Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing

M

MIREGMGR

#21
For (a) then: yes, I could write up a procedure which documents requirements for the behavior of our personnel to ensure that they do not adversely affect ... the work environment (including any equipment within). But that's not what this paragraph says! It says the personnel should not adversely affect the product! And although in a generic sense, outside of ISO, our 'product' does happen to be a piece of equipment that's in this particular environment ... for the purposes of this standard, our 'product' is our servicing efforts. And here is where I fail to see how the behavior of our personnel could adversely affect that.
I'd describe your product as servicing of medical equipment to restore it to desired/specified operation. It seems self-evident to me that personnel behaviors could affect that product, or disrupt their work environment. Your personnel could work while ill with a contagious disease, or smoke, or wear heavy perfume, or be personally unsanitary in various ways. Of course, they know not to do or be any of these because they've been so trained. The point of the requirement is for you to document those "obvious" behavioral issues, so as to indicate that you understand what's required and accomplish it, and so as to allow a non-expert auditor to verify that you do what you say.

As for (b), no matter how you shake it, I can't see how this could apply: our servicing efforts do not require specific environmental conditions (fine, we don't do well in hail ...), nor, for that matter, does our equipment, even if as I said above, that's not the 'product' to which we're referring in this standard.
Again: document that which is required. Particularly if it's "obvious" to you, document it. Those are the things that you know it would be dumb for your people to do, and you know they will not do, and you want the auditor to verify they are not doing.

So on to (c): again, I can mostly ignore the specifics of the way this paragraph is written and blithely write up something about how our personnel are to behave working, say, on the 'clean side' of a hospital central sterilization department. We cover this anyways in general training -- gown, booties, etc. Still, these departments are our work environment and in performing equipment service, we always work in these 'special environmental conditions' -- whereas the standard asks us to ensure that we train if personnel are required to work temporarily in these conditions within the work environment. Is this hair-splitting, or is this simply not applicable?
It's hair splitting. Write up what you do. That's what the standard wants.

And finally (d): here I completely buy the common sense in your example. Problem is, that example doesn't apply to how we work. 98% of our equipment, for instance, is fixed in place within these departments. The 'post-servicing re-validation' of the -- for us -- operating room, not only isn't our responsibility, but is actually instead a rigorously standard 'pre-surgery' disinfection procedure, done before each and every operation irrespective of whether there have been equipment servicing activities in the room or not.

It goes without saying that we do not, of course, engage in service activities while the room is being used for a sterile procedure.
The whole point of the standardization and verification process is that nothing "goes without saying". Somewhere there's a company in the same business as you that would do it wrong. Your point is to write up how you do it right, even if it's obvious. Then the auditor will verify that, and you're good to go.

You come a bit closer when you talk about the sterilizer, however. Do we follow 'procedures to avoid contamination that would defeat the sterilizer's purpose'? May I ask you to think closely about that for a second? The 'sterilizer's purpose' is to eradicate contamination. The very nature of a sterilizer is that it regularly deals with contaminated items.
As a matter of engineering, this statement is incorrect for the equipment with which I'm familiar. A sterilizer is (generally) designed to kill and/or disable and limit reproduction of harmful organisms. It might be designed to provide a washing/cleaning function prior to sterilization, to remove hydrocarbons (fats, lipids) and their oxidation products (varnishes), proteins and the compounds that result when they dry onto surfaces, and similar biologically originating materials. Usually a sterilizer (in my experience) will not be designed to remove non-biological toxic/carcinogenic/mutagenic contaminants. So it would be inappropriate for your service work to leave such a contaminant in a sterilizer such that it might be deposited on processed devices. Thus if a large power supply or a high voltage transformer involved biphenyls in its insulation systems and a component failure had spread that insulation substance into the processing system, you would assure its removal, not further spread it. If a high temperature insulation system or a seam in a liquid handling chamber had failed, you probably wouldn't utilize asbestos materials or metallic lead materials in the repairs. All of those kinds of non-biological contaminants would be unaffected by sterilization per se.

The entire [central sterilization] department is all about processing of soiled, contaminated items.
Biologically soiled and contaminated. Thus your procedures needn't focus on biological contamination at the dirty end of the process. Potential biological contamination at the clean end, however, remains highly important.

Again: if it's "obvious" or something that of course your people know to do, write it up. Then make sure that your people in fact do all know to do everything. Then you're done.
 
