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TS 16949 Training

Presented by:

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Training Objectives:
• Review Quality Policy
• Quality Objectives
• Why have TS?
• Management’s Role

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Quality Policy

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What is ISO 9000?
The ISO 9000 Series consists of a trio of
standards.
•ISO 9000:2000 - management terms and definitions.
•ISO 9001:2000 - specifies the requirements for a
quality management system. (clauses 4,5,6,7,8)
•ISO 9004:2000 - is a guidance standard.

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Where does it come from?
• The ISO 9000 series is based on the
national standards of several ISO
member countries, including Great
Britain, France, Germany, Netherlands,
Canada and the U.S.A.

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• It is
– A management systems standard.
– Concerned with how organizations provide consistent
quality in products and services all the time. (customer
focus)
– A process which involves all departments and
functions.
– A starting place for all-encompassing quality efforts.
– It requires Management that is committed, involved,
focused, and responsive.
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• It is not
– A product specification standard.
– Limited to production or processing.
– A guarantee that the company produces a quality
product.

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ISO 9000:2000/TS 16949
Process Approach emphasizes1
• Understanding and
meeting requirements
• The need to consider
processes in terms of
added value
• Obtaining results of
process performance
• Continual
Improvement
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External Benefits of Registration

• Customer Requirement
• Higher Perceived Quality
• Improved Customer Satisfaction
• Competitive Edge
• Reduced Customer Audits
• Increased Market Share
• Quicker to Market
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Over 350,000 companies world are
registered to ISO 9000:
They have found -
• Improved consistency of service and product performance
• Higher customer satisfaction levels.
• Improved customer perception
• Improved productivity and efficiency
• Cost reductions
• Improved communications, morale and job satisfaction
• Competitive advantage and increased marketing and sales
• opportunities.

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Internal Benefits of Registration

• Customer Focus
• Better Documentation
• Greater Quality Awareness
• Positive Cultural Awareness
• Increased Efficiency
• Enhanced Communications
• Reduced Scrap/Rework
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What is a Quality Management System
(QMS)?

• A QMS refers to the activities you perform


within your organization to satisfy the
quality-related expectations of our
customers.

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Top Management Role with the
QMS 1
• To establish and maintain the quality policy and
quality objectives of the organization.
• To promote the quality policy & quality objectives
throughout the organization.
• To ensure focus on customer requirements.
• To ensure an effective & efficient QMS is
established & maintained.
• To ensure the availability of necessary resources.
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Top Management Role with the
QMS 1
• To review the quality management system
periodically
• To decide on actions regarding the quality
policy and objectives
• To decision on actions for improvement of
the QMS.

1 = ISO/TS 16949

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What is a registrar?

• A registrar is a third-party organization that


is contracted to:
– Evaluate an organization's quality management
system to the requirements of the TS 16949
– Issue a registration certificate.

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What can I do?
• The system cannot be the responsibility of
one person.
– Responsibilities must be assigned to a variety
of people
Don’t assume that the Management Rep has to be
responsible for everything.
– Everyone has activities involving:
Corrective action, Training Records, Equipment,
Quality Records and Internal Audits.

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Documentation Requirements

• Objectives in the revision of the ISO 9000


series of standards have been:
1. To develop a simplified format that will address small
as well as medium and large organizations, and
2. For the amount and detail of documentation required to
be more relevant to the desired results of the
organization’s process activities.
3. Requires documents that are relevant, understandable
and consistent with processes

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Documentation Requirements
• ISO 9001 requires (and
always has required):
– A “Documented Quality
Management System”
– Not a “system of documents”

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Quality System Documentation
Progression

Policies Approach and Responsibilities

Procedures Who, What, and When

Work Instructions How you do it

Prompts recording of
Records information and
becomes a quality
record
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Overview of Documentation

• Policies are contained in the Quality Manual.


State the intent of your quality system and
responsibilities
• Procedure describes what you do to carry out
your Policies (also perhaps who, where & when)
• Work Instructions & Visuals describe how a
job is done
• Records offer evidence that Procedures and
Work instructions are followed
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4.2.1 General documentation
Requirements 1
• Quality Policy and Quality Objectives
• Quality Manual
• Documented procedures requirement by the standard
• Documents to ensure effective planning, operation and
control of its processes.
• Records required by the standard
• Extent may differ due to size and type of organization,
complexity and interaction or processes, and competence
of personnel.
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What procedures are required
by ISO 9000:2000/TS 16949
Documented Procedures:
ISO 9001:2000 specifically requires the organization to
have procedures for these processes:
4.2.3 Control of Documents
4.2.4 Control of Quality Records
8.2.2 Internal Audit
8.3 Control of Nonconforming Product
8.5.2 Corrective Action
8.5.3 Preventive Action
6.2.2.2 Training

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Customer Specific Requirements
The “Other” Requirements
• Reference manuals
– PPAP
– SPC
– MSA
– APQP
– FMEA
• IATF Manuals
• GM - ISO 19011

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