ISO 9001:2015 Quality Manual Sample

[Pages:24]ISO 9001:2015 Quality Manual Sample

Selected pages (not a complete manual) Sample includes:

Quality Manual Pages Forms Examples

Contact: First Time Quality 410-451-8006



Pat [Pick the date]

Questions? Call First Time Quality 410-451-8006

[CompanyName]

Corporate Quality Manual

Operating Policies of the

[CompanyName] Quality Systeem s Version g [Date]

Effective Date: [Date] Version notes Initial issue

Pa Approval Signature and Date: ___________________________________ _____________________ d President/ Date

cte Documents provided by [CompanyName][CompanySuffix] disclose proprietary information as well

as copyright information registered with the U.S. Patent and Trademark Office. Please hold these

le documents in confidence and do not share them with other organizations, even if you do not Se charge a fee. Submittal of documents does not transfer copyright ownership.

Questions? Call First Time Quality 410-451-8006

CORPORATE QUALITY MANUAL TABLE OF CONTENTS

1. [CompanyName] Quality Management System ................................................................................... 5 1.1. Scope ................................................................................................................................................... 5 1.2. [CompanyName] Quality Policy ........................................................................................................... 5 1.3. Key Elements of the [CompanyName] Quality Management System ................................................. 5

2. Quality System Management and Responsibilities ............................................................................. 10 2.1. Overview............................................................................................................................................ 10 2.2. [CompanyName] Quality Policy ......................................................................................................... 10 2.3. Quality Duties, Responsibilities, and Authority ................................................................................. 10 2.4. Quality System Performance Measures ............................................................................................ 13

s 2.5. Customer Satisfaction Performance Measures ................................................................................. 13 e 2.6. Exceptions.......................................................................................................................................... 13 g 3. Project Quality Assurance/Quality Control Plan ................................................................................. 14 a 3.1. Overview............................................................................................................................................ 14

3.2. Project Quality Risk Assessment........................................................................................................ 14

P 3.3. [CompanyName] Project License and Qualification Requirements .................................................. 14

3.4. Project Personnel and Qualifications ................................................................................................ 15

d 3.5. Project Quality Assurance/Quality Control Plan................................................................................ 16

3.6. Identification of Quality Controlled Work Tasks................................................................................ 16

te 3.7. Project Quality Inspection and Test Plan ........................................................................................... 16

3.8. Project Quality Communications Plan ............................................................................................... 16

c 3.9. Project Quality Training Plan ............................................................................................................. 16 le 3.10. Project Subcontractor And Suppliers............................................................................................... 17

3.11. Customer Training On Operation and Maintenance ....................................................................... 17

e 3.12. Project Records and Documentation Plan ....................................................................................... 17 S 4. Contract Specifications....................................................................................................................... 18

4.1. Overview............................................................................................................................................ 18 4.2. Contract Technical Specifications ...................................................................................................... 18 4.3. Contract Drawings ............................................................................................................................. 18 4.4. Needs and expectations of interested parties................................................................................... 18 4.5. Contract Risk Assessment.................................................................................................................. 18 4.6. Contract Submittals ........................................................................................................................... 18 4.7. Customer Submittal Approval ........................................................................................................... 20 4.8. Contract Warranty ............................................................................................................................. 21 4.9. Contract Review and Approval .......................................................................................................... 21 5. Design Review and Control ................................................................................................................ 22 5.1. Overview............................................................................................................................................ 22

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5.2. Design Input Review .......................................................................................................................... 22 5.3. Project Design Quality Assurance/Quality Control Plan .................................................................... 22 5.4. Design Progress Reviews ................................................................................................................... 23 5.5. Design Output Verification and Approval.......................................................................................... 23

6. Project-Specific Quality Standards ..................................................................................................... 24

