Reasons to change certification body and typical costs

TPMB4

Quite Involved in Discussions
#1
Two questions so I'll start with the last one.

What's a typical fee for an auditor to certify to iso 9001: 2015? Based on size, number of sites and complexity in sure. But say 50 employees, one site and low to average level of complexity for an automotive manufacturer (2nd/3rd tier). Is there any difference in fees should you change auditor or will they just charge the same sort of fees as a full recertification cyclem? We're currently on a 3 year cycle of one 2 day recertification and two 1 day surveillance audits.

What reasons are valid to change auditor? We feel we're not getting value from our auditor. It doesn't feel like an improvement process more a box tick to keep our automotive work. Whilst I still stress about it because I want our system to improve it really only comes up with 30 minute corrective actions if any at all. Last surveillance had 2 OFIs that only one is remotely valid and worth pursuing.

Basically I guess I'm talking about pain to change. What's your view? Will it cost as much as a new certification to change? What's the implications? The certificate after change will have a very recent date, any implications on that?

We've had certification from the start up of the business so it's been a selling point in some ways. Instils trust I think. Could this be lost? Any implications? Do they get outweighed by the benefits of a good auditor improving your system?
 
Elsmar Forum Sponsor

JoshuaFroud

Involved In Discussions
#2
Can I just confirm before anyone answers any further, by change auditor do you mean the individual auditor as a person or the auditing agency? Thanks.
 

Randy

Super Moderator
#3
Remember, the CB's are trying to make money. It's a business and everything is done by contract, not on a whim.

What you're charged shouldn't change from what you're under contract to pay.

You can request at any time that an auditor not be sent back and is not welcome at your facility.
 

JoshuaFroud

Involved In Discussions
#5
To change Notified Body is a very similar status to getting accredited in the first place. There is likely to be a stage 1 and stage 2 assessment.

The rates are usually charged at a day rate for the auditor which is likely to be similar to what you currently pay, however different NB will charge different amounts. For example in the UK, Lloyds Register is known to be cheaper than BSI.

As for a valid reason, you do not need one. You pay them to do a role, if they are not doing it then change. Do be aware there will be an increased cost in moving to a new NB over continuing with your current body due to the increased man-hours to administer the transition.
 

Mark Meer

Trusted Information Resource
#6
Personally, if you're goal is to maintain certification, unless:
(a) your CB is making bad calls (you have to continually dispute);​
(b) their auditors are unprofessional;​
(c) they are unresponsive / have poor customer service; or​
(d) they are overcharging (other CBs offer more competitive quotes)​
then I wouldn't consider switching.

Don't expect the certification process to necessarily drive improvement - your CB offers a certification service.
Focus on your own internal audit processes for improvement instead.
 
#7
Two questions so I'll start with the last one.

What's a typical fee for an auditor to certify to iso 9001: 2015? Based on size, number of sites and complexity in sure. But say 50 employees, one site and low to average level of complexity for an automotive manufacturer (2nd/3rd tier). Is there any difference in fees should you change auditor or will they just charge the same sort of fees as a full recertification cyclem? We're currently on a 3 year cycle of one 2 day recertification and two 1 day surveillance audits.

What reasons are valid to change auditor? We feel we're not getting value from our auditor. It doesn't feel like an improvement process more a box tick to keep our automotive work. Whilst I still stress about it because I want our system to improve it really only comes up with 30 minute corrective actions if any at all. Last surveillance had 2 OFIs that only one is remotely valid and worth pursuing.

Basically I guess I'm talking about pain to change. What's your view? Will it cost as much as a new certification to change? What's the implications? The certificate after change will have a very recent date, any implications on that?

We've had certification from the start up of the business so it's been a selling point in some ways. Instils trust I think. Could this be lost? Any implications? Do they get outweighed by the benefits of a good auditor improving your system?
I didn't see any actual replies to your questions, so I'll offer the following:

Go to www.IAF.nu and look for "MD-5" under the publications tab. On page 12 (IIRC) there's a table of headcount and duration of audits (stage 1 plus stage 2) Stage 1 is usually 1 day on site, so the remainder is for the stage 2.

The cost/audit day is averaging at $1300(for ISO 9001 audits). Fees will vary all over the place. Application fees, document fees, corrective actions review fees. BE CAREFUL when getting quotes. READ THE SMALL PRINT. Travel will also be extra - sometimes at cost, other times with additional fees... Changing auditor should be simple. Changing CB should be fairly simple too. If you are currently with an ANAB (or similar IAF body) accredited CB, then changing CBs is straightforward. When I was in business development for a top 5 CB it was a cake walk. The next audit scheduled can be the one to hand over to the new CB - but it can't happen if you have open (major) ncs for example.

