Procedure to define Signing Authority for Procurement Limits

G

Gumby24

#1
Hi folks,

For medical devices do I need a procedure to define signing authority for procurement limits then also for QMS activities such as document approvals, records, contracts, DHR, etc.

I've seen very simple examples of an approval matrix but not sure if it should cover purchasing limits, etc.

Thanks,
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hi...
Your question is purely how you want to establish your purchasing $$$$ approvals.
This can be addressed in your procedure as the type and extent of controls applied.
 
K

Kingfisher88

#3
You should check with your CFO.

It involves:
1. size of company
2. cash flow,
3. payment schedules for AP,
4. incoming of materials,
5. inventory holding cost and etc.

It will help decide your limits.
 
Thread starter Similar threads Forum Replies Date
Crusader Local Control Document procedure....define it or not? Document Control Systems, Procedures, Forms and Templates 24
Q Supplier PPAP: Procedure or Flow Chart to define Responsibilities and Actions? APQP and PPAP 4
J Procedure doesn't define the process - 7.1 Planning of Product Realization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
Moncia Production Planning procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
L Purchasing procedure and workload ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Roles and accountabilities procedure? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Procedure equals a process? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
M EU MDR - RA procedure for EU EU Medical Device Regulations 5
F Procedure for Device End of Life/Obsolescence Other Medical Device and Orthopedic Related Topics 3
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
U Product Lifecycle Procedure Guidance Design and Development of Products and Processes 7
V Datron 4707 or 4708 33K, NAVAIR or TB cal procedure General Measurement Device and Calibration Topics 1
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
I Containment procedure for parts after a power outage. IATF 16949 - Automotive Quality Systems Standard 1
F ISO 17025:2017 Format for Procedure and Records Document Control Systems, Procedures, Forms and Templates 3
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
E AS9100 installtion procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Procedure on Privacy Policy in the ISO 13485 quality management system ISO 13485:2016 - Medical Device Quality Management Systems 3
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Substance of concern (SOC) management procedure wanted Reliability Analysis - Predictions, Testing and Standards 2
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Different procedure templates for different standards - We have two different management systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
T Something between a manual and a procedure? Document Control Systems, Procedures, Forms and Templates 9
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
D Risk Assessment Procedure in accordance with ISO 17025:2017 ISO 17025 related Discussions 5
F Internal Audit - Procedure example Internal Auditing 5
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
J ISO 17025 Documented Procedure for 6.2.5 - Determining competency ISO 17025 related Discussions 4
U Own Procedure was not effectively implemented Problem Solving, Root Cause Fault and Failure Analysis 3
M Procedure or Specification For Extending Gages Calibration Calibration Frequency (Interval) 2
A Process Control / Control Charting Procedure Capability, Accuracy and Stability - Processes, Machines, etc. 1
R Real Example of a currently marketed Procedure Pack CE Marking (Conformité Européene) / CB Scheme 1
DuncanGibbons Additive Manufacturing/3D printing for aerospace (certification procedure) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom