Business Quality Compliance
INTERIM MANAGEMENT, QUALITY MANAGEMENT, PROJECTS, EUROPEAN DIRECTIVES, service with experience in blue chip companies, international operations, small companies, micro electronics, hybrid thick film, surface mount technology, car industry electronics, conductive polymer on plastic, defence systems design and manufacture, telecoms, consultancy and service companies. We assist companies meet the requirements for a Quality Management System and the technical requirements necessary to sell and export their products or capital systems into the European Union. We have completed over 250 projects on quality systems installation, quality manuals and European Directive technical construction files for CE Marking.
Do you need an Interim Manager or Quality Manager for a day per week, short or longer term? Contact us for support anywhere in the United Kingdom on ISO9001:2008, business process development, quality audits, continuous improvement, management reviews, innovation, profitability, strategy, managing change.
Cost Cut and help all staff to improve their work and reduce documentation for ISO9001 procedures and process documentation with the clarity of a Flow Chart Method. Let us demonstrate the method and show your staff with minimum training. The method and training is included in a low cost package and will save hours of work and money on documentation. Contact by clicking QUALITY ENQUIRY
European Directives and Technology |
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Quality Management |
Do you need a quality manager for a day per week or longer term? Contact us for anywhere in the United Kinkdom. ISO9001:2008. Business system design, audits, management, continuous improvement. Manufacturing, Design and service sectors. Contact by clicking QUALITY ENQUIRY |
Training Courses |
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Any Questions? | Send an email to SOLUTIONS ENQUIRY telling us what your problem, question or requirement is on the European Directives, CE Approval, Quality Management or Training. We will answer your initial questions for free. |
Cost typical example | For EMC technical construction files we can guide you in how to write the file ( £1500UK ) or write the complete file and test plan for you ( £5500UK). |
Solutions | We are NETWORKED with 1200 professional chartered engineers, designers, business analysts and IT specialists in Europe, USA, Australia, Hong Kong. One of us can provide the answer to your business or engineering problem? We are the ants who can help the elephants. Send an email to SOLUTIONS ENQUIRY |
Business Quality Compliance, Oxfordshire, United Kingdom
CEMARKING,EUROPEAN DIRECTIVES,QUALITY,EMC,SAFETY,TELECOMS,ISO9000,TRAINING,TONY BLAIR,WESTMINSTER.
Medical Devices Directive (93/42/EEC plus new amendments)
Background: The MDD covers all medical products not covered by the active implantable medical directive and the in vitro diagnostics directive. It clearly has the widest application because of the sheer range of products which it covers. The MDD became law on June 15th 1998 for supplying Medical Devices into Europe.
Our Service: You need to put all your documentation together in a file covering EMC, Safety and Quality so that you can demonstrate control and present the evidence. Do not despair on the detail required as we can do the documentation. We use a file format and specially developed checklists for the directive to ensure that everything is covered and traceable against the Essential Requirements of the Directive for your specific application and company. We have software which produces a detailed report to confirm the medical classification of your product(s) against the specific rules in the directive. We will check all your current documentation or assist you as necessary or do the complete technical file and supporting evidence ready for presentation to the Notified Body and for CE Marking. Request information by sending an email to MEDICAL ENQUIRY
Radio and Telecoms Terminal Equipment Directive (RTTE) (1999/5/EC)
Background : The introduction of this directive was on 8th April 2000 and brings a major change in the way manufacturers of radio and telecommunications terminal equipment can access the European markets. The transition period ended on 7th April 2001 and you cannot now use the previous SESED or TTED and previous certification on products has ceased. Manufacturers do not now have the comparative comfort of a type approval certificate but need to consider the consequences of product liability. There is much greater flexibility but also much more responsibility for conformance. Where Notified Bodies are used they have no power to prevent a product being placed on the market. It is the manufacturer who makes the final decision as to whether it complies or not and assumes full responsibility for meeting the requirements.
Our Service: You will need to address the essential requirements and the LVD Directive (2006/95/EC) together with the EMC Directive (2004/108/EC) and to demonstrate that your equipment effectively uses the spectrum. We will check all your current documentation or assist you as necessary or do the complete file for you. We will have an unbiased engineering look at what information you have. We can discuss the use of harmonised standards or the use of a technical construction file and which conformity assessment procedure / Annex I to V to use together with supporting evidence ready for self declaration. We are helping major players in this and they are not finding it easy particularly on some products which have been borderline in meeting the requirements previously. We can help to build your assurance and confidence in your system. Request information by sending an email to RTTE ENQUIRY
EMC Directive (2004/108/EC dated 15 December 2004, repealing 89/336/EEC)
Background: This became law on 1 January 1996 for electromagnetic compatibility in Europe. Most electrical and electronic products made or sold in Europe, including imports must be so constructed that they do not cause excessive electromagnetic interference and are not unduly affected by electromagnetic interference. European standards, which set out the technical details, are the most common means by which the essential requirements of the directive are met.
