Developing National Standard Methods and Document Control

Developing National Standard Methods

It takes on average about a year to draft and issue a new National Standard Method (also known as a National Standard Operating Procedure - SOP). We have an agreed format and work from first principles searching the literature to find best practice. Drafts are written and then agreed at the appropriate working group followed by wider consultation with our password holders.

The consultation process is undertaken by posting the draft document on this password protected website and asking for comments within a given time. The comments received on each SOP are compiled into a new document (termed Review of Service Comments) and comments are reviewed at the working group meetings.

The Reviews of Service Comments documents are also placed on this web site. Two consultations are usually carried out. At the second consultation, laboratories are asked to 'try out' the SOP and to feed back any problems. The SOPs are subsequently issued to HPA laboratories with a six week time scale for implementation.

National Standard Methods are revised and reissued according to a schedule. They are also revised and reissued if there is an area of concern that needs modification to the document.

Document Control

All draft and issued documents are subject to a rigorous document control process within the Standards Unit, ESL. All drafts are kept within the Quality System and administered by the SOP administrator. A Guidance Note on document control is available (QSOP 2) and is being updated to reflect our new paperless system.

After the SOPs are issued, the responsibility for document control lies with the Quality Manager in the receiving laboratory.