Does ISO 9000 require documentation of nonconforming incidents

Paper to QMS ad
Elsmar Forum Sponsor
R

rrramirez

#3
#3
Nonconforming incidents

Claes Gefvenberg said:
It is. See 8.3 and 4.2.4.

/Claes
Click to expand...
Do this mean "each time" that i dectect a nonconforming situation it´s necessary to write a NCR?
That is my question.
 
Claes Gefvenberg

Claes Gefvenberg

Admin
#4
#4
Each time? No, it doesn't have to be that way (fortunately). You have to describe how you handle nonconforming products in a documented procedure. There's the key. Write the procedure in a way that fits your operation. For instance, nothing in 8.3 tells you that you have to write a NCR for each occurence, so there is nothing preventing you from bunching similar problems together.

In some way most of us do that.

I suggest a trip to the Nonconformance and Corrective Action Systems forum.

This very question has been turned inside out several times there, and good solutions have been forwarded. The thread Priorizing Non-conformances is one example.

/Claes
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N How does a company determine what ISO standard (9000 or 9001) to register to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R ISO 9001 Vs. QS-9000 - Does ISO 9000 not require a Control Plan, FMEA, etc.? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M How does the ISO 9000 revision affect QS 9000 and VDA 6.1 VDA Standards - Germany's Automotive Standards 2
K How does ISO/TS 16949 differ from QS-9000? IATF 16949 - Automotive Quality Systems Standard 10
K Does TQM fit in with ISO 9001:2000 and QS-9000 (now TS 16949)? Preventive Action and Continuous Improvement 9
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
Q Does our material suppliers’ supplier have to be at least ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 3
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Does ISO 9001 mandates cooking procedure for restaurants ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Tagin Does ISO 9001:2015 require a full internal audit annually? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
Q Does ISO 9001 require CARs for all customer complaints? Customer Complaints 2
S RSL (Remote Site Location) Laboratory - Does it need to be ISO 17025 IATF 16949 - Automotive Quality Systems Standard 5
qualprod ISO 9001 Cl. 4.1 and 4.2 - What does monitoring and review mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Sidney Vianna ASQ apparently doesn't know ISO does not issue ISO 9001 certificates? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does MDSAP replace ISO 13485, or do both have to be maintained? ISO 13485:2016 - Medical Device Quality Management Systems 25
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
thisby_ ISO 14971 - ALARP and P2 - New ISO 14971 does not allow the concept of ALARP? ISO 14971 - Medical Device Risk Management 3
C Optic Patchcord Cables - Does 8.3 (Design) Apply Here? ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Does AS9100 require Suppliers to be Certified to ISO or AS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
G Does ISO 9001:2015 call for a Policy or a Statement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Does ISO 9001 Requirement for Document Approval (a service organization) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Does Calibration to ISO/IEC 17025 conform to Z540.3? ISO 17025 related Discussions 1
J Does the word "claim" in ISO 9001 Clause 8.2.2 mean "requirement"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 9001:2008 Certification Scope does not mention "manufacturing" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Where does 5S technique fit into ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
L What does "conformance matrix" means in terms of ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Does AS9100 Certificate include ISO 9001 Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S BSI's ISO 13485 certificate does not mention AC 2009 corrigendum Registrars and Notified Bodies 5
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
F Does United Kingdom (UK) follow ISO 17025 and ISO 17020? ISO 17025 related Discussions 14

Similar threads

Top Bottom