Must I have documentation of calibration upon receiving equipment?

K

KathyS

#1
#1
Calibration

When ordering a new piece of equipment that requires calibration on a yearly basis, must I have documentation of calibration upon receiving equipment, or can I wait for one year. The company I purchase this from will be the one doing the calibration every year.
 
Download Free White Paper
Elsmar Forum Sponsor
K

Ken K

#2
#2
I couldn't imagine using a new piece of equipment without knowing if it was calibrated. What would happen if you waited a year to have it calibrated and find out it was way out of tolerance?
I don't know what kind of equipment you are talking about, but how can you justify a yearly schedule on a new piece of equipment?
I wouldn't feel confortable doing this.

Just my thoughts.
 
A

Al Dyer

#3
#3
Agree with kevin and would like to note that there may be some equipment that is calibrated by a suuplier before you bet it or during set-up. The might include items such as CMM's, granite plates , and gage blocks.

I believe a calibration certificate for them would be acceptable, but don't forget bias, linearity and stability which should be done at your facility to validate the state of the gage to meet your process requirements.

ASD...
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E What documentation must I provide during a 2nd party audit? General Auditing Discussions 10
A What specific Quality "Must have's" would you like included in a Request For Quotation? Customer and Company Specific Requirements 3
N Must PFMEA Occurrence Factor be Changed Periodically? FMEA and Control Plans 17
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Y Must Initial importers have any QMS? US Food and Drug Administration (FDA) 1
S How long the QMS must be maintained after device EOL? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Must VDA 6.3 be assigned to certain project? VDA Standards - Germany's Automotive Standards 0
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 10
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet Must COPQ always be quantified as a monetary ($) amount? IATF 16949 - Automotive Quality Systems Standard 2
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
A Read instruction manual - What Graphic Symbol must I use? US Food and Drug Administration (FDA) 7
M What kind of instrument that must be calibrated? General Measurement Device and Calibration Topics 3
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Customer VDA Audit - We must provide refresher training? VDA Standards - Germany's Automotive Standards 4
J Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting ISO 13485:2016 - Medical Device Quality Management Systems 13
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
Q IATF 16949 - Product audit - Must each product be audited? IATF 16949 - Automotive Quality Systems Standard 6
G From an ISO 17025 auditor perspective must micrometer calibration check anvil flatness? General Measurement Device and Calibration Topics 4
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
T Must all Disposable Medical Devices be DEHP Free for MDR? EU Medical Device Regulations 1
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 9
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
S Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
armani ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented? Management Review Meetings and related Processes 15
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
M Contacting a "Must Use" (aka Sole Source) Supplier's Registrar Supplier Quality Assurance and other Supplier Issues 6
T Auditor states my Oven Thermocouples must be Calibrated General Measurement Device and Calibration Topics 18
K Must I update the Quality Policy? (ISO 9001:2008) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
U Must every procedure be proceeded by a policy? Document Control Systems, Procedures, Forms and Templates 2
P Must all parts of a product be RoHS compliant? EU Medical Device Regulations 5
N Must electrodes for Rx/prescription stimulators be Rx only? Other US Medical Device Regulations 2
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
F Electronic Signatures (21CFR Part 11) - Must They Appear on Printed Documents Document Control Systems, Procedures, Forms and Templates 9
R What are the "Must Have" Specs and Standards for AS9100 Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
L Must we do Receiving Inspection for everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
U Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited labs? ISO 17025 related Discussions 8
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
leftoverture Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
N Must Employees Be Evaluated Annually? Training - Internal, External, Online and Distance Learning 19
A Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540? ISO 17025 related Discussions 38
D How long must we provide service parts to Ford? IATF 16949 - Automotive Quality Systems Standard 7
E Must Patent Numbers be Shown on Product Labels? Other Medical Device and Orthopedic Related Topics 18

Similar threads

Top Bottom