Documented quality management systems and their associated standard operating procedures (SOP) underpin all of your client laboratories’ operations. It is what your client is assessed against and will often attract the most scrutiny from inspectors during audits. Documented procedures must be kept up to date, be sufficiently detailed so the procedure can be carried out in a consistent manner and be sufficiently robust to avoid room for misinterpretation and misunderstanding.
Your Client may ask you to provide written procedures of the work you have contracted to perform for them. This is to enable your client to maintain compliance with quality and regulatory requirements.
Your client will need the documents you supply to describe the procedure you follow to be:
Sufficiently clear so that it can be easily understood by a trained, but uninformed reader
Sufficiently detailed so that the procedure can be reproduced in a consistent manner, and can be reconstructed by your client.
It is meeting this finnal criterion that can prove the most challenging aspect of developing appropriate documentation as you are seeking to communicate often very technical information to people who’s professional background is in a different disciple to your own and who my be unfamiliar with the relevent terminology.
DOCUMENTED QUALITY MANAGEMENT SYSTEMS FOR LABORATORY SERVICE BUSINESSES
In this regard we can develop protocols to validate your company’s procedures.
We can advise and assist with the development of:
Quality mission statements
Standard Operating Procedures (SOPs)
Quality management systems
Validation of laboratory systems
I can also provide ongoing management support for existing quality systems, ensuring they continue to be relevant, up to date and compliant. Thus, allowing you to focus on running your company.