Sample Pages
ISO 9001 Quality System Model
table of contents
quality manual - procedures - flowcharts
Content
  • Introduction
  • Quality System Model (manual, procedures, work instructions, master lists, forms)
  • Checklist of ISO 9001:2000 Requirements
  • Documentation/Procedures Development Guide
  • Implementation Plan and Schedule
  • Documentation Development Files
Documents and Procedures
  • Quality Manual (1)
  • Operating Procedures (49), including 70 control forms
  • Work Instructions (6),
  •  Document master lists (16)
Operating Procedures and Work Instructions by Department
The standard ISO 9001 requires 6 mandatory documented procedures. It is up to the discretion of the organization to document additional procedures included in this quality system model, or just to implement them in order to meet the requirements of the standard.
Engineering 
EG 01 Design Activities, Coordination and Control
EG 02 Document and Data Control (Engineering) 
EG 03 Quality Planning Process 
EG 04 Request for Design Initiation and Design Change

Manufacturing 
MF 01 Health and Safety Training 
MF 02 Cycle Counts 
MF 03 Traceability of Manufactured Product 
MF 04 Production Scheduling 
MF 05 Material Resource Planning 
MF 06 Manufacturing Process Control 
MF 07 Set-Up Procedure 
MF 08 Preventive Maintenance of Equipment 
MF 09 Regulatory Requirements, compliance

Purchasing 
PU 01 Purchase Orders, processing and follow-up 
PU 02 Supplier Database, set-up and maintenance 
PU 03 Purchasing Product-Database 
PU 04 Assessment, Eval., Appr., Rating of Suppliers 
PU W 01 Suppliers Performance Rating System

Quality Assurance 
QA 01 Control of Nonconforming Product 
QA 02 Receiving Inspection 
QA 03 In-Process Inspection 
QA 04 Inspection and Testing of Finished Product 
QA 05 Control of Monitoring and Measuring Devices 
QA 06 Out Of Calibration Report 
QA 07 Measurement Device Analysis 
QA 08 Customer Return Analysis 
QA 09 Positive Recall Control
QA 10 Customer Approval of Production Parts		 Quality System Administration 
QS 01 Document Review 
QS 02 Training 
QS 03 Document and Data Control
QS 04 Operational Performance 
QS 05 Evaluation of Customer Satisfaction 
QS 06 Customer Complaints 
QS 07 Customer Satisfaction Survey 
QS 08 Internal Quality Audits 
QS 09 Preventive Action 
QS 10 Corrective Action 
QS 11 Continual Improvement 
QS 12 Control of Records 
QS W 01 Corrective Action Request
QS W 02 Problem Analysis 
QS W 03 Quality Improvement Proposal 
QS W 04 Document Identification

Sales 
SA 01 Warranty Control 
SA 02 Review of Quotations and Contracts 
SA 03 Product/Price File and Customer File 
SA 04 Order Taking and Processing 
SA 05 Delivery Performance, order entry 
SA 06 Customer Returns 
SA 07 Service Requirements

Warehouse 
WH 01 Shipping of Product 
WH 02 Receiving of Product 
WH 03 Handling and Storage of Product 
WH 04 Temperature Control
Forms
Forms or control forms are part of operating procedures or work instructions. These forms facilitate the performance of activities, document results, and provide evidence of compliance with requirements. In most cases, these forms can be used without documenting the applicable procedure, and it is up to the organization to document the procedure or only to implement the procedure and using the control form to ensure compliance and create records.
Engineering
- Design Activities, Coordination and Control
- Design Project Plan and Schedule
- Design Review Checklist
- Engineering Document and Data Control
- Documeent Distribution Log
- Document Receiving Log
- Quality Planning – Project Plan and Schedule
- Process FMEA
- Manufacturing Plan
- Design Project Request

Manufacturing
- Training Attendance Record Form
- Cycle Count Records Form
- Material Requirement for Production Form
- Process Sheet
- Manufacturing Order Form
- Material Supply Order Form
- Product Identification Tag
- Tools and Fixture Requisition Sheet
- Request for QC-Approval (first-off/last-off) Form
- Preventive Maintenance - Master List of Equipment
- Preventive Maintenance Checklist
- Equipment Replacement Parts - MIN / MAX  inventory
- Weekly Maintenance Schedule of Equipment Sheet
- Maintenance Record

Purchasing
- Supplier Database - Setup and Maintenance Form
- Product Database - Setup and Maintenance Form
- Supplier Self Assessment Questionnaire
- Supplier Evaluation and Approval Sheet
- Approved Supplier List		 Quality Assurance
- Quarantined Product Tag
- Quarantine Order Sheet
- Receiving Inspection Report
- Rejected Product Tag
- In-Process Inspection Report
- In-Process Inspection Report - Master List
- First – Off Tag
- Approved for Shipping Tag
- Last–Off Tag
- Final Inspection Report
- Final Inspection Report – Master List
- Master List of Measuring, Monitoring, Testing Devices
- Calibration Status Tag
- Calibration and Maintenance Record Sheet
- Out Of Calibration Report
- Authorization for Positive Recall Form
- Under Positive Recall Control Tag

Quality System Administration
- Training Record
- Templates: manual, procedures, work instructions
- Performance Statistics Form
- Customer Complaints Log
- Customer Satisfaction Survey Form
- Internal Quality Audit Plan / Schedule
- Audit Report Form
- Corrective Action Request Sheet
- Problem Analysis Form
- Quality Improvement Proposal Sheet

Sales
- Quotation Sheet
- Project Order Form
- Customer File Setup and Maintenance Form
- Product/Price Record Form
- Customer Order Sheet
- Material Return Authorization Form
- Service Report Form

Warehouse
- Temperature Record Sheet
Sample Page of Quality Manual
Sample Page of Operating Procedure
Sample Page of Operating Procedure - flowchart format