Risk classification guide for medical device establishment inspections (GUI-0079): Glossary
- Deviation
- Departure from an approved instruction or established standard. (ICH Q7)
- Harm
- Injury or damage to the health of people, or damage to property or the environment. (ISO 14971:2019)
- Hazard
- Potential source of harm. (ISO 14971:2019)
- Hazardous situation
- Circumstance in which people, property or the environment are exposed to 1 or more hazards. (ISO 14971:2019)
- Observation (medical devices)
- A deviation, deficiency or failure to comply with the Food and Drugs Act or the Medical Devices Regulations that an inspector:
- sees during an inspection of a medical device establishment
- confirms in an inspection report given to the establishment
Consult the Overview page for more information about how observations are classified by risk.
- Person
- Includes a partnership and an association. (Section 1, MDR)
- Risk
- Combination of the probability of occurrence of harm and the severity of that harm. (ISO 14971:2019)
- Severity
- Measure of the possible consequence of a hazard. (ISO 14971:2019)