ISO/TS 16949 All in One Documentation & Training Package Contents

• ISO/TS 16949 Quality Manual* • Quality System Procedures* • Related QMS Forms * • Intro to ISO/TS 16949 Presentation Materials* • ISO/TS 16949 Gap Checklist * • ISO/TS 16949 Internal Audit Checklist* • ISO/TS 16949 Internal Auditor Training Materials * • ISO/TS 16949 Employee Training * • Employee Newsletters

*Samples Included

Quality Manual

Page 9 of 42Date printed 3/26/10 3:19 PM

4.1 General requirementsYour company has established, documented and implemented a QualityManagement System (QMS) in accordance with the requirements of ISO9001:2008 and TS 16949:2009. The system is maintained and continuallyimproved through the use of the quality policy, quality objectives, audit results,analysis of data, corrective and preventive action and management review.To design and implement the QMS Your Company has:

§ Identified the processes needed for the QMS and their applicationthroughout the organization and documented them on the Process FlowDiagram at the end of this section of the Quality Manual

§ Determined the sequence and interaction of these processes, andillustrated them on the Process Flow Diagram

§ Determined criteria and methods needed to ensure that the operation andcontrol of the processes are effective, and documented them in qualityplans, work instructions and the Measuring, Monitoring and AnalysisTable

§ Ensured the continuing availability of resources and informationnecessary to achieve planned results and continual improvement of theseprocesses

§ Established systems to monitor, measure and analyze these processes,and

§ Established processes to identify and implement actions necessary toachieve planned results and continual improvement of these processes

When Your Company out sources any process that affects product conformity,technical responsibility is maintained and the control of these processes areidentified within the QMS.

4.2 Documentation Requirements

4.2.1 General

The QMS documentation includes:

§ A documented Quality Policy

§ This Quality Manual

§ Documented Procedures

§ Documents identified as needed for the effective planning, operation andcontrol of our processes, and

§ Quality Records

P-630Infrastructure

Infrastructure Page 1 of 2Date printed 3/26/10 3:35 PM

1.0 Purpose

1.1 This procedure describes the process for determining, providing and maintainingthe infrastructure needed to achieve conformity to product requirements.

2.0 Responsibilities

2.1 Maintenance personnel are responsible for the preventive maintenance offacilities and equipment.

2.2 The Facilities Manager is responsible for facilities and equipment planning usinga multidisciplinary approach.

2.3 Manufacturing Engineering for developing and implementing the evaluation andmonitoring of the effectiveness of existing operations.

2.4 The Facilities Manager is responsible for maintaining the contingency plans.

3.0 Definitions

3.1 Infrastructure: buildings, workspace and utilities, process equipment andsupporting services.

4.0 Equipment/Software

4.1 Not Applicable.

5.0 Instructions

5.1 Infrastructure needs are identified during quality planning and planning ofrealization processes. Planning processes are documented in the Quality Manualand the Planning of Product Realization Processes Procedure. (MP-710).

5.2 Infrastructure is maintained by using a Preventive Maintenance Program.

5.2.1 Maintenance evaluates facilities, equipment and other infrastructure todetermine areas where preventive maintenance work needs to be done.

5.2.2 The preventive maintenance database or spreadsheet lists each item thatrequires preventive maintenance, and the maintenance schedule.

5.2.3 The maintenance manager is responsible for generating a preventivemaintenance schedule for each maintenance cycle and distributing themto the appropriate individual or function.

5.2.4 The maintenance staff will perform the maintenance according to workinstructions or equipment manuals. The schedule lists the due date forthe work to be completed.

5.2.5 Records of the maintenance performed are maintained on work orders orin maintenance logs.

P-630Infrastructure

Infrastructure Page 2 of 2Date printed 3/26/10 3:35 PM

5.2.6 Maintenance personnel sign and date the PML or work order when thework is completed, and return it to the maintenance manager.

5.2.7 The maintenance manager updates the spreadsheet or database toindicate that the maintenance has been completed.

5.3 Work orders are also issued for unscheduled maintenance (repairs). Data onunscheduled maintenance is collected by the maintenance manager, andsummarized for management review.

5.3.1 Preventive maintenance schedules may be changed based on theanalysis of data at management review.

5.4 Facilities layout

5.4.1 Under the direction on the Facilities Manager a multidisciplinary approachis used to optimize the facility space for material handling and productflow.

