ISO/TS 16949:2009
Quality Management System Model

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Sample Pages
   
or Indu
  
Table of content and sample pages of the quality manual, procedures, flowcharts,
form of internal audits
and ISO/TS 16949:2009 requirements checklist

  All files are available in MS WORD format for easy editing

Content of the Quality Management System Model ISO/TS 16949:2009
  • Introduction
  • ISO/TS 16949:2009 Quality System Model (manual, procedures, flowcharts, work instructions, master lists, forms)
  • Checklist of ISO/TS 16949:2009 Requirements
  • Documentation/Procedures Development Guide for SO/TS 16949 
  • Implementation Plan and Schedule for ISO/TS 16949
  • Documentation Development Files
     
Documents and Procedures for compliance with ISO TS 16949:2009
  • Quality Manual (1) incl. flowchart of the interaction of processes of the quality system
  • Operating Procedures (57), incl. 78 control forms and 8 procedures with optional flowchart version
  • Work Instructions (6)
  • Document master lists (16)
Procedures and Work Instructions by Department
The standard ISO/TS 16949 requires 7 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 
EG01  Quality Planning of Product/Processes
EG02 Document and Data Control (Eng.), + flowchart version
EG03 Request for Design Initiation and Change
EG04 Out-Contracting of Tooling Construction/Design
EGW0 Process of Quality Planning, Product/Process
     
Manufacturing
MF01 Health and Safety Training
MF02 Cycle Counts
MF03 Traceability of Manufactured Product
MF04 Production Scheduling
MF05 Material Resource Planning
MF06 Manufacturing Process Control
MF07 Set-Up Procedure
MF08 Preventive Maintenance of Equipment
MF09 Regulatory Requirements, compliance
MF10 Housekeeping
           
Purchasing 
PU01 Purchase Orders, processing and follow-up 
PU02 Supplier Database, set-up and maintenance
PU03 Purchasing Product-Database
PU04 Assessment, Eval., Appr., Rating of Suppliers
PUW 01 Suppliers Performance Rating System
         
Quality Assurance 
QA01 Control of Nonconforming Product, + flowchart version
QA02 Receiving Inspection 
QA03 In-Process Inspection 
QA04 Inspection and Testing of Finished Product 
QA05 Control of Monitoring and Measuring Equipment 
QA06 Out Of Calibration Report 
QA07 Measurement Equipment Analysis 
QA08 Customer Return Analysis
QA09 Positive Recall Control
QA10 Customer Approval of Production Parts
QA11 DMRs to Suppliers
QA12 Layout Inspection and Functional Testing
   
Quality System Administration 
QS01 Document Review 
QS02 Training, + flowchart version
QS03 Control of Documents, + flowchart version
QS04 Operational Performance 
QS05 Evaluation of Customer Satisfaction 
QS06 Customer Complaints
QS07 Customer Satisfaction Survey 
QS08 Internal Quality Audits,  + flowchart version
QS09 Preventive Action, + flowchart version 
QS10 Corrective Action, + flowchart version 
QS11 Continual Improvement 
QS12 Control of Records, + flowchart version 
QSW01 Corrective Action Request
QSW02 Problem Analysis 
QSW03 Quality Improvement Proposal
QSW04 Document Identification
          
Sales 
SA01 Warranty Control 
SA02 Review of Quotations and Contracts 
SA03 Product/Price File and Customer File 
SA04 Order Taking and Processing 
SA05 Delivery Performance, order entry 
SA06 Customer Returns 
SA07 Service Requirements
         
Toolroom
TR01 Tooling Construction
TR02 Approval of Customer-Supplied Tooling
TR03 Prev. Maintenance, Repair, Admin. of Tooling
TR04 Tooling Repair Request
    
Warehouse 
WH01 Shipping of Product 
WH02 Receiving of Product 
WH03 Handling and Storage of Product
WH04 Temperature Control
     
Forms by Department

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 of ISO/TS 16949:2009 . 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 with ISO 16949 and create records for internal audits .
   
