Professional Documents
Culture Documents
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
1 = ISO/TS 16949
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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)?
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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.
1 = ISO/TS 16949
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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?
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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
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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
Prompts recording of
Records information and
becomes a quality
record
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Overview of Documentation
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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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