What defines Top Management after a Merger? Quality Management Review (9.3.1)

Southern Cross

Involved In Discussions
The requirement for 9.3.1 is:
Top management shall review the organization's QMS at a planned interval to ensure its continuing
•suitability
•adequacy
•effectiveness and
•alignment with the strategic direction of the organization.

What defines Top management? Through a merger we recently became a global company with HQ in Germany. Under the old management, the review was handled at Regional level, with the Regional leaders present.

With the new management, they seem to be wanting to push things like this down to the local level. Which means that I'll be calling a review with the local managers for other functions, rather than regional. The merged company doesn't seem to want Regional leaders of some functions. For example the position of Regional Quality Manager is now redundant.

Any thought on how this might play out when we go for the upgrade to 2015 certification? Any other thoughts?

** NOTE: We are certified still at a regional level, which I think may be relevant. There are plans to chase down global certification at a future date.
 
Last edited:

howste

Thaumaturge
Trusted Information Resource
The requirement for 9.3.1 is:
Top management shall review the organization's QMS at a planned interval to ensure its continuing
•suitability
•adequacy
•effectiveness and
•alignment with the strategic direction of the organization.

What defines Top management? Through a merger we recently became a global company with HQ in Germany. Under the old management, the review was handled at Regional level, with the Regional leaders present.

With the new management, they seem to be wanting to push things like this down to the local level. Which means that I'll be calling a review with the local managers for other functions, rather than regional. The merged company doesn't seem to want Regional leaders of some functions. For example the position of Regional Quality Manager is now redundant.

Any thought on how this might play out when we go for the upgrade to 2015 certification? Any other thoughts?

** NOTE: We are certified still at a regional level, which I think may be relevant. There are plans to chase down global certification at a future date.
Top Management in ISO 9000:2015 is defined as "person or group of people who directs and controls an organization at the highest level."

It comes down to how you define your organization in the scope of your QMS. If you have a multi-site certificate with regional leadership currently, then top management is the regional leadership. If you are going to maintain certification as-is, then the regional leadership being removed would be a problem. You may have to change the certification structure to single site until a global certificate becomes a reality. If you want a global certification including the HQ in Germany, then top management is most likely there. You would need to implement a common QMS that applies globally.
 
Thread starter Similar threads Forum Replies Date
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C IEC EN 60601-1-8: What defines a visual alarm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P What defines a campus? (Scope of ISO 14001 registration) ISO 14001:2015 Specific Discussions 4
H What defines a Quality Record ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
S Aerospace Standard - What document defines reliability concept AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
ScottK What defines the need for the ISO9001 Design & Development process? Design and Development of Products and Processes 15
N What Defines Flight hardware? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
A NO2 Output - 4.5.1. How often to measure? Who defines an 'appropriate' period? Miscellaneous Environmental Standards and EMS Related Discussions 2
Marc IIA (Institute of Internal Auditors) Defines Internal Auditing Internal Auditing 25
S What defines a "change in process" QS-9000 - American Automotive Manufacturers Standard 5
L How to prepare Top Management for IMS Surveillance Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Clever ways to get top management involved? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Sidney Vianna IATF 16949 News IATF News - Top 10 IATF 16949 nonconformities and more..... IATF 16949 - Automotive Quality Systems Standard 7
S Additional registration requirements for different EU-states on top of standard CE-registration? EU Medical Device Regulations 3
G Auditing Top management: 6.3 ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Booker Leadership non-conformity, Top Management's involvement in Problem Solving IATF 16949 - Automotive Quality Systems Standard 10
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Top opening of enclsoure against fire in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B OSHA Top Ten webinar, March 31 (free online) [Deleted] Misc. Quality Assurance and Business Systems Related Topics 1
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
E Resources for Planning for top quality Business Continuity & Resiliency Planning (BCRP) 6
Sidney Vianna Informational ISO 13485 Certificates Top 10 Countries - 2004 to 2017 ISO 13485:2016 - Medical Device Quality Management Systems 0
Sidney Vianna Informational ISO 14001 Certificates Top 15 Countries - 1999 to 2017 ISO 14001:2015 Specific Discussions 3
E Functional Gage for TOP applied at RFS Design and Development of Products and Processes 5
D Doing both a top-down and a bottom-up risk assessment - How to combine ISO 14971 - Medical Device Risk Management 30
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
K About ionizers - How far can we place a table top ionizer from the IC devices Manufacturing and Related Processes 1
M Medical Device News ECRI – 2019 Top 10 Health Technology Hazards Medical Device and FDA Regulations and Standards News 0
Q Top Management Change Prior to Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Sidney Vianna Top 10 Major and minor NC's during IATF 16949:2016 Audits IATF 16949 - Automotive Quality Systems Standard 8
Q Risks Examples in Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Additional KPI to Top Management beside Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Top Executive Management ISO 9001:2015 and IATF 16949 Overview IATF 16949 - Automotive Quality Systems Standard 4
N Root Cause Challenge: The guy at the top ... Problem Solving, Root Cause Fault and Failure Analysis 4
M ECRI Top 10 Health Technology Hazards for 2017 Other Medical Device and Orthopedic Related Topics 3
L Auditing Top Management - Meeting Competency Requirements and Questions to Ask General Auditing Discussions 11
Q Who can Change goals and kpi of top management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L Engaging Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Marc 15 minute Top Management presentation on ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
alimary15 FTA-Top/Down approach to Risk Analysis ISO 14971 - Medical Device Risk Management 2
SATHYABALARAMAN OHSAS 18001:2007 4.4.1 Top management appointee Occupational Health & Safety Management Standards 8
A Creative ways to access Expert Information when you can't afford a top $ Consultant Misc. Quality Assurance and Business Systems Related Topics 7
D Best Engineering Practices related to Top Assembly Drawings Document Control Systems, Procedures, Forms and Templates 6
R Performance Qualification on a Table Top Centrifuge ISO 13485:2016 - Medical Device Quality Management Systems 3
Chennaiite Can an Auditor question Top Management decision to approve deviation? IATF 16949 - Automotive Quality Systems Standard 30
Y Differences between Top Management, Management & Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc ISO 9001:2015 Structure - Top Level Clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T Uncertainty (Top Down Method)! Auditor argues that this is not enough Measurement Uncertainty (MU) 14

Similar threads

Top Bottom