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TS 16949 Training

Presented by:

Training Objectives:
Review Quality Policy Quality Objectives Why have TS? Managements Role

Quality Policy

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.

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.

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.

It is not
A product specification standard. Limited to production or processing. A guarantee that the company produces a quality product.

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

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.

Internal Benefits of Registration

Customer Focus Better Documentation Greater Quality Awareness Positive Cultural Awareness Increased Efficiency Enhanced Communications Reduced Scrap/Rework

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.


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.
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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.


What can I do?

The system cannot be the responsibility of one person.
Responsibilities must be assigned to a variety of people
Dont 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.


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 organizations process activities. 3. Requires documents that are relevant, understandable and consistent with processes


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


Quality System Documentation Progression

Policies Procedures Approach and Responsibilities

Who, What, and When

Work Instructions Records


How you do it
Prompts recording of information and becomes a quality record

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

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 Training


Customer Specific Requirements

The Other Requirements
Reference manuals