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"I've created a QMS from scratch at my last company, but didn't want to spend the time again. Our Registrar recommended The 9000 Store to us as a good source for Quality Manual Templates. Not only did they save time, but they were easy to use because they flow with the standard. I would highly recommend The 9000 Store to anyone creating or improving a QMS."
- HA, Quality Manager at Advanced Polymer Compounding A Division of Ferro
Building your QMS is a cornerstone of any successful ISO 9001 Registration. But why take the risk of starting from scratch? With our fully customizable Quality Manual and Procedures Package you will have all the processes and documents you need. Select the correct QMS for your organization.
All you have to do is edit and customize each element to suit your own organization and needs. The Quality Manual and Procedures package is ideally suited for organizations and consultants in search of a proven, simple pathway to successful Registration with quality documentation.
As you implement your ISO 9001 system you will also need checklists and training. You can save time and money by purchasing our Certification Packages!
Profit from the years of work that have gone into creating and refining this package. The key to an effective Quality Management System is designing the Quality Management Processes for efficiency and ease of use. The processes must be carefully thought out, well-organized, and carefully designed to work together to lead your organization to continuous improvement.
We save you time and money in gaining ISO 9000 certification.
How long would it take you to create hundreds of pages, formatted to comply with ISO 9001? Just think about the labor savings alone!
Our experienced ISO 9000 professionals have done the hard part for you. Our system is the result of continual improvement of processes and procedures that have been tried, proven and improved over the last decade. They have lead thousands of companies across the globe to successful ISO 9001 Registration, and more importantly to internal improvements including increased productivity and profits that ISO 9000 training and implementation brings.
Every purchase is backed by our guarantee so there is little risk in trying.
Samples
Although our products are easy to use, we still offer World Class Support for your project - for FREE!
Our products have been proven over 10 years - longer than anyone else - and have helped companies around the world become certified. We don't flood our packages with unnecessary forms and other "fluff" to make them look complete. Ours ARE complete, and get the job done with quality documentation.
Experienced ISO professionals are available to answer questions about your Quality Manual Template and help you develop and implement your QMS with quality documentation.
ISO 9001:2008 Documentation Scheme

ISO 9001:2008 Documentation Requirements
How Much Documentation Do You Need For Your ISO 9001 process?
Much depends on the size and complexity of your organization. You should have enough procedures to cover each section of the standard that applies to your business.
The ISO/IAF Guidelines says: "The auditee/auditor considers that each clause or sub-clause of ISO 9001 must be defined as a separate process". Do you purchase anything that could have an impact on meeting the customers' requirements? Then you'll need a Purchasing Procedure to describe section 7.4 - yet that isn't "required".
There are actually 20 different related (ISO 9000) processes called out in the standard. The 9000 Store has designed clearly written procedures to describe each section of the standard. That is why our QMS process is better than the rest - we cover the entire standard. Don't think you can only provide a few procedures and call it an ISO 9001 QMS. The result can be a very poor ISO 9001 process. Is it worth the savings?
ISO 9001 has 20 requirements. All of our QMS products address the requirements in the Quality Manual, but the different versions provide separate procedures for more detailed processes.
Which QMS is right for me?
ISO 9001 also suggests statistical tools for your Corrective/Preventive Action and sampling. We have included optional procedures for this in the Complete QMS.
| Quality Manual | Lean QMS | Service QMS | Complete QMS | |
|---|---|---|---|---|
| Free Support throughout your project! | ![]() |
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| 4 PowerPoint Presentations | ![]() |
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| Step-by-Step Guide | ![]() |
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| Complete Quality Manual | ![]() |
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| 2 hour Online ISO 9001 Project Manager Training | ![]() |
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| Level 2 Procedures | 6 | 13 | 22 | |
| Forms, Tables, & Attachments for Records | 40 | 40 | 41 | |
| Templates for Processes & Work Instructions | 3 | 3 | 3 | |
| ISO 9001 Process Flow Charts | 3 | 13 | 27 | |
| Quality Policy Sample & Template | ![]() |
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| SmartDraw |
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Mandatory Procedures |
Quality Manual | Lean QMS | Service QMS | Complete QMS |
| Sec. 4.2.3 Document Control | ![]() |
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| Sec 4.2.4 Control of Quality Records | ![]() |
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| Sec. 8.2.2 Internal Audits | ![]() |
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| Sec. 8.3.0 Control of Nonconforming Product | ![]() |
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| Sec. 8.5.2 Corrective Action | ![]() |
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| Sec 8.5.3 Preventive Action | ![]() |
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Operating Procedures |
Quality Manual | Lean QMS | Service QMS | Complete QMS |
| Sec 5.0.0 Management Responsibility | ![]() |
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| Sec. 6.2.2 Competence, Awareness and Training | ![]() |
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| Sec. 6.3.0 Infrastructure | ![]() |
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| Sec. 7.1.0 Planning of Product Realization Processes | ![]() |
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| Sec. 7.3.0 Design and Development | ![]() |
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| Sec. 7.4.0 Purchasing | ![]() |
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| Sec. 7.2.0 Customer Related Processes | ![]() |
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| Sec. 7.5.0 Control of Production and Service | ![]() |
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| Sec. 7.5.3 Identification and Traceability | ![]() |
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| Sec. 7.5.4 Customer Property | ![]() |
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| Sec. 7.5.5 Preservation of Product | ![]() |
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| Sec. 7.6.0 Control of Monitoring and Measuring Equipment | ![]() |
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| Sec. 8.2.1 Monitoring, Measuring and Analysis of Customer Satisfaction | ![]() |
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| Sec. 8.2.4 Monitoring, Measuring & Analysis of Product & Realization Processes | ![]() |
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| Sec. 8.4.1 Root Cause Analysis | ![]() |