5.4.2 Manufacturing Engineering has developed and implemented methods formonitoring and evaluating the effectiveness of the operations.

5.4.3 In the event of an emergency that interrupts product realization processessuch as power, labor or equipment failures, contingency plans maintainedby the Facilities Manager will be implemented to satisfy customerrequirements.

6.0 Forms and Records

6.1 Preventive Maintenance Spreadsheet or database.

6.2 Preventive maintenance summaries

7.0 Attachments

7.1 None

8.0 Related Documents

8.1 P-560 Management Review Procedure

8.2 P-710 Planning of Product Realization Processes Procedure

8.3 Quality Manual

8.4 Contingency plans

9.0 References

9.1 None

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Trainer’s Guide

©Copyright 2009 16949 Store16949store.com

©Copyright 2009 16949 Storewww.16949store.com

Introduction to ISO/TS 16949:2009Materials

This course is designed to train employees on the requirements of ISO/TS 16949and covers the structure, emphasis and requirements of the standard.

Requirements of TS 16949 – a 120 slide PowerPoint (see sample agenda below)o Covers the requirements of the standard by sectiono Includes speaker notes on key points and will take approximately 3-4

hours if everything is coveredo The length may be changed by covering less detail.

You can also add the suggested group exercisesAmount of detail is determined by the audience and constraints.

To begin preparing for the training session:• Print the Notes pages of the PowerPoint presentation. (Open the

PowerPoint presentation, select “Print”, and select “Notes Pages”).• Print a copy of the Student Manual. You will then be able to prepare for

the presentation using this guide and reviewing the speaker notes andstudent manual.

The content of the student manual matches the information in the PowerPoint. Let students knowthis at the beginning of the presentation to make it easier for them to take notes.

You will need one copy of the standard for the trainer, and you may want copies for eachstudent to refer to for details.Standards are available electronically from: http://16949store.com/Buy-Standards.aspx

©Copyright 2009 16949 Storewww.16949store.com

AgendaSample Agenda for the Requirements: (This agenda allows time for attendees to askquestions during the presentation, as well as at the end)

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For a more in-depth training, add the group exercises to the agenda.

Suggestions for Group Exercises1. Identify Key Processes for each department represented. (In department groups)

i. Process Map these processesii. List procedures required

2. Identify permissible exclusions3. Review current quality policy. Develop measurable goals for each department to

support this policy.4. Develop a program to communicate the importance of meeting customer

requirements.5. Develop a communication program for training employees on the importance of

their position and it’s affect on meeting quality objectives.

Additional Information

• TS 16949 Training: 16949store.com/16949-Employee-Training.aspx• Automotive Industry Action Group: https://www.aiag.org/scriptcontent/• Society for Automotive Engineering www.sae.org• Order standards online from: 16949store.com/Buy-Standards.aspx• You may wish to have your students review “Basics of TS 16949” in preparationfor this more in depth class. This tutorial is available free here:16949store.com/Free-16949-Tutorials.aspx

INSERT COMPANY NAME/LOGO HERE

©2009 16949 Store Page 1 of 116

The Gap Analysis Checklist

This list has been prepared for you by the 16949 Store. Keep in mind, this gap analysis worksheet is intended to identify your organization’s gaps against the criteria of ISO/TS16949:2009. Since ISO/TS16949:2009 requires process-based audits; this gap analysis checklist is not designed to substitute for your internal audit worksheets. You will need to have a copy of the ISO/TS16949:2009 Standard to use along with this checklist. There are some spaces on the checklist that you will need to fill in from the Standard. You will see these as you review the checklist. You will see questions on the checklist that refer to the specification and highlighted in yellow are the ones that are additions to ISO 9001 and required for ISO/TS compliance of your Quality Management System. As you work through the checklist take notes on what is in place, and what needs to be developed. Reference procedures or other documents that you have reviewed and that will provide information for the new QMS. Take notes on the status of the documents, will they need to be revised for the new system? Or can they be used as is. Also note where processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed. While you do want to know if procedures and processes are being complied with, compliance is not your main focus for this audit. Remember that the final outcome of this audit should be a list of things that your organization needs to do to conform to ISO/TS 16949:2009.

