SBS - The best value in QMS software

Covering an acquired company in our ISO 13485 certification

SGquality

Quite Involved in Discussions
#1
A quick question on ISO 13485 certification:

My company (an ISO 13485 certified) acquired another medical device design company (also ISO 13485 certified) and both our certification bodies are different.

Need your advise on the following questions:

1. Though we acquired this company, the financials are not aligned and both are operating as individual companies, and may be another 2 years before merging under one umbrella. In this scenario of different operating companies, can we take this new company under our ISO certification prior to merging them financially?

2. How do we approach certification bodies with this request?

Thank you as always :agree:
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
1. Though we acquired this company, the financials are not aligned and both are operating as individual companies, and may be another 2 years before merging under one umbrella. In this scenario of different operating companies, can we take this new company under our ISO certification prior to merging them financially?
Finances are irrelevant. In my opinion you can either keep running under two separate certifications, or merge under your certification if you also align the two QMSs.

2. How do we approach certification bodies with this request?
When you are ready to consolidate, just notify the purchased company’s CB that you wish to drop (not renew) their certification, and coordinate with your own CB to have the extended certification (covering both companies) processed and issued prior to that discontinuation.
 
Thread starter Similar threads Forum Replies Date
E Covering letter to CDSCO Other Medical Device Regulations World-Wide 2
Ajit Basrur Quality Agreement with supplier covering medical devices and consumer requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc Medical Device and FDA Regulations and Standards News 0
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendm Medical Device and FDA Regulations and Standards News 3
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
JoCam Medical Device Recalls - Manufacturer's obligation for covering cost EU Medical Device Regulations 17
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario Medical Device and FDA Regulations and Standards News 1
M Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
J Is this practice common? 1 Quality Manager covering QA, QC, QE, SQE IATF 16949 - Automotive Quality Systems Standard 20
6 Sample SOP covering Handling of Line Stoppages and Interuptions wanted Food Safety - ISO 22000, HACCP (21 CFR 120) 3
T Good training courses covering Risk Management Tools Training - Internal, External, Online and Distance Learning 4
K Quality Control on Braided Metal Hose covering Stainless Steel Pipe - Fixing Dents Benchmarking 7
D Internal Audit Training Material covering ISO 9001, ISO 14001 & OHSAS 18001 Training - Internal, External, Online and Distance Learning 1
S Standard covering all the organization - What standards must I buy? Document Control Systems, Procedures, Forms and Templates 7
B In a Linearity Study covering the operating range is it necessary to do Bias Study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
B Covering Quality Manager/QMR JD (Job Description) with QMR Roles in Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q 1 QMS and ISO 9001 registration certificate covering 2 plants ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
C Plating process not covering solder, any ideas? Manufacturing and Related Processes 4
J 5S Procedure - Does anyone have a procedure covering 5S for Work Stations? Preventive Action and Continuous Improvement 7
Ajit Basrur Combined Audit Check List Covering Multiple Standards General Auditing Discussions 10
C Internal audit checklist covering various standards/regulations Internal Auditing 2
T Do I have to write a procedure covering 6.4 Work environment? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Raffy Internal Audit - Covering all relevant areas - What areas might NOT be relevant? Internal Auditing 6
D Objective evidence for covering all shifts and locations General Auditing Discussions 6
B Certification covering work place at clients' premises ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
supadrai Effect of a Merger on Acquired Company's Medical Device Licenses Other Medical Device Regulations World-Wide 2
JoCam Acquired Medical Devices - Company A buys the entire rights EU Medical Device Regulations 4
S Labeling Requirements for Acquired Medical Device Inventory Other US Medical Device Regulations 2
M Merging Two Quality Management Systems when a Company is Acquired Misc. Quality Assurance and Business Systems Related Topics 8
B What happens to your ISO 9001 registration if you are acquired by a Company Without ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Integrating acquired existing product into Quality Management System Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 1
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
L Have been purchased by a corporate company ISO 13485:2016 - Medical Device Quality Management Systems 7
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S Malcolm Baldrige Company Dashboard Quality Tools, Improvement and Analysis 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
R MDEL and company affiliate Canada Medical Device Regulations 0
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7

Similar threads

Top Bottom