ISO 9001:2015 man days for surveillance audit

qcman

Registered Visitor
#1
Is there a chart anywhere that shows the required surveillance audit man days for x number of employees? Fortunately we are still up and running albeit reduced from 2 10hr shifts with 185 employees to 1 - 8hr shift with 85 employees. Figured this would reduce the man days from 2.5 to 1 for the surveillance audit in 2 weeks but registrar still says 2 on sight and 1/2 off.
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
I think the cutoff for 1 day audits is 25 employees, so with 85 employees active you would still be well above that cutoff.
Edit: maybe that's just the criteria that the company that audits us uses...not sure if there's a universal norm.
 

jmech

Trusted Information Resource
#4
Yes, assuming that your CB is following IAF rules. See IAF Mandatory Document 5 (link below).

Per IAF MD 5 Section 5, the required surveillance audit time should be about 1/3 of the initial certification audit time. It is not clear if the surveillance audit time should be based on the number of employees at the time of the initial audit or at the time of the surveillance audit.

In contrast, for recertification audits, IAF MD 5 Section 6 makes it clear that the recertification audit should be about 2/3 of the time that would be required for an initial certification audit based on the number of employees at the time of the recertification audit.

IAF MD 5 Annex A Table QMS 1 shows the required time based on effective number of personnel (although this can still be modified based on the risk categorization of the organization's activities). From this table, the required initial audit days for 66 - 85 effective personnel is 6 days and for 86 - 125 personnel is 7 days, so 2 or 2.5 days for a surveillance audit of an organization with approximately 85 personnel looks about right.

https://www.iaf.nu/upFiles/IAF MD5 Issue 4 Version 2 11112019.pdf
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
It is not clear if the surveillance audit time should be based on the number of employees at the time of the initial audit or at the time of the surveillance audit.
The estimation should be done taking into account the number of employees at the TIME OF THE EVENT. Some seasonal businesses experience massive fluctuation, in terms of employee numbers.
 

qcman

Registered Visitor
#7
Thank you for your replies. I did see MD5 after posting. Talking with the registrar this morning they agreed the reduction to 85 would require 2 man days versus 2.5. The main question was whether employee count would return right back to pre levels. Hope projections are wrong as they show staff trickling back over months. This indicates count is at the time of the event as Sidney stated.
 

jmech

Trusted Information Resource
#8
I did not look closely enough at the second half MD5 Section 5 earlier, which states:
The CAB shall obtain an update of client data related to its management system as part of each surveillance audit. The planned audit time of a surveillance audit shall be reviewed at least at every surveillance and recertification audit to take into account changes in the organization, system maturity, etc. The evidence of review including any adjustments to the audit time of management systems audits shall be recorded.
I think this makes it pretty clear that the surveillance audit time should be based on the count at the time of the event, as Sidney stated.

However, although it shouldn't apply to your situation, there is an exception to this for seasonal operations in Section 2.3.1:
In case of seasonal operations (e.g. harvesting activities, holiday villages and hotels, etc.) the calculation of the effective number of personnel shall be based on the personnel typically present in peak season operations.
You could also review Section 2.3 to see if you can claim any others reductions in effective number of personnel.
 

Randy

Super Moderator
#9
The requirements for me are that I'm to verify employee count, effective employee count, duration and any justifications for increase or reduction during every audit and place that information in the report.....Every single one!

Integrated systems also require the same for each MS involved and the inclusion of requirements from IAF MD-11 (Integrated Systems).

To complicate things further multiple locations require MD-1 application for Multi-Sites.

I have clients where I have to employ MD-5, MD-11 and MD-1,where everything has to balance out and be able to pass an ANAB audit.

These days we're also employing MD-4 for doing Remote audits (ICT)

Next week while working at home I will be under MD-1, MD-5, MD-11, MD-4 (available free to everyone involved) as well as ISO 17021 (not free).
 

jmech

Trusted Information Resource
#10
Randy, in your experience, are QMS audit times normally determined solely based on IAF MD 5 Annex A Table QMS 1 or are there frequently adjustments made based on risk, complexity, system maturity, repetitive processes, etc.?
 
Thread starter Similar threads Forum Replies Date
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 1
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
lanley liao How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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
F Logistics and IT clauses in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Gun46 ISO 9001 : 2015 Lead Auditor Exam General Auditing Discussions 16
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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
I ISO-9001:2015 and "Relevant Parties" Management Review Meetings and related Processes 2
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
qualprod Why new clause (7.1.6) in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V ISO 9001:2015 7.2 Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
A Process Documentation for ISO 9001:2015 Internal Auditing 2
C Migrate ISO 9001:2015 Certificate Registrars and Notified Bodies 4
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14

Similar threads

Top Bottom