From the practical point of view, this paper briefly introduces the requirements of the quality management system from three aspects: background, goal, significance and content.
Background and dynamics of 1 TS 16949
In order to coordinate the international automobile quality system specifications, the world's major automobile manufacturers and associations set up a special organization called International Automobile Task Force (IATF) on 1996. The members of IATF include the Technical Committee for Quality Management and Quality Assurance of the International Organization for Standardization (ISO/TC 176), the Italian Automobile Manufacturers Association (ANFIA), the French Automobile Manufacturers Committee (CCFA), the Automobile Equipment Industry Alliance (FIEV), the German Automobile Manufacturers Association (VDA) and other automobile manufacturers such as BMW and Chrysler. Fiat, Ford, GM, Renault and Volkswagen.
IATF coordinated three European specifications VDA6. 1 (Germany), VSQ (Italy), EAQF (France) and QS9000 (North America), and based on the combination of ISO900 1:2000: 2000, it was approved by ISO/TC 176.
On March 1 2002, ISO and IATF issued the international technical specification TS 16949:2002. This technical specification is applicable to the parts and service supply chain of the whole automobile industry, including automobile factories. The 2002 version of TS 16949 has come into effect and started the certification work.
On April 24, 2002, Ford, GM and Chrysler held a press conference in Detroit, Michigan, USA, and announced a unified supplier quality system specification, namely TS 16949. If the supplier fails to pass the TS 16949 certification, it will also mean losing the qualification as a supplier.
At present, French Citroen, Peugeot, Renault and Nissan all force their suppliers to pass the certification of TS 16949.
2 timetable
A) TS 16949:2002 has been implemented worldwide since last April;
B) The first edition of ISO/TS16949:1999 will be abolished in June 65438+February 65438+May 2003;
C) IATF provides a conditional grace period for enterprises that have registered TS 16949: 1999: Before June 65438+February 65438+May 2004, these enterprises must update their current certification to TS 16949: 2002. This so-called conditional is that all customers of the enterprise must agree to the deadline of 65438+February 65438+May 2004. During this grace period, the supervision and audit of certification companies will continue as planned;
D) The third edition of QS 9000 (based on ISO9000: 1994) is valid until June 65438+February 65438+April 2006. In fact, in
After 65438+February 2003 15, QS9000 certification will become a separate certification, which no longer includes ISO-900 1 certification. TS 16949: 2002 covers 90% of QS9000;
Before the end of 2006, in addition to newly established companies or companies that have not passed the system certification before, the existing 22,000 companies registered in QS9000 will also be registered in TS 16949.
3 IATF's working network
In order to effectively implement ISO/TS 16949, IATF has set up five regional international automobile supervision bureaus around the world. These five supervision departments adopt the same procedure to supervise the management, operation and implementation of TS 16949. The responsibilities of each oversight body include:
A) On behalf of IATF, implement and manage the whole registration process of TS 16949 through the same procedures. Including witness audit activities, qualification training and examination of registered auditors, and supervision of the quality of work of certification companies and registered auditors;
B) Coordinate with other regulatory agencies to ensure the global consistency of the registration scheme of TS 16949;
C) Implement and implement IATF policies and decisions;
D) coordinating standards between IATF and global automobile manufacturers;
E) Establish and maintain IATF registration management information database.
The five regulatory authorities are ANFIA, IAOB France, SMMT, VDA-QMC and IAOB. The IAOB responsible for the Asia-Pacific region is located in Southfield, Michigan, USA. Only certification bodies that have signed contracts with them can issue TS 16949 certificates recognized by IATF. At present, the automobile supervision bureau has approved 48 certification bodies around the world. Up to now, IATF has issued about 1700 TS 16949 certificates through certification bodies all over the world, and most of the certified companies are located in Europe and North America.
4. Characteristics of ISO/TS16949
TS 16949 is the technical specification of the international automobile industry, which was added to the automobile industry on the basis of ISO900 1.
Industrial technical specifications. This specification is completely consistent with ISO9000:2000, but it pays more attention to defect prevention and reduces the quality fluctuation and waste that are easy to occur in the supply chain of automobile parts.