Elsmar Forum Sponsor
X

XeniAnnoula

#22
MIREGMGR, I really appreciate the time and effort you're putting into this problem, however, I think we may have some philosophical differences when it comes to ISO. I just plain don't want to make ISO a useless, bureaucratic burden -- and so I avoid like the plague writing things up for the sake of writing things up, or, God forbid, writing things up to make the auditors happy.

It says "if applicable" for a reason. If in my most honest opinion about the way our company functions it's not applicable, I won't write it up. If the auditors insist, I'll go back and do it. That simple.

You largely lost me on the sterilizer specifics, but I'm not an engineer. Our engineers who specialize in hospital sterilization, however, feel that the steps we're taking are sufficient. My feeling was that the examples you cited were exaggerated to support the position that yes, it could apply to us ... but my very real opinion about the nature of the job our company does is that this doesn't apply.

However, out of respect for the time you've taken here, I promise I will look at it fresh tomorrow and perhaps I will understand better your stance.
 
X

XeniAnnoula

#23
Good morning --

I will continue this discussion mostly to help continue to clarify my own mind before I face auditors, and also should it be of any future use to anyone else in a similar position.

It seems self-evident to me that personnel behaviors could affect that product, or disrupt their work environment. Your personnel could work while ill with a contagious disease, or smoke, or wear heavy perfume, or be personally unsanitary in various ways.
Personnel wearing perfume could affect our servicing of medical equipment? How, exactly? Extending this to our male service staff, shall I conclude that if they wear after-shave that also will affect our servicing efforts? How about antiperspirant? Scented sunscreen?

As for smoking: if the department allows it, our employees may indulge if they insist. If it doesn't, they mustn't. Period.

Contagious disease? Again, what guidelines does the hospital have for their own personnel? We'll respect those. Stay home? Wear a mask? Cover cuts with band-aids? Bear in mind, however, that unlike the hospital personnel, our personnel aren't handling the specific items which are processed in our equipment (bedpans, surgical instruments, whatever).

Honestly, I fail to see your logic here. And it seems that 'this way lies madness'. In other words, of course I can come up with a bunch of things our personnel ought not to do, but where does this end? A statement along the lines of 'reasonable and customary measures of personal hygiene and behavior are expected' is about as far as I believe we need to go.

The point of the requirement is for you to document those "obvious" behavioral issues, so as to indicate that you understand what's required ... Particularly if it's "obvious" to you, document it. Those are the things that you know it would be dumb for your people to do, and you know they will not do, and you want the auditor to verify they are not doing.
Uh, no, I won't start down the road of documenting the obvious! There's no end to that, and it would soon enter the realm of the absurd.

It's hair splitting. Write up what you do. That's what the standard wants.
"ISO wants" and "the standard wants" are philosophies I don't agree with. But a summary or two might be in order. How about: that all personnel working within the customers' premises are obligated to adhere to the customers' rules.

The whole point of the standardization and verification process is that nothing "goes without saying". Somewhere there's a company in the same business as you that would do it wrong. Your point is to write up how you do it right, even if it's obvious.
It's very clear we differ greatly in our approach to ISO. While I make references such as "as needed" or "if appropriate" in our documentation, I wouldn't dream of spelling out what we do in any more detail. The idea, for me, is not for the ISO documentation to comprise work instructions for every single, blessed process in our company (that we have work instructions we do -- "as needed"!). Is my approach correct? Well, we've had certification against 9001 for just about a decade, and during that time we haven't had a single audit non-conformity or even an observation ... and by the way, we've argued a point with our auditors several times (they're not gods) and 'won' each one. We respect their knowledge of ISO ... but we insist that they respect our knowledge of our business!

All of those kinds of non-biological contaminants would be unaffected by sterilization per se.
Yes, true, no debate. However? Sterilization takes place within a sealed chamber. We don't work within that chamber. We work outside with the wiring and the valves and the pumps, and our tools are screwdrivers, allen keys, wrenches, various gauges, etc. The single consumable used occasionally in our servicing efforts is a silicone compound. What contaminants are we likely to leave behind? So, again, I'd say "not applicable".

Potential biological contamination at the clean end, however, remains highly important.
Sure it is. Which is why we, like the hospital personnel who work in that area, follow 'any applicable instructions' from the hospital.

Okay, seriously, at this point: :deadhorse: but thanks again one and all!
 
