ISO 9001 Quality Manual & Procedures

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iso 9001 all in one package

Testimonials

"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.

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.

Features

  • Quality Manual in MS Word format for ease of editing
  • 22 Procedures are written in MS Word and are ready for your customization
  • 39 Related Forms are written in MS Word or Excel
  • Text to address each requirement of the ISO 9001:2008 Standard
  • Very clear instructions in obvious Blue Text to show you where to customize your Manual and Procedures
  • Required references to the recommended procedures and forms for your quality management system
  • Intuitive architecture for easy Document Control
    • We've numbered the sections of the Quality Manual to correspond with the sections of the ISO 9001 Standard. Registrars LOVE this feature!
    • Procedure and Form numbers relate to the section in the Quality Manual.
  • This is a downloadable product.
    • You will also have the option of purchasing the files on a Jump-Drive during checkout but it is not necessary.
  • smartdraw flowcharting software Our FlowChart Package includes a fully functional copy of SmartDraw Flowcharting Software as well as 27 Flow Charts

Samples

iso 9001 quality manual sample
Quality Manual

iso 9001 quality manual sample
Procedure

iso 9001 flow chart examples
Flow Chart

Contents

  • Includes Technical Support
  • Quality Policy Template & Sample
  • 35 page Quality Manual
  • 22 Procedures
  • 39 Forms referenced by the Quality Manual and Procedures
  • 3 Templates to create additional Procedures, Forms and Work Instructions
  • PowerPoint Presentations:
    • Executive Overview
    • Benefits of ISO 9001
    • Implementing ISO 9001
    • Understanding Document Control
  • ISO 9001 Project Manager's Guide
  • Implementation Tips and Techniques Article
  • Flowcharts to help you document your business processes

iso 9001 documentation scheme

ISO 9001:2008 Documentation Scheme

 

ISO 9001:2008 Documentation Requirements

Quality Manual Lean QMS Service QMS Complete QMS


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Free Support throughout your project! ? ? ? ?
4 PowerPoint Presentations ? ? ? ?
Step-by-Step Guide ? ? ? ?
Complete Quality Manual ? ? ? ?
2 hour Online ISO 9001 Project Manager Training ? ? ? ?
Level 2 Procedures   6 13 22
Forms, Tables, & Attachments for Records   40 40 39
Templates for Processes & Work Instructions   3 3 3
ISO 9001 Process Flow Charts   5 13 27
Quality Policy Sample & Template   ? ? ?
SmartDraw smart draw flowchart softwareFlowchart Software Included     FREE FREE

Mandatory Procedures

Quality Manual Lean QMS Service QMS Complete QMS
Sec. 4.2.3 Document Control   ? ? ?
Sec 4.2.4 Control of Quality Records   ? ? ?
Sec. 8.2.2 Internal Audits   ? ? ?
Sec. 8.3.0 Control of Nonconforming Product   ? ? ?
Sec. 8.5.2 Corrective Action   ? ? ?
Sec 8.5.3 Preventive Action   ? ? ?

Operating Procedures

Quality Manual Lean QMS Service QMS Complete QMS
Sec 5.0.0 Management Responsibility     ? ?
Sec. 6.2.2 Competence, Awareness and Training     ? ?
Sec. 6.3.0 Infrastructure       ?
Sec. 7.1.0 Planning of Product Realization Processes     ? ?
Sec. 7.3.0 Design and Development     ? ?
Sec. 7.4.0 Purchasing     ? ?
Sec. 7.2.0 Customer Related Processes       ?
Sec. 7.5.0 Control of Production and Service       ?
Sec. 7.5.3 Identification and Traceability       ?
Sec. 7.5.4 Customer Property       ?
Sec. 7.5.5 Preservation of Product       ?
Sec. 7.6.0 Control of Monitoring and Measuring Equipment     ? ?
Sec. 8.2.1 Monitoring, Measuring and Analysis of Customer Satisfaction       ?
Sec. 8.2.4 Monitoring, Measuring & Analysis of Product & Realization Processes     ? ?
Sec. 8.4.1 Root Cause Analysis       ?
Sec. 8.4.0 Statistical Techniques       ?

