ISO9001:2015 Program Manager Lead Auditor BSEE, MSEE, MBA 760-458-3879 (office/cell) 3. DQS-ULManagementSystemsSolutions© 3 www.ul-dqsusa.com http://ul-dqsusa.com/ISO-90012015/ 4. DQS-ULManagementSystemsSolutions© Today’s Presentation ISO9001:2015 1. Scope 2. Normative reference 3. Terms and definitions 4. Context of the organization 5. Leadership March 25, 2015 6. Planning 7. Support April 29, 2015 8. Operation 9. Performance evaluation May 26, 2015 10. Improvement ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards. 4 … Final Webinar on July 29, 2015 . 5. DQS-ULManagementSystemsSolutions© Questions? 5 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to: Next Webinar: April 29, 2015 6. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 6 Q1 What is the current difference between element approach and process approach? Explanation of Process Approach was included in slides 30-49. ISO9001:2015 requires all Processes (value-added activities of the organization) be identified and managed as a process. Element-based standards just outline the requirements. 7. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 7 Q2 What do you mean by the standard now requires min 17 "documented information" “Retain Documented Information“ appears 17 times in the Standard. Namely, in sections 4.4, 6.2.1, 7.1.5, 7.2, 8.1.e), 8.2.3, 8.3.5, 8.3.6, 8.4.1, 8.5.2, 8.5.6, 8.6, 8.7, 9.1.1, 9.2.2, 9.3.2 and 10.2.2. This is equivalent to the current Quality Records requirement, where the information can be in any media or format. For clarification, please note that “Maintain documented information“ is equivalent to the current “Documented Procedure“ requirement. 8. DQS-ULManagementSystemsSolutions© 8 PROCESS (DO) INPUT OUTPUT Plan Check Act Questions From The Last Webinar Q3 What does PDCA stand for? Slides 15-19. 9. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 9 Q4 How do I obtain training in Risk Management? Will numbering align with ISO14k and the OHSAS18k? We will be covering Risk Management as part of our April 20 Webinar. TS16949, AS9100, TL9000 have already indicated that they will update . 10. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 10 Please refer to slides 56-63 and FAQ question A5. Q6 What will be the deadline to update documentation to the 2015 standard after release? If we just got re-certified, will we have to do it again, or can we do it at the next 3 year cycle? 11. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 11 http://ISOtc.ISO.org/livelink/livelink/open/tc176SC2public. As of March 25, 2015, the link is still active. Q7 The ISO 176 link is no longer valid. Can you supply the new link? 12. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 12 Q8 Can you provide the FAQ location again? http://ul-dqsusa.com/ISO-90012015/ 13. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 13 Q12 You showed several examples of "not a process map" and one bad process map. Could you explain what a good process map looks like, requires, etc.? ISO9001:2015 requires all processes to be identified. Furthermore, clause 4.4b requires the “sequence and interaction of the process“ be defined”. 14. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 14 Q16 So we will have to re-do our internal auditor certifications that we currently have? Not necessarily. Please see FAQ questions B1, B2 and B3. 15. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 15 ISO committee is made up of 163 member countries, each with a single vote. All ISO standards are normally reviewed every five years to assure that they are still relevant and adequate in an ever changing world. Q17 Why change to ISO 9001:2015, just stay at ISO 9001:2008. 16. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 16 Q26 For family owned companies, involvement of management is very rare and the real actions are really limited to the doers in the company. I am afraid that we will not be able to implement the new requirements On the contrary, the new requirements have been defined so as to make them easier to implement in smaller organizations. With reduced need for documentation, the ISO9001:2015 is less prescriptive. 17. DQS-ULManagementSystemsSolutions© Sections 1-5 17 1 Scope 2 Normative References 3 Terms and Definitions 4 Context of the Organization 5 Leadership 18. DQS-ULManagementSystemsSolutions© Sections 1-5 18 1 Scope 2 Normative References 3 Terms and Definitions 4 Context of the Organization 5 Leadership 19. DQS-ULManagementSystemsSolutions© Section 1- Scope 19 • Needs to demonstrate its ability to meet customer/statutory/regulatory requirements • Aims to enhance customer satisfaction This Standard specified requirements for a quality management system where an organization All requirements are generic and intended to be applicable to all types of organizations, regardless of type, size and product (or service) provided. 20. DQS-ULManagementSystemsSolutions© Sections 1-5 20 1 Scope 2 Normative References 3 Terms and Definitions 4 Context of the Organization 5 Leadership 21. DQS-ULManagementSystemsSolutions© Section 2 21 2 Normative References. There are no normative references for DIS ISO9001:2015. This section is included to maintain clause numbering alignment with other ISO management system standards. 22. DQS-ULManagementSystemsSolutions© Sections 1-5 22 1 Scope 2 Normative References 3 Terms and Definitions 4 Context of the Organization 5 Leadership 23. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.02 – INTERESTED partY Person or organization (3.01) that can affect, be affected by, or perceive themselves to be affected by a decision or activity. 3.01 – person or group of people that has its own functions (3.25) with responsibilities, authorities and relationships to achieve its objectives (3.08) 23 24. