100+ ISO 9001-2015 Quality Management System SOPs (Excel XLSX)

BENEFITS OF THIS EXCEL DOCUMENT

1. Provides a complete set of ISO 9001:2015 SOPs to streamline your organization's Quality Management System.
2. Enables fast implementation of compliant processes across leadership, risk management, and product realization.
3. Supports continuous improvement and audit readiness with ready-to-use Excel templates for every SOP.

ISO 9001 EXCEL DESCRIPTION

This product (100+ ISO 9001-2015 Quality Management System SOPs) is an Excel template (XLSX), which you can download immediately upon purchase.

Curated by McKinsey-trained Executives


Unlock Total ISO 9001:2015 Compliance with 100+ Ready-to-Use SOPs – Complete Excel Template Package

Achieve ISO 9001:2015 certification faster, smarter, and more efficiently with our comprehensive SOPs package – a complete Excel-based solution designed for quality professionals, auditors, and managers who demand fully compliant, ready-to-implement quality management processes. This 100+ SOPs Excel template covers every facet of the ISO 9001:2015 standard, from strategic leadership and risk management to customer satisfaction and continuous improvement. Stop wasting time creating SOPs from scratch – get the ultimate ISO 9001:2015 SOP toolkit today!

Our package includes meticulously structured SOPs across all key ISO 9001:2015 clauses:

1. Quality Management System (QMS) Framework
1. QMS Scope and Structure
2. Quality Manual Preparation and Maintenance
3. Documentation Control
4. Internal and External Documentation Management
5. Document and Record Retention Policy
6. QMS Internal Audit Procedure
7. Corrective and Preventive Action (CAPA)
8. Management Review Process
9. Management Commitment and Responsibility
10. Risk Management Procedure
11. Risk-Based Thinking in QMS
12. Customer Satisfaction Measurement

2. Leadership and Strategic Direction
13. Leadership Responsibility and Authority
14. Quality Objectives Setting and Monitoring
15. Strategic Planning and Direction for Quality
16. Communication of Quality Policy
17. Role of Top Management in Quality Assurance
18. Organizational Structure and Responsibility
19. Resource Management for QMS

3. Resource Management
20. Resource Planning and Allocation
21. Human Resources Competence and Training
22. Employee Engagement and Motivation
23. Infrastructure Management
24. Work Environment and Ergonomics
25. Supplier Management and Evaluation
26. Supplier Development Procedure
27. Supplier Performance Evaluation
28. Supplier Qualification and Auditing
29. Preventive Maintenance of Equipment
30. Calibration of Instruments and Tools
31. Energy and Environmental Management in QMS

4. Product Realization
32. Product Planning and Development
33. Design and Development Process
34. Product Design Validation and Verification
35. Product Requirement Review
36. Design and Development Change Control
37. Control of Externally Provided Processes
38. Production Planning and Scheduling
39. Production Process Control
40. Control of Non-Conforming Products
41. Traceability of Products
42. Product Release and Delivery
43. Packaging and Labeling Procedures
44. Product Delivery and Distribution
45. Monitoring and Measuring Equipment Control
46. Production and Service Provision Monitoring
47. Test and Inspection Procedures
48. Material Control and Inventory Management
49. Product Handling and Storage

5. Risk and Opportunity Management
50. Risk Management Process
51. Risk Assessment and Evaluation
52. Identification of Opportunities for Improvement
53. Mitigation and Control of Risks
54. Business Continuity Planning
55. Hazard Identification and Risk Control
56. Failure Mode Effects Analysis (FMEA)

6. Performance Evaluation
57. Performance Monitoring and Measurement
58. Key Performance Indicators (KPIs) Development
59. Quality Metric Collection and Analysis
60. Customer Satisfaction and Feedback
61. Process Performance and Product Conformance
62. Audit Effectiveness Measurement
63. Internal Audit Scheduling and Execution
64. Supplier Performance Reviews
65. Non-Conformance Reporting and Management
66. Corrective and Preventive Action (CAPA) Management
67. Review of Audit Findings and Actions
68. Complaint Management and Resolution
69. Continuous Improvement Process (CIP)
70. Data and Information Management
71. Analysis of Data and Corrective Actions

