Question for those who have completed Transition Audit for ISO 9001

S

Sigvadr

#1
Hello everyone :bigwave: !!

I have a question for those who have already completed their transition audit for the 2015 standard. When being audited what were the differences in which leadership was handled by your registrar auditor?

Where VP's, CFO, ect. all audited if they where available? I am currently contracted to help a company transition from 2008 to 2015 and all top management are off campus.

I am unsure as to how much the project/facility manager should understand of the quality system in regards to the 2015 changes. He is very green on even the 2008 standard and new to the position, I have been asked to give him a crash course on quality management as they haven't had a QA manager for a little over a year. I had planned to give everyone an updated crash course near the end of my transition for them. I am just unsure as to how focused other auditors have been on leadership/management.

Any other new activities or areas of interest registrar auditors have been focusing on that you have noticed compared to 2008 standard audits would also be very helpful if you have any.

I appreciate you reading this and thank anyone in advance for any response given.

Kind regards! :bonk:
 
Elsmar Forum Sponsor
T

Tyler C

#3
Hi Sigvadr. I have not been through the transition yet, so I don't know how registrars are acting during the transition. So this is just based on the standard itself.

In the 2015 version, they have removed the requirement for a Management Representative, and instead allowed companies to put this responsibility on all of top management. However, it is not a requirement to get rid of the Management Rep.

So, I think it depends. If the company you are working with has a Management Rep, then I don't think there will be much focus on top management, so long as you can provide evidence that the Management Rep is meeting all requirements of section 5 of the standard. If there is no Management Rep, then yes, I think top management would need to be present.

I also feel there will be a lot of focus on how companies have sufficiently met requirements of Risk-Based Thinking and Organizational Knowledge (the two biggest changes from 2008 to 2015).

I hope this helps, and good luck with the transition.
 
#4
I don't know about all certification bodies, but the ones I have encountered have several questions in their workbook for the auditors to ask the leadership group. It is assumed that leadership is a group, not an individual most of the time so it is expected that most of the time a group will be interviewed, not an individual.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
#5
Hello everyone :bigwave: !!

I have a question for those who have already completed their transition audit for the 2015 standard. When being audited what were the differences in which leadership was handled by your registrar auditor?

Where VP's, CFO, ect. all audited if they where available? I am currently contracted to help a company transition from 2008 to 2015 and all top management are off campus.

I am unsure as to how much the project/facility manager should understand of the quality system in regards to the 2015 changes. He is very green on even the 2008 standard and new to the position, I have been asked to give him a crash course on quality management as they haven't had a QA manager for a little over a year. I had planned to give everyone an updated crash course near the end of my transition for them. I am just unsure as to how focused other auditors have been on leadership/management.

Any other new activities or areas of interest registrar auditors have been focusing on that you have noticed compared to 2008 standard audits would also be very helpful if you have any.

I appreciate you reading this and thank anyone in advance for any response given.

Kind regards! :bonk:
What I have done is have a Teleconference with the Management that are offsite, out-of-state and so forth.

If you are able to provide this, I feel that it would be sufficient. Just my opinion.
 
#6
Hello,

We split our transition into 2 visits by our registrar. The first was last month and the auditor spent a substantial amount of time with our President and Vice President. His questions were all related to the new requirements, strategic direction, context of organization, interested parties, risk and opportunities, etc. As well as old requirements, quality policy, objectives, etc. We held meetings with our P and VP to help establish the new requirements and also refreshed them prior to the audit, so they were both well versed when asked questions about their responsibilities...:rolleyes:
 
A

anders.kemper

#7
We had our transision in April (I have some minors to fix). But focus was on strategic planing as markmets wtites. My CEO was not at site this time and it was not a problem ( I didn't like it). Before the transision the CEO was involved together with top management in the strategic planing.


Skickat från min iPhone med Tapatalk
 

Crusader

Trusted Information Resource
#8
We are a very small company so pretty much everyone was audited. The focus was on leadership and those with that authority though!
 
Thread starter Similar threads Forum Replies Date
M Cleanroom Question Manufacturing and Related Processes 6
T Aircraft GAPP Software Testing Compliance Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
sonflowerinwales Quick question M3 screw plug gauge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
M An interesting question about import company Other Medical Device Regulations World-Wide 5
Sam.F Question about training Training - Internal, External, Online and Distance Learning 17
B Labeling question about different manufacturers on a single label Manufacturing and Related Processes 4
J Question regarding classification of custom made device EU Medical Device Regulations 5
Sam.F Question about granite surface plates out of spec AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
B GD&T Question, True Position Confusion Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
D Initial Importer question Other US Medical Device Regulations 1
Ed Panek Calibration question Manufacturing and Related Processes 4
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
sonflowerinwales Metric or Imperial; that is the question... After Work and Weekend Discussion Topics 6
M Can someone help me with this CMM programming question? Manufacturing and Related Processes 2
A A strange question about predicate device selected in 510(k) submission Medical Device and FDA Regulations and Standards News 8
S Question regarding AQL - ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
JoeRandom11 Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485: 2016 Lot numbering question ISO 13485:2016 - Medical Device Quality Management Systems 4
S Nadcap - Heat Treatment Proof of Verification question for Digital results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
JoeRandom11 Question of Calibration Cycles AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
B 8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
C Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Question regarding PCR workstation Fume Hood upon first use ISO 13485:2016 - Medical Device Quality Management Systems 0
Moncia ISO 9001 calibration question please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Quality Specialist Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
D ISO 13485--Question regarding performing calibrations in house. ISO 13485:2016 - Medical Device Quality Management Systems 13
S Document numbering question? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Has the facility been inspected? question in Certificate to Foreign Government application Other US Medical Device Regulations 0
M ESTAR 510(k) submission question Medical Device and FDA Regulations and Standards News 0
J Question on clause 5.2.2 IEC 62304 - Medical Device Software Life Cycle Processes 2
Ed Panek ISO 15223 Question EU Medical Device Regulations 2
R Question: Cg/Cgk formula Capability, Accuracy and Stability - Processes, Machines, etc. 2
J Quick question on responsible person's experience requirements UK Medical Device Regulations 3
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Question regarding "Customer Property" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
T Noob question regarding sample size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K 510(k) Manufacturer question (private label and manufacture under another persons 510(k)) US Food and Drug Administration (FDA) 1
M Question About Rolled Throughput Yield Manufacturing and Related Processes 5
M Quick Gage R&R Question Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
S Question: Best alternatives to audits for ensuring compliance Quality Tools, Improvement and Analysis 5
Ed Panek Question from 13485 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 2
C Question on KAFO (Knee Ankle Foot Orthosis device) classification CE Marking (Conformité Européene) / CB Scheme 0
T BMW GS 93010-2 Question Various Other Specifications, Standards, and related Requirements 1
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
Ron Rompen Question regarding CMM probe damage General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom