Standardize and document the policy cycle in SOPs


Also the management activities of the laboratory need to be standardized to ensure that these are always done according to the correct procedure.


Standardize all the management activities in SOPs. In phase 3 the policy cycle was established. This cycle consists of the following activities:

  • Making a Quality Year Plan in line with the Quality Policy, long term goals, Quarterly Reports and Management Review of previous year
  • Translating the Quality Year Plan into a SMART action plan
  • Monitoring laboratory performance and implementation of SMART action plans, reporting in Quarterly Reports
  • Performing a Management Review at the end of the quality year
  • Drafting a new Quality Year Plan and starting the cycle over again

Up to now only the process of drafting a Quality Year Plan was standardized and documented in an SOP (click here to go to the activity in which this was done). All the other activities of the policy cycle also need to be standardized and documented in SOPs.

How & who

Laboratory Manager

  1. Make a list of procedures related to the policy cycle that need to be standardized in SOPs.
  2. Develop the SOPs following the protocol for writing a Procedure SOP in the Master SOP and Using the template for a Procedure SOP attached to the Master SOP.
  3. Review and authorize the SOP according to the procedures described in the SOP for Document Control.

Quality Officer:

  1. Assist the Laboratory Manager where needed.

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This activity belongs to the QSE Organization


ISO15189:2007: 4.2.1