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Understanding The ISO/TS 16949:2002 Standard

1. TS 16949 SCOPE  

1.1 General 

This Standard specifies requirements for your QMS to: 

a)    demonstrate your ability to consistently provide product that meets customer and regulatory requirements  

b)    enhance customer satisfaction by: 

c)    effective application of your QMS 

d)    continual improvement of your QMS 

e)    providing assurance of conformity to customer and applicable regulatory requirements. 

Note: The term “Product” applies to product intended for or required by a    customer 

This Standard in conjunction with ISO 9001: 

  •         Defines QMS requirements for the design, development, production, installation and servicing of automotive related products 
  •         Is applicable to organizational sites where customer-specific product is manufactured for production and/or service applications.  
  •        Can be applied throughout the automotive supply chain 

Support functions, whether onsite or remote (such as design centers, corporate HQ and distribution centers cannot obtain stand-alone certification to TS 16949. They shall be audited as part of the site they support. 

 

Key Explanation Points and Tips: 

Þ      Your QMS must do two things – 1. Meet requirements consistently and 2. Enhance customer satisfaction in three different ways (see above). 

Þ      Ability refers to the capability of your organization to – determine your customer needs and requirements; design and develop product; know-how and capacity to manufacture product; package product; deliver on time; provide service and support; etc;  

Þ      Consistency is being able to repeat your capability within specified parameters for quality as defined by customers, your own organization or regulatory bodies. Can you consistently make conforming product or service, day in day out? 

Þ      To achieve and demonstrate your capabilities, you must effectively plan, operate and control the processes, within your organization that provide them. These processes collectively form the scope of your quality management system (QMS).  

Þ      The effectiveness application of your QMS can be determined by - how well QMS activities and results measure up to planned performance indicators.  

Þ      Continual improvement of the QMS is achieved by - increasing the ability of the QMS to meet requirements through raising the performance indicators and more efficient use of resources. 

Þ      Assurance of conformity to requirements may be achieved by providing confidence that requirements will be fulfilled. This confidence may be achieved through – implementing prevention based controls; conducting internal/external audits; 3rd party certification of your QMS; etc. 

Þ      This standard provides specific requirements to effectively plan, operate, control and improve your QMS processes. These requirements focus on prevention based controls and to a lesser extent detection based controls, as well as continual improvement of your QMS.  

Þ      It is important to note that the ISO 9001 standard does not specify requirements for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By effectively controlling and continually improving your QMS processes, there will obviously be a positive impact on product quality performance. 

Þ      Don’t overlook regulatory requirements applicable to your organization. These requirements may come from your customer; the industry you are in; from within your own organization; or state or federal organizations. You may need to apply regulatory requirements to your suppliers and outsourced processes (subcontractors). 

Þ      Your ultimate objective is to enhance customer satisfaction. You achieve this by planning, operating and improving your QMS to effectively meet customer and regulatory requirements. As this standard represents specific automotive OEM’s, your QMS must provide objective evidence that your QMS processes can identify and manage these requirements and that customer-specific requirements are effectively implemented.   

Þ      Scope (under this section) refers to the type of automotive supply chain facilities, TS 16949 is applicable to. “Automotive" includes cars, trucks (light, medium and heavy), buses, motorcycles. It excludes industrial, agricultural, off-highway (mining, forestry, construction, etc.). It includes all supplier ‘sites’  providing value-added parts, components, products , sub-assemblies and services up the supply chain to the OEM. TS 16949 requirements may be applied to any site in the supply chain by its customer (see clause 7.4.1.2). 

Þ      TS 16949 applies to all supply chain facilities or ‘sites’ that manufacture production materials; production and service parts; assemblies; or provide (value-added) finishing services such as heat treating, welding, painting; etc., for the automotive OEM’s subscribing to this standard

Þ      This means that all Tier 1 suppliers providing such products or services directly to subscribing (see last paragraph below for OEM’s subscribing to TS 16949) automotive OEM’s, must get TS 16949 certification and they in turn may flow TS 16949 conformity or certification requirements down to Tier 2 suppliers and so on (see clause 7.4.1.2). The flow down to tier 2 or 3 has now become more the norm than the exception. 

Þ      TS 16949 cannot be applied to: 

Þ      Automotive after-market service parts made to original subscribing OEM specifications, but not procured and released through them.  