7. Customer Focus
72. Customer Requirement Management
73. Customer Feedback Collection
74. Customer Complaint Management
75. Customer Communication Management
76. Customer Satisfaction Measurement
77. Customer-Centered Quality Policy
78. Customer Requirement Verification

8. Change Management
79. Change Control Procedure
80. Change Communication and Documentation
81. Change Impact Assessment
82. Design and Development Changes
83. Organizational Change Management
84. Process Change Control
85. Risk Assessment of Changes

9. Non-Conformance Management
86. Identification of Non-Conforming Products
87. Non-Conformance Reporting
88. Disposition of Non-Conforming Products
89. Rework and Reprocess Management
90. Control of Non-Conforming Materials
91. Root Cause Analysis of Non-Conformances
92. Escalation Procedure for Non-Conformances
93. Preventive Measures for Non-Conformance

10. Supplier and External Provider Management
94. Supplier Approval and Selection
95. Supplier Quality Assurance Program
96. Supplier Performance Monitoring
97. Supplier Risk Management
98. Supplier Audits and Evaluation
99. Outsourcing Control Procedure
100. Vendor Quality Agreements
101. Monitoring Supplier Compliance
102. Document Creation and Approval
103. Document Review and Revision Control
104. Digital Document Management System (DMS)
105. Record Keeping and Data Integrity
106. Archive and Retrieval of Records
107. Data Privacy and Security for Records
108. Confidentiality and Intellectual Property Protection
109. Regulatory Compliance for Documentation
110. Record Retention Periods
111. Training Needs Analysis
112. Competency and Skill Gap Analysis
113. Employee Training Program Development
114. Internal Auditor Training and Certification
115. Supplier Training Program
116. Effectiveness Evaluation of Training
117. Employee Skills and Competence Evaluation
118. Onboarding and Orientation Procedures

11. Internal Audits and Inspections
119. Audit Planning and Scheduling
120. Internal Audit Procedure and Execution
121. Auditor Qualification and Independence
122. Audit Checklist Development
123. Audit Report Writing
124. Audit Follow-Up Actions
125. Audit Frequency and Scope Determination
126. Internal Audit Training
127. Supplier Audit Management

12. Corrective and Preventive Actions (CAPA)
128. Corrective Action Request (CAR) Process
129. Preventive Action Request (PAR) Process
130. CAPA Root Cause Analysis
131. CAPA Effectiveness Review
132. CAPA Closure and Documentation
133. Preventive Action Implementation and Monitoring

13. Product Inspection and Testing
134. Incoming Material Inspection
135. In-Process Inspection and Testing
136. Final Product Inspection
137. Destructive and Non-Destructive Testing
138. Testing Procedure Development
139. Sampling Plans for Inspections
140. Calibration of Testing Equipment
141. Validation and Verification of Test Results

14. Continuous Improvement
142. Continuous Improvement Framework
143. Lean Manufacturing and Process Optimization
144. Kaizen and Employee Involvement
145. Failure Mode and Effect Analysis (FMEA)
146. Root Cause Analysis (RCA) Methodologies
147. Process Improvement Teams
148. Innovation and Quality Improvement
149. Process Efficiency Monitoring
150. Quality Circles and Improvement Groups

This all-in-one Excel SOP package is your ultimate shortcut to ISO 9001:2015 compliance, boosting operational efficiency, enhancing product quality, reducing audit risks, and ensuring your organization's quality management system is robust, auditable, and ready for certification.

Get instant access to 100+ ISO 9001:2015 SOPs in Excel – save time, reduce errors, and accelerate your certification journey today!



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Source: Best Practices in ISO 9001 Excel: 100+ ISO 9001-2015 Quality Management System SOPs Excel (XLSX) Spreadsheet, SB Consulting