Determining number of employees within the "Scope" of the QMS

M

malasuerte

#1
This is more of an interpretation question: When determining scope of the QMS, have you written the scope in a manner that limits the # of employees considered supporting that scope?

Example:

Scope of the QMS = Manufacture of Steel Pipes; therefore, # of employees are only those that support that specific scope.

I ask, because a registrar which I have been interviewing is suggesting that our company include every single employee when determining audit days. The suggestion, at the # of employees at each site, we would be having audits for about 9 months of audit days (20 sites * 12 audit days per IAF table). Even if 3 auditors are sent to each site that is still 80 days of audits. Just makes no sense.
 
Elsmar Forum Sponsor
M

malasuerte

#3
Thanks Sidney. I have all this, including the registrars document too.

I am looking for folks methodology or interpretation.

In short, I disagreed with the registrar I was interviewing (btw. our company is already certified - I am interviewing new registrars due to displeasure with performance of current registrar).

We have a defined scope for our QMS already. The registrar was insisting that the cafe workers, security, etc need to be counted, as per 2.3.4 states. I challenged that notion, since the cafe does nothing to support the scope. (and please don't say "they feed the employees and make them happy").

I contend that if you apply the scope of the QMS to some sort of boundary condition, then only those employees that support that 'directly' should be counted. A cafe worker does not support the QMS!
 

try2makeit

Quite Involved in Discussions
#4
Yea, I'd draw the line somewhere and ask him what it states in your scope. Does it state make coffee and serve lunch anywhere? That would be my answer.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#5
Thanks for the clarification. Section 1.9 of the IAF MD5 document and several paragraphs of section 2 allude to within the scope of certification. So, absolutely, your expectation is reasonable, especially because it is exactly in line with the IAF guidance.

Let me offer something to you: your account is obviously a highly desirable account to any CB, because your audits involve a large number of audit-days. CB's would "kill" to sign you up, as a customer. In your CB interviews and discussions, just make sure this issue is a deal breaker. You will see how reasonable and accommodating the CB sales folks will become.

Good luck.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#7
Good day @malasuerte;
You are getting good council here. Consider this... the scope of the standard is ... (paraphrase)...
- Meet customer requirements
- Ensure customer satisfaction

Therefore, I would hope that the scope of YOUR organization defines the processes required...which in turn would (should ?) not include the cafe, etc....
Summary: Consider scoping in the applicable PROCESSES and not the ASSOCIATES.

Hope this helps.
Be well.
 
M

malasuerte

#8
Good day @malasuerte;
You are getting good council here. Consider this... the scope of the standard is ... (paraphrase)...
- Meet customer requirements
- Ensure customer satisfaction

Therefore, I would hope that the scope of YOUR organization defines the processes required...which in turn would (should ?) not include the cafe, etc....
Summary: Consider scoping in the applicable PROCESSES and not the ASSOCIATES.

Hope this helps.
Be well.

Thanks....I agree with all said above. It is just stunning to me, the lack of knowledge by registrars and the ridiculous interpretations happening. I had a 2nd interviewed registrar tell me that they define our scope after interviewing us and getting an "understanding of our organization". :rolleyes: I politely said good bye and stopped the interview 15 minutes in.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#10
It is just stunning to me, the lack of knowledge by registrars and the ridiculous interpretations happening.
In fairness, CB's are under heightened scrutiny by AB's on the issue of lowballing audit days, compromising the integrity of the certification process (even more). However, this lack of knowledge is just another by-product of the commoditization and trivialization of the certification sector. Commoditizing your services mean that, without a question, you are not able to afford real talent working for you, be it as an auditor, a sales person, a certification issuer, etc...
 
Thread starter Similar threads Forum Replies Date
D Determining the the maximum number of reprocessing cycles of attachments CE Marking (Conformité Européene) / CB Scheme 2
G Determining the "Detection" Number Component of the FMEA RPN FMEA and Control Plans 5
F Determining the Number of Samples for receiving large lots of wire? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Determining the number of Internal Audit Man-Days Internal Auditing 15
Dazzur Difficulty in determining who should be addressing NCRs Nonconformance and Corrective Action 7
L Determining effectiveness and efficiency Process Maps, Process Mapping and Turtle Diagrams 6
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Kap.4.3 Determining the scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
U Determining population defect rate from sample defect rate Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Determining FIPS 140-2 compliance in a medical device Medical Information Technology, Medical Software and Health Informatics 2
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
J Process Capability - Determining the process capability of certain equipment Lean in Manufacturing and Service Industries 6
S Determining Sample Size and Method Quality Tools, Improvement and Analysis 12
S Determining a device category according to the MDR EU Medical Device Regulations 3
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Determining Adverse Effects of Corrective/Preventive Actions ISO 13485:2016 - Medical Device Quality Management Systems 2
S Determining sample sizes for PQ Qualification and Validation (including 21 CFR Part 11) 4
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Determining a tolerance value for Measuring devices in-house inspection General Measurement Device and Calibration Topics 12
R Determining Uncertainty from Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Determining SPC tolerance Statistical Analysis Tools, Techniques and SPC 21
B Determining SAT Offsets vs TUS Offsets per SAE AMS 2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B Determining sample size for device sterility Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
S Clause 8.2.2 Determining the requirements for products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
I Determining Calibration Tolerance of a Measurement Device General Measurement Device and Calibration Topics 2
J ISO 17025 Documented Procedure for 6.2.5 - Determining competency ISO 17025 related Discussions 4
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
J ISO 9001 8.4.1 - Determining controls applied to externally provided processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Determining what is good and what is bad can be subjective - when is it a quality issue? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
D Determining Critical Components for conformity with IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
Q ISO 9001, section 4.3 Determining the scope of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Determining Sample Size for Medical Device Component Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
A What does 8.2.2.1, Determining the requirements related to products and services,mean IATF 16949 - Automotive Quality Systems Standard 1
A Determining Retention Period for Medical Device QMS documents Document Control Systems, Procedures, Forms and Templates 5
S Surveillance Sampling Test - Determining Sample Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
F ISO 9001:2015 4.3 - Determining the scope of the quality management system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Standards Needed In House - Determining what standards are applicable Various Other Specifications, Standards, and related Requirements 3
W Determining Medical Device Classification in Mexico Other Medical Device Regulations World-Wide 5
K Determining Effect of Failure without a DFMEA (Design FMEA) FMEA and Control Plans 1

Similar threads

Top Bottom