Quality Manual, Procedures and Forms

For a complete set of ISO/TS16949:2009 documentation, visit the 16949 Store. We have designed and documented a Quality Management System for you to use as the foundation of your documentation system. This system addresses all of the requirements of the Standard, from setting quality objectives and measurement criteria for your processes to internal audits and continual improvement. All the procedures interrelate to provide you with an efficient, effective Quality Management System. Customize these documents instead of starting from scratch and benefit from the expertise of our ISO/TS16949 professionals. We guarantee our products and are confident that using our documentation will save you time and effort and result in a superior Quality Management System. Our ISO/TS16949 professionals support our products and are available to answer your questions as you proceed with your project. Add our expertise to your implementation team and let us help you succeed.

INSERT COMPANY NAME/LOGO HERE ISO/TS 16949:2009 Gap Analysis Checklist

©2009 16949 Store Page 2 of 116

4 QUALITY MANAGEMENT SYSTEM

REQUIREMENTS

CURRENTLY IN PLACE

(List documents or evidence)

CONFORMING

Y/N? Estimated %

Complete

ITEMS NEEDED

4.1 General Requirements

This clause asks you to identify how management applies the process approach to achieve the effective and efficient control of processes, resulting in performance improvement. Specifically this section is looking for an overall process evaluation of all quality related processes and their interrelationships. Look to see that your organizational processes are defined and that consideration is given to the items described below. Is there a Quality Management System in

place that has been established and documented to meet the requirements of the ISO/TS 16949:2009 Technical Specification?

Look for documentation of the processes included in the QMS

Look for information on the relationship and sequence of the QMS processes.

Ask Management if operation and control of processes is effective. How do they know if it is effective?

Ask how they are able to know if resources and information needed to support processes have been provided.

Is there any information on the effectiveness of processes?

INTERNAL AUDIT CHECKLIST TS/ISO 16949

Copyright ©2009 16949 Store Page 1 of 32

4 Quality Management System Observation/Comments Results 4.1 General Requirements Has your organization established a management system (QMS) giving consideration to:

a) Identifying the processes needed and the application of the processes throughout the organization:

b) Determining the sequence and interaction of the processes?

c) Determining the criteria and methods for operation and control of the processes?

d) Ensuring the availability of resources and information to support the processes?

e) Monitoring, measuring and analyzing these processes?

f) Implementing actions to achieve planned results and the continual improvement?

If your organization out sources any processes that affects product conformity, are the outsourced process controlled and identified? Does your organization maintain control over outsourced processes assume responsibility for conformity to all customer requirements?

4.2 Documentation Requirements 4.2.2 Quality Manual Does your organization have a quality manual? Does it include the following:

a) The scope of your QMS and justifications and details of any exclusions

b) The documented procedures for the QMS or reference them?

c) A description of interactions between the processes of the QMS?

4.2.3 Control of Documents

ISO/TS 16949:2009

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Internal Auditor Training Requirements

The intent of this course is to provide the level of knowledge and base-levelproficiency required to conduct process-based internal auditing within theautomotive sector.

Only through the development of skills, training, education and experience anauditor achieves competency.

This course is not intended to provide a working level knowledge andproficiency in:

- Core Tools

- Basic Statistical Knowledge

- Customer Specific Requirements

- Disciplined Problem Solving

Course Pre-requisites

We recommend that the trainer:

• Be an experienced QMS internal/lead auditor• Is competent to provide the necessary training• Has the ability to provide examples and lessons of relative auditing experience to his/her

classroom participants.• Is competent in:

§ understanding and applying the clauses of ISO/TS 16949§ understanding the Core Tools§ understanding of the process approach§ understanding of the International Automotive Task Force’s approach to auditing

along with their terms and definitions

Participant Requirements:

We recommend that participants have successfully completed the Basic ISO/TS 16949 Trainingprior to engaging in this course and have had significant Core Tools training.

To successfully complete the requirements of this course, each participant is required to:

• Read the USA Automotive Company case study• Complete quizzes for Sections 1 & 2 if those sections are being skipped• Engage in class discussions by asking questions• Successfully pass all graded quizzes (70% pass on each quiz)• Successfully pass the team breakout session exercises• Participation and demonstrated understanding of the course content through on-going

trainer observation• Full attendance of each module that your organization requires you to attend

It is recommended that the first audit the student is involved with be under the guidance of alead auditor who has audit experience.