TS 16949 is a technical specification of international automobile industry, and its pertinence and applicability are very clear: this specification is only applicable to automobile OEMs and their direct parts manufacturers. These manufacturers must be directly related to automobile production, be able to carry out processing and manufacturing activities, and add value to their products through such activities. There are strict restrictions on the qualifications of certified companies and manufacturers. Those units that only have supporting functions, such as design centers, corporate headquarters, distribution centers, etc., cannot independently obtain the certification of TS 16949: 2002. Manufacturers who manufacture equipment and tools for automobile factories or auto parts factories cannot obtain the certification of TS 16949: 2002. Therefore, the implementation of TS 16949:2002 will have a direct impact on the three major automobile companies and their parts manufacturers.
TS 16949 pays special attention to the manufacturer's finished products and the ability to realize the quality system of the finished products. It believes that this is the basis of the whole manufacturing process. Another feature is that it pays special attention to the effectiveness of an organization's quality management system.
The audit of TS 16949: 2002 changed from single factor audit to process audit. The process audit will focus on user-centeredness. It evaluates manufacturers' activities according to users' requirements and measures manufacturers' performance around users' satisfaction. In addition, the three major automobile manufacturers put forward special requirements for their suppliers, and the audit of TS 16949: 2002 also includes the process audit to meet these requirements.
TS 16949 puts user requirements and technical specifications in the same important position. Therefore, the certification company's certification audit of manufacturers is similar to the audit of Party B in many places.
One of the main features of TS 16949: 2002 is that it is a single global quality system standard and registration procedure recognized by IATF. Mutual recognition will reduce the audit of the second and third parties and save costs for manufacturers. In addition, TS 16949 pays more attention to process audit than document audit.
As TS 16949: 2002 already contains all the contents of ISO 900 1: 2000, obtaining the certification of TS 16949: 2002 also marks that it conforms to the ISO 900 1: 2000 standard.
5. Requirements for the auditee
TS 16949: 2002 Certification and registration are only applicable to automobile manufacturers and their direct parts manufacturers. These manufacturers must be directly related to automobile production, have processing and manufacturing capabilities, and add value to their products through the realization of this capability.
A company required to obtain TS 16949: 2002 certification registration must have at least 12 months of production and quality management records, including complete records of internal audit and management audit.
The newly established processing site can also be audited if there is no record of 12 months. If it meets the requirements of the quality system specification after examination, the certification company may issue a letter meeting the requirements of the specification. When you have a record of 12 months, you will be certified, audited and registered.
If the certification body that has been awarded the certificate cannot continue to maintain the normal operation of the quality system and the consistency of product quality, it will face the risk of revocation of the certificate.
6. Requirements for auditors
The certification company (auditor) must be audited, approved and authorized by the international automobile organization in advance. The audit activities of certification companies will always be under the strict supervision of international automobile institutions. The International Automobile Agency has the right to witness the audit activities of certification companies and implement a scoring system for certification companies. Deduction rules are very strict (including users' complaints about their certified suppliers). If the violation score reaches a certain level, the qualification will be cancelled.
I. Origin of TS 16949 Standard
Although QS9000 has been widely recognized and about 23,000 organizations have registered, it is undeniable that automobile manufacturers in different countries must also use their own national standards to control the quality of suppliers and their parts. Whether a truly universal automobile quality management system can be established is a matter of great concern to automobile manufacturers all over the world.
The International Automobile Task Force (IATF) undertook this urgent task. The International Automobile Task Force (IATF) is a special group, and its members include representatives of the three major American automobile companies BMW, Fiat, Peugeot, Renault and Volkswagen, as well as national business associations in the United States, Germany, France, Italy and Britain. In April, 2002, TS 16949:2002 (second edition) "Specific requirements for quality management system applying ISO900 1:2000 standard in automobile production and related service organizations" was issued.
