Información financiera

The requirements for staff competence, methodologies, equipment testing and calibration, and test methods are outlined in this section. The requirements are broken down into 10 subsections:

5.1 General 5.2 Personnel

5.3 Accommodation and environmental conditions 5.4 Test and calibration methods and method validation 5.5 Equipment

5.6 Measurement traceability 5.7 Sampling

5.8 Handling of test and calibration items

5.9 Assuring the quality of the test and calibration results 5.10 Reporting the results

Annexes

Two annexes and a bibliography are included. Annex A: Nominal cross-references to ISO 9001:2000 provides links between this standard and ISO 9001, important as this standard includes requirements not covered in ISO 9001.

Annex B: Guidelines for establishing applications for specific fields gives accreditation seekers explanations of

specific requirements to better complete their applications.

Accreditation

Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.

National accreditation bodies are primarily responsible for accrediting laboratories to ISO/IEC 17025. Laboratories can use either a domestic organization or some other internationally recognized body in cases where the domestic organization "has either no international recognition or where it lacks recognition in parts of the world relevant to the laboratory’s operations." Laboratories typically select a range of common and frequently used methodologies that could readily benefit and demonstrate a comprehensive quality system that those methodologies run under.

Further reading

• "Complying with ISO 17025" [1] (PDF). United Nations Industrial Development Organization. October 2009. pp. 106.

External links

• ISO 17025:2005 [2]

• ISO 17025:2005 [3] on the ISO Online Browsing Platform

References

[1] http://www.unido.org/fileadmin/user_media/Publications/Pub_fr/Complying_with_ISO_17025_A_practical_guidebook.pdf [2] http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883

[3] https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en

ISO/TS 16949

Manufacturers of automotive parts supplied to automakers most certainly must get ISO/TS 16949 certified to remain competitive.

ISO/TS 16949 is an International

Organization for Standardization (ISO) technical specification for the development of a quality management system, specifically for the development, production, and, when relevant, installation and servicing of automotive-related products. The standard provides for continual improvement of these processes, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 standard.

History

ISO/TC 16949 is based on DaimlerChrysler, Ford, and General Motors' QS-9000 quality systems standards as well as the ISO 9000 family of standards. In June 1988, at the ASQ Automotive Division conference, a group of parts suppliers suggested to the attending vice presidents the need for a set of quality assessment standards separate from the ISO 9000 standards, which were introduced only a year earlier. At that time suppliers noted that ISO 9000 "lacked some elements in current automotive industry documents, such as business plans, customer satisfaction, continuous improvement, manufacturing capabilities, and much of the advanced quality planning content." The QS-9000 manual — based on content from ISO 9001 — was eventually released in August 1994, followed by a second edition in February 1995, which caught on worldwide with other original equipment manufacturers (OEMs). A few months later, at a European QS-9000 implementation meeting, representatives for the U.S. automakers learned that similar efforts had already been underway in the forms of "VDA 6.1 in Germany, AVSQ in Italy, and EAQF in France." A desire to further unify these disparate standards was expressed, resulting in the creation of the International Automotive Task Force (IATF).

The ISO Technical Committee (TC) 176, responsible for quality management and assurance standards, took notice and, not wanting to fraction ISO 9000 standards into sector-specific branches, attempted to convince the IATF to adopt ISO 9000. However, after several meetings, the TC 176 agreed the family of standards was not comprehensive enough for the automotive industry and vowed to include updates in the next version. Though the technical committee worked with the IATF, their needs were different enough that the automotive-specific changes would not be able to make it into the upcoming 2000 iteration. By November 1997, the two groups agreed on using the ISO technical report as a tool for the requirements, which would be based off of ISO 9001:1994.

By the time the first draft document was created in the fall of 1998, a new type of ISO document became available: a Technical Specification (TS). The IATF agreed to this format, and in November 1998, ISO/TS 16949 was initially approved as the first ISO Technical Specification, with a second official printing arriving in March 1999. In March 2002, a revised ISO/TS 16949:2002 was released to align with changes to ISO 9001, putting more focus on how "to improve effectiveness and efficiency of the entire process instead of a narrow focus on mere compliance with standards." The current version is ISO/TS 16949:2009. It was released in July 2009 and draws off of ISO 9001:2008, "emphasizing defect prevention and the reduction of variation and waste in the supply chain."

The standard

ISO/TS 16949 applies to the design, development, production and, when relevant, installation and servicing of automotive-related products. The requirements are intended to be applied throughout the supply chain, with vehicle assembly plants being encouraged to seek ISO/TS 16949 certification so as to improve system and process quality, to increase customer satisfaction, to identify problems and risks in production process and supply chain, and to take preventive measures to ensure effectiveness.

The technical specification is organized as follows:

Introduction

This section introduces the perceived importance of quality management systems as well as adopting a process-based approach to their development and implementation. It also addresses its relationship to the ISO 9001, 9004 and 14001 standards.

Scope

The scope and application of the standard is described as defining "the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products."

Normative references

This section states the definitions in ISO 9000:2005 are vital to applying the specification.

Terms and definitions

Additional definitions like "control plan," "error proofing," and "laboratory scope" are defined.

Quality management system

The requirements for the operational effectiveness of a manufacturer's quality management system are outlined in this section. The requirements are broken down into two subsections:

4.1 General requirements 4.2 Documentation requirements