Quality Manual

Page 9 of 42Date printed 3/26/10 3:19 PM

4.1 General requirementsYour company has established, documented and implemented a QualityManagement System (QMS) in accordance with the requirements of ISO9001:2008 and TS 16949:2009. The system is maintained and continuallyimproved through the use of the quality policy, quality objectives, audit results,analysis of data, corrective and preventive action and management review.To design and implement the QMS Your Company has:

§ Identified the processes needed for the QMS and their applicationthroughout the organization and documented them on the Process FlowDiagram at the end of this section of the Quality Manual

§ Determined the sequence and interaction of these processes, andillustrated them on the Process Flow Diagram

§ Determined criteria and methods needed to ensure that the operation andcontrol of the processes are effective, and documented them in qualityplans, work instructions and the Measuring, Monitoring and AnalysisTable

§ Ensured the continuing availability of resources and informationnecessary to achieve planned results and continual improvement of theseprocesses

§ Established systems to monitor, measure and analyze these processes,and

§ Established processes to identify and implement actions necessary toachieve planned results and continual improvement of these processes

When Your Company out sources any process that affects product conformity,technical responsibility is maintained and the control of these processes areidentified within the QMS.

4.2 Documentation Requirements

4.2.1 General

The QMS documentation includes:

§ A documented Quality Policy

§ This Quality Manual

§ Documented Procedures

§ Documents identified as needed for the effective planning, operation andcontrol of our processes, and

§ Quality Records

P-630Infrastructure

Infrastructure Page 1 of 2Date printed 3/26/10 3:35 PM

1.0 Purpose

1.1 This procedure describes the process for determining, providing and maintainingthe infrastructure needed to achieve conformity to product requirements.

2.0 Responsibilities

2.1 Maintenance personnel are responsible for the preventive maintenance offacilities and equipment.

2.2 The Facilities Manager is responsible for facilities and equipment planning usinga multidisciplinary approach.

2.3 Manufacturing Engineering for developing and implementing the evaluation andmonitoring of the effectiveness of existing operations.

2.4 The Facilities Manager is responsible for maintaining the contingency plans.

3.0 Definitions

3.1 Infrastructure: buildings, workspace and utilities, process equipment andsupporting services.

4.0 Equipment/Software

4.1 Not Applicable.

5.0 Instructions

5.1 Infrastructure needs are identified during quality planning and planning ofrealization processes. Planning processes are documented in the Quality Manualand the Planning of Product Realization Processes Procedure. (MP-710).

5.2 Infrastructure is maintained by using a Preventive Maintenance Program.

5.2.1 Maintenance evaluates facilities, equipment and other infrastructure todetermine areas where preventive maintenance work needs to be done.

5.2.2 The preventive maintenance database or spreadsheet lists each item thatrequires preventive maintenance, and the maintenance schedule.

5.2.3 The maintenance manager is responsible for generating a preventivemaintenance schedule for each maintenance cycle and distributing themto the appropriate individual or function.

5.2.4 The maintenance staff will perform the maintenance according to workinstructions or equipment manuals. The schedule lists the due date forthe work to be completed.

5.2.5 Records of the maintenance performed are maintained on work orders orin maintenance logs.

P-630Infrastructure

Infrastructure Page 2 of 2Date printed 3/26/10 3:35 PM

5.2.6 Maintenance personnel sign and date the PML or work order when thework is completed, and return it to the maintenance manager.

5.2.7 The maintenance manager updates the spreadsheet or database toindicate that the maintenance has been completed.

5.3 Work orders are also issued for unscheduled maintenance (repairs). Data onunscheduled maintenance is collected by the maintenance manager, andsummarized for management review.

5.3.1 Preventive maintenance schedules may be changed based on theanalysis of data at management review.

5.4 Facilities layout

5.4.1 Under the direction on the Facilities Manager a multidisciplinary approachis used to optimize the facility space for material handling and productflow.

5.4.2 Manufacturing Engineering has developed and implemented methods formonitoring and evaluating the effectiveness of the operations.

5.4.3 In the event of an emergency that interrupts product realization processessuch as power, labor or equipment failures, contingency plans maintainedby the Facilities Manager will be implemented to satisfy customerrequirements.

6.0 Forms and Records

6.1 Preventive Maintenance Spreadsheet or database.

6.2 Preventive maintenance summaries

7.0 Attachments

7.1 None

8.0 Related Documents

8.1 P-560 Management Review Procedure

8.2 P-710 Planning of Product Realization Processes Procedure

8.3 Quality Manual

8.4 Contingency plans

9.0 References

9.1 None