Engineering
- Quality Planning – Project Summary Form
- Engineering Document and Data Control  Form
- Document Distribution Log 
- Document Receiving Log 
- Design/Development Project Request Sheet
- Quality Planning Project - Plan and Schedule
- Project Review Checklist
- Process FMEA Form
- Control Plan
   
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
- 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
- Discrepant Material Report
   
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
   

Toolroom

- Tooling Work Plan
- Try-Out Record
- Tooling Inspection Report
- Preventive Maintenance Tag
- Tooling Inventory Log
- Preventive Maintenance Report
- Tooling Repair Request Form
   

Warehouse

- Temperature Record Sheet
      

Checklist of ISO/TS 16949:2009 requirements
This detailed checklist of 57 pages assists with the identification of - and compliance with - the requirements of ISO/TS 16949:2009. 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/TS 16949:2009.     

                       

Sample page
of ISO/TS 16949:2009 Quality Manual, page 35 

    

RC
Auto-Parts Manufacturing

Quality Manual


Page No. :
35 of  42
Revision : 00
Issued     : 2009/09/01


   
8.1.2 Knowledge of basic statistical concepts
   
Department heads, with the assistance of the Management Representative ensure that personnel is trained in the use and application of basic statistical concepts defined by quality planning and used in their respective departments. Training records are maintained (QS02).
     
8.2 Monitoring and measurement
8.2.1 - 8.2.1.1 Customer satisfaction
Periodic customer satisfaction surveys (QS07) are conducted by management to verify if customer satisfaction has been achieved. Survey results, which include customer complaints and feedback, customers’ business disruptions (QS06), customer returns of nonconforming product (SA06) and delivery performance (QS04) are analyzed and evaluated (QS05). As required, management takes corrective or preventive action. The effectiveness of these corrective or preventive actions is monitored by the Management Representative.
   
8.2.2 - 8.2.2.1 Internal audit of the quality management system
Following the established documented procedure QS08 Internal Quality Audits, the Management Representative is responsible for internal audits. Internal audits are planned and scheduled in such a way that all applicable clauses of ISO/TS 16949:2009 and other additional quality system requirements are audited regarding compliance with this implemented quality management system and ISO/TS 16949:2009. Audits do also verify if the quality management system is effectively implemented and maintained, and that it meets the requirements of RCAPM, including planned actions, objectives and results. 
   
The Management Representative selects the auditors and ensures that they have required experience and knowledge to perform auditing activities. 
   
Audits are scheduled on the basis of the importance of the activity to be audited. Audit activities are assigned to personnel not responsible for the area or activity to be audited.  
   
Audit results are recorded and corrective action is taken as required. Where applicable, follow-up audits are conducted to ensure that corrective action was implemented and is effective. 
   
Records of internal audits are maintained. As appropriate, management is informed of the results of audits and follow-up audits and takes additional corrective action. The Management Representative ensures that audit results are part of Management Review.
   
8.2.2.2 Manufacturing process audit
In addition to the normal internal audits of the quality management system, the Management Representative coordinates with the Manufacturing department the auditing of all manufacturing 
   
    

 

Sample page
of an ISO/TS 16949:2009 operating procedure Internal Quality Audits
    


RC
Auto-Parts Manufacturing


Operating Procedure

   QS 08       

Page No. : 01 of  05
Revision : 00
Issued     : 200
9/09/01
Effective : 
2009/09/01

Title: Internal Quality Audits

Prepared by:
Herb S.

Date
  01-09-2009

Dept. Head
John K.

Date
  0-09-2009

Mgmt. Rep.
Herb S..

Date
01-09-2009

 

  

Changes made:
   
new issue
   
Purpose:  Ensure proper planning and conducting of internal quality audits, to verify whether the quality management system is in compliance with the requirements of ISO/TS 15949, whether quality activities are in compliance with the established procedures, to determine the effectiveness of the quality management system in achieving the company's quality goals and objectives; to provide a tool and basis for corrective action, preventive action and improvement, and to verify if results of corrective and preventive actions are successful.   
   
Scope:  

Quality management system and quality activities of RCAPM, including all shifts.   
   

     
Procedure
   
1   General                       
1.1
The Management Representative prepares an annual plan and schedule for auditing activities to ensure that internal quality audits are conducted at least once per year and in such a way that all activities of the quality management system and requirements and clauses of ISO/TS 16949 are audited. This schedule is prepared with close cooperation of all departments affected. Audits shall verify if planned objectives and actions which are established according to the requirements in clause 7.1 are effectively pursued or have been successfully completed. All auditing activities include the verification of compliance with established procedures, technical specifications from internal and external sources, as well as regulatory requirements.
   
