QA Management Limited is a consultancy specialising in many sectors, such as : industrial, environment and medical devices. Originally established as a Partnership in the early 90’s to assist Companies achieve ISO 9000 and to provide training in quality assurance management systems. We have since expanded into other sectors including manufacturing; transport and distribution; sectors of the NHS; printing, surveying and medical device manufacture and CE Marking.

QA Management Ltd conducts Internal Auditing courses for medical device manufacturers to the standard ISO 13485:2003. The courses are designed to suit in-house training and will give the trainees an understanding of ISO 13485 and the auditing standard ISO 19011.

In addition the Company has experience in obtaining CE marks for medical devices under the Medical Directive 93/42 EEC for a variety of companies. 510k submissions can be compiled and written for submission and approval under the FDA regulations. Some examples of the devices QA Management have obtained CE Marking are spinal implants, ocular lenses, airway management, neurological diagnosis, ENT applications, surgical instruments.

The company has experience in assisting companies obtain ISO 14001 the environmental systems standard. The WEEE regulations for the disposal of electronic goods and compliance with the Directive 2002/96/EC are with us now. Training in the requirements of the WEEE regulations and the Directive is available from QA Management Ltd. In addition to the regulations producers should not produce goods that contain hazardous substances. The Restrictions of Hazardous Substances (RoHS) Directive 2002/95/EC applies to producers. The impact of the Directive and compliance with the requirements can be discussed with potential Clients. QA Management will assist companies in understanding and implementing the requirements of the Directives 2002/95/EC and 2002/96/EC.

• Quality Management -  ISO 9000, AS 9100

• Environmental Management - ISO 14001, EMAS   

• BS 8555

• Medical Device -  ISO 13485

• CE Marking

• QA Management also offer training courses in Quality  System, Documentation, Environment, TQM

• Internal Auditing

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