scope:

This guideline presents evidence-based suggestions for preparing different types of laboratory documents. In addition, a process is described for how laboratory documents can be managed and controlled from the time a need is recognized for a new or revised document, through the document's use and control, until the time it is retired. This guideline is applicable to documents used by medical laboratories of any size, complexity, or specialty, including point-of-care testing.

QMS02 is intended for use by the following:

• Administrative and technical personnel who develop laboratory documents
• Manufacturers
• Educators
• Regulatory and accreditation organizations

QMS02 is a guideline for how to implement requirements established in international standards, and by regulatory and accrediting organizations for laboratory documents and procedures manuals. QMS02 is not a standard; that is, this guideline does not set requirements for laboratory documents and procedures. Instead, this guideline describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards2-13 for documents and document management, and provides suggestions and examples for fulfilling the requirements.