7.5.3 Identification and Traceability vs. 7.5.3.1 Id and Traceability - Supplemental

X
#1
7.5.3 Identification and Traceability
Where appropriate, the organization shall identify the product by suitable means throughout product realization...

7.5.3.1 Identification and Traceability - Supplemental
The words "Where appropriate" in 7.5.3 shall not apply.


----------------------------------------------------------------------------------

Any comments? Am I the only one who finds this strange? :confused:
 
Elsmar Forum Sponsor
M

M Greenaway

#2
I only find it strange that the 'where appropriate' statement appeared in ISO9001:2000 in the first place !

I can only think it might not be appropriate to service industries ?
 
D

D.Scott

#3
I don't find it strange at all. The original statement is part of the ISO standard on which 16949 was based. The exclusion of "where appropriate" is to allow the ISO statement without change (otherwise you couldn't make the statement that ISO 9000:2000 is incorporated in this document) while allowing the automotive "lot traceability" to remain a dominant feature of the requirements.

This was the same with ISO 9000 / QS9000.

Dave
 
M

M Greenaway

#4
Its doubly strange that the standard doesnt define traceability, or say traceability to what.

Its even stranger the MS Word always gives me a spelling error for traceability !!
 
X
#5
Good call Dave...it makes sense now. I was forgetting that ISO was in the box while additional requirements were outside.

Guess I need to "think outside the box" maybe? :vfunny:

It's Monday...enough said... :ko:
 
A

anilo

#6
help about traceability

hello everybody.
this is my first post, and i apologize for my unfluent english.
i'm a brand new quality manager ( after a 800 hours course By EU) and i'm a stageur in an automotive factory which designs and manifactures electronic engine management systems.
our most important client asked us a total traceability of all the components assemblied into the printed circui board.
This is a graeat work to do, and i would ask to the forum if someone cuold give me some example.
thank you:bigwave:
 
Thread starter Similar threads Forum Replies Date
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Identification and Traceability with an ERP system - Barcode Labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Stefan Mundt ISO 9001:2015 - 8.5.2 Identification and Traceability Manufacturing and Related Processes 14
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
DeeDeeM IATF16949, clause 8.5.2.1 Identification and traceability-supplemental IATF 16949 - Automotive Quality Systems Standard 1
DeeDeeM IATF 16949 - Clause 8.5.2 Identification and Traceability IATF 16949 - Automotive Quality Systems Standard 7
J Customer Identification and Traceability in Manufacturing Plans Manufacturing and Related Processes 5
R Drilling Service Identification and Traceability Requirements Quality Manager and Management Related Issues 4
G Required Chains Identification for Traceability Calibration and Metrology Software and Hardware 3
x-files Thermal Powerplant - 7.5.3 Identification and Traceability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Are we doing enough to meet Identification and Traceability 7.5.3 Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Identification and Traceability 7.5.3 - What is considered Traceable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Identification and Traceability for Oil & Gas Production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Y AS9100C 7.5.3 Identification and Traceability - Interpretation and Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
S Size of Identification, Traceability and Status Labels? Food Safety - ISO 22000, HACCP (21 CFR 120) 3
A Identification and Traceability down to the smallest detail of the component AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
T Age Sensitive Materials - Identification and Traceability procedure - Powder Coat ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
T Identification and Traceability 7.5.3 by Location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Buckyb AS9100 7.5.3 Identification and Traceability - Difference between actual and agreed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Identification & Traceability Procedure example wanted Document Control Systems, Procedures, Forms and Templates 9
E Root Cause Corrective Action - Identification and Traceability Problem Solving, Root Cause Fault and Failure Analysis 5
J Identification and Traceability requirements - Clause 7.5.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Identification and (material) traceability - Intent of the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Anerol C How are you handling Identification and Traceability? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Identification & Traceability Application Differences ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Where traceability is required, the unique identification of the product is recorded ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Is Identification and Traceability a procedure or more of a guideline? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
L Product Identification & Traceability (when a part number changes) ISO 13485:2016 - Medical Device Quality Management Systems 7
O Identifying Raw Material Part Numbers - Product Identification and Traceability ISO 13485:2016 - Medical Device Quality Management Systems 6
GStough Identification & Traceability - ISO13485:2003 - Clause 7.5.3.2 - Distributors ISO 13485:2016 - Medical Device Quality Management Systems 4
B Lot Tracking - Automotive Requirements - Identification and Traceability Records and Data - Quality, Legal and Other Evidence 18
S Incorporating SOP Into ISO 9001 Procedures - 7.5.3 Identification and traceability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J 7.5.3 Identification and traceability including FIFO and Inventory IATF 16949 - Automotive Quality Systems Standard 7
R Identification and Traceability During the Product Realization Process IATF 16949 - Automotive Quality Systems Standard 9
L TS 16949 7.5.3 Identification and traceability IATF 16949 - Automotive Quality Systems Standard 6
J Identification and Traceability in Medical Device Tracking - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
A Identification and Traceability - Labeling spaces in warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Identification and Traceability - Mixing different work orders of the same part 7.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 7
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
qualprod Monitoring of lead time - Good KPI identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
qualprod Controlled sticker for product identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Watchcat Identification of Test Sample in Test Reports? Design and Development of Products and Processes 22
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom