Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, May 3, 2019.
Facts matter. Thank you Tony.
NC worthy or not, I feel very relieved my high risk delivery wasn't in this hospital ... ("JUST a room for ...")
(This discussion did start some questions/worries... but the hospital I went to (and where my baby will have some serious surgery next month) has a NIAZ Qmentum label and has the complete audit report posted on its website. Reading it made me feel a lot better.)
Good for you. Provincial hospitals here in the Philippines may not have the state-of-the-art facilities and systems and accreditation from Dutch and European organizations but they strive to deliver quality healthcare services to their patients.
Not in my copy it doesn't. It simply says maintained. Things break. Doesn't mean they aren't maintained. Making this a (major) NC is ridiculous.
There is no requirement? How do you know that? Who are the interested parties? Are there requirements set out by the state, municipality, insurance or other entity? If so, does the hospital promise to follow those requirements as part of its service to the customers and visitors? What does the policy say?
We are not discussing a widget factory. Health care quality customer requirements will very possibly include safety to an extent that makes manufacturing people feel like over reach or auditing to the wrong standard. Not having been present for the context (including what was reviewed and discussed between the auditor, guide and client), I still think it is not wise to continue to beat this topic without having more data.
Because ISO 9001:2015 was the ONLY criteria stated here. And that states simply the infrastructure must be maintained. Lights can be maintained, doesn't mean they won't fail in use. Once again to claim you weren't there points to how poorly the auditor reported the situation.
Emergency lights, as I have clarified here with Bev, whether they are installed in a hospital or a widget factory have the same use i.e. provide temporary illumination until the power outlet is supplied with electricity from the main source or the stand by generator. Since the hospital has a stand by generator, sudden darkness due to power outage at any time can immediately be rectified. The impact of a broken light is negligible with the available infrastructure.
Yes there are requirements like the Fire Code, but it doesn't prohibit expiration of bulb. It does require inspection and the hospital performs it. It just that in that unfortunate day the bulb reached its expiration at the time of the audit, and the auditor discovered it before the maintenance personnel carry out his/her next inspection schedule.
I'm not sure I understand. What "hook" are you referring to? Is this a rhetorical question? As a CB auditor, are you asking because you need to know the answer?
Thank you, but I have never seen a requirement for battery operated emergency lighting "except when a backup generator provides the illumination". Generators also fail, but that is beside the point. The question was one of requirements, as it was described that no requirement existed.
I have watched the trickle of additional information as this thread has progressed, ranging from conjecture to your now describing that one bulb as having burned out on that one day. Not having been present and not having caught the post describing your having asked your friend for more information and received xyz in response, it is hard for me to feel sure I know all there is to know about this specific event. I have read there is a maintenance program, but I did not read it was conclusively shown this light was included. (I have identified safety equipment not included in the programs due to oversight).
So please forgive my stubbornness and rudeness, but I will remain outside of the group that declares no nonconformance exists based on second hand, evolving, incomplete information.
ISO 9001:2015 requires interested party requirements to be identified and fulfilled. A hospital's list of regulatory requirements for quality will very possibly include the authorities regulating fire and emergency/safety. Of course we don't know that for sure because we were not on this audit, did not see the list of requirements etc. etc. etc., nor did we see the exact write up.
For clarity, then, you are saying there IS a non-conformity?
I am saying there is not information to be as comfortable saying "no" as many of my good associates here.
So it's a yes, then...
It is "there is not information to be as comfortable saying "no" as many of my good associates here." Fact versus inference.
I believe, at this juncture, information necessary for an auditor to decide whether his/her audit finding is a conformity or nonconformity are already provided.
So you're in the group that will slap the hospital with a major NC or minor NC based on second hand, evolving, incomplete information?
Surely, if viewed from the responsibility of a Lead Auditor, the position should be "It's not a non-conformity until there's sufficient objective evidence to support that it is". A bit like the law" Innocent until proven guilty". It seems to me that standards of objectivity have turned 180 degrees. I'm wondering if the (AB) pressure to report negative findings has caused this...
Only in your mind, it appears. Others disagree.
What have you been smoking? It's always been my responsibility to provide evidence to prove my company's innocence.
Respectfully, I am not in either group because I still feel I do not have all the needed information to make a valid decision.
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