Last edited by a moderator:
K

ken butler 4321

#26
Hi Steve.

Many thanks for the sample procedure. Its a great help. I am new to this web site so having some difficulty in navigating, so opologies for my slow reply. I just realised that you are in Manchester. I'm based in Belfast myself!

I am totally new to the standard for 13485 as I have been given the opportunity to run a quality system (what I use to do) thats coming on stream in the next few months, so I really appreciate your help as Im trying to get to grips with words like "advisory notes" and risk management etc. So thanks again and no doubt I will call on your assistance again. That procedure along is worh a bottle of good irias whiskey!! tell me where to send it and its on its way. Ken
 
Thread starter Similar threads Forum Replies Date
L Need HELP with Internal Audit Program ISO 13485.2003 Quality Management System (QMS) Manuals 3
R ISO 13485 Software Validation Requirements - Help needed ISO 13485:2016 - Medical Device Quality Management Systems 4
S Please help on ISO 13485 medical device related services Other Medical Device Related Standards 1
X Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 39
G Need help in an upcoming ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 7
S Freshman needs help with ISO 13485 Audit Process ISO 13485:2016 - Medical Device Quality Management Systems 46
R ISO 13485 Surveillance Audit Nonconformances and Report Help Needed ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 Help - Determining what processes I specifically need to document ISO 13485:2016 - Medical Device Quality Management Systems 9
K ISO 13485 Audit help needed General Auditing Discussions 20
R Help for implementing ISO 13485 (provision of software to Hospitals) ISO 13485:2016 - Medical Device Quality Management Systems 4
J Need step-by-step ISO 13485 implementation help ISO 13485:2016 - Medical Device Quality Management Systems 8
E Contract manufacturer seeking help understanding ISO 13485 Validation requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
P Can somebody help me to identify the 27 ISO 13485:2003 procedures? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ISO 3310 Clarification Help - Aperture sizes for sieves used for particle sorting Other ISO and International Standards and European Regulations 2
L Please help me with the process of getting ISO 9001 certified Quality Management System (QMS) Manuals 15
A ISO 9001 Help - New Quality Manager - Upper Management Support Issues ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S ISO 17025 - Help in Getting accreditation- Where to start from ISO 17025 related Discussions 12
D Customer Audit - Root Cause Help - ISO 9001:2008 Cl. 7.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
S How will ISO 9001 help the machinists in a very small Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S ISO 9001:2008 Clause 8.2.3 Monitoring and Measurement of Processes Help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Informational Please help this newbie understand ISO 9001 Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
Q ISO 9001 - 3 BIG questions to help a Newbie's Sanity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Help me understand the ISO section 7.5.2 from API Q1 perspective Oil and Gas Industry Standards and Regulations 4
R First ISO 9001 Management Review....HELP Management Review Meetings and related Processes 7
0 The Uncertainty of an Estimate of the Bias ISO 5725-1 - Help Measurement Uncertainty (MU) 8
Q New Auditor looking for help with ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
P Supplier Scorecard for ISO 9001 - Help me review the draft from my purchasing team ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R OHSAS 18001 & ISO 9001 Implementation - help! Process Maps, Process Mapping and Turtle Diagrams 7
S Help with Master Thesis focusing on ISO/TS 16949 and CSR in automotive SC IATF 16949 - Automotive Quality Systems Standard 2
R ISO 9001 Implementation in the Bus/Coach Industry - Confused and Help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
O ISO 9000 section 7.2.1(c) Compliance help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Bi-Annual ISO 9001 Surveillance Audit Help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
C CRMs (Customer Relationship Management) to help achieve ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 14001 Implementation Help & Question about Supplier Approval ISO 14001:2015 Specific Discussions 5
T Design & Development in Updating Machines and Equipment - ISO 9001 Help Design and Development of Products and Processes 4
1 I don?t have any experience with ISO 9001 - Help Quality Manager and Management Related Issues 9
P ISO 9001:2008 Gap Analysis Template - Please help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J ISO 9001 and Improvement of Business Performance - Research help Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Help with ISO 9001 Implementation in Oil Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Incidents that occur during a Third Party Supplier Audit - Help for ISO 9001 General Auditing Discussions 23
S ISO 2859-1 or Ansi ASQ Z1.4 in using AQL or AOQL - Need Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K ISO 9001 Clause 4.2.4 Control of Records - Documented Procedure help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom