Sample Pages
ISO 9001:2008 Quality System Model
table of contents
quality manual - procedures - flowcharts
ISO 9001 requirements checklist
Content
  • Introduction
  • Quality System Model (manual, procedures, work instructions, master lists, forms)
  • Checklist of ISO 9001:2008 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 Equipment 
QA 06 Out Of Calibration Report 
QA 07 Measurement Equipment 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 Equipment
- 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
Checklist of ISO 9001:2008 requirements
This detailed checklist of 31pages assists with the identification of - and compliance with - the requirements of ISO 9001:2008. A handy tool for the development of documentation, procedures and auditing processes, as well as the identification of documents that address specific related requirements of ISO 9001:2008. 



Sample Page of an ISO 9001:2008 Quality Manual
                 

 
RC 
 General
 Manufacturing

Quality Manual 

Page No.  : 28 of  28
Page Revision  : 00
Issued      : 2009/01/05  



8.5.2 Corrective action
It is the responsibility of the Management Representative to implement and maintain the documented procedure QS10 Corrective Action which defines a corporate approach for corrective action.

 Following the established procedure for corrective action (QS10), nonconformities are identified, root causes are determined (QSW02), corrective action is evaluated and defined, recurrence of the nonconformity is prevented, corrective actions and their results are recorded, and the effectiveness of corrective action taken is reviewed. Corrective actions are appropriate to the importance and impact of the addressed nonconformity.

 It is the responsibility of the department heads to inform the Sales/Service department of all customer complaints (QS06) and related corrective actions.

 It is the responsibility of the department heads to establish and maintain records of corrective actions and their results.

 8.5.3 Preventive Action
It is the responsibility of the Management Representative to implement and maintain the documented procedure QS09 Preventive Action which defines a corporate approach for preventive action to prevent the occurrence of potential nonconformities, deficiencies or problems. Any employee can suggest a preventive action to the responsible department head by initiating a CAR (QSW01).

 The process of preventive action includes the following steps:

·        identify potential nonconformities, deficiencies or problems

·        determine the root causes

·        determine the necessary preventive action

·        implement the action

·        follow-up on status and results

·        review the effectiveness of preventive action taken.

 Department heads analyze and evaluate data of statistics (QS04) and perform periodic reviews of procedures (QS01) in order to detect deficiencies and problems, and to take preventive action as required.

 It is the responsibility of the department heads to establish and maintain records of preventive actions and their results. The Management Representative ensures that relevant information on preventive action is on the agenda of management reviews.

 

 






Sample Page
of an ISO 9001:2008 Operating Procedure                                   

       
 
RC 
 General
 Manufacturing

Operating Procedure
QS 09

Page No.  :
01 of  01
Page Revision  : 00
Issued      : 2009/01/05  

Title:
Preventive Action
Prepared by                             Date  

Herb S.     January 05/2009
Reviewed/approved by                 Date  
Department Head:  
John K.       January 05/2009
eviewed/approved by                     Date  
Management Representative:  
Herb S.    January 05/2009
                   
                          

Changes made:

New issue

Purpose: 

Establish and document the procedure for preventive action, using the appropriate information to detect, analyze and eliminate potential causes of nonconformities and deficiencies.

Scope:

Products, processes, activities, operational performance within RCGM. Quality management systems, customer satisfaction.



Procedure  


General  
A professional judgment should be applied by all functions to ensure that preventive actions are appropriate and proportional to the importance of the potential problem to be addressed. It is the responsibility of the department heads to approve preventive actions. Procedures and documents affected by the implementation of preventive actions shall be updated, and new procedures shall be established as required.  

To identify and analyze nonconformities and deficiencies, and to prevent their occurrence, the following approach for preventive actions shall be taken as a minimum: 

1   At least once within 24 months, each department head reviews all procedures issued by his/her department, following the operating procedure Document Review.  

2   Statistics prepared by the Management Representative as per operating procedure Operational Performance, are analyzed by the responsible department head(s). As a result from these analysis, performance trends on product quality, manufacturing processes, technical service, delivery, customer concerns and customer satisfaction are identified and preventive action is taken by issuing a CAR or as appropriate.  

3   As per established operating procedure Evaluation of Customer Satisfaction, the General Manager evaluates customer dissatisfaction and takes preventive action as appropriate.  

4   The suitability and effectiveness of preventive actions is reviewed and evaluated by management during management reviews and action is taken as required. The effectiveness of implemented preventive actions shall also be monitored for an appropriate period by department heads, and results shall be recorded.  

5   Department heads ensure that records of preventive actions are made available to the Management Representative who ensures that they are part of management reviews.  

 




Sample Page
of an ISO 9001:2008 Operating Procedure
Flowchart-Format

       
 
RC 
 General
 Manufacturing

Operating Procedure
QS 09

Page No.  :
01 of  01
Page Revision  : 00
Issued      : 2009/01/05  

Title:
Preventive Action
Prepared by                             Date  

Herb S.     January 05/2009
Reviewed/approved by                 Date  
Department Head:  
John K.       January 05/2009
eviewed/approved by                     Date  
Management Representative:  
Herb S.    January 05/2009
                   
                          

Changes made:

New issue

Purpose: 

Establish and document the procedure for preventive action, using the appropriate information to detect, analyze and eliminate potential causes of nonconformities and deficiencies.

Scope:

Products, processes, activities, operational performance within RCGM. Quality management systems, customer satisfaction.





   

Sample Page
of a Form "Corrective Action Request" 
of an ISO 9001:2008 Quality Management System

       
 
RC 
 General
 Manufacturing

Work Instruction 
QS W01

Page No.  :
04 of  05
Page Revision  : 00
Issued      : 2009/01/05  

Title:
Corrective Action Request

Attachment: 1




Sample Page
of the ISO 9001:2008 Requirements Checklist

      
 

Requirements Checklist for ISO 9001:2008
For internal use only                                                                                                                                                        Page 3 of 31

Important: This checklist shall assist with the assessment of compliance with requirements of ISO 9001:2008. The standard ISO 9001:2008 shall be used for the interpretation of the standard.

Review performed by: _______________________________________________  Date:________________________________________

Y = yes, I = improvement needed, N = no,  X = not applicable

 
ISO 9001 System Clauses / Requirements
                  

 
M

 
Procedures

 
Y

 
I

 
N

 
X

(continues 4.2.2 Quality Manual)

The manual shall include
a) - the scope of the quality management system
           
    - details of any exclusions            
    - justification for any exclusions            
b) - documented procedures, or reference to them            
c) - a description of the interaction of the processes
       included in the quality management system
           
 
4.2.3 Control of Documents
Documents required for the quality management system
- shall be controlled
           
Records
- shall be controlled according to the requirements in  clause 4.2.4
           
For the control of documents
- a documented procedure shall be established
           
The documented procedure shall define the controls needed
a) - to approve documents for adequacy prior to issue
           
b) - to review documents as necessary            
    - to update documents as necessary            
    - to re-approve documents as necessary            
c) - to identify changes of documents            
    - to identify current revision status of documents            
d) - to have applicable revisions of documents
      available at use
           
e) - to maintain documents legible            
    - to maintain documents readily identifiable            
f) - to identify documents of external origin            
    - to control the distribution of external documents            
g) - to prevent unintended use of obsolete documents            
    - to properly identify obsolete documents that are
      retained for any purpose