Audits cover all shifts as applicable. The Management Representative appoints the auditors and ensures that they have sufficient knowledge and experience to conduct internal quality audits. As per discretion of the Management Representative, auditors are trained by the Management Representative or take outside training courses. Qualifications, experience and provided training, including qualification for lead auditor is documented and kept in the employee’s file. Where required, the Management Representative performs the function of a Lead Auditor or appoints a Lead Auditor. Personnel who carry out audits should not be responsible for the  activities or area being audited.
   
At least one per year each manufacturing process is audited regarding its effectiveness. At randomly scheduled quarterly audits, products are audited at selected stages of production and delivery to verify conformity to all requirements, including dimensions, functionality, packaging and labeling. Audit results are included in Management Reviews.
    
   
1.2   The Management Representative ensures that quality audits contain at least: 
  •  
 the Audit Plan, covering specific areas and/or activities to be audited, the reason or cause for carrying out the audit (organizational changes, routine checks and surveys, reported deficiencies, compliance  with ISO/TS 16949, etc.) as well as the transmission of information to functions concerned and who should be informed of audit findings, results, conclusions and recommendations. The auditing process includes as applicable: previous audit results, evaluation and verification of activities regarding their compliance with the quality manual, procedures, work instructions, quality

   

     

                                        

Sample page
of an ISO/TS 16949:2009 operating procedure Internal Quality Audits
flowchart format (page 1 of 2)


    

RC
Auto-Parts Manufacturing


Operating Procedure

   QS 08       

Page No. : 01 of  02
Revision : 00
Issued     : 200
9/09/01
Effective : 
2009/09/01

Title: Internal Quality Audits

Prepared by:
Herb S.

Date
  01-09-2009

Dept. Head
John K.

Date
  0-09-2009

Mgmt. Rep.
Herb S..

Date
01-09-2009

 

Changes made:
   
new issue
   
Purpose:  Ensure proper planning and conducting of internal quality audits, to verify whether the quality management system is in compliance with the requirements of ISO/TS 15949, whether quality activities are in compliance with the established procedures, to determine the effectiveness of the quality management system in achieving the company's quality goals and objectives; to provide a tool and basis for corrective action, preventive action and improvement, and to verify if results of corrective and preventive actions are successful.   
   
Scope:  

Quality management system and quality activities of RCAPM, including all shifts.   
   

Procedure
   

  
      

 

 

Sample Page
of the Checklist of ISO/TS 16949:2009 Requirements (page 45 of 57)
  

  Requirements Checklist for ISO/TS 16949:2009
Page 45 of 57
 For internal use only
 Important: This checklist shall assist with the assessment of compliance with documentation requirements of
 ISO/TS 16949:2009. The standard ISO/TS 16949:2009 shall be used for the interpretation of the standard.
 

   
  Review performed by: _______________________________________________ 

 
Date:_________________________________

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

   
ISO/TS 16949 System Clauses / Requirements  
    


 
M

   
Procedures
 
     


Y


I
 


N
 


X

    
8.2.2 Internal audit
A documented procedure for internal audits
- shall be developed and maintained

 

 

 

 

 

 

Periodic internal audits
- shall be conducted

 

 

 

 

 

 

These audits shall determine whether the quality management system
a) - conforms to planned arrangements (clause 7.1)

 

 

 

 

 

 

- conforms to the requirements of this international standard

 

 

 

 

 

 

- conforms to the quality management system requirements of the organization

 

 

 

 

 

 

b) is effectively
   
- implemented

 

 

 

 

 

 

    - maintained

 

 

 

 

 

 

Audit programs shall be
- planned

 

 

 

 

 

 

Audit planning shall take into consideration
- the status of the activities/areas to be audited

 

 

 

 

 

 

- the importance of the activities/areas to be audited

 

 

 

 

 

 

- the results of previous audits

 

 

 

 

 

 

The
- audit criteria shall be defined

 

 

 

 

 

 

- audit scope shall be defined

 

 

 

 

 

 

- audit frequency shall be defined

 

 

 

 

 

 

- audit methods shall be defined

 

 

 

 

 

 

Objectivity and impartiality of audit processes shall be ensured through
- proper selection of auditors

 

 

 

 

 

 

- proper conduct of audits

 

 

 

 

 

 

Auditors 
- shall not audit their own work