Sample Pages
of
 ISO / TS 16949:2009 Quality System Model
table of contents
quality manual - procedures - flowcharts
requirements checklist

Content of the Quality Management System Model ISO/TS 16949:2009
  • Introduction
  • Quality System Model (manual, procedures, flowcharts, work instructions, master lists, forms)
  • Checklist of ISO/TS 16949:2009 Requirements
  • Documentation/Procedures Development Guide
  • Implementation Plan and Schedule
  • Documentation Development Files
Documents and Procedures
  • 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)
Operating 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 
EG 01 Quality Planning of Product/Processes
EG 02 Document and Data Control (Eng.), + flowchart version
EG 03 Request for Design Initiation and Change
EG 04 Out-Contracting of Tooling Construction/Design
EGW 01 Process of Quality Planning, Product/Process

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
MF 10 Housekeeping

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, + flowchart version
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
QA 11 DMRs to Suppliers
QA 12 Layout Inspection and Functional Testing		 Quality System Administration 
QS 01 Document Review 
QS 02 Training, + flowchart version
QS 03 Control of Documents, + flowchart version
QS 04 Operational Performance 
QS 05 Evaluation of Customer Satisfaction 
QS 06 Customer Complaints 
QS 07 Customer Satisfaction Survey 
QS 08 Internal Quality Audits,  + flowchart version
QS 09 Preventive Action, + flowchart version 
QS 10 Corrective Action, + flowchart version 
QS 11 Continual Improvement 
QS 12 Control of Records, + flowchart version 
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

Toolroom
TR 01 Tooling Construction
TR 02 Approval of Customer-Supplied Tooling
TR 03 Prev. Maintenance, Repair, Admin. of Tooling
TR 04 Tooling Repair Request

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
- 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 an ISO/TS 16949:2009 Quality Manual, page 41 
    

RC
Auto-Parts Manufacturing

 Quality Manual


Page No. : 41 of  42
Revision : 00
 Issued     : 2009/09/01




The objectives of the corporate quality policy are taken into consideration for planning of improvement. During Management Reviews, the effectiveness of continual improvement is reviewed and opportunities for improvement are identified.  


8.5.1.2 Manufacturing process improvement
It is the responsibility of personnel in Manufacturing to continually monitor the performance of manufacturing processes regarding conformity with product characteristics and process parameters. In monthly meetings with the production staff, process performance of production areas are analyzed, and opportunities for improvement are identified and implemented (QS11).


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, 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.


8.5.2.1 Problem solving
To determine the root cause of a problem or deficiency, and to establish required corrective action, a disciplined problem solving method as outlined in the work instruction QSW02, or any other suitable method, is used as appropriate.


8.5.2.2 Error-proofing
As appropriate, the Quality Team applies error-proofing methods in the corrective action process to prevent recurrence of the problem.


8.5.2.3 Corrective action impact
As applicable, the Quality Team applies implemented corrective action to other similar processes or products in order to correct nonconformity.

 
Sample page
of an ISO/TS 16949:2009 operating procedure Corrective Action
    


RC
Auto-Parts Manufacturing


Operating Procedure

   QS 10       

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

Title: Corrective Action
Prepared by:

Herb S.		            Date

   Sept. 01/2009
Reviewed/approved
by Dept. Head
John K.		            Date

   Sept. 01/2009
Reviewed/approved
by Mgmt. Rep.
Herb S..		            Date

Sept. 01/2009

 

 
Changes made: new issue
Purpose:  Document the process for corrective action activities, including analysis, root causes, action taken and monitoring the effectiveness of corrective action.
Scope:  

Nonconformities and deficiencies of products, manufacturing processes, services, technical service, customer returns, customer complaints, products and services provided from internal and external suppliers, including carriers. Preventive action.



Procedure


General
If there is a need of establishing a documented record of an internal nonconformity or deficiency which requires a formal approach of corrective action, a Corrective Action Request (CAR) is issued (see Work Instruction Corrective Action Request).

No CAR should be issued without prior communication with functions concerned. There should be no CAR issued for a minor problem that can be taken care of with a simple phone call or a five-minute conversation. 

The benefits of using a CAR are 

·        that the problem, nonconformity or deficiency is described in detail and documented

·        that responsibilities are defined and assigned

·        that temporary corrective action is taken if required, in order to satisfy the immediate needs    of the (external or internal) customer

·        that root causes are determined

·        that corrective action is taken to permanently correct the problem,  nonconformity or   deficiency

·        that the suitability and effectiveness of results is monitored, reviewed and recorded

 
For the processing of a CAR, the work instruction Corrective Action Request (CAR) is followed. 

If corrective action requires changes to documents of established procedures, the responsible department head ensures that documents and procedures are updated and that changes are implemented. New procedures are established, documented and implemented as required. Similar processes are analyzed and corrective action shall be applied to these processes as appropriate. 

Where appropriate and applicable, a structured problem solving method is used, such as the method outlined in the work instruction Problem Analysis, a customer-prescribed method, or any other suitable problem solving method. Error-proofing shall be part of the corrective action.

Customer complaints are handled according to the operating procedure Customer Complaints.

Sample page
of an ISO/TS 16949:2009 operating procedure Corrective Action
flowchart format (page 1 of 2)

    

RC
Auto-Parts Manufacturing


Operating Procedure

   QS 10       

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

Title: Corrective Action
Prepared by:

Herb S.		            Date

 Sept. 01/2009
Reviewed/approved
by Dept. Head
John K.		           Date
 
   Sept. 01/2009
Reviewed/approved
by Mgmt. Rep.
Herb S..		            Date

Sept. 01/2009

 

Changes made: new issue
Purpose:  Document the process for corrective action activities, including analysis, root causes, action taken and monitoring the effectiveness of corrective action.
Scope:  

Nonconformities and deficiencies of products, manufacturing processes, services, technical service, customer returns, customer complaints, products and services provided from internal and external suppliers, including carriers. Preventive action.

Procedure

 

 
 

Sample page
of an ISO/TS 16949:2009 control form Corrective Action Request
(page 1 of 2)





 

 


Sample Page
of the Checklist of ISO/TS 16949:2009 Requirements (page 55 of 57)  


Requirements Checklist for ISO/TS 16949:2009
For internal use only                                                                                                                                                        Page 55 of 57

Important: This checklist shall assist with the assessment of compliance with 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 9001 System Clauses / Requirements
                  

 
M

 
Procedures

 
Y

 
I

 
N

 
X


8.5.1.1 Continual improvement of the organization
A process for continual improvement shall 
- be defined 		           

8.5.1.2 Manufacturing process improvement
Manufacturing process improvement shall continually focus on
- control of variation in product characteristics		            
- control of variation in manufacturing process parameters               
- reduction of variation in product characteristics            
- reduction of variation in manufacturing process parameters            

8.5.2 Corrective action
To eliminate the cause of nonconformities in order to prevent their recurrence,
- corrective action shall be taken		            

Corrective action shall be
- appropriate to the impact of the nonconformity encountered

            

A documented procedure for corrective action
- shall be established and maintained

            

The documented procedure for corrective action shall define the requirements for
a) - reviewing nonconformities (including customer complaints)

            
b) - determining the causes of nonconformity            

c) - evaluating the need for action to ensure that nonconformities do not recur

            
d) - determining corrective action needed            
    - implementing corrective action needed            
e) - records of results of action taken            
f) - reviewing corrective action taken