Setting up a corporate umbrella QMS

G

Garnett

#1
Hi All,
I currently manage our company's ISO 9001 QMS for a single site of around 70 people.
We are part of a bigger organisation (9 sites in US and Europe) and i have been asked to think about setting up a corporate umbrella for an integrated QMS covering both 9001 and 13485.
Do companies such as BSI, TUV, LRQA offer services that would help in the setting up of such processes?
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
Garnett,

They shouldn't because such consulting could undermine the value of their independent certificates of conformity.

Even so, they may.

Why not discuss and develop the architecture of your QMS here?

John
 
T

Tara Monson

#3
Garnett,

We are currently on the same page. We are merging our QMS with another site. Currently, we are combining the upper level documents, keeping them as simple as possible. This basically shows how our QMS meets the standard.

Within those upper level documents, we reference the site specific procedures...i.e - the process of Supplier Assessment is done differently at each site, so we each have our procedures.

When writing those upper level documents, it has given us a good chance to see how our sister company is performing their duties, which is a great opportunity for improvement.

Good luck!
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
They shouldn't because such consulting could undermine the value of their independent certificates of conformity.

Even so, they may.
Bottom line is they can do one or the other at an individual company, but not both. That's what has gotten some registrars in hot water over the years. Some companies such as Perry Johnson have (or at one time did have) separate "divisions" for consulting vs. registration. Theoretically they are separate entities and can not (supposedly) communicate/influence each other.

What we're looking at is conflict of interest in one company/CB doing both for a company - A big No No....
 
G

Garnett

#5
thanks to all that have posted so far, i appreciate your feedback.

I guess i need one company to act in a consultancy role to help set up the corporate multi site integrated QMS and a different company to act as CB once the QMS is in place.
 
Thread starter Similar threads Forum Replies Date
D How do I make the Corporate QMS work in the manufacturing setting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Setting accuracy limit for a read out General Measurement Device and Calibration Topics 4
B Setting flexible packaging specification limits ISO 14971 - Medical Device Risk Management 4
I Setting action completion dates Nonconformance and Corrective Action 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
S Heat Sealers Upper and lower limit setting during OQ for Heat Sealer Qualification and Validation (including 21 CFR Part 11) 0
Ed Panek GDPR in Urgent Healthcare Setting Other ISO and International Standards and European Regulations 1
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
Ashok sunder What are the criteria for setting a target KPI value against a quality objective? Benchmarking 7
K Setting Quality Objectives (for the first time) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
R ISO 11137 Gamma sterilization validation, dose setting, dose audit Other Medical Device Related Standards 1
M Best Practice for setting tolerances on a Drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
T Setting up a quality department in an Engineering Firm Quality Management System (QMS) Manuals 11
B Software for setting up New Warehouse Manufacturing and Related Processes 0
S Setting up the process - First piece inspections Statistical Analysis Tools, Techniques and SPC 3
A Add-On software for VMC to calculate setting time, Idle Time, OEE etc.. Manufacturing and Related Processes 2
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
A Setting up an LLC as a Consultant Paid Consulting, Training and Services 27
A Setting initial Expiry Date of an IVD per BS EN 23640:2015 Other Medical Device Related Standards 12
Q Setting Quality Objectives with a Timeframe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Proud Liberal Setting up Prolink's QC-Gage to a Keyence IM-6225 Vision System Statistical Analysis Tools, Techniques and SPC 2
P Setting Acceptance Quality Limits (AQL) for New Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Hami812 Cpk Setting Tolerance - Cart before the Horse? (Wifi Routers) Capability, Accuracy and Stability - Processes, Machines, etc. 3
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
A New company, no employees, Setting up a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F Setting up a new sterilization unit in a new facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C ISO 14001 Recertification without setting Targets ISO 14001:2015 Specific Discussions 3
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
M Setting up a M1003 QA Program for the AAR Various Other Specifications, Standards, and related Requirements 2
A Setting up a Medical Device Distributor in Malaysia Other Medical Device Regulations World-Wide 16
R Irradiation Sterilization Dose Setting and Dose Audit Flow Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
J Setting Up New QMS - New US Location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Setting air gauging outside of a part tolerance Capability, Accuracy and Stability - Processes, Machines, etc. 2
S Target Setting - Internal metric(s) to drive Internal Processes Six Sigma 1
S MSA Help or guidelines - Plastics - Setting up an MSA on a multi cavity fixture Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
T Setting Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W Setting up from scratch - Looking for help (ISO9001 / ISO13485) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Setting up a New QMS for Certification when ISO 9001 is about to Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
P New to AS9100 Rev. C - Setting KPIs and FAI Reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
B Setting Lower Control Limit on Attributes Charts Statistical Analysis Tools, Techniques and SPC 9
J Lean 5S - Setting Min/Max Inventory Levels Lean in Manufacturing and Service Industries 3
V Setting Specification Limits for UOD (Uniformity) for Live Bacteria or Spores Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
J Setting Quality Objectives for Service, Repair and Sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Setting Specification Limits Quality Tools, Improvement and Analysis 11
C Mitutoyo SJ210 Settings - Is there an Industry Standard Surface Measurement Setting? General Measurement Device and Calibration Topics 4
W Setting up a Zmike for Pin Gage Calibration General Measurement Device and Calibration Topics 3
W Zero setting of correlation graph when plotting best fit linear regression Statistical Analysis Tools, Techniques and SPC 7
G Setting up a 3 Factor, 2 Level,2 response DOE in Minitab Using Minitab Software 7
B Quality Goals and Improvements in a Bioanalytical Laboratory Setting Quality Tools, Improvement and Analysis 1
N Setting up MSA system in a machine shop environment. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5

Similar threads

Top Bottom