According to my understanding the auditors should be independent and a rotation system should be in place.
The Swiss State Secretariat for Economic Affairs, SECO (accreditation body) confirms that only in EN 9104:2013 / EN 9100, EN9110 and EN 9120, certification companies are obliged under chapter 8.3.8 to change auditors after 2 consecutively certification cycles.
For ISO 9001, there is no obligation to change an auditor after he or she has conducted the audit in the same company 2 or more times.
The negative impact in terms of quality is obvious.
The question for me is why ISO has not stipulated rotation rules for auditors in ISO 9001?
Any clue?
Subject: Batch Record Review, Deviations and Change Control, CAPA Corrective and Preventive Action, Deviation & Document Transfer
Any advice as the Pharma company is going through "SHUTDOWN", they are closing the site. What are the most important things one have to take into considerations primarily?
Would appreciate greatly if you could have some lines. Any link, document or knowledge would be highly appreciable. Thanks in advance
Best regards to you
Saima
Unfortunately I have no additional information.
Beste regards
Beat
In response to your question, I offer the following:
"ISO makes standards and does not get involved in the certification business." This is the "standard" response to your question.
I agree that there should be rotation of auditors because after the same auditor continually performs audits on the same auditee, the auditor will become overly familiar to the Management System that he/she audits and most likely will not be able to add much value to the organization audited, or worse, act more as a "consultant." Also too much familiarity between the auditor and auditee and their Management System may cause a less effective audit result.
Also, to my knowledge the IAF has not imposed any specific rules or restrictions either.
Regards,
john F. Mascaro, Fellow
ASQ Audit Division
Vice Chair - Technology
It is really the responsibility of the certification bodies to take care of these ethical and coral elements of auditing and composition of the aufit teams. What the mantioned standards requires, and why it is not in practice, may be to ask the accreditation bodies and the policies of the certification bodies themselves. In the end, the market knows who is who. If a certified organisation only wants a picture on the wall, not the real improvements to their management systems with standard implementaions, which they basically are used for, then they don't care who audit them, and are more likely to rejoice the witness by the known autiror, as you declare.
Personally, I think that if the auditgs practices continue with bad tendencies, the certification bodies, or at least some, cut the branch they are sitting on and that will be very vengeful to them, anytime.
Vladimir Simic
Beat Schlumpf:
In Switzerland, companies conducting audits use the same auditors for years in the same companies. It is a win-win situation for the certification company (for example same routine over years = less expenses) and for the Company itself (same auditor = high fulfilment rate)
According to my understanding the auditors should be independent and a rotation system should be in place.
The Swiss State Secretariat for Economic Affairs, SECO (accreditation body) confirms that only in EN 9104:2013 / EN 9100, EN9110 and EN 9120, certification companies are obliged under chapter 8.3.8 to change auditors after 2 consecutively certification cycles.
For ISO 9001, there is no obligation to change an auditor after he or she has conducted the audit in the same company 2 or more times.
The negative impact in terms of quality is obvious.
The question for me is why ISO has not stipulated rotation rules for auditors in ISO 9001?
Any clue?
Though the standard does not require it you can request a different auditor. I do believe there should be a rotation to maintain the integrity of the Audit. As for now it is up to us in management to request and ensure there is a rotation.