In fact, like other international standards, 16949 is also a compromise product. This standard is mainly based on the opinions of automobile manufacturers in the United States, Germany, France, Italy and Japan, especially the major differences between German VDA-6. 1 and American QS9000 need to be resolved. First of all, QS9000 includes all ISO 900 1: 1994 standards, plus the supplementary requirements of the automobile industry. The difference is that VDA-6. 1 is based on the ISO9004 standard. Therefore, VDA-6. 1 contains concepts that are not available in ISO900 1 or QS9000 (3rd edition), such as cost analysis of new products and employee satisfaction. Secondly, QS9000 adopts the pass/fail (coincidence/non-coincidence) method, while VDA-6. 1 conforms to the percentage method.
Second, the composition and content of the standard
TS 16949 standard is formed by adding special requirements of automobile industry on the basis of ISO900 1:2000 standard. In order to clearly distinguish the original text of ISO900 1:200 1 from the newly added content, the provisions of ISO900 1:2000 standard are framed in the file format. The copyright in the box belongs to the International Organization for Standardization. The content outside the box describes the special requirements of the automobile industry, and its copyright belongs to IATF related national organizations and automobile manufacturers.
While releasing TS 16949, IATF also formulated and released TS 16949:2002 Guide, TS 16949:2002 Checklist and TS 16949:2002 Accreditation Rules.
TS 16949:2002 Guide concisely lists examples, applications, practices or explanations according to the terms of TS 16949, and provides guidance information on how to correctly implement the specification, which is helpful for understanding and applying TS 16949. The guide points out that IATF members who signed TS 16949:2002 may have reference materials specified for customers' special requirements. For organizations that have no special requirements for customers, this guide refers to the reference manuals listed in the bibliography (such as APQP, FMEA, MSA, SPC, PPAP, etc. ) should be applicable. )
The checklist of TS 16949:2002 provides audit guidelines. According to the requirements of various clauses in TS 16949, this guide lists the contents of evidence to be found. However, this is only a reference, not a mandatory requirement. Pay attention to the pattern method based on process.
The "TS 16949:2002 Accreditation Rules" is also called the "Rules of Certification Organization TS 16949:2002 Automobile Certification Scheme". These rules include the accreditation of certification bodies, the auditing process of certification bodies, the accreditation and registration of auditors of certification bodies, etc. This is a very detailed regulatory document.
Three. Scope of application of TS 16949
The scope of application of this standard is to organize the manufacturing site of production parts and maintenance parts designated by customers. That is where the manufacturing process takes place. Note that the departments that support the site, such as design department, headquarters and distribution center, form a part of the site and are subject to audit both inside and outside the site, but these support departments cannot be registered separately. This is different from ISO9000 certification. In addition, the standard is also applicable to automobile manufacturers, which is different from QS9000.
Fourthly, some differences and requirements between TS 16949 and QS9000 standards.
First, because QS9000 is based on ISO9000 94 and 16949 is based on ISO9000 2000, 16949 needs to turn to the concept of "process mode" and PDCA technology, which requires great changes in methods and file formats. The audit method has also changed from the original department/element to the "process" orientation.
Secondly, a large number of new and extensive changes show that there is still a lot of work to be done to change from QS9000 based on quality assurance system to quality management system that can obtain TS 16949: 2002 registration. There are about 80 differences with QS9000 in details. For example, the requirements for internal audit have been greatly strengthened, the manufacturing process audit is mandatory, a specific checklist is used, and internal auditors are required to be qualified.
Thirdly, IATF requires that there must be at least 12 months of "operating performance records" and the previous 12 months of internal audit and planning records and management review results.
Fourthly, there must be a list of qualified internal auditors and a list required by customers/specific customers. Fifth, there must be evidence of customer complaint management.
Verb (abbreviation for verb) authentication and recognition
The accreditation rules of the National Accreditation Committee for certification bodies shall be implemented, which are the same as those of ISO9000 and QS9000. When accepting an application, the applicant organization needs to submit the following documents:
quality manual
Plans and results of internal audit and management review in recent 12 months.
List of approved internal auditors
List of special requirements of customers
Customer complaints
It has been operated for at least 12 months recently.