SBS - The best value in QMS software

What determines the frequency of third party (registrar) audits?

R

RosieA

#11
#11
I'd like to resurrect this discussion based on all the downsizing that is currently going on...

When we were certified in 1995, we had twice the number of heads than we currently do.

Should the current recert audit be based on the original audit, or on the size of the organization as it is today? I have 4 man days scheduled for a recert on a company with 159 people. Does that seem like a lot?
 
Elsmar Forum Sponsor
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#12
#12
RosieA said:
Should the current recert audit be based on the original audit, or on the size of the organization as it is today?
Click to expand...
The determination of the audit-days should be based on the estimated headcount at the time of the audit.
RosieA said:
I have 4 man days scheduled for a recert on a company with 159 people. Does that seem like a lot?
Click to expand...
Not really. As mentioned numerous times, the IAF MD5 document is freely available. That is the document most CB's should be using. That document states:

RECERTIFICATION​
6.1 The duration of the recertification audit should be calculated on the basis of the updated information of the client and is normally approximately 2/3 of the time that would be required for
an initial certification audit (Stage 1 + Stage 2) of the organization if such an initial audit were to be carried out at the time of recertification (i.e. not 2/3 of the original initial certification audit duration). The audit duration shall take account the outcome of the review of system performance (ISO/IEC 17021 cl. 9.4.1.2). ​
​
​
​
​
Click to expand...
In your case, with 159 employees, the STARTING POINT (for initial audit) would be 8 audit days. 2/3 of that would be approximately 5.5 audit days. So, it looks like your CB is giving you some allowance, for system performance, or another reason and has reduced the number of audit days for your re-certification audit.​
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Logic that determines what production testing is needed ISO 13485:2016 - Medical Device Quality Management Systems 2
D AS9100 - Who Determines What This Applies To In My Facility? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M What determines a Critical Subcontractor? Other ISO and International Standards and European Regulations 5
J What determines the contents of an FMEA (Failure Modes and Effects Analysis)? FMEA and Control Plans 12
R Procedure style determines motive? Document Control Systems, Procedures, Forms and Templates 8
M Bioburden Frequency (sterile MD) Other Medical Device Related Standards 2
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
L Calibration Frequency for Surftest SJ-400 General Measurement Device and Calibration Topics 0
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
H Frequency of shelf life/sterilization/bench studies conducted on a medical device Other Medical Device Related Standards 1
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
M Leakage current measurement with non-frequency-weighted device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Requirements for Interval Measurement test & Frequency Response test clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 1
bobdoering SPC Charting frequency calculator for X hi/lo chart Imported Legacy Blogs 0
D IATF 16949 surveillance audit frequency IATF 16949 - Automotive Quality Systems Standard 16
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
J 95% reliability for calibration frequency Calibration Frequency (Interval) 7
R Internal Audit Frequency - Remote Site (a Design Center) IATF 16949 - Automotive Quality Systems Standard 3
V Periodic Audit Trail Review - Scope, Content & Frequency Qualification and Validation (including 21 CFR Part 11) 10
JoCam Required Frequency of Notified Body reviews of Technical Files EU Medical Device Regulations 6
Q AMS 2750E System Accuracy Test (SAT) Frequency AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B MHRA Unannounced Audits Frequency Changed? EU Medical Device Regulations 2
P IATF 16949 - Internal Audit Frequency Requirements Internal Auditing 2
P Frequency and Sample Size Requirements for an MSA Studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Q Objective and Goals - ISO 9001:2008 Frequency Revision Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q RFID (radio frequency identification) registration for Medical Device Other Medical Device Regulations World-Wide 6
G Sequence and Frequency of Calibration for Thread Gauges General Measurement Device and Calibration Topics 2
N Tool frequency change - Data Analysis needed Statistical Analysis Tools, Techniques and SPC 9
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
Y FDA's Inspection Frequency for Foreign Manufacturer Other US Medical Device Regulations 1
R TS 16949 Process Re-Validation Frequency Requirements IATF 16949 - Automotive Quality Systems Standard 3
Marc Calibration Frequency (Interval) Discussions Sub-Forum General Measurement Device and Calibration Topics 0
kedarg6500 Could I have a recalibration frequency of +/- 15 days ? Calibration Frequency (Interval) 23
J Appropriate In-Process Monitoring Frequency for 2X per day Change Set-Up. Statistical Analysis Tools, Techniques and SPC 3
S Recertification Frequency for TS 16949 Lead Auditors General Auditing Discussions 4
Gman2 Frequency of Internal Audits per TS 16949 Requirements IATF 16949 - Automotive Quality Systems Standard 12
J Digital Scale Re-Calibration Interval Frequency General Measurement Device and Calibration Topics 10
M A Guide or Standard for Calibration Interval (Frequency) Calibration Frequency (Interval) 2
P Frequency of Bioburden Testing EU Medical Device Regulations 3
smryan Weight Calibration Standards - External Calibration Frequency General Measurement Device and Calibration Topics 11
G UID Compliance Verifier Calibration Test Card Calibration Frequency General Measurement Device and Calibration Topics 3
R Why is 10 MHz cited as the reference frequency? Measurement Uncertainty (MU) 2

Similar threads

Top Bottom