ISO/IEC 17025:2005 Clause 4.1.5 and 4.1.6

Hershal

Metrologist-Auditor
Trusted Information Resource
This one gets its own post because it is such a large Clause.....feel free to inform us of what you have seen or done to fulfill any of this, or ask questions.....remember, I want to help, but am NOT the Oracle of Delphi.....

a) The lab must have both managerial and technical personnel - that is both the folks managing the lab and oh, yeah, the folks actually doing the work.....and they MUST - no option is provided - have the authority and resources to carry out their duties which includes the implementation, maintenance, and the improvement of the management system (covered under 17025); to identify issues, and to take some level of appropriate action to prevent or minimize issues.....this is a HUGE requirement.

b) Have arrangements (what that is or may be is not specified) to make sure that management and other personnel are free from several undesirable influences to include but not necessarily limited to, commercial, financial, and other unethical influences that can have a negative impact on the quality of their work.....this could be construed as wide open.....after all, what constitutes financial? If the tech gets an offer that boosts his/her pay by 50% (not unknown in some markets for Metrology professionals), then how is that handled within the lab? I can tell what often happens.....

c) this one is critical.....have policies and procedure to protect customer confidential and proprieitary information, whether physical or electronic.....customer confidentiality is one the absolute keys to ISO/IEC 17025, hence this sub-Clause is considered by many (including me) to be one of THE most critical Clauses in the standard.

d) This Clause is similar to b, in that the lab must have arrangements to ensure that there is no involvement in things that dimish confidence (which is often a perception thing) in the lab's ability to do its job and this sub-Clause lists certain aspects specifically.....competence, impartiality, judgment, or operational integrity.

e and f) I put these two together because they are pretty closely related, along with Clause 4.1.4 discussed earlier.....define the responsibilities of personnel, define and document the organization, its place within any parent organization, and the relationships between personnel.....generally this is done by position, not name.....

g) Provide adequate supervision by experienced personnel

h) Technical management (seemingly as opposed to general management) must have responsibility and resources to carry out operations.....before anyone asks, yes, I have written CARs for lack of resources.....it is important for the operations of the lab.....

i) A member of Staff must be appointed as Quality Manager.....this can get dicey at times.....the QM must have DIRECT access to the "...highest level of management at which decisions are made on laboratory policies or resources" which basically means the Top Management as relevent to the lab.....and if in a parent, and that is someone in the parent's Exec Staff, then the lab's QM must have DIRECT access to that individual.....

j) There must be Deputies for each key position.....generally that means the Technical Manager and the Quality Manager (by whatever titles they may be known), but is not limited to that.....

k) make sure that personnel are aware of the importance of what they do and how it contributes to the achievement and objectives of the management system.....this concept is not a bad one, but comes from the ISO 9001 world.....in my personal opinion, most of the requirements that came from the ISO 9001 world are good, but the manner in which they were integrated into ISO/IEC 17025:2005 and ANS/ISO/IEC 17025:2005 (U.S. version) was not so good.....

Clause 4.1.6) Top Management (this is in regards to the lab, so refer to 4.1.5.i) must make sure that communications channels are established and used, and information is communicated regarding effectiveness of the management system

Now, sometimes small labs get an advantage because everyone talks to each other almost constantly (well, most of the time) where large or multiple-location labs may not find that so easy.....

Large labs though sometimes get an advantage in resources - NOT ALWAYS - but at least there are more people to designate for positions.....

Side note - and the other assessors on here, and the labs, chime in.....are larger or multiple-location labs held to a higher expectation regarding making sure that the Quality Manager and internal auditors get training specific to those functions? Or in making sure that Technical managers get some management and leadership training?
 
A

amanbhai

I would suggest you to please use the same thread as much as you can so that we could see things in continuation. However, this is just a suggestion.

About the requirement of clause 4.1.5 k: It is a good requirement for it requires participation of all its staff members. It is good since you can not bring any change or improve the organization of the lab or QMS unless you take all its personnel onboard.When everyone is onboard and he/ she knows their roles, lab implement system of KPIs of its personnel. Everyone knows what lab management is expecting from them in quantitative terms.
Beleive me this would improve your management system alot.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
I have not forgotten this, just travelling my tail off.....
 

BradM

Leader
Admin
Hershal.. awesome stuff here. I do have some questions about how you write your citations for insufficient resources.

Oh, BTW... yes, you are: The One. :notme:
 

Hershal

Metrologist-Auditor
Trusted Information Resource
Please post your questions.....THAT is what makes this discussion go.....and truly what is needed.....I can post my thoughts, but questions and discussion - even occasionally heated discussion - is what will create value in this discussion.....
 

rudolfrm

Starting to get Involved
hi folks.

Could some one tell me, where i can find on 17025 the part where talk about the processes map?, the standar says if you achieve with 17025 you achieve to iso 9001.
I shall to get a general processes map for implementing 17025?

thank you

Rodo
 
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