Preparation of QA Manuals and supporting documentation


Product Quality is enhanced by working in a systematic manner to formalised procedures designed to eliminate the occurrence of deficiencies and non-conformances.

It is the responsibility of manufacturers to compile, implement and integrate the requirements of such procedures into their regular working routines and to ensure that all such methods are clearly designed, defined and documented.

RSQA provide consultancy and advice on setting up documented quality management systems tailored to specific requirements.

Basic documentation definitions:
QA Manual
the base document of the system and the means of controlling the other tier(s) and the quality system practices.
Procedures Manual
describes the procedures to be followed to ensure consistent results.
Work Instructions
provides the necessary information/instruction required to carry out the work or process.

RSQA Ltd have assisted many manufacturing companies with writing their QA Manual and with their Procedures Manual, the means of implementing the requirements of the QA Manual. We also advise upon and provide the record forms necessary to comply with the Statutory Requirements contained in the Medical Device Directive 93/42/EEC as from time-to-time amended.

We provide the knowledge and experience to overcome problems encountered within existing systems; troubleshooting etc where external auditors have raised non-compliances against such systems.

RSQA have long experience of the above matters and provide training courses in-house on the requirements of the Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC. See Training page for more information.

Post marketing surveillance, complaints, and vigilance reports.

Further information

For further information please email us or call us on +44 (0) 207 936 9412.

Russell Square Quality Associates Ltd.
Ludgate House, 107-111 Fleet Street, London. EC4A 2AB
Telephone: 0207 936 9412   E-mail: