SBS - The best value in QMS software

Acquisition (Merger) of an ISO certified to ISO 9001:2000 company

D

delaneya

#1
Hello All,

I have some questions.

1. We have acquired a business in the UK who is ISO certified to ISO 9001:2000 and they have a survelliance audit scheduled in June. I would like to bring them onto my (US) certificate. My survelliance audit is in October. I am going to have a recert to the 9001:2008 in Sept. 2010. My question is those who have experienced mergers, what is the best, most practical way of bringing them onto a different certification?

2. Will a registrar recertify to an old standard if they know that a company is being merged?

3. The US company is also certified to ISO 13485, would it be beneficial to have all certfications at the same time, meaning bring the UK up on the new standard (9001:2008) and 13485 or do it one step at a time?

Thank you all in advance for your assistance.

--Confused but learning:(
 
Elsmar Forum Sponsor

jkuil

Quite Involved in Discussions
#2
Are the quality systems applied in the US and UK identical and are both locations governed by the same executive management board. If so, you can bring them under one certificate as for ISO you are considered a single organization. You are not required to, you may consider it easier to have separate certificates, but that comes with seprate QS audits by your notified body.

If each location (US and UK), has their own quality system and or management, each organization should maintain their own appropiate QS certification. You can not bring them under one certificate. If the UK business supllies any products, components or services to the US business, the UK business should be added as a significant supplier to your CE annex II full quality assurance certificate (if you have one).

Please consult with your Notified Body and discuss your situation. They will advise you on the best practice under your circumstances.
 
D

davidbrown

#3
If the executive management board after the merger in US & UK are same and quality systems in both countries are identical then you can bring them under one certificate as for ISO purpose you are considered a single organization. If the quality system in US and UK differs then each organization has to maintain their own QS certification.
 
Last edited by a moderator:

normzone

Trusted Information Resource
#4
Two questions:

Isn't the certificate contingent upon the address, or is that urban legend ?

Second, didn't certification to 9001:2000 become impossible a few years after 9001:2008 was released?
 

howste

Thaumaturge
Super Moderator
#5
Two questions:

Isn't the certificate contingent upon the address, or is that urban legend ?

Second, didn't certification to 9001:2000 become impossible a few years after 9001:2008 was released?
A certificate can have multiple addresses listed on it.

9001:2000 certificates are no longer valid, but they would have been in early 2009 at the time of the original post.
 
Thread starter Similar threads Forum Replies Date
D DFARS (Defense Federal Acquisition Regulation Supplement) Raw Material Information Various Other Specifications, Standards, and related Requirements 1
K DFARS (Defense Federal Acquisition Regulations) Certs for a Qualifying Country Various Other Specifications, Standards, and related Requirements 2
P Acquisition of a company that manufactures a PMA device-FDA notification requriements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Steps to Preserve ISO 9001 Certification during Corporate Acquisition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B ISO 9001 Certified Company and acquisition of non-ISO 9001 Certified Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T What actions would the NB require on completion of a Product Acquisition EU Medical Device Regulations 2
K CMM Productivity and Internal Rate of Return (IRR) to justify a new Acquisition Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Q Company acquisition prior to QMS and ISO Audits ISO 13485:2016 - Medical Device Quality Management Systems 1
Q DFARs 252-225-7014 (7008, 7009) (Defense Federal Acquisition Regulation Supplement) Various Other Specifications, Standards, and related Requirements 1
V DFARS (Defense Federal Acquisition Regulation Supplement) Licensing? Bulgaria Various Other Specifications, Standards, and related Requirements 14
N Please recommend data acquisition system for temperature logging General Measurement Device and Calibration Topics 5
A Post Acquisition Integration Stage ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T 510(k) after acquisition of other company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Company Acquisition - What do we need to update with our registrar? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Small Business Set Asides - FAR (Federal Acquisition Regulations) Subpart 19.5 Consultants and Consulting 2
D FMEA as a tool for identifying possible failures in Acquisition / New Start Up FMEA and Control Plans 4
M Company Acquisition with QS-9000 QS-9000 - American Automotive Manufacturers Standard 2
O Need documentation - Designing a data acquisition system for the enviromental chamber Design and Development of Products and Processes 3
Sidney Vianna IATF 16949 News PSA and FCA Merger IATF 16949 - Automotive Quality Systems Standard 0
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
Sidney Vianna Informational TIA (Telecommunications Industry Association) and QuEST Forum Announce Merger TL 9000 Telecommunications Standard and QuEST 0
Ajit Basrur Informational Merger of PAC and APLAC to form the Asia Pacific Accreditation Cooperation (APAC) General Measurement Device and Calibration Topics 0
supadrai Effect of a Merger on Acquired Company's Medical Device Licenses Other Medical Device Regulations World-Wide 2
S What defines Top Management after a Merger? Quality Management Review (9.3.1) Management Review Meetings and related Processes 1
Marc U.S. rejects GM's call for government financial help in a merger World News 2
Stijloor G.M. and Chrysler Explore Merger World News 12
S QMI - SAI Global Merger Question Registrars and Notified Bodies 25
B Large North American Registrar up for sale/merger Registrars and Notified Bodies 39
L Is it mandatory to update all controlled documents if a company gone through a merger ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J How many 'Covers' have experienced a buy out or a merger? Career and Occupation Discussions 45
C Sanctioned Interpretation - Merger / Joint Venture Miscellaneous Environmental Standards and EMS Related Discussions 19
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 8
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0

Similar threads

Top Bottom