This question periodically arises whenever certification bodies aim to enter the healthcare sector, which is quite often. Firstly, if ISO 9001 were suitable for healthcare institutions, the ISO organization would not have developed and launched the ISO 7101 standard. Therefore, even ISO itself does not consider the ISO 9001 standard to be an adequate solution for healthcare organizations. ISO 9001 is a generic standard developed for all industries. I can’t recall any hospital significantly improving patient safety simply because it had an ISO 9001 certificate.
The European Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, in Chapter III, Article 8, point 6c, states: “The Member State of affiliation may refuse to grant prior authorization for the following reasons: this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment.“
Even the European Union considers the ISO 9001 quality management system standard insufficient to prove quality of care and patient safety, explicitly mentioning terms such as quality of care, patient safety, and accreditation.
ISO 9001 has several serious shortcomings when it comes to the healthcare sector because it does not address many crucial aspects specific to healthcare: patient safety, adverse events, near misses, critical processes such as reporting of critical and/or unexpected diagnostic results, follow-up of patients who intend to leave the healthcare organization against medical advice, process for “hand-off” communication between staff at the time of shift changes or transfers between units within the healthcare organization, central sterile and decontamination validations, surgery “time-out” and pre-operative surgical site identification, discharge of a patient from one healthcare environment to another, infection control, and preventing medication errors, to name just a few.
Comparing the ISO 9001 standard to accreditation standards is like comparing traveling first class by plane to traveling in a medieval carriage. And I’m not just referring to the AACI standard. All accreditation standards available on the market today are at a higher level than any future revision of the ISO 9001 standard will ever reach.
Another point is the revision of standards: Accreditation standards are revised according to the guidelines of various organizations such as WHO, ISQua, or similar professional organizations. The revision of a standard can also be initiated by the accreditation body itself based on new medical findings or, for example, adverse events. For example, the AACI accreditation standard has undergone six major revisions since 2015. Guess what? ISO 9001 is still in its 2015 version. Do you know how much the world and medicine have advanced in 10 years?
The question is, can a hospital have equally good clinical indicators and outcomes with only ISO 9001 certification? Of course, it can, but not because it has ISO. It is because it has staff capable of translating ISO principles such as process approach or measurement, monitoring, and improvement into “clinical language,” which is precisely what the AACI accreditation standard does. But how many people in the world can write a clinical standard using ISO principles? I would say very few, too few.
Similarly, a hospital can have excellent outcomes even if it is not accredited. There are numerous examples of this. But such hospitals spend millions of dollars on quality and patient safety without anyone forcing them to. If your hospital is in that group, I advise you never to pursue accreditation.
Therefore, ISO 9001 is a standard for a Quality Management System, while we in accreditation talk about Quality of Care and Patient Safety. It doesn’t take much insight to see that we are discussing two different things.
NOTE: AACI is an accredited certification body according to ISO 17021-1 and issues certificates according to ISO 9001:2015.