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| Sec. 8.4.0 Statistical Techniques | ![]() |
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Forms |
Quality Manual | Lean QMS | Service QMS | Complete QMS |
| F-423-001 Master Document List | ![]() |
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| F-423-002 Software Inventory Spreadsheet | ![]() |
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| F-423-003 Document Change Request Form | ![]() |
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| F-423-004 Document Revision Checklist | ![]() |
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| F-424-001 Quality Records Table | ![]() |
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| F-500-002 Key Process Master List | ![]() |
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| F-500-001 QMS Monitoring, Measuring and Analysis Table | ![]() |
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| A-500-001 Quality Policy | ![]() |
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| A-550-001 Organization Chart | ![]() |
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| F-560-001 Management Review Agenda | ![]() |
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| F-560-002 Management Review Checklist | ![]() |
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| F-622-001 Training Action Plan | ![]() |
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| F-622-002 Group Training Record | ![]() |
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| F-622-003 Job Description Form | ![]() |
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| F-630-001 Equipment Problem Report | ![]() |
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| F-630-002 Equipment Maintenance Record | ![]() |
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| F-700-005 Clause 7 Inclusion-Exclusion Worksheet | ![]() |
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| F-710-001 Quality Planning Table | ![]() |
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| A-710-010 Process Flow Chart | ![]() |
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| F-720-001 Client Assessment Memo | ![]() |
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| F-730-001 Design Plan | ![]() |
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| F-730-002 Design Review Record | ![]() |
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| F-730-003 Design Change | ![]() |
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| F-740-001 Supplier Quality Reports | ![]() |
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| F-740-002 Supplier Corrective Action Request | ![]() |
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| F-740-003 Approved Supplier List | ![]() |
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| F-750-001 Process Routing - Summary | ![]() |
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| F-750-002 Process Routing - Detail | ![]() |
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| F-752-001 Process Validation Worksheet | ![]() |
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| F-753-001 Traceability Serial Number Log | ![]() |
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| F-754-005 Customer Property Control Log | ![]() |
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| F-755-001 Storage Inspection Report | ![]() |
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| F-760-001 Equipment List | ![]() |
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| F-821-001 Customer Satisfaction Survey | ![]() |
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| F-822-001 Internal Audit Plan | ![]() |
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| F-822-002 Internal Audit Report | ![]() |
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| F-822-003 Applicable Procedures by Work Area | ![]() |
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| F-822-004 Audit Point Checklist | ![]() |
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| F-824-001 Product Realization Monitoring, Measuring and Analysis Table | ![]() |
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| F-830-001 Rejected Material/Disposition Report-NCR | ![]() |
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| F-841-001 Root Cause Analysis and Action Plan | ![]() |
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| F-852-001 Corrective/Preventive Action Request | ![]() |
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Process Flow Charts |
Quality Manual | Lean QMS | Service QMS | Complete QMS |
| FD-400 Structure of the QMS | ![]() |
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| FD-410 Business Process Map | ![]() |
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| FD 415 Management Functions | ![]() |
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| FD-423 Control of Documents | ![]() |
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| FD-424 Control of Records | ![]() |
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| FD-500 Management Responsibility | ![]() |
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| FD-510 Management Commitment | ![]() |
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| FD-540 Planning Product Realization, Monitoring and Measurement | ![]() |
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| FD-545 Quality Objectives | ![]() |
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| FD-600 Resource Management | ![]() |
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| FD-610 Resource Management | ![]() |
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| FD-700 Realization of Product | ![]() |
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| FD-710 Manufacturing Process | ![]() |
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| FD-712 Contributors-5Ms | ![]() |
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| FD-714 Product Realization Quality Plan | ![]() |
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| FD-720 Customer Related Processes | ![]() |
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| FD-730 Design and Development | ![]() |
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| FD-731 Project Timing - Design and Development | ![]() |
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| FD-732 Sequence of Development | ![]() |
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| FD-740 Purchasing | ![]() |
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| FD-750 Process Control | ![]() |
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| GD-751 Process Control Steps | ![]() |
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| FD-752 Post Delivery Service Process | ![]() |
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| FD-753 Identification and Traceability | ![]() |
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| FD-800 Measurement, Analysis and Improvement | ![]() |
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| FD 840 Continual Improvement | ![]() |
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| FD-852 Corrective Action | ![]() |
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* SmartDraw was designed for Microsoft Windows operating systems (7, Vista, XP, ME, 2000 and 98). It is currently not offered in a Mac version. You may try running SmartDraw using a PC emulation like Virtual PC, but it is not guaranteed to work as intended. The SmartDraw Academic Edition adds a small watermark to all graphics created with the program.