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Quality Management

Quality Management Standard ISO9001 is the most widely adopted Quality Management standard in the world. Over one million organisations have been certified to this global standard in over 170 different countries.

The standard provides a well accepted model for the management and improvement of business processes which affect the quality of products and services delivered to customers. It is applicable to all organisations, businesses and voluntary organisations regardless of size or market sector that provide products, services, capital or software to others.

ISO9001:2008 is based on sound managerial and business principles and helps drive improved business performance and improvements in service and products delivered to customers. Organisations that implement an ISO 9001 conformant quality management system can be independently assessed by an accredited assessment body. Once approved they can publicise the fact that they are “ISO9001 certified” or “ISO9001 registered” and can display the registration logo of their assessment body. Assessment bodies for ISO9001 in the UK are listed on the UKAS (United Kingdom Accreditation Services web site at www.ukas.org.uk)

Certification to ISO9001 (or a similar derivative standard), although voluntary, is a pre-requisite for supplying to a number of major customers and government departments within the UK. Even for purchasers that do not stipulate such requirements, an ISO9001 certificate will often lead to a higher ranking on their supplier approval criteria.

Business Partners have been assisting companies to implement management system standards, ISO9001 and similar standards for over 12 years and are expert in applying the principles of ISO9001 to any type and size of organisation. The support we provide can include: preparation of quality manuals, process plans and procedures, assistance with implementation, quality audit training and overseeing your first formal management review. If you would like to do more of the work yourself, that’s fine, we will take more of a facilitator’s role, show you what to do, how to do it and keep you on track up to assessment.

If you already have a quality management system but feel that it is not reaping real business benefits, we can review your current situation and recommend where improvements can be made. See also our web page on management system audit and improvement services.

Contact us today for a no-obligation meeting to discuss your needs or just to enquire more about our services.

ISO13485 Quality Management Systems for Medical Devices

ISO13485:2003 is a management system standard based on ISO9001 but including additional specific requirements for organisations required to meet medical device industry based regulatory and statutory requirements in addition to the requirements of customers.

ISO13485 is applicable to all organisations Supplying, designing and/or manufacturing medical devices regardless of size or type. Medical device regulations are harmonized across the EU and ISO13485 includes requirements specifically for such devices but excludes some clauses of ISO9001 which are not conducive to the regulatory environment. Therefore, if your ISO 13485 quality management system is to be integrated with ISO9001, a small number of ISO9001 specific requirements will also need to be addressed. Business Partners will provide guidance and hands-on assistance to meet both standards with a fully integrated quality management system if this is your preferred approach.

Organisations placing medical devices in to the EU market place are required to ensure that the products are conformant with harmonized EU directives: 93/42/EEC, 90/385/EEC and 98/79/EC and to add the CE mark.

Business Partners consultants provide assistance to companies wishing to implement an ISO13485 conformant management system.

TS16949 Consultant, TS16949 Automotive Quality Management Systems, Automotive Quality Consultant

TS16949 is a sector specific standard for organisations that design and manufacture component parts for the automotive OE supply chain. The standard is based on ISO9001 and incorporates all of the ISO9001 requirements but also adds industry specific requirements and the need to apply certain quality engineering assessment and improvement tools.

The certification process for TS16949:2009 is overseen by the IATF (International Automotive Task Force) who appoint agent organisations (oversight offices) in different geographical regions. The UK oversight office is run by the SMMT (Society of Motor Manufacturers and Traders). IATF accredited assessment bodies for TS16949 are listed on the IATF web site. www.iatfglobaloversight.org

TS16949:2009 replaces previous version TS16949:2002 and supersedes the former automotive standard QS9000. In addition to meeting the requirements of the standard, suppliers to OE automotive supply chain are required to identify pertinent customer specific requirements and to incorporate these into their management system.

Business Partners consultants have expertise in the implementation of TS16949 and application of the IATF 3rd edition assessment rules. We provide practical help and guidance in the implementation of TS16949 and provide training in application of quality tools: APQP/PPAP, SPC, MSA, Disciplined Problem Solving, FMEA and Control Plan methodology.