Changing actual auditors is simply a case of calling up and saying "Don't send them back", but you have to do something to avoid it happening again. Some CBs have auditor who are train wrecks in process, but they have no clue and it's clear that the auditor's paperwork isn't being reviewed by anyone who has a clue - otherwise you'd see some improvement.

Be aware though, that ditching an auditor may result in the CB having another one have to travel, so costs may increase. Also, many auditors are contractors and some CBs share auditors! One I knew, in CA, worked for 5 different CBs because of his specialty.
 
#8
To change Notified Body is a very similar status to getting accredited in the first place. There is likely to be a stage 1 and stage 2 assessment.

The rates are usually charged at a day rate for the auditor which is likely to be similar to what you currently pay, however different NB will charge different amounts. For example in the UK, Lloyds Register is known to be cheaper than BSI.

As for a valid reason, you do not need one. You pay them to do a role, if they are not doing it then change. Do be aware there will be an increased cost in moving to a new NB over continuing with your current body due to the increased man-hours to administer the transition.
Be careful not to confuse NB practices with CBs. Were aren't talking about accreditation - just changing an ISO 9001 certificate, so your comments are not exactly accurate - in this case the OP is asking about.
 

JoshuaFroud

Involved In Discussions
#9
Be careful not to confuse NB practices with CBs. Were aren't talking about accreditation - just changing an ISO 9001 certificate, so your comments are not exactly accurate - in this case the OP is asking about.
Fair point, poor choice of words on my part, using accredited when certificated would have been more appropriate.
 

John Broomfield

Staff member
Super Moderator
#10
Review your registrar selection criteria first.

For example:

A. Find out from your customers and prospective customers which registrars or certificates they admire or value the most.
B. Do these registrars provide rigorous auditors or people who make suggestions?
C. Do these registrars and their auditors hold your top management to account (are they respected by TM)?

Criteria like these may result in better value from your registrar.
 
Thread starter Similar threads Forum Replies Date
L Reasons to submit a new PPAP or notify the customer APQP and PPAP 3
L Valid reasons to omit an "ear-tag" type label on a cable? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Common Reasons for Out Of Tolerance condition of DC Calibrator or any reference std General Measurement Device and Calibration Topics 1
C Reasons for Approval Signatures for Records 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
V Monitoring Specific Reasons and Categories of Yield Loss of Online Rejects ISO 13485:2016 - Medical Device Quality Management Systems 1
P 25 Reasons why I owe my mother Funny Stuff - Jokes and Humour 0
K Reasons for Issuing Uncontrolled Documents Document Control Systems, Procedures, Forms and Templates 10
Sidney Vianna Reasons for the Decline of ISO 9001 Registrations in North America (circa 2010) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 142
S Root Cause Analysis Taxonomy - Categorising the reasons for non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Top Three Reasons why TPM (Total Productive Maintenance) Initiatives Fail Manufacturing and Related Processes 39
P Seeking sample Resignation Letter - Health and Relocation reasons Career and Occupation Discussions 3
E What are the main reasons to update data in MDS Sheet? RoHS, REACH, ELV, IMDS and Restricted Substances 4
M Practical Reasons Behind The ISO 13485/QSR Regulations ISO 13485:2016 - Medical Device Quality Management Systems 6
T Reasons for retaining Obsolete Documents and Retention Time Document Control Systems, Procedures, Forms and Templates 13
Q Dock Audit - Reasons to do dimensional checks during product dock audit Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Wes Bucey More reasons to think before clicking on links After Work and Weekend Discussion Topics 12
J Reasons for Implementing ISO 9001 - Findings from a Survey of 326 Businesses The Reading Room 0
N Non UKAS certification bodies - reasons for their avoidance required... Registrars and Notified Bodies 41
Q Top 10 reasons why ASQ is not ISO 9001 registered ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
K Compelling reasons for a certifying agency to withdraw a ISO certificate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Reasons for early termination of an audit? General Auditing Discussions 23
A Reasons to Continue QS-9000 in a Company? QS-9000 - American Automotive Manufacturers Standard 4
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
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 3
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N China - Start manufacturing before change approval? China Medical Device Regulations 1
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
U Change Management vs Change Control? Design and Development of Products and Processes 4
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 1
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
Similar threads


















































Top Bottom