1. TS Training
Presented by:
Internal Auditor Training

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

3. Quality Policy
Internal Auditor Training

4. What is ISO 9000? The ISO 9000 Series consists of a trio of standards.
ISO 9000: management terms and definitions.
ISO 9001: specifies the requirements for a quality management system. (clauses 4,5,6,7,8)
ISO 9004: is a guidance standard.
Another relevant standard is ISO Guidelines for Quality & EMS auditing
Internal Auditor Training

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

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

12. 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
Internal Auditor Training

13. 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

14. 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

15. 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

16. 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.

17. 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

18. 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

19. 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

20. 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 give the following examples:
Paper/hard copy
Magnetic
Electronic or optical computer disc
Photograph
Master sample
Internal Auditor Training

21. 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

22. 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: Control of Documents Control of Quality Records Internal Audit 8.3 Control of Nonconforming Product Corrective Action Preventive Action Training
Internal Auditor Training

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