Our Service: For complex or large products or groups of product we put your technical construction file together with a test plan and rationale that will meet Competent Body assessment criteria. We can check your current documentation and testing prior to any Competent Body assessment or assist as necessary or do the complete file compilation for assessment by the Competent Body and to achieve CE Marking. Request information by sending an email to EMC ENQUIRY
Low Voltage Directive (2006/95/EC replacing 73/23/EEC) and Machinery Directive (2006/42/EC formerly 98/37/EC and 89/392/EEC)
Background: The directives provide only essential requirements which can be met through the use of Harmonised Standards, of which there are many. The directives require the manufacturer or his authorised representative located in the European Union to be responsible for the internal production control aspect of the manufacturing and compliance of a product design placed on the market. So much appears to be a question of engineering judgement and interpretation. Misunderstand the requirements and the price of your machines could double. How do you put together a technical file for self certification that will be easy to maintain?
Our Service: We can produce your technical file. We use a tried and tested format for a file that will pull all the required testing, technical rationale and evidence together and check it using risk analysis and against our proven checklists using the standards and using a critical components list. We include the maintenance requirements for the file to ensure it stays in conformance and is current for years to come. You then self certify using a Declaration of Conformity with confidence against the evidence presented in the technical file. Request information by sending an email to SAFETY ENQUIRY
Quality Management Systems
Background: ISO 9001 for design and production or TL9000 for telecoms or QS9000 for the car industry or ISO13485 (Application of ISO9001 to the manufacture of medical devices). Have you the time or expertise to spend on this. If you get it wrong and produce an inefficient system then just watch the money, frustration and effort to maintain the system accumulate. Are you aware of the new revision ISO9001:2008 ? Do you need to switch to a process oriented control system now? We have hands on experience to help.
Our Service: With our many years experience we work with you to identify the gaps in your quality system and documentation, close the gaps at your pace, progressively with you, to achieve ISO 9000 certification, TQM or to make specific improvements or organise change management. We can train your internal auditors or write your Quality Manual. Request information by sending an email to QUALITY ENQUIRY
- Management of Quality
- Internal Quality and Audits
- Supplier Quality and Audits
- Sub-contractor Management.
- E-Business
Some thoughts on this to consider are
- Quality will be a key differentiator, you must survive in this or go to the wall
- The networked economy is decentralised and anti-hierarchical
- Customer loyalty can vanish very quickly or may not even exist
- What are the workable approaches for each e-business
We also have a strong background in international multi-site quality management of hybrid thick film, photonics, optoelectronics and surface mount technology, custom design, small and high volume, microsystems integration, chip and wire, integrated circuits for professional, medical, telecoms, avionics and military systems and communications markets. We can support your management as required to any level, perform audits or train your staff, inspectors or internal auditors. Request information by sending an email to MANAGEMENT ENQUIRY
EMC Training Course
Background: We have a lot of current experience in the practical solutions used to improve design for EMC. This has been packaged into a comprehensive course on EMC Design on compact disc for Printed Circuit Boards and Component Use.
Practical Ideas are given throughout the course. The emphasis is on the practical to get ideas across without too much mathematics. The compact disc course is for use at your own speed at home on your PC or at work. The course is in modules covering Main Essentials , Design Strategy Approach, Component Types and Use, PCB Layout, PCBs at Varying Speed up to Very High. The course comes with questions to test your understanding during the course and a final assessment of your progress on each module.
ORDER the compact disc at £199UK or request an outline of the course by sending an email to ORDER
EMC Problems? - we can help on the following:-
Photonics and Optoelectronics Training Course
Photonics and Optoelectronics, new course available for staff training in this technology. Available as 3 modules, one for an outline feel for the technology, one for manufacturing and one for manufacturing, test and laboratory staff. Suggested training groups up to 8 people in number so that good interactive teaching can take place. Instead of new staff adsorbing information only by osmosis over a long time, get them clued up quickly. This training course is also available on compact disc with presentation notes and using PowerPoint.
ORDER the compact disc at £99 or request an outline of the course and prices by sending an email to ORDER
Electronic mail address BQC
The Office phone is in Shrivenham, Oxfordshire in the United Kingdom. The country code is 44.
Tel. Number +44 (0) 1793 783245
For example, from USA Dial, 011 44 1793 783245. From Canada Dial, 00 44 1793 783245
Company Name
Business Quality Compliance
Experience in quality management in blue chip companies, international operations, micro electronics, hybrid thick film, surface mount technology, car industry new polymer for electronics, defence systems design and manufacture, telecoms and service companies. Completed over 250 European Directive technical construction files, certification and formal assessments.
Current projects include RoHS, China RoHS, EMC testing on a military aircraft, RTTE Directive approval for a satellite telephone, quality system installation for a defence company, for a car industry company and a service company, training course on photonics technology, for TL9000 in telecoms, files for railway signal and control system, expert witness testing, training of internal auditors, Technical Construction File writing for an electronic development tool and telecoms network equipment, and assessment of EMC files prior to Competent Body submission.
