INTRODUCTION

INTRODUCTION TO
ISO 9001:2000

INTRODUCTION TO
ISO/TS 16949

SYNOPSIS OF
ISO 14001

INTRODUCTION TO
ISO/IEC 17025

SYNOPSIS OF
ISO 9001/AS9100

Introduction to ISO/TS 16949

 ISO/TS 16949 is a Technical Specification (TS) using ISO 9001 as its base, with additional requirements specific to the automotive area. The International Automotive Task Force (IATF), and the Japan Automotive Manufacturers Association Inc., (JAMA) developed the ISO/TS 16949 standard with full support from Technical Committee176.
 
Why Was ISO 9001 Changed, and What Happened to QS-9000?

 Just as the standard requires continual improvement of the QMS, the standard itself must also conduct continual improvement.

Previous to the adoption of ISO/TS 16949, automotive and truck OEM’s developed a technical specification for North American suppliers called QS-9000.

With the increase of overseas suppliers and manufacturing, an international technical specification was needed. Based on this need, ISO/TS 16949 was developed. The current version is ISO/TS 16949:2002.

The Old QS-9000

Revised ISO 9000 Series and Related Standards

Key Differences Between the Old QS-9000 and the New ISO/TS 16949:2002:


 
ISO/TS 16949:2002 ~ A Process Approach

The “Process Approach” looks at the natural flow of events and how all the requirements of the standard are applied and met.

The process approach includes identification of inputs and outputs for each requirement of the standard.

This can be accomplished in a number of ways: Graphical, policies, procedures, instructions, flow charts, visual or electronic methods.


 

9 Steps Towards Transition

1.)    IDENTIFY AND UNDERSTAND:
•       Start with a clear understanding of how the requirements apply to the organization
 
2.)    DETERMINE THE SCOPE:
•      What type of certification is the company looking for?
•     Corporate: Covering multiple sites
•     Individual: Certification for each individual site
•     Automotive only: This may require non-automotive operations to certify to ISO 9001:2000
 
3.)    DEVELOP A TRANSITION OR CERTIFICATION PLAN:
(The same as you would for any design or engineering change.)

The Plan should include:
•·       Key milestones
•      Task sequencing
•      Timing requirements
•      Resource requirements
     
4.)    PERFORM A GAP ANALYSIS:
•       Conduct the gap analysis to confirm the current QMS conformance to ISO/TS 16949
     
5.)    DETERMINE IF THE QMS REFLECTS THE PROCESS APPROACH
•       If yes, go to step 7, if not, go to step 6
     
6.)    ALIGN THE QMS:
•       To reflect the process approach
•       Identify key processes, sequence, interactions, inputs and outputs
 
7.)    DETERMINE IF THE REQUIREMENTS ARE MET:
•       Review the gap analysis
•       Determine if all ISO/TS 16949 requirements are met
•       Correct deficient areas
•       Prepare to audit
 
8.)    DETERMINE DOCUMENTATION STRATEGY:
•       The matrix approach
•       Revise the current documentation
•       Create or reinvigorate (rewrite) the existing system
 
9.)    REVISE, REFERENCE OR CREATE
•       The QMS documentation as determined in step 8
•       Accomplish using a cross-functional team
•      Validate the accuracy
•       Include the document users in validation