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.06 - EFFECTIVENESS Extent to which planned activities are realized and planned results achieved. 24 25. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.08 – OBJECTIVE Result to be achieved. 25 26. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.09 - RISK Effect of uncertainty on an expected result. The effect can be positive or negative consequence - Risk is characterized by potential events and consequences. 26 27. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.11 – DOCUMENTED INFORMATION Information (3.50) required to be controlled and maintained by an organization (3.01) and the medium on which it is contained. 27 28. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.12 – PROCESS Set of interrelated or interacting activities which transforms inputs into outputs (3.46). 28 29. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.20 – CORRECTIVE ACTION Action to eliminate the cause of a nonconformity (3.19) and to prevent recurrence. 29 30. DQS-ULManagementSystemsSolutions© Section 3 – Terms & Definitions 3.24 – CONTEXT OF THE ORGANIZATION (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. - Business Environment, organizational environment or ecosystem of an organization. 30 31. DQS-ULManagementSystemsSolutions© Section 4 - Context Of The Organization 31 4.1 Understanding the Organization and Its Context 4.2 Understanding The Needs And Expectations Of Interested parties 4.3 Determining The Scope of The Quality Management System 4.4 Quality Management System And Its Processes 32. DQS-ULManagementSystemsSolutions© Section 4 - Context Of The Organization 32 4.1 Understanding the Organization and Its Context 4.2 Understanding The Needs And Expectations Of Interested parties 4.3 Determining The Scope of The Quality Management System 4.4 Quality Management System And Its Processes 33. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 33 UL DQS : Mission and values We want to be the preferred partner for certification, auditing, and assessments of management systems. Values – Our corporate values drive common attitudes: Success - We like to be successful, just like our customers. Respect We treat people with respect, always. 34. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 34 Customer orientation Customer needs come first – generate value for customers. Employee orientation Our employees, auditors, are our greatest success factor. Mutual trust Mutual trust enables cooperation in achieving goals. Responsibility Take responsibility for results and behavior Integrity / credibility Independence, competence and attitude to ensure integrity. Reliability Keep our promises. Trust us! 35. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 35 The vision drives the development of UL DQS. It reflects the expectations of the essential stakeholders: Preferred partner for certification, auditing, and assessments; Recognized for our competence in Supporting business success and organizational health of our customers. 36. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 36 Other Internal Factors May Include Management Strategy Business Continuity Work Environment Employee Satisfaction Overall Compensation 37. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 37 4.1 The organization shall determine external and internal issues that are relevant to its purpose and its strategic decision and that affect its ability to achieve the intended results. The organization shall monitor and review the information about these external and internal issues. 38. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 38 Internal Environment Society External Environment Government OwnersFinancial Customers Suppliers 39. DQS-ULManagementSystemsSolutions© 4.1 – Understanding-Organization-Context 39 Internal Environment Society External Environment Government OwnersFinancial Customers Suppliers SocialCulturalPolitical DemographicGrowthFactors 40. DQS-ULManagementSystemsSolutions© Section 4 - Context Of The Organization 40 4.1 Understanding the Organization and Its Context 4.2 Understanding The Needs And Expectations Of Interested parties 4.3 Determining The Scope of The Quality Management System 4.4 Quality Management System And Its Processes 41. DQS-ULManagementSystemsSolutions© 4.2 – Understanding Needs and Expectations 41 Due to impact on organization’s ability to meet customer, statutory and regulatory requirements, the organization shall Identify the interested parties that are relevant to the quality management system. Identify the requirements of these interested parties Organization to monitor and review the information about these interested parties and their relevant requirements. 42. DQS-ULManagementSystemsSolutions© 4.2 – Understanding Needs and Expectations 42 Corporate Policies of UL DQS governed by Customers Employees and Auditors External Auditors, Business partners Shareholders 43. DQS-ULManagementSystemsSolutions© 4.2 – Understanding Needs and Expectations 43 Employee expectations UL DQS employees expect above-average working conditions and jobs that provide learning opportunities in the long term. They also expect an income commensurate with their performance, recognition for their achievements, and support for attractive professional development. 44. DQS-ULManagementSystemsSolutions© 4.2 – Understanding Needs and Expectations 44 Employee Policy - Example Employee commitment and competence is an essential principle of success for business activities. With attractive working conditions, performance-oriented culture, and respectful interaction with each other, the goal is to be an organization preferred by employees.. 