Effective Standard Operating Procedures (SOP)

The SOP is one of the fundamental documents for the analytical laboratory according to EN ISO 17025. This document creates a procedural infrastructure that delineates the laboratory activities.

The purpose of a correct implication of SOPs are:

- Understand the mandates for clearly delineated processes set forth by the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), the International Organization for Standardization (ISO), and other governing bodies

- Have increased understanding of the role of written procedures in maintaining effective and compliant business activities

- Understand the importance of document integrity and established controls

- Understand how to prevent overlaps, contradictions, and disconnects in documents

- Have increased confidence in planning and writing various process documents

- Understand how English tenses work and how they serve to make process documents clear and logical

- Understand how to write in the third person, use the imperative voice, and pare the passive

- Be able to control the language so that every word counts and messages are clear to readers

- Know the answers to your questions about language anomalies

- Understand the industry standards for procedure writing, including typical components of documents, and using document templates

- Know how to review and revise documents

- Understand the full life cycle of SOPs and other documents

- Understand how training is integral to document approval

- Know how to build a non-binding style guide to support the writing process.