PO Requirement - Documents of external origin are identified and controlled

A

Andrews

#1
If a particular standard given in a company's P.O refers to a standard but the auditor finds that this standard is not available with company then under which clause will the auditor book the non-conformity.Can it be booked under 7.1c) clause where it says " the organisation shall determine the criteria for product acceptance".
 
Elsmar Forum Sponsor
C

Carl Exter

#2
Are you referring to industry standards like UL specs? For things of this sort we usually got dinged under 4.2.3 Control of documents f) "to ensure that documents of external origin are identified and their distribution controlled."

IMO it doesn't matter really too much what section the nonconformity is filed against as the nonconformity will be the same and will require resolution regardless.
 
Thread starter Similar threads Forum Replies Date
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
A Documents of External Origin - Approaching & Satisfying this Requirement? Document Control Systems, Procedures, Forms and Templates 17
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
N What Documents are Required for each ISO 9001 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Singapore Distributor - IVD requirement for CSDT/STED documents Other Medical Device Regulations World-Wide 2
J Records Procedure - Requirement for a Register of all Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Requirement for Review and Re-Approval of Documents - ISO 9001 Clause 4.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P AS9100 4.2.3 Control Of Documents - Requirement to retain Obsolete Documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Is it a requirement to control all documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Re-Issue of Documents - Requirement to re-issue a document after so many revisions? Document Control Systems, Procedures, Forms and Templates 2
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
briteme4 AS9102 FAIR Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
E Translation requirement labels EU Medical Device Regulations 4
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ROHs compliance requirement REACH and RoHS Conversations 1
E Language requirement DoC EU Medical Device Regulations 3
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 11
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4

Similar threads

Top Bottom