Objective evidence Vs requirements
While auditing the laboratory , the audetee claim that emergency shower is not required for the lab activities , mentioning low risk analysis finding . If you are an auditor, how to address this issues ? can you mention objective evidence in ISO 15189 requirements that the lab against ? Some times the auditee make argument in related issues . Share me your experiences
Comments
Even though ISO 15189 does not talk about safety equipment but however its make reference to ISO 15190 Clause 12.10 which emergency shower falls under. Despite the low risk analysis findings, emergency shower is needed in Biosafety level 2 laboratory as one of the basic equipment require and therefore the argument of the auditee is invalid unless the laboratory he/she is working is biosafety level 1
Thank you Daron, sound comment & hope working . Does a lab who apply for ISO 15189 accreditation also require to fulfill ISO 15190 (requirements for laboratory safety ) in your country experience ?
Accreditation by ISO 15189 requires fulfilment of the requirements of ISO 15189 not ISO 15190. If there are some overlapping requirements in both ISOs they must be emphasized by the ISO 15189 as a requirement else the lab accredited by the ISO 15189 is not bonded by any other requirements it has not subscribed to ie ISO 15190.
ISO 15189:2012 does not go into details issues of safety and security except for clause 5.2 which talks about accommodation and environment. However, for the SLIPTA checklist which is based on 15189:2012, section 12 is dedicated for facility and safety which is mainly made up of ISO 15190:2003 with some top of 15189:2012 clause 5.2. For a laboratory to meet the requirement of the SLIPTA checklist, it must also meet the requirement of ISO 15190:2003. Under bibliography of 15189:2012 it references ISO 15190:2003.
If accreditation for ISO 15189:2012 is not bound to the fulfillment of requirements of ISO 15190:2003 then Clement why laboratories;
NOTE: ALL MY SUBMISSION IS BASED ON ISO 15189:2012 AND ISO 15190:2003. WE MAY EXPLORE WHAT THE NEW ISOs SAY
I do agree with Daron on this and it was also emphasized by Prof. Beatrice that in the event where you do not have the ISO-15190, the ISO-15189 can also be used as well. Risk has been assessed, and that there is a likelihood of fire or spillage to occur. So depending on the hazard safety shower can be consider a first approach in addressing the hazard.
Section: 12.9 a,b,c,g,h are specific for ISO-15190 as a requirement in the checklist clause 7.4 of the standard. This in my mind as student in laboratory auditing will allow you to ask probing questions like ; request for the safety manual, and other related SOP or Job Aids on the following topics (a,b,c,g,h).
Old ISO 15189 :2012 actually address this on 5.2.2 e) Safety facilities and devices are provided and their functioning regularly verified. then it goes on to give example Operation of emergency release, intercom and alarm systems for cold rooms and walk-in freezers; accessibility of emergency showers and eyewash, etc. Therefore the agument of the auditee is ungrounded .
Thanks Isack for your valuable objective evidence and consider in future activities .
Still in general hospital where there is only one emergency shower at central lab , separated lab in another location like Genexpert for TB dignosis and microbiology don't have own emergency shower .
This is where the risk assessment comes in , not necessary each unit to have their own emergency shower but the distance shouldn't be long between workstation and safety devices because in the event of body splash when the distance is long before you reach there the damage is already mild to severe.
ISO 15189 ALWAYS REFERS TO 15190 ON MOST SAFETY ISSUES. ITS LIKE NOT WANTING TO REINVENT THE WILL.I AGREE WITH DARON