SYS-005: Facility, Plant, and Equipment Maintenance Procedure

Equipment maintenance is commonly forgotten during audits. Do you have a Facility, Plant and Equipment Maintenance Procedure (SYS-005)? To meet the requirements for ISO 13485:2016, Clause 6.3, you need a facility, plant, and equipment maintenance procedure.  This is one of the most commonly forgotten quality system requirements by auditors, but why? There are several reasons. Maintenance is usually not included in your management reviews as an input unless your company is tracking compliance with your preventive maintenance schedule as a process metric. Another reason why auditors overlook maintenance is that they spent too much time in conference rooms and not enough time looking at the equipment and facilities. The third reason is that most companies have a reactive approach to maintenance instead of a proactive approach.  Using similar approaches to equipment maintenance and calibration helps ensure that there is a routine monitoring of equipment, but auditors need training on the process approach to auditing.