Stage 2 audit initial cert, few data points

#1
Hello,

I'm helping a new start up company of 4 employees with ISO 13485: 2016 and they passed stage 1 audit, with stage 2 coming up. No major findings during stage 1.

The procedures are fully in place but many of the processes still do not have actual data because there were few sales. For example, no complaint, no feedback, no trend to track, no CAPA opened, two QO were opened but no data to track, a couple of complete sales records. The reason is the company is a virtual manufacturer, with design and production outsourced to the CMO. Would stage 2 audit have a problem with many processes without actual data or usage only procedure?

The reality is the company is really young and has generated very few sales. They do have complete supplier audit of CMO with many related records such as complaint obtained from the CMO during supplier audit.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Wasn’t that aspect discussed during the stage 1 audit? Readiness to proceed to stage 2 is one of the main objectives of stage 1 and the auditor should have made the conclusion very clear.

From the ISO Paper on the two stages approach:

evaluating if internal audits and management reviews are being planned and performed, and whether the level of implementation of the management system substantiates that the client is ready for the stage 2 audit.
 
#3
Let me break this down:

Wasn’t that aspect discussed during the stage 1 audit? Readiness to proceed to stage 2 is one of the main objectives of stage 1 and the auditor should have made the conclusion very clear.
Stage 1 passed with few recommendations to fix procedures and QMS was deemed ready to proceed to stage 2. This is with BSI btw.

evaluating if internal audits and management reviews are being planned and performed, and whether the level of implementation of the management system substantiates that the client is ready for the stage 2 audit.
big items such as internal audit, CMO audit, management review were done, have quality agreement with CMO, all SOP fully in place. So there was no reason for stage 1 audit to not recommend to go to stage 2. But my question which didn’t get answered is some procedures and process such as complaint handling, have not been utilized yet since company have not received any complaint therefore for stage 2 there is no real world data to see. Will this be a problem? The reason is there are few sales for this company so the QMS is fully in place but not being utilized in some process yet. This is the case for several processes such as CAPA and others I mentioned. So I feel this can be subjective based on each auditor. Maybe we can show CMO data for some of these areas.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
So I feel this can be subjective based on each auditor.
Yes, some lenient auditors might not be bothered with lack of verifiable evidence before they issue a recommendation for certification. And, I repeat, the readiness/timing for the stage 2 audit should have been the MOST critical aspect of the stage 1 audit. If the auditor in question does not seem to have a problem with the lack of verifiable evidence for some of the processes, you will just collect a number of opinions here, while the only one that really counts is the one from the individual who will have to go on the record, recommending the system to be certified.
 
#5
This is a question best answered by the certification body itself. There seems to be a wide varience from one CB to another as to what is sufficient. Some are happy with two or three months of data and some want more. Don't forget that for a while the IAQG insisted on 12 months of data for AS9100. There seems to be some latitude for individual circumstances too.
 
Thread starter Similar threads Forum Replies Date
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
Jacquie Collins Stage 2 Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
A A purpose of a Stage 1 audit - Off site document review Registrars and Notified Bodies 3
W Closing of Stage 2 Audit Nonconformances AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E Interesting Discussion Was this the fastest ever stage 2 ISO9001:2015 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
Q Stage 1 audit observations - documented report? General Auditing Discussions 5
K AS9100 - No NCR's or CA's during Stage 2 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S We had our Stage 2 Audit on 2/19 & 2/20.... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J Major Nonconformance on Stage 2 Audit causes to start over Stage 1? IATF 16949 - Automotive Quality Systems Standard 2
N AS9110 Audit Stage 2 - What procedures are required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Root Cause - Left 5.6.2 paragraph (f) out of Quality Manual during Stage 1 Audit Nonconformance and Corrective Action 21
M What to do during a Stage 1 External Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S Is a Stage 1 Audit required for ISO 50001 Certification? Sustainability, Green Initiatives and Ecology 1
B Certification Body insist on evidence of Preventive Action during Stage 2 audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Implementing an AS9100 Quality System - Stage 1 Audit for AS9100 is Oct 2012 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
D ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 8
K Internal Audits - Necessary before Stage 1 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
J Waiting for an Auditor after our AS9100 Stage Two Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
C Contract Manufacturer and Stage 2 Audit for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
K Stage 1 Audit Advice for a new Lead Auditor General Auditing Discussions 5
L Is a Gauge R&R Study needed for ISO 9001 Stage 1 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J AS9100 Rev.B Registrar Audit Plan for Stage 2 Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Questions that auditor may ask during the certification or 2nd stage audit. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
P Peer Review prior to Stage 2 Audit - Acceptable or Not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
P NC from TS16949 stage 2 audit - Internal Auditing - Auditor did not record evidence General Auditing Discussions 15
T ISO 22000 Stage 1 Audit Completed Successfully Other ISO and International Standards and European Regulations 4
J What to expect during Stage 1 and Stage 2 audits - Certification Audit ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Is it Compulsory to complete Management Review before Stage 1 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
Anerol C Stage 1 Audit for ISO 9001 and Notifying/Preparing Employees General Auditing Discussions 27
D At what stage should we proceed with manufacturing process audit? General Auditing Discussions 6
D What is the TS 16949 Stage 1 Audit Requirement on Internal Audit? Internal Auditing 16
W TS 16949 Audit - Examples of Major & Minor NC's and Observations for Stage 1&2 audit. IATF 16949 - Automotive Quality Systems Standard 11
M ISO/TS 16949 Stage 2 Audit Tips General Auditing Discussions 4
M Readiness Review Failed - Stage one audit for TS16949 IATF 16949 - Automotive Quality Systems Standard 7
L We succeeded in our stage 1 audit this afternoon! IATF 16949 - Automotive Quality Systems Standard 2
S TS 16949 Stage 2 Audit Preparedness - Need Advice General Auditing Discussions 5
A Non-conformance logged following a TS16949 Stage 2 audit - APQP Control Plan IATF 16949 - Automotive Quality Systems Standard 15
L Stage One Audit vs. Document Review - TS16949 - Need clarification IATF 16949 - Automotive Quality Systems Standard 5
P TS 16949 Audit - Stage 1 passed! IATF 16949 - Automotive Quality Systems Standard 29
B Stage 1 - Adequacy Audit (pre-assessment) - University - What do they look for? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S We just Passed our ISO 14001 Stage 2 Audit! Miscellaneous Environmental Standards and EMS Related Discussions 17
somashekar Justification for Non-applicable clause at Stage 2, in clause 4. ISO 13485:2016 - Medical Device Quality Management Systems 11
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
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
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11

Similar threads

Top Bottom