Rules to respect when changing from Certification Body

F

Filip M.

#1
#1
Dear,

we have different plants in China that are certified accordingly different standards eg.: ISO 9001, ISO 14001, ISO/TS, …

What are the rules defined by CNCA that must be respected when we change from our current certification body to another ? Can we change immediately ? What must we do ? What must be done by the current certification body ? What must be done by the new certification body ?.

As for this moment, we also have two group certificates, one for China and one for the rest of the world. Can we go for “one” group certificate that comprehend all our plants or are there also regulations that restrict that ? Please can you clarify this also.

Has someone experience whith those issues and can clarify ?

Thanks in advance for a reply.

Best regards,

Filip
 
Paper to QMS ad
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
#2
There are some CB folks here who can better answer than I can, but essentially you have to establish a relationship/contract with the new CB. They will tell you what you need to do to get certs "transferred". Usually it entails the new CB doing a complete audit and if everything goes well they will issue a new certificate, but changing CB's isn't "immediate". You will probably have a time of overlap with the old CB and the new CB so your old certificates should be valid during the transition unless you terminate your contract with your old CB before the new CB does its audit(s) and issues you their certificate(s).
 
F

Filip M.

#3
#3
Hi Marc, thanks already for the information.

Nevertheless, I hope that someone or somebody of the mentioned CB folks can give us an answer on the CNCA (Chine) topic; See also start of this thread. For us it's totaly not clear what the rules are defined by CNCA.

By the way, assume that we terminate alreeady our contract with our current body before the new CB performed audits. What will happens with our cerificates, are they still valid or will our certificates withdrawn even they have an expiration date eg.: 2018.03.01
 
R

radame

Starting to get Involved
#4
#4
Hello

Antecedent
I have an issue as my actual CB performed the IATF transition (Stage 1 and 2) audit but after two weeks of the audit they told us the audit was not valid due the reason we are out of the date indicated in the IATF rules:

"...- If the next regularly scheduled audit was to be a recertification audit, the allowable timing for this transition audit shall meet the recertification timing requirements for recertification audits according to the IATF Rules, section 5.1.1 (-3 months / +0 days). The transition audit can be performed earlier than -3 months without requesting a waiver from the relevant IATF Oversight Office. In situations where the timing (+0 days) cannot be met, the certification body shall start over with an initial certification audit with the following approved deviation: ..."

We were delay by 3 days (last day of audit), but the root cause was the CB as they changed us the date at last minute under the excuse some of the auditors were not available, then on Monday next week they delay again one more day and they never told us we will be out of the deadline to perform the transition.

I escalated this to the Oversight office but I got no answer from them...

Now the only option CB offer us is to perform another audit , stage 2 (at no cost but only the auditor expenses, travel, etc) with 4 auditors (original audit were only 2).

Actual situation
We want to get rid of this CB but a new CB implicates more time and expense to my company and we are in a hurry to get the new IATF certificate, so there will be no other option but to accept the offer and reschedule another audit with the actual CB as we can not waste more time to get our certificate.

If we accept the offer from the actual CB I know we are stick to them for the surveillance audits until the next 3 years for re-certification.

The question
Is there any possibility we can change the CB after the transition audit based on the issue we had documented on the problems they caused to us?? or do we need to live with them until the next re-certification?

Any help on this will be appreciated

Thanks
 
qualprod

qualprod

Trusted Information Resource
#5
#5
Contact your new CB, they Will help You to make the changes
recently I was with one CB in the transition, but didn't want to continue with them, we contacted our new CB and they guided us properly, don't worry they will help you
Hope this helps
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
O Release of Sanctioned Interpretations (SIs) related to Rules 5th Edition and Sanctioned Interpretations related to IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 0
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 9
M Indian Medical Device Rules --Manufacturing and Whole sale Lic. Required ? Other Medical Device Regulations World-Wide 0
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Drugs and Cosmetics Rules - India Other Medical Device Regulations World-Wide 0
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
M Informational TGA – Advertising health products: Rules about safety claims in advertising Medical Device and FDA Regulations and Standards News 0
D Volkswagen Complaints Management Rules Customer and Company Specific Requirements 0
M Informational US FSA – Surgical staples – Guidance and proposed rules Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
M Why have IATF rules required the CBs to audit remote supporting functions at first? IATF 16949 - Automotive Quality Systems Standard 11
T Informational Family or Baseline PFMEA Rules FMEA and Control Plans 22
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
M Medical Device News FDA Withdrawals Two Proposed Rules Other US Medical Device Regulations 0
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C What are rules to notify customers if IATF cert is put on hold? IATF 16949 - Automotive Quality Systems Standard 2
L What are the rules on significance of digits in numbers in IEC/ISO standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Rules associated with introducing new QMS processes IATF 16949 - Automotive Quality Systems Standard 1
R IATF 16949 certification rules IATF 16949 - Automotive Quality Systems Standard 5
K Rules or guidelines for quoting FDA announcements and such? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M INDIA - GSR 78 (E) - New Medical Device Rules - 2017 Other Medical Device Regulations World-Wide 6
L Hypothesis Testing + Thumb Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
L Percentage Thumb Rules for Quality Costs Misc. Quality Assurance and Business Systems Related Topics 1
A EASA Easy Access Rules for Continuing Airworthiness - June 2017 EASA and JAA Aviation Standards and Requirements 0
Sidney Vianna IATF 16949 Areas of Impact - Rules 5th Edition Document (February 2017) IATF 16949 - Automotive Quality Systems Standard 0
Uriel Alejandro Including "Internal Rules" as Controlled Documents in a QMS Document Control Systems, Procedures, Forms and Templates 7
Marc Rules for Posting in the Paid Consulting, Training and Services Forum Paid Consulting, Training and Services 3
M I am looking for the text of the copyright 'rules' for AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Anerol C IATF or ISO TS 16949 rules about Scope of QMS IATF 16949 - Automotive Quality Systems Standard 7
Crimpshrine13 Rules of achieving and maintaining IATF recognition - Determining audit days IATF 16949 - Automotive Quality Systems Standard 2
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
A PUWER (Provision and Use of Work Equipment Regulations) and old machines (UK rules) Occupational Health & Safety Management Standards 4
M Translating and Rotating Rules when programming or measuring with a CMM Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Are there specific rules regarding ISO 13485 and R&D? ISO 13485:2016 - Medical Device Quality Management Systems 4
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4
M ISO/TS 16949 Rules about Commodities IATF 16949 - Automotive Quality Systems Standard 4
N IATF Appeals on ISO/TS16949 Rules - 4th Ed. - Removal of Site Extensions IATF 16949 - Automotive Quality Systems Standard 2
M Scope content of TS 16949 certificate under Rules 4 IATF 16949 - Automotive Quality Systems Standard 6
L IMDS Overcheck Rules RoHS, REACH, ELV, IMDS and Restricted Substances 9
A Attribute Sampling Plans with Switching Rules - Software Recommendations Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Suspension Status - Rules 4th Edition IATF 16949 - Automotive Quality Systems Standard 5
J Audit days calculator based on Rules 4th IATF 16949 - Automotive Quality Systems Standard 2
R Long Range OC Curves - Acceptance Sampling Switching Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
D Japan Rules for Marketing Authorization Holders Japan Medical Device Regulations 1

Similar threads

Top Bottom