Quality Assurance / Management System Certification Solutions

TUV PS/BABT, one of the leading quality assurance and certification providers worldwide, provides a vast array of certification solutions to assist in meeting your certification objectives.

TUV PS/BABT provides:

• ISO 9001:2000 certification
• PQC - an accredited standalone alternative to ISO 9001:2000 for the IT and Telecoms markets
• TL 9000
• R&TTE Directive Full Quality Assurance Approval
• ISO 14001
• ISO 13485/88 for medical devices

We can also offer 2^nd party auditing services for retailers and network operators whereby we audit your suppliers against your specification/standard.

Quality Assurance/Quality Control under ISO 9001:2000

The benefits of ISO 9001:2000

• The potential to make organisations more cost effective and efficient
• Greater consistency of products and services
• It is a powerful competitive tool to help businesses grow and prosper
• Potential cost savings

For organisations seeking certification now, it is important that they select an accredited certifier best suited to understanding their organisation and its business aims. Only in this way can the real benefits from an on-going partnership in business improvement be gained.

Globally, TUV Product Service and BABT are one of the 10 largest management systems certification bodies in Europe, North America and Asia.

Nearly 500 auditor’s service more than 10,000 customers in more than 50 countries, speaking their language of added value and continuous improvement. We provide our customers with global recognition while locally serving and supporting small and large customers alike. Our staff are highly qualified and trained, our audit teams are prepared and knowledgeable, and our certification process is structured to ensure client success and continual process improvement through our business partnership. BABT also benefits from UKAS Accreditation and RvA Accreditation for our quality assurance/quality control certification services.

Quality Assurance/Quality Control with BABT PS 340 - Production Quality Certification

• An accredited and unique 1-day alternative to ISO 9001:2000
• Assists in the demonstration of due diligence in the control of manufacturing to support compliance to the R&TTE Directive under Internal Production Control (required under Annex II, III and IV of the Directive)
• Demonstrate to existing and prospective clients that compliance elements within your quality management system are maintained
• Can be used as a route to demonstration of continuing compliance under BABT Product Certification Schemes such as the BABT CNC (Certified for Network Connection) scheme.
• BABT Approved Mark recognised worldwide

Quality Assurance/Quality Control with TL 9000

TUV Product Service can offer certification to the latest Telecoms specific Quality Assurance/Quality Control Specification, TL9000. If you combine this with other audits such as a BABT FQA, we can also reduce time and cost.

TL9000 is being driven by major players in the industry to reduce the cost of quality - estimated to be $10-$15 billion per annum worldwide. TL9000 introduces a range of 'metrics' which allow individual companies to judge their own performance against industry benchmarks.

Quality Assurance/Quality Control with R&TTE Directive Full Quality Assurance Approval

The conformity assessment procedure which minimises the RTTE Directive compliance risk to manufacturers is Full Quality Assurance (FQA) Approval. FQA Approval is a quality management system approval which permits the application of the CE mark of the RTTE / R&TTE Directive.

Quality systems based upon ISO9000 and test facilities operating to EN45001 (or ISO17025) inherently meet many of the requirements for FQA Approval under the Directive.

Following an assessment of your design and manufacturing quality system, BABT FQA Approval enables you to make Declarations of Conformity under Annex V of the RTTE / R&TTE Directive without the need for Technical Construction File (TCF) submissions to a Notified Body. This permits fast market entry. A product may be placed on the market as soon as a Declaration of Conformity is drawn up and signed.

Environmental Management Systems Certification with ISO 14001

Protection of the environment is one of society’s key goals. Significant increases in environmental awareness and stricter environmental regulations have resulted in many organisations integrating environmental protection into their corporate management structure. Now, a proven effective organisational tool is available in the form of the internationally recognised standard, ISO 14001. ISO 14001 provides a framework for managing environmental responsibilities so they become more efficient and more integrated into overall business operations.

Whether environmental operations at your company mean running your own waste water pre-treatment plant or simply contracting with a recycling service, ISO 14001 is flexible to meet your needs. Heavy manufacturing, light industry and service industries are all taking advantage of both the management systems and marketing related benefits that accompany an ISO 14001 system.

Benefits of ISO 14001

• Minimise business impact on environment
• Competitive edge through demonstrating commitment to minimise impact on environment
• Lower risk of financial penalties
• Improved efficiency
• Improved regulatory relations

Quality Assurance/Quality Control with ISO 13485 / ISO 13488

The certification of a quality management system, specifically for medical devices, to ISO 9001 and ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

In the European Union, the fulfilment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.

The current European medical device quality system standard is EN ISO 13485:2003 published July 24, 2003. This standard replaces harmonised standards EN ISO 13485:2000 and EN ISO 13488:2000 with a three year transition period ending July 2006.