Medical device companies who wish to market their devices in the United States must comply with the FDA quality system regulations (QSR) codified in 21 CFR Part 820. The FDA QSR establishes the requirements for medical device quality systems, including requirements for medical device companies to develop and document standard operating procedures (SOPs) for manufacturing and quality management processes.
The contents of a quality management system can be thought of as a "documentation pyramid." The highest level documents that define the structure of the QMS can be found at the top. The documentation in the next level down describes the procedures that are maintained as part of the QMS. The section below that contains specific instructions for use or procedures, and the base of the pyramid is documented records or proofs. Standard operating procedures can be written to deliver work instructions for part of the manufacturing process or to describe a standard operating procedure related to the QMS itself.
Search through the FDA QSR and you'll find exactly one mention of standard operating procedures, under section 820.70. Under this section, medical device companies must produce documented instructions, SOPs, and methods that define and control the manner of production. This means that medical device companies must produce an SOP for each aspect of the manufacturing process necessary to ensure that medical device products meet their intended specifications. These SOPs fall under "work instructions" in the documentation pyramid.
Besides that singular explicit mention of standard operating procedures, there is another phrase used commonly throughout the FDA QSR that should signal medical device companies to write an SOP: "establish and maintain.” When FDA uses the phrase "establish and maintain," it's usually meant to tell medical device companies to establish and maintain a procedure or plan, something that can be documented in an SOP. For example:
Medical device companies should write their own standard operating procedures to ensure all work instructions and procedures are correctly documented in the QMS. Here's what should be included in each standard operating procedure for medical devices:
Purpose - explain the purpose of the SOP and assign a reference number to the document itself
Scope - define what activities or procedures are covered under the SOP
Definitions - define any novel terms that are referenced in the SOP and how they should be interpreted by the reader
Background - document any relevant background information that is helpful for understanding and interpreting the SOP
Roles and Responsibilities - identify the parties that are responsible for maintaining and executing the various steps of the procedures described in the SOP document
Procedure Steps - list the steps for the procedure in plain language so that they can easily be followed by those responsible for maintaining or executing the procedure
Revision History - to comply with FDA QSR document control requirements, each SOP should include a revision history
Reference Documents - if the SOP makes reference to any other SOPS or other documents in the QMS, include references to those documents along with the reference number
Greenlight Guru's medical device QMS software serves as a single source of truth for medical device companies, with secure cloud storage for all SOP documents that can be readily accessed by approved users of the platform. Greenlight Guru's purpose-built software solution makes it easy for medical device companies to maintain an up-to-date repository of standard operating procedures that seamlessly link to every document in the system.