Section 4.7 & Accreditation by January

L
#1
Good afternoon,
I am currently working towards iso 17025 accreditation. Unfortunately, the co. that I work for has not been certified anytime prior to my employment. I have just started working on the quality manual documentation and setup. I am a bit rushed because I have been informed that management wants the lab to be certified by January. Not sure it is too realistic as that gives me three months to prep for accrediation. Am I correct?
Also, concerning quality manual info related to section 4.7, service to the client. The standard states that: the lab shall afford clients.... cooperation....to monitor the lab's performance....
My question is what all do we have to allow them to monitor to comply with the standard.
Any help is appreciated!!!!
Thank you.
 
Elsmar Forum Sponsor

Jerry Eldred

Forum Moderator
Super Moderator
#2
I am not an ISO17025 assessor, so take my reply comments in that regard. My take on that would be regarding any calibration work done for a given client. If a particular department has a unit cal'd by the lab, they must have the right to monitor anything in the lab's performance which could potentially detract from the validity of calibration results on their instruments. If you have a dimensional lab, an RF lab and a DC/Low Freq lab for example. I believe a customer who only had calipers done by the lab would have to be granted access to the dimensional lab as appropriate in such a way that they could monitor how their calipers are calibrated, applicable environmental conditions, certificates and so forth on the standards.

I think philosophically this is to preclude labs that operate as a "black box" (i.e.: won't ever let any customer see how calibrations are done).

Cooperation means that when they have any valid question as to calibration of their unit, you help them as needed to assure they have adequate reasonable confidence in the cal. I don't think it refers to letting anyone who wants to go anywhere they want to in the lab. I believe it refers to those legitimate issues that occur now and then, and to the lab's responsibility to assure they are adequately addressed and resolved.

As to monitoring, I believe I covered that. Customers essentially have the right to assure confidence that units are calibrated correctly. Calibration is a customer service business (internal lab or commercial). The customer uses calibrated units to do their business. They have a legitimate need to know that the instruments they trust to conduct their business are doing what they are supposed to. And they have a right to receive appropriate cooperation from the lab.

Hope I have covered it (in my layman's view).
 
L
#3
Jerry,
I want to make sure I understand you correctly.
Therfore, if a part of our lab is experimental/developmental ....then that standard does not apply to that area, it only applies to the areas were calibrations are conducted on the customer's instruments?
 
D

DICKIE

#4
You have your work cut out for you. Most auditors will want a complete competency results for yoour entire scope of accredation either through proficiency testing, round robins etc. These will take some time.

Greg
 
D

D.Scott

#5
I agree with the comments made by Jerry and certainly with the comment by Greg.

The cooperation clause in my understanding applies only to that portion of the lab relating to the work you are doing for a specific customer. Proprietary and confidential information relating to any other part of the lab would be excluded. Unless of course you were doing the experimental/development work for the customer requesting the information.

If one of you 17025 guys thinks this is wrong, please let me know so I can patch it up before my next audit. Thanks.

Dave
 
R

Ryan Wilde

#6
Lynn,

I was in your shoes, and I have thankfully taken off those shoes and put on a very comfortable set of senior cal tech shoes instead ;) (I've been through the accreditation as the point of contact).

Let me quote the section verbatim with my comments in italics (ISO 17025 parts are copyrighted, so don't steal them, okay? I don't care if you steal my comments, they are free ;-/ ):

4.7 SERVICE TO THE CLIENT

The laboratory shall afford clients or their representatives cooperation to clarify the client's request and to monitor
the laboratory’s performance in relation to the work performed, provided that the laboratory ensures confidentiality
to other clients.


This refers to the fact that 17025 requires that you allow your client to do what we used to call an "over-the-shoulder", which affords them the opportunity to explain exactly what they need and to know that you are, in fact, doing it to their satisfaction. This, of course, cannot preclude the confidentiality of your work for other clients.

NOTE 1 Such cooperation may include:
a) providing the client or the client's representative reasonable access to relevant areas of the laboratory for the witnessing of
tests and/or calibrations performed for the client;


Again, this states that you only have to include access for them to view work on THEIR equipment, not your overall operation.

b) preparation, packaging, and dispatch of test and/or calibration items needed by the client for verification purposes.

This states that you will send you client's stuff to allow verification of your work (third-party assessment is becoming a more common method of evaluation).

NOTE 2 Clients value the maintenance of good communication, advice and guidance in technical matters, and opinions and
interpretations based on results. Communication with the client, especially in large assignments, should be maintained
throughout the work. The laboratory should inform the client of any delays or major deviations in the performance of the tests
and/or calibrations.

NOTE 3 Laboratories are encouraged to obtain other feedback, both positive and negative, from their clients (e.g. client
surveys). The feedback should be used to improve the quality system, testing and calibration activities and client service.


These last two notes seem to be good ways of avoiding having your client put you through the first part. If you ask a lot of pertinent questions and appear to really know what you are doing, they will generally trust that you do, in fact, actually know what you are doing. If you do NOT ask questions, and continually do not provide them what they need, they will want to see what you are doing, or worse yet, find someone else that will.

