TS 16949 Training Presented by: Internal Auditor Training

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

Quality Policy Internal Auditor Training

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. Another relevant standard is ISO 19011 Guidelines for Quality & EMS auditing Internal Auditor Training

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. Internal Auditor Training

It is ISO-9000 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. A documented quality system that meets the standard Each employee understands and follows the documented quality system. The quality system is maintained through internal and external audits. Internal Auditor Training

It is not ISO-9000 A product specification standard. Limited to production or processing. A guarantee that the company produces a quality product. Internal Auditor Training

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 Internal Auditor Training

External Benefits of Registration Customer Requirement Higher Perceived Quality Improved Customer Satisfaction Competitive Edge Reduced Customer Audits Increased Market Share Quicker to Market Internal Auditor Training

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 Auditor Training

Internal Benefits of Registration Customer Focus Better Documentation Greater Quality Awareness Positive Cultural Awareness Increased Efficiency Enhanced Communications Reduced Scrap/Rework Internal Auditor Training

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. To ensure that Pilkington has a QMS in place, customers insist that your organization demonstrate that your QMS conforms to TS 16949. Internal Auditor Training

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 Internal Auditor Training

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 Internal Auditor Training

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. BVQI is Pilkington’s registrar. Internal Auditor Training

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.

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 Some organizations (usually large organizations) may require additional documented procedures in order to implement an effective QMS. Other organizations may require additional procedures, but the size and or culture of the organization could enable these to be effectively implemented without necessarily being documented. Because ISO 9001:2000 is less prescriptive than the 1994 versions of the standard, an organization may be able to carry out some streamlining and/or consolidation of existing documents in order to simplify its QMS. Internal Auditor Training

Documentation Requirements ISO 9001 requires (and always has required): A “Documented Quality Management System” Not a “system of documents” The goal is to move beyond a system of documents, and make each document meaningful. Internal Auditor Training

Quality System Documentation Progression Approach and Responsibilities Policies Procedures Who, What, and When Work Instructions How you do it Prompts recording of information and becomes a quality record Records Internal Auditor Training

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 Documents may be in any form or type of medium. ISO 9000:2000 clause 3.7.2 give the following examples: Paper/hard copy Magnetic Electronic or optical computer disc Photograph Master sample Internal Auditor Training

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. Quality Plan(control plan is an output) - Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract. Record - Document stating results achieved or providing evidence of activities performed 1 = ISO/TS 16949 Internal Auditor Training

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 Internal Auditor Training

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