Number Of Surveillance Audit Days For Remote Sites

C

CHRISKOCAJ

#1
MY REGISTRAR TELLS ME THAT IATF HAS NEW GUIDELINES FOR THE NUMBER OF AUDIT DAYS/FREQUENCY FOR REMOTE SITES, SUCH THAT EACH REMOTE SITE MUST BE SURV. AUDITED EVERY 6 MONTHS DURING THE NORMAL 3 YR CERTIFICATION CYCLE. I CANNOT FIND THESE GUIDELINES. HELP!:confused: :confused:
 
Elsmar Forum Sponsor
J

JaySturgeon

#2
Chris

So have the reigstrar support what they are saying in writing

If it's in black and white they should have a copy they can send you.

Good luck.:truce:
 
J

JaySturgeon

#4
Which Standard

Chris

IF YOU LOOK AT THE QS-900 THIRD ED. APPENDIX H PG. 108 IT SHOULD CLARIFY SOME THINGS FOR YOU.

We are in the process of transition to TS-16949 and I assume it is the same.

The minimum number of audit days is listed.

Tom makes a good point. I assumed that your remote cite was listed on the cert based on the wording of your question, but, of course I could be wrong.

Jay
 
T

tomvehoski

#5
It should all be spelled out in this document: ISO/TS 16949:2002 Automotive Certification Scheme - Rules for Achieving IATF Recognition, 1st edition for ISO/TS 16949:2002

You can purchase from AIAG. I can't find my copy right now - probably buried in the back of the car. I'll see if I can dig it up and post some more info.

Tom
 
C

CHRISKOCAJ

#6
REMOTE SITE AUDIT DAYS

I RECEIVED A CLARIFICATION TODAY. EACH REMOTE SITE MUST BE SURV. AUDITED AT LEAST ONCE PER EVERY 12 MONTHS. SO IF THE SITE CALCULATES OUT TO 6 TOTAL SURVEILLANCE AUDIT DAYS, IT CAN BE SURV AUDITED ONCE / 12 MONTHS FOR 6 DAYS OR TWICE PER YEAR (EVERY 6 MONTHS) FOR 3 SURV AUDIT DAYS.

THIS IS SUPPOSEDLY IN THE CERT RULE SCHEME DOC, BUT IMHO, NOT VERY CLEAR.
 
T

tomvehoski

#7
If the site is big enough for you to require at least 2 days per year they will probably make you go the six month route. I prefer this myself since it does not allow you to let things slide for 11 months. About the only time registrars let us do annual any more is if it is a small company and they only need 1 day per year. They don't like to split auditors into 1/2 days.

Tom
 
Thread starter Similar threads Forum Replies Date
D Number of Audit Days for AS9100C Surveillance Audit (20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
G Attribute Gage R&R - Number of Samples - OFI during our TS-16949 surveillance audit Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
L Average number of Nonconformances during a surveillance assessment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
D Determining the the maximum number of reprocessing cycles of attachments CE Marking (Conformité Européene) / CB Scheme 2
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
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
Q How is Medical Device Number (MDL) assigned to companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 9
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
I Number of decimals in equation calculated by MiniTab Using Minitab Software 0
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
G Belgium - How do I get an enterprise CBE Number Other Medical Device Regulations World-Wide 0
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
S How to number and control translated SOPs - Three languages Document Control Systems, Procedures, Forms and Templates 4
qualprod Calculate number of people in processes, considering cycle time/takt time = quantity of people Lean in Manufacturing and Service Industries 9
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
J DoE - Number of runs in Plackett-Burman (Minitab) Using Minitab Software 2
G Heat Number on CofC - Stainless steel tube Manufacturing and Related Processes 2
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
qualprod What tier number fits in a company producing paper labels stuck on automotive parts? IATF 16949 - Automotive Quality Systems Standard 7
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
J Question on very low NDC number with tolerable GRR ratio's Capability, Accuracy and Stability - Processes, Machines, etc. 7
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
D IMDS for machining - Can my customer request a IMDS number for a part? APQP and PPAP 2
shimonv GTIN Number on the Packaging of a Serviced Medical Device EU Medical Device Regulations 0
W Is the RPN (risk priority number) in the PFMEA really a RPN without the detectability ISO 14971 - Medical Device Risk Management 4
M How to count the number of employees? Other Medical Device and Orthopedic Related Topics 4
bobdoering "nds" or Number of Discriminate Samples - the Necessary Tool to Work With "ndc"! Imported Legacy Blogs 0
H FDA product code and regulation number Other US Medical Device Regulations 3
P FDA's DRLM (Device Registration & Listing Module) Listing Number Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
Sidney Vianna High number of certificate suspensions in the IAQG OASIS database AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
J GLP Animal Study - Change number of treatment sites Other US Medical Device Regulations 2
S My department inherited a large number CAPAs ISO 13485:2016 - Medical Device Quality Management Systems 4
R Remote Support - Calculating Number of Employees IATF 16949 - Automotive Quality Systems Standard 2
I Number of HEPA filter in a room US Food and Drug Administration (FDA) 3
Mikey324 GR&R - Little to no part to part variation in single part number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14

Similar threads

Top Bottom