Please ask questions or make comment or suggestions and send us an email to SOLUTIONS ENQUIRY telling us what your problem is on the European Directives, CE Approval, Testing, Quality Management or Training. We will answer your initial questions for free. We are committed to finding the best and most appropriate solutions that suit our clients' specific needs. Our ability to consistently deliver reliable, effective, cost saving documentation to our clients allows them to meet the European Directives and Quality System Requirements and understand how to continue when their organisation is changing and new equipments, products and systems are to be marketed in Europe.
We have network contact daily with many electrical, electronic, IT and power professional engineers and managers, as many as a large company would have, so try us for your specialist needs and answers. Someone should know the answer to your question and how to resolve it.
Visit the UK government site from number 10 Downing Street, Westminster, London, and Mr Gordon Brown, you may find it interesting by clicking here at http://www.number10.gov.uk
Find out more about the U.K by visiting at http://www.bbc.co.uk with live web cameras in London.
Legal Comment
1. Higher Fines on Regulatory Offences in the U.K
The Court of Appeal in London dealing with regulatory offences in 1998 decided a fresh view was needed for sentencing companies. Historical average fines may no longer be treated as the the main factor. Individual cases will consider gravity of the offence, extent of danger, a continuing unsafe state of affairs and seriousness of the injury. Fines are likely to be high enough to make a difference to companies so that more notice is taken. The defendant's ability to pay (how much money they have) could become the dominant criteria in the level of sentencing companies.
2. Product Liability
In an English case in 2000, a supplier was unable to rely on a defence based on 'risk during development' because the supplier could not prove that the defect was undiscoverable at that time. Companies should note that for the safety of products placed on the market, the company being sued has to prove that there was not a method available by which the defect could have been discovered. In other words, if you could have checked it, then you should have checked it.
Click on the web address site below to go directly to it.
IEC, CISPR Standards available from IEC, 3 rue de Varembe, CH-1211 Geneva 20, Switzerland.
Internet http://www.iec.ch/
EC Documents available from EC Official Publications Office, 2 rue Mercier, L-2985 Luxembourg.
UK Regulations available from The Stationary Office, P.O Box 276, London, SW8 5DT. Tel +44 (0) 870 600 5522.
Internet http://www.the-stationery-office.co.uk/
ETSI documents available from ETSI, F-06921 Sophia Antipolis, CEDEX, France. Tel +33 4 92 94 4200. Internet http://www.etsi.fr/home.htm
Company Directory of Suppliers for Europe plus resource for medical manufacturing professionals http://www.devicelink.com/company/euro
Radiocommunications Agency(RA) http://www.radio.gov.uk
European Notified Bodies list at http://forum.europa.eu
UK public telecoms operators and network interface details at http://www.oftel.gov.uk
For further information on Quality, European Directives or Training click on http://www.supaquality.supanet.com
Quality resources and directory http://www.quality.org
Juran Institute with over 100 quality articles http://www.juran.com
Institute of Quality Assurance http://www.iqa.org
Web Links - International Standards and Developing Bodies Directory
Some sites provide information on equivalencies and pricing and offer on line ordering. If you are looking for all standards on one specific topic then one of the commercial catalogues may be the best place to look as listed immediately below. Click on the web address site to go directly to it.
Commercial Catalogues:
Custom Standard Sevices Inc http://www.cssinfo.com
Document Engineering Co. http://www.doceng.com
International Organisations:
International Organisation for Standardisation http://www.iso.ch
International Electrotechnical Commission http://www.iec.ch
European Organisation for Conformity Assessment http://www.eotc.be
World Standards Services Network . Public accessible servers of standards organisations http://www.wssn.net
Individual Countries of the World in alphabetical order click on as follows below:
Argentina http://www.iram.com.ar
Australia http://www.standards.org.au
Austria http://www.on-norm.at
Belgium http://www.bec-ceb.be email address: centraloffice@bec-ceb.be Belgian Electrotechnical Committee
Brazil http://www.abnt.org.br/index.html
Canada http://www.pwgsc.gc.ca/cgsb and http://www.csa.ca
Chile http://www.inn.cl
Columbia http://www.icontec.org.co
Croatia http://www.dznm.hr
Denmark http://www.ds.dk
Europe http://www.cenelec.be and http://www.cenorm.be
Finland http://www.sfs.fi
France http://www.afnor.fr
Germany http://www.stri.is
International http://www.iec.ch and http://www.iso.ch
Ireland http://www.nsai.ie
Italy http://www.unicei.it
Japan http://www.hike.te.chiba-u.ac.jp/ikeda/JIS
Netherlands http://www.nni.in
Norway http://www.standard.no
Portugal http://www.ipq.pt
Russia http://www.gost.ru/sls/gost.nsf
South Africa http://www.sabs.co.za
Spain http://www.aenor.es
Sweden http://www.sis.se
Turkey http://www.tse.org.tr
United Kingdom http://www.bsi-global.com
United States http://www.ansi.org and http://www.nssn.org and http://www.astm.org and http://www.standards.ul.com:82
If you find any of these links not working please let the webmaster know at LINKS
Notice - Every precaution is taken to ensure accuracy of content: however the publisher cannot accept responsibility for the correctness of the information supplied or for any opinion expressed.