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.
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