External prints - Should copies should be marked ?Controlled Copy??

M

michael busha

#1
External prints

Our service manager receives prints from our customer by email for a small build job along with a P.O. He prints them and distributes copies to manufacturing. He wants to know if the copies should be marked “Controlled Copy”. I told him that we should treat them the same way we treat our in-house designs which we mark “Controlled Copy”. He says that they are not our designs and therefore do not need to be controlled. I say that if the prints are going out to the floor for manufacture, they need to be controlled. Help me fight this one please!
 
Elsmar Forum Sponsor
L

Laura M

#2
Originally posted by michael busha:
He says that they are not our designs and therefore do not need to be controlled.!
Send him back to ISO/QS9000 class 101.

I say that if the prints are going out to the floor for manufacture, they need to be controlled. Help me fight this one please![/B]
You win! QSA 5.1 "Are documents of external origin under document control?"
Now you can ask if stamping them controls them. There is NO requirement for a stamp - most places just find that works best.
 
D

Dave Davis

#3
I completely agree with Laura (how could you not). We chose to stamp ours. The method of control must be defined somewhere (if not obvious - stamping and placing in some form of document retention for later retrieval). Tell him that if the control mechanism is not obvious then he'll need to write a procedure and indicate the method of control... that usually gets them.

Best of luck!
 
Thread starter Similar threads Forum Replies Date
A Control of Documents (External Drawings) and Marking Up Prints Document Control Systems, Procedures, Forms and Templates 5
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Qualifying commercial off the shelf (COTS) external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
qualprod The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
A External Auditor issue with Internal Audits Internal Auditing 7
R Do we need to treat local law as external origin documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
D ISO 9001:2015 Clause 8.4.3 "Information for External Providers" buying from online retailers. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Necessity of external watchdog next to internal watchdog ISO 14971 - Medical Device Risk Management 1
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
I AS9100 8.4.2 Type and Extent of Control - External provider test reports Manufacturing and Related Processes 24
P AS9120B Control of External Providers for Franchised Distribution AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Tools and equipment provided by customer - Considered as external provider? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Transportation - External Service Provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S ISO9001:2015 Clause 9.1 - What the external auditor will look at? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
N IATF 16949 7.1.5.3.2 External Laboratory - Calibration of Nikon machine in factory IATF 16949 - Automotive Quality Systems Standard 24
H External power supply - requirements in safety/EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ashok sunder How to determine the internal and external issues in ISO 45001 standard? Occupational Health & Safety Management Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
J Ignoring a Failed Gage R&R and upcoming external audit IATF 16949 - Automotive Quality Systems Standard 22
sswaim IATF 16949 7.1.5.3.2 External Calibration Laboratory Requirelents IATF 16949 - Automotive Quality Systems Standard 15
S Risk Approach doesn't address External Issues (Auditor's Comment) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
J Use of External Documents in Product Realization Document Control Systems, Procedures, Forms and Templates 7
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
qualprod ISO 9001 - 9.3.2 c) 7 is answer for 8.4.1? Performance of external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A AS9120 External Provider Registry Scope of Approvals AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T Relevant internal and external communication - ISO 9001:2015 section 7.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K EMS Manual - External auditor expectations Miscellaneous Environmental Standards and EMS Related Discussions 5

Similar threads

Top Bottom