6.1. Overview............................................................................................................................................ 24 6.2. Regulatory Codes............................................................................................................................... 24 6.3. Industry Quality Standards ................................................................................................................ 24 6.4. Material Specifications ...................................................................................................................... 24 6.5. Equipment Specifications .................................................................................................................. 25 6.6. Work Process Specifications .............................................................................................................. 25 6.7. Controlled Material Identification and Traceability .......................................................................... 25 6.8. Measuring Device Control and Calibration........................................................................................ 26 6.9. [CompanyName] Quality Standards .................................................................................................. 26 6.10. Application of Multiple Sources of Specifications ........................................................................... 26

s 7. Project Purchasing ............................................................................................................................. 27 e 7.1. Overview............................................................................................................................................ 27 g 7.2. Qualification of Outside Organizations and Company Departments ................................................ 27 a 7.3. Quality Responsibilities of Key Subcontractor And Supplier Personnel ............................................ 28

7.4. Requirements for Subcontractor QC Plan ......................................................................................... 29

P 7.5. Subcontractor And Supplier Quality Policy........................................................................................ 29

7.6. Purchase Order Requirements .......................................................................................................... 30

d 7.7. Project Purchase Order Approvals..................................................................................................... 30

8. Process Controls................................................................................................................................. 31

te 8.1. Overview............................................................................................................................................ 31 c 8.2. Project Startup and Quality Control Coordination Meeting .............................................................. 31

8.3. Preparatory Project Quality Assurance/Quality Control Plan Planning............................................. 31

le 8.4. Weekly Quality Planning and Coordination Meetings....................................................................... 32

8.5. Process Control Standards................................................................................................................. 32

e 8.6. Daily Quality Control Report.............................................................................................................. 34 S 8.7. Monthly Quality Control Report ........................................................................................................ 34

9. Inspections and Tests ......................................................................................................................... 35

9.1. Overview............................................................................................................................................ 35 9.2. Required Work Task Quality Inspections and Tests........................................................................... 35 9.3. Material Inspections and Tests .......................................................................................................... 35 9.4. Work in Process Inspections.............................................................................................................. 36 9.5. Work Task Completion Inspections ................................................................................................... 36 9.6. Inspection of Special Processes ......................................................................................................... 37 9.7. Independent Measurement and Tests .............................................................................................. 37 9.8. Commissioning Functional Acceptance Tests .................................................................................... 37 9.9. Hold Points for Customer Inspection................................................................................................. 37 9.10. Quality Inspection and Test Specifications ...................................................................................... 37

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9.11. Inspection and Test Acceptance Criteria ......................................................................................... 38 9.12. Inspection and Test Status............................................................................................................... 38 9.13. Independent Quality Assurance Inspections ................................................................................... 38 9.14. Inspection and Test Records............................................................................................................ 38 9.15. Project Completion and Closeout Inspection .................................................................................. 39 10. Nonconformances and Corrective Actions....................................................................................... 41 10.1. Overview.......................................................................................................................................... 41 10.2. Nonconformances ........................................................................................................................... 41 10.3. Corrective Actions ........................................................................................................................... 42 11. Preventive Actions ........................................................................................................................... 44 11.1. Overview.......................................................................................................................................... 44 11.2. Identify Preventive Actions for Improvement ................................................................................. 44 11.3. Train Preventive Actions for Improvement ..................................................................................... 44 12. Quality System Audits ...................................................................................................................... 46

s 12.1. Overview.......................................................................................................................................... 46 e 12.2. Project Quality System Audit ........................................................................................................... 46 g 12.3. Company-wide Quality System Audit .............................................................................................. 46 a 13. Record and Document Controls........................................................................................................ 48

13.1. Overview.......................................................................................................................................... 48

P 13.2. Quality System Documents ............................................................................................................. 48

13.3. Document Controls.......................................................................................................................... 48

d 13.4. Record Controls ............................................................................................................................... 49 te 14. Appendix.......................................................................................................................................... 51 c 14.1. Definitions of Terms ........................................................................................................................ 51 Sele 15. Forms ............................................................................................................................................... 55

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