ISO 9001:2015

GENERAL DESCRIPTION

This course includes e-Learning with audio description (EN)+ 1/2 day  discussion with trainer (RO/EN)

The course focuses on interactivity; the participants are stimulated to take part in training. The course alternates theoretical presentation with practical examples of requirement’s fulfills, examples based on trainer’s consulting experience. The participants are incited to identify performance indicators and to present particular ways of requirements fulfills applied in their organizations.

OBJECTIVES 

Participants will be able to:

  • Know the quality concepts evolution and their different approaches
  • Know the quality management principles and the requirements arising from these
  • Know the terminology used in quality management standards
  • Understand the Quality Management Systems requirements from the customer’s point of view
  • Identify and establish the necessary processes and their indicators
  • Understand and plan a QMS in their own organization through a correct interpretation of this technical specification’s requirements
  • Awareness of the advantages which follow from QMS implementation and certification

WHO SHOULD ATTEND

  • Quality managers
  • Top management
  • Operational management
  • Every person interested in knowing the QMS standards    

PREREQUISITE

  • Not required

TRAINING AGENDA

  • Introduction and overview of the course
  • The intentions of the 2015 revision of the standard ISO 9001
  • Quality Management principles
  • Terms and definitions (ISO 9001:2015)
  • Presentation of requirements ISO 9001:2015
  • Context of the organization (chapter 4): Discussions about the importance of understanding the context of the organization and the needs and expectations of workers and other stakeholders
  • Leadership (Chapter 5): Description of the role of top management in management system
  • Planning (Chapter 6): Hazard identification and risk and opportunity assessment; Determination of of quality objectives and their planning; Changes management
  • Support (Chapter 7): Resources; Human Resources Management; Documented information
  • Operation (Chapter 8): Operational planning and control
  • Performance evaluation (Chapter 9) – Monitoring, measurement, analysis and evaluation; Internal audit; Management review
  • Improvement (Chapter 10) — Improvement; Non-compliance and corrective action; Continuous improvement

1
1. Presentation
2
2. Symbols used
3
3. Quality approaches
4
4. What is ISO?
5
5. International Organization for Standardization
6
6. ISO 9000 family
7
7. ISO 9001 - History
8
8. Inputs for a new revision
9
9. Intentions of review
10
10. Basic changes
11
11. Changes in structure
12
12. What is the SL Annex?
13
13. SL Annex - Benefits
14
14. Changes in terminology
15
Brief Knowledge Check!
5 questions
16
15. Changes to QM principles
17
16. QM principles
18
17. 1. Customer focus
19
18. 2. Leadership
20
19. 3. Engagement of people
21
20. 4. Process approach
22
21. Customer-Supplier Relationship Internally
23
22. 5. Improvement
24
23. 6. Evidence – based decision making
25
24. 7. Relationship management
26
25. Risk-based thinking
27
Brief Knowledge Check!
5 questions
28
26. ISO 9001 - Contained
29
27. PDCA cycle applied to the quality management system
30
28. Clauses and subclauses
31
29. 1. Scope
32
30. QMS requirements
33
31. 4. Context of the organization
34
32. 4.1 Understanding the organization and the context in which it operates
35
33. 4.2 Understanding the needs and expectations of stakeholders
36
34. 4.3 Determination of the scope of the QMS
37
35. 4.4 SMQ and its processes
38
36. And, for every process, PDCA
39
37. And, for every process...
40
38. Context of the organization – Summary
41
39. Exercise - Process Diagram
42
Brief Knowledge Check!
5 questions
43
40. 5. Leadership
44
41. 5.1 Leadership and commitment
45
42. 5.1.2 Customer focus
46
43. 5.2 Politics
47
44. 5.3 Organizational roles, responsibilities and authorities
48
45. Leadership - Summary
49
Brief Knowledge Check!
5 questions
50
46. 6. Planning
51
47. 6.1 Actions to treat risks and opportunities
52
48. 6.2 Quality objectives and planning for their achievement
53
49. 6.3 Change planning
54
50. Planning – Summary
55
Brief Knowledge Check!
5 questions
56
51. 7. Support
57
52. 7.1 Resource
58
53. 7.1.2 Personal
59
54. 7.1.3 Infrastructure
60
55. 7.1.4 Environment for process operation
61
56. 7.1.5 Measurement and monitoring resources
62
57. Measurement and monitoring resources
63
58. Measurement and monitoring resources
64
59. 7.1.6 Organizational knowledge
65
60. 7.2 Competence
66
61. 7.3 Awareness
67
62. 7.4 Communication
68
63. 7.5 Documented information
69
64. Documented information
70
65. Support – Summary
71
Brief Knowledge Check!
5 questions
72
66. 8. Operation
73
67. 8.1 Operational planning and control
74
68. Operational planning and control
75
69. 8.2 Requirements for products and services - 8.2.1 Communication with the customer
76
70. 8.2.2 Determination of requirements for products and services
77
71. 8.2.3 Analysis of requirements for products and services
78
72. 8.2.4 Changes to requirements for products and services
79
73. 8.3 Design and development of products and services - 8.3.1 General
80
74. 8.3.2 Planning design and development
81
75. 8.3.3 Input elements of design and development
82
76. 8.3.4 Design and development controls
83
77. 8.3.5 Output elements of design and development
84
78. 8.3.6 Control of changes in design and development
85
Brief Knowledge Check!
5 questions
86
79. 8.4 Control of externally supplied processes, products and services - 8.4.1 General
87
80. 8.4.2 Type and extent of control
88
81. 8.4.3 Information for external suppliers
89
82. 8.5 Production and provision of services - 8.5.1 Control of production and provision of services
90
Brief Knowledge Check!
5 questions
91
83. 8.5.2 Identification and traceability
92
84. 8.5.3 Property belonging to external customers or suppliers
93
85. 8.5.4 Preservation
94
86. 8.5.5 Post-delivery activities
95
87. 8.5.6 Control changes
96
Brief Knowledge Check!
5 questions
97
88. 8.6 Release of products and services
98
89. 8.7 Control of non-compliant output elements
99
90. Control of non-compliant output elements
100
91. Operation - Summary
101
Brief Knowledge Check!
5 questions
102
92. 9. Performance evaluation
103
93. 9.1 Monitoring, measurement, analysis and evaluation - 9.1.1 General
104
94. 9.1.2 Customer satisfaction
105
95. 9.1.3 Analysis and evaluation
106
96. 9.2 Internal audit
107
97. Internal audit
108
98. 9.3 Management review - 9.3.1 General
109
99. 9.3.2 Input elements of the analysis
110
100. 9.3.3 Output elements of the analysis
111
Brief Knowledge Check!
5 questions
112
101. 10. Improvement
113
102. 10.1 Improvement - General
114
103. 10.2 Non-compliance and corrective action
115
104. Non-compliance and corrective action
116
105. 10.3 Continuous improvement
117
106. Analysis and improvement - Summary
118
Brief Knowledge Check!
5 questions
119
107. Correlation tableISO 9001:2015 - 2008
120
108. Correlation tableISO 9001:2015 - 2008
121
109. Correlation table ISO 9001:2015 - 2008
122
110. Correlation table ISO 9001:2015 - 2008
123
111. Correlation tableISO 9001:2015 - 2008
124
112. At the end...
125
Final Evaluation!
32 questions

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Enrolled: 1 student
Lectures: 112

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