Forms

Quality Manual Lean QMS Service QMS Complete QMS
F-423-001 Master Document List   ? ? ?
F-423-002 Software Inventory Spreadsheet   ? ? ?
F-423-003 Document Change Request Form   ? ? ?
F-423-004 Document Revision Checklist   ? ? ?
F-424-001 Quality Records Table   ? ? ?
F-500-002 Key Process Master List   ? ? ?
F-500-001 QMS Monitoring, Measuring and Analysis Table   ? ? ?
A-500-001 Quality Policy   ? ? ?
A-550-001 Organization Chart   ? ? ?
F-560-001 Management Review Agenda   ? ? ?
F-560-002 Management Review Checklist   ? ? ?
F-622-001 Training Action Plan   ? ? ?
F-622-002 Group Training Record   ? ? ?
F-622-003 Job Description Form   ? ? ?
F-630-001 Equipment Problem Report   ? ? ?
F-630-002 Equipment Maintenance Record   ? ? ?
F-700-005 Clause 7 Inclusion-Exclusion Worksheet   ? ? ?
F-710-001 Quality Planning Table   ? ? ?
F-720-001 Client Assessment Memo   ?

?

?
F-730-001 Design Plan   ? ? ?
F-730-002 Design Review Record   ? ? ?
F-730-003 Design Change   ? ? ?
F-740-001 Supplier Quality Reports   ? ? ?
F-740-002 Supplier Corrective Action Request   ? ? ?
F-740-003 Approved Supplier List   ? ? ?
F-750-001 Process Routing - Summary       ?
F-750-002 Process Routing - Detail       ?
F-752-001 Process Validation Worksheet   ? ? ?
F-753-001 Traceability Serial Number Log   ? ? ?
F-754-005 Customer Property Control Log   ? ? ?
F-755-001 Storage Inspection Report   ? ? ?
F-760-001 Equipment List   ? ? ?
F-821-001 Customer Satisfaction Survey   ? ? ?
F-822-001 Internal Audit Plan   ? ? ?
F-822-002 Internal Audit Report   ? ? ?
F-822-003 Applicable Procedures by Work Area   ? ? ?
F-822-004 Audit Point Checklist   ? ? ?
F-824-001 Product Realization Monitoring, Measuring and Analysis Table   ? ? ?
F-830-001 Rejected Material/Disposition Report-NCR   ? ? ?
F-841-001 Root Cause Analysis and Action Plan     ? ?
F-852-001 Corrective/Preventive Action Request   ? ? ?

Process Flow Charts

Quality Manual Lean QMS Service QMS Complete QMS
FD-400 Structure of the QMS       ?
FD-410 Business Process Map       ?
FD 415 Management Functions       ?
FD-423 Control of Documents       ?
FD-424 Control of Records       ?
FD-500 Management Responsibility       ?
FD-510 Management Commitment       ?
FD-540 Planning Product Realization, Monitoring and Measurement       ?
FD-545 Quality Objectives       ?
FD-600 Resource Management       ?
FD-610 Resource Management       ?
FD-700 Realization of Product       ?
FD -710 Manufacturing Process       ?
FD-712 Realization of Products       ?
FD-720 Customer Related Processes       ?
FD-730 Design and Development       ?
FD-731 Project Timing - Design and Development       ?
FD-732 Sequence of Development       ?
FD-740 Purchasing       ?
FD-750 Process Control       ?
GD-751 Process Control Steps       ?
FD-752 Post Delivery Service Process       ?
FD-753 Identification and Traceability       ?
FD-800 Measurement, Analysis and Improvement       ?
FD 840 Continual Improvement       ?
FD-852 Corrective Action        


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