45. DQS-ULManagementSystemsSolutions© Section 4 - Context Of The Organization 45 4.1 Understanding the Organization and Its Context 4.2 Understanding The Needs And Expectations Of Interested parties 4.3 Determining The Scope of The Quality Management System 4.4 Quality Management System And Its Processes 46. DQS-ULManagementSystemsSolutions© 4.3 - Determining Scope of QMS 46 The scope shall be available and be maintained as a documented information stating the: • Products and services covered by the quality management system • Justification for any instance where a requirement of this international standard cannot be applied. . 47. DQS-ULManagementSystemsSolutions© Section 4 - Context Of The Organization 47 4.1 Understanding the Organization and Its Context 4.2 Understanding The Needs And Expectations Of Interested parties 4.3 Determining The Scope of The Quality Management System 4.4 Quality Management System And Its Processes 48. DQS-ULManagementSystemsSolutions© 4.4 - QMS and its Processes 48 The organization shall identify the processes and shall determine: The inputs required and the outputs expected The sequence and interaction of these processes The criteria, methods, including performance indicators The resources needed The assign of the responsibilities and authorities The risks and opportunities 49. DQS-ULManagementSystemsSolutions© 4.4 - QMS and its Processes 49 PROCESSINPUT OUTPUT • Production Processes (stamping, welding, painting) • Management Processes (administration, audits, CAR, HR) • Support Processes (maintenance, warehouse, purchasing) • Customer Processes (sales, customer satisfaction) • Service Processes (Bank- deposit, withdrawal, loan processing, mortgage application, monthly statements) “set of interrelated or interacting activities which transforms inputs into outputs” 50. DQS-ULManagementSystemsSolutions© 50 4.4 - QMS and its Processes 51. DQS-ULManagementSystemsSolutions© 51 4.4 – QMS - and its Processes - Service 52. DQS-ULManagementSystemsSolutions© 52 PROCESS (DO) INPUT OUTPUT Plan Check Act 4.4 - QMS and its Processes parts Per Million Machine Up Time parts Per Hour Cost of Quality - rework STAMPING 53. DQS-ULManagementSystemsSolutions© 4.4 – STAMPING Process Map 53 Inputs/Needs Process Operations Outputs/Results Responsibility Work Order Material identified with tag Verify Schedule Adjust setup SupervISOr Set up for Production Run First off Set Up Lead Inspect Q.C. Inspector Set Up Lead Update NCMR database Resume Full Production Operator N Y 54. DQS-ULManagementSystemsSolutions© 4.4 – STAMPING Process Map OBJECTIVE ACTUAL GOAL ACTION PPM 25 50 Continue to Monitor Machine Up Time 82 % 95% Increase PM, have spare parts available, staffing parts Per Hour 235 215 Continue to Monitor Cost of Rework $496 <$500 per month Continue to Monitor/consider risk Quality Objectives For The Stamping Process 55. DQS-ULManagementSystemsSolutions© 4.4 - QMS and its Processes 55 56. DQS-ULManagementSystemsSolutions© 4.4 - QMS and its Processes 56 The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. 57. DQS-ULManagementSystemsSolutions© Sections 1-5 57 1 Scope 2 Normative References 3 Terms and Definitions 4 Context of the Organization 5 Leadership 58. DQS-ULManagementSystemsSolutions© 5 - Leadership 58 • 5.1.1 Leadership and commitment for the QMS • 5.1.2 Customer Focus 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities 59. DQS-ULManagementSystemsSolutions© 5 - Leadership 59 • 5.1.1 Leadership and commitment for the QMS • 5.1.2 Customer Focus 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities 60. DQS-ULManagementSystemsSolutions© Leadership 60 Taking accountability of Effectiveness Ensure Quality Policy & Objectives in place Ensure QP is communicated and understood Integration of QMS with business processes Leadership and Commitment 61. DQS-ULManagementSystemsSolutions© Leadership 61 Promoting awareness /Process Approach Availability of Resources Communicate the importance of effective QMS Ensure QMS achieves intended results Leadership and Commitment 62. DQS-ULManagementSystemsSolutions© Leadership 62 Engaging, directing and supporting Promoting Continual Improvement Support other management roles Leadership and Commitment 63. DQS-ULManagementSystemsSolutions© 5 - Leadership 63 • 5.1.1 Leadership and commitment for the QMS • 5.1.2 Customer Focus 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities 64. DQS-ULManagementSystemsSolutions© 5 - Leadership 64 • 5.1.1 Leadership and commitment for the QMS • 5.1.2 Customer Focus 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities 65. DQS-ULManagementSystemsSolutions© 5 - Leadership 65 • 5.1.1 Leadership and commitment for the QMS • 5.1.2 Customer Focus 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities 66. DQS-ULManagementSystemsSolutions© 5 - Leadership 66 is appropriate to the purpose and context of the organization Provides a framework for setting and reviewing quality objectives Includes a commitment to continual improvement of the quality management Includes a commitment to satisfy applicable requirements Quality Policy 67. DQS-ULManagementSystemsSolutions© 5 - Leadership 67 • 5.1.1 Leadership and commitment for the QMS • 5.1.2 Customer Focus 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities / authorities 68. DQS-ULManagementSystemsSolutions© 5 - Leadership 68 system conforms to the requirements of ISO all processes are delivering their intended results reporting on the performance promotion of customer focus Organizational Roles and Responsibilities Maintain Integrity 69. DQS-ULManagementSystemsSolutions© Questions? 69 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to: Next Webinar: April 29, 2015 70. DQS-ULManagementSystemsSolutions© Questions? Contact me: Joe Mansour ISO9001:2015 Program Manager 70 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to: Next Webinar: April 29, 2015
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