Þ      Manufacturers of tooling; production equipment; jigs; fixtures; molds; etc used by the auto industry. 

Þ      Remanufactured automobile parts. 

Þ      Distribution centers; warehousers; parts packagers; logistics support; and sequencers. 

Þ      Determine whether your activities or location is a site or support function. Note that the definition of ‘site’ (under clause 3.1 Terms and definitions) is a location where value-added manufacturing occurs and a support function is a value-adding non-manufacturing process that supports a site. The support function may be on-site or at a remote location.  

Þ      The rules for third party Certification Body (Registrar) auditing of sites and remote locations are specified in an IATF document called “Automotive Certification Scheme for ISO/TS 16949:2002 – Rules for achieving IATF recognition”. The general rule is that sites may obtain stand-alone TS 16949 certification, but support functions, cannot obtain stand-alone certification.   

Þ      Support functions may include a variety of non-manufacturing activities such as – design; purchasing; HR; sales; distribution centers; warehousing; sequencing; logistics; etc. 

Þ      All support functions (whether on-site or off-site) that support a site must be included in that site’s QMS scope. As such they must be audited to all applicable TS 16949 requirements including their interaction with site activities.  

Þ      Both manufacturing as well as support activities may be outsourced (i.e. performed by an independently owned organization, on your site or off-site). Organizations performing outsourced manufacturing activity must be subject to the same TS 16949 requirements that would apply if the activity were done by your organization. Such organizations can obtain independent TS 16949 certification if required by their customers. 

Þ      Organizations performing outsourced support functions (e.g. warehousing or HR services) may be subject to specific TS 16949 requirements imposed by their customers, however they cannot obtain independent TS 16949 certification for such support activities. They may obtain independent ISO 9001 certification. More on outsourcing under clause 4.1. 

Þ      The organizations subscribing to the TS 16949 standard include: General Motors; Ford; Daimler Chrysler; Fiat; PSA Peugot-Citreon; Renault SA; FIEV: Opel Vauxhall; Audi; BMW; VW; Mercedes Benz; etc. The Japanese OEM’s while participating in the development of the TS 16949 standard, do not formally subscribe to it or require it of their supply chain. 

 

Preface - TS16949
◦  Introduction
◦  Major Clauses
◦  Process Approach -1
◦  Process Approach-2
◦  Plan/Do/Check/Act
◦  Cont Improve Model
◦  Compatibility
◦  TS 16949 Scope
◦  Application
◦  Normative References
◦  Terms And Definitions
◦  4.1 General Reqmts
◦  4.2.1 Documentation Reqmts
◦  4.2.2 Quality Manual
◦  4.2.3 Document Control
◦  4.2.4 Control Of Records
◦  5.1 Mgmt Commitment
◦  5.2 Customer Focus
◦  5.3 Quality Policy
◦  5.4.1 Quality Objectives
◦  5.4.2 QMS Planning
◦  5.5.1 Quality Responsibility
◦  5.5.2 Mgmtt Rep
◦  5.5.3 Internal Communications
◦  5.6 Mgmt Review
◦  6.1 Resource Provision
◦  6.2 Human Resources
◦  6.3 Infrastructure
◦  7.1 Planning Product Realization
◦  7.2 Customer Processes
◦  7.3.1 D & D Planning
◦  7.3.2 D & D Inputs
◦  7.3.2 D & D Outputs
◦  7.3.4 To 7.3.6 - Review, Verification And Validation
◦  7.3.6.2 Prototypes-PPAP-Changes
◦  7.4.1 Supplier Mgmt
◦  7.4.2 Purchasing Information And Supplier Performance Monitoring
◦  7.5.1 Production Control-1
◦  7.5.1 Production Control-2
◦  7.5.2 Production Process Validation
◦  7.5.3 to 7.5.5 Identification--Customer Property, etc
◦  7.6 Monitoring And Measuring Devices
◦  8.1 Measurement, Analysis & Improvement
◦  8.2.1 Customer Satisfaction
◦  8.2.2 Internal Audits
◦  8.2.3 Monitoring Processes
◦  8.2.4 Product Monitoring And Measurement
◦  8.3 Control Of NC Product
◦  8.4 Analysis Of Data
◦  8.5.1 Continual Improvement
◦  8.5.2 Corrective Action
◦  8.5.3 Preventive Action
◦  TS 16949 Annex A - Control Plan


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