SOP Documentation

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. SOP helps an organization to get / Maintain ISO certifications.

SOPS aim to assist that organization to maintain their quality control and quality assurance processes, as well as to ensure compliance with governmental regulations. Staff needs to understand SOPs, be trained on them and follow them, otherwise SOPs serve little purpose and will not guarantee quality control. SOP can document and track training on SOPs.

As far as possible, it is advisable to break the information into a series of logical steps to avoid a long list. The level of detail provided in the SOP may differ based on, e.g.

  • Whether the process is critical.
  • The frequency of that procedure being followed.
  • The complexity of the activities described.
  • The number of people who will use the SOP.
  • Whether training is not routinely available..

Organization follows certain processes and procedures on a regular basis. Thus, SOPs may be written:

  • For any repetitive administrative activity.
  • For any technical procedure.
  • For any operational or functional process..

Examples are technical SOPs instructing the user:

  • How to perform a specific analytical method to be followed in the laboratory or field (such as field testing using an immunoassay kit).
  • How to validate a specific software.
  • How to handle unbinding information in clinical research activities.
  • How to report serious adverse events.
  • How to collect a sample in order to preserve the sample integrity and representativeness (such as collection of samples for future analysis of volatile organic compounds or trace metals).
  • How to conduct a bio assessment of a freshwater site.

Technical SOPs are also needed to cover:

  • Activities such as data processing and evaluation (including verification and validation).
  • Modeling.
  • Risk assessment.
  • Business operations and auditing of equipment operation.