QMS 3 - PATH OF WORKFLOW

PURPOSE:

Standard Operating Procedures ensure accurate and reliable testing results by providing best laboratory practices and standardizing the process. 

In this activity, participants will learn the different elements of an examination procedure as required in ISO 15189 5.5.3 Documentation of Examination Procedures.  

KEY MESSAGES:

• SOPs define and standardize best laboratory practices.  If properly followed, SOPs ensure a laboratory consistently produces accurate and reliable test results.
• SOPs take complex tasks and break them into simple steps, thereby assuring completion of the entire task.
• SOPs must be complete, clear, concise, and easy to follow.
• If an SOP is not available, participants can easily create one for their own laboratories using the SOP template and available technical information such as the operator’s manual or package insert.

SELF ASSESSMENT:

Can you:

• Recognize the components of a correctly written SOP?
• Write a clear, concise SOP that includes all the steps of a specific process?
• Read reference material to find the steps of a procedure?
• Use skills gained in this activity to write an SOP for his/her own laboratory, if the need arises?
• Describe various circumstances in which one will use SOPs in a laboratory?