I hope this helps. I'm not the authority, but I've had some time with it. I am, as always, available by email, free of charge for anyone that wants a bit of help (I won't write your system, but I'll do what I can).

A point that I must bring up is this:

If you TRULY want the $64,000 answer, the best way to find out is to call your accreditation body. They will ALWAYS clarify any question that you have. Do not be afraid to bug them, you are paying them a lot of money for a service, and you should use it to its fullest. It is good business, and they ARE the authority.

Ryan
 
R

Ryan Wilde

#7
Oops,

Sorry, I forgot to answer a question. Is three months adequate to get ready for ISO 17025 assessment? That depends:

a) Will you have many parameters covered under your scope of accreditation?

b) Do you have your uncertainty budgets already worked out?

c) Do you have exempliary training records?

d) Do you have full management support, including a lot of human and financial resources at your disposal?

e)Do you actually require sleep and/or sub-125 hour work weeks?

Don't let me get you down, but getting ready for this does take some time. Working out uncertainties takes time. Dedicating resources to performing Type A evaluations takes money and time. If you don't know uncertainties inside and out, the class you will wind up taking will cost money, and by the time you take it, you have less time to perform the evaluations.

I have no idea what point you are at technically (the quality parts of the assessment are easy if you are used to good ol' 9000 audits), or just how involved your scope will be. If you are only accrediting a few tests, you are probably not bad off at all. If you have several parameters to cover, you will be hard pressed to make it in time.

You may want to consider a consultant at this point. I know of a few that are very good (although I didn't get to use one :mad: ), and they may be the smartest way with such a short time period at your disposal.

Ryan
 
Thread starter Similar threads Forum Replies Date
C How do we add FMDSS 206 section 3.1, 3.2 to our internal scope of accreditation? General Measurement Device and Calibration Topics 4
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
K Why 'FD&C act section number' and 'section number' in the title of the act are different? US Food and Drug Administration (FDA) 1
M API Spec. Q1, 8th Ed. Section 7.5.2 vs. Q1, 9th Ed. Section 5.7.1.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
K IPC-610 Section 10.4.2.2 clarification - Distance to be measured Various Other Specifications, Standards, and related Requirements 0
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C IATF 16949:2016 Section 8.5.1.2 item d) accessible for use at the designated work area(s) IATF 16949 - Automotive Quality Systems Standard 5
W Tying the need for Demand Planning to a section of AS9100/9110 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9102 Form 1 Section 13 Detail or Assembly Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
eternal_atlas Section 7.8.4 Specific requirements for calibration certificates ISO 17025 related Discussions 2
T MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b) EU Medical Device Regulations 1
M ASTM A6 Material Standard - Section Nominal Sizes Manufacturing and Related Processes 1
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
T Relevant internal and external communication - ISO 9001:2015 section 7.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y IEC 62304 Section 4.3(a) - 100% probability of failure IEC 62304 - Medical Device Software Life Cycle Processes 3
C AIAG's IATF 16949 section 7.1.5.1.1 - Torque MSA Requirement Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Documented processes required by IATF 16949 section 4.4.1 IATF 16949 - Automotive Quality Systems Standard 1
L AS9100D Requirements vis-a-vis Section 8.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q ISO 9001, section 4.3 Determining the scope of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
J NADCAP NDT (specifically RT) - Checklist AC7114 Rev. K, section 8.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Medical Device Accessories - Health Canada - CMDR Section 21 Canada Medical Device Regulations 1
R Background of Annex X section 1.1d of MDD 93/42/EEC EU Medical Device Regulations 74
WCHorn Rendering Scrap Unusable before Disposal (AS9100D, Section 8.7) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Sam Lazzara Preferred Location for Revision History Section in Documents Document Control Systems, Procedures, Forms and Templates 16
O CQE Handbook - Missing Section VII - Risk Management Misc. Quality Assurance and Business Systems Related Topics 1
T ISO 17025 Section 5.9.1 - Assuring Quality of Tests - Requirements ISO 17025 related Discussions 4
B IATF 16949 Section Clause 8.3.4.1 - Monitoring - Design and Development Input(s) IATF 16949 - Automotive Quality Systems Standard 3
J Bill of Materials required according to MDD93/42/EC Annex II Section 3.2 ISO 13485:2016 - Medical Device Quality Management Systems 5
B IATF 16949 Section 8.5.1.5 (Total Productive Maintenance) IATF 16949 - Automotive Quality Systems Standard 19
B Calibration/Verification Records - IATF 16949 section 7.1.5.2.1 f) IATF 16949 - Automotive Quality Systems Standard 6
B TS16949 Section 8.2.2.3 Product Audit - Requirements for various Customers IATF 16949 - Automotive Quality Systems Standard 10
M Complying with AS9100 D Section 8.4.3 m. Ensuring that persons are Aware of... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
S ISO9001:2015 Section 4.4.1 - Support Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q ISO 9001 Section 7.6 - Computer Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
K ISO 9001:2015 Section 8.5.3 - Property belonging to customers or external providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Salt Bath Probe Style SAT requirement Waiver per AMS 2750 Rev E Section 3.4.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom