ISO Evidence Based Practice – Clause 7.1.5

ISO Evidence Based Practice

Hospital patient care processes are built on the foundation of evidence based practices. Protos Solution is now providing ISO Evidence Based Practice to support healthcare in the continued improvement of processes that support patient care.

The clauses found in clause 7.1.5 of the ISO standard outline the requirements for measurement equipment management. With ISO 9001:2015 these requirements have no significant change. Organizations refer to these chapters as the calibration requirements or Preventive Maintenance by others. Regardless how organizations have defined these chapters the fundamental focus is to protect the customer/patient. This is accomplished by understanding our measurement systems, associated controls and deeper look at essential quality management principles. While there are many technical aspects that could be discussed let me share just a couple common ISO Evidence Based Practices that apply to all systems managing measuring equipment:

Risk Based Analysis
  1. During the calibration process, have a defined protocol for managing equipment that is found deficient to calibrations standards by the Bio-Med group. These occurrences are often “hidden” to patient care; however the ISO standard indicates that the measurement equipment and product/service must be evaluated. Typically the Bio-Med or Calibration groups will manage the equipment however the affected product or services are at risk. This can be easily remedied by aligning the incident or corrective action process for reporting and evaluation purposes. These reports typically flow to the Risk or Quality committee for identified risks to be evaluated, affected products or services to be managed and customer or patient protected.
    Look Back Process
  2. Another aspect to consider is to assure that the Bio-Med group has a look back process built into the policy for equipment preventive maintenance (PM’s). This is mainly applicable to test equipment used in the calibration/PM of other medical equipment. The famous example that Charles “Woody” Conway uses is related to a personal analgesic device. We know that at any given hospital there are at minimum dozens of these devices and literally hundreds in some organizations. When test equipment is maintained assure that:
  • A review process is in place for each piece of equipment with focus on the “as received” section. Basically, determine if the equipment was “out of calibration” when it was received by the contracted service.
  • If the record states received in “out of calibration” status, then the look back process must be followed. This means that a thorough review of every item calibrated by the test equipment, until there is certainty that the test equipment was in calibrated status.
  • Follow the incident or corrective action process as defined in the ISO Evidence Based Practice in item 1.) above.

These are just two basic concepts that every hospital should assure are implemented into the practice of equipment preventive maintenance. DNV-GL surveyors have been trained to evaluate these topics as well as other topics that we will introduce periodically on the Protos Solution website. This information will become a part of our homepage as well as the DNV-GL Protos Solution LinkedIn group.

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William J. Metzcar
William J. Metzcar
Founder & CEO

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