SBS - The best value in QMS software

Substance of concern (SOC) management procedure wanted

Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Good day Deepak,

You did not mention what industry you operate in, so it is difficult to direct you in a specific manner. Further, what your customer is asking for is what your organization is doing, not what others are doing. Your management procedure should reflect your practices and controls. The best I can suggest is the results of a Google search so you can see what others have to say on the subject.

I hope this helps.
 
#4
We are manufacturing high pressure CNG cylinder for automotive application. Our customer required out of GADSL requirements.
Pls. suggest what is the guidelines to make the procedure. If you have any, pls. share.
 
Thread starter Similar threads Forum Replies Date
M How To Include Substance of Concern (SOC) Free Into TS16949 Internal Audit Plan IATF 16949 - Automotive Quality Systems Standard 1
T Mercury is covered under RoHS but is not a substance of very high concern (SVHC) ? RoHS, REACH, ELV, IMDS and Restricted Substances 2
Q SVHC (Substance of Very High Concern) Declaration for Packaging Material RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
K Contains hazardous substance symbol EU Medical Device Regulations 1
A Teamcenter Substance Module RoHS, REACH, ELV, IMDS and Restricted Substances 0
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 9
S Compliance to GADSL (Global Automotive Declarable Substance List) RoHS, REACH, ELV, IMDS and Restricted Substances 4
B Mitigation of emission of flames, molten metal, poisonous or ignitable substance IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Dimethylnitrosoamine CAS:62-75-9 as prohibited substance acc. GADSL RoHS, REACH, ELV, IMDS and Restricted Substances 5
W REACH - Candidate List Substance vs. Authorisation List Substance in EEE RoHS, REACH, ELV, IMDS and Restricted Substances 1
Q Restricted Substance in my Product - How to declare problem? RoHS, REACH, ELV, IMDS and Restricted Substances 3
Kales Veggie Ford RSMS (Restricted Substance Management System) 2008 released / GADSL categories RoHS, REACH, ELV, IMDS and Restricted Substances 16
Kales Veggie Global Automotive Declarable Substance List (GADSL) 2009 released..... Miscellaneous Environmental Standards and EMS Related Discussions 2
Z 'Duty to Declare' substance - Is submission of IMDS sufficient? RoHS, REACH, ELV, IMDS and Restricted Substances 2
E The EU regulation for 'Restriction of hazard substance' (RoHS)? RoHS, REACH, ELV, IMDS and Restricted Substances 5
G Trying to find CAS numbers - The Database of chemical substance information IATF 16949 - Automotive Quality Systems Standard 3
S Is Toluene (Methylbenzene) a banned or restricted substance Miscellaneous Environmental Standards and EMS Related Discussions 4
M Substance reporting for PPAP GMW 3059 APQP and PPAP 41
N Incoming Product Quality - Receiving inspection for chemical substance Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T OFI (Opportunity for Improvement) vs. AOC (Area of Concern) - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
M Informational EU – Candidate List of substances of very high concern for Authorisation Medical Device and FDA Regulations and Standards News 0
E Canada Chemicals of Concern - Similiar program for chemicals like the EU Canada Medical Device Regulations 0
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Nemko AS & DQS - Concern over notification as a Medical Device NB Registrars and Notified Bodies 5
M Medical Device Software "Level of Concern" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J Level of Concern - Ultrasound Medical Device Systems ISO 14971 - Medical Device Risk Management 2
R ISO 14644-1 maximum particulate concentration limits concern Other ISO and International Standards and European Regulations 2
L IEC 62304 and FDA Level of Concern IEC 62304 - Medical Device Software Life Cycle Processes 8
T Level of Concern for Class II Medical Device Software 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Fender1 PPAP-PSW Accuracy Concern - Laser Cut Holes In Formed Fabricated Steel Part APQP and PPAP 15
D Company Percentile Ranking - Customer Concern and Warranty Costs Benchmarking 4
M Level of Concern (FDA) vs. Software Safety Classification(IEC) US Food and Drug Administration (FDA) 3
N Minor Concern - Medical Device Software and Risk Management ISO 14971 - Medical Device Risk Management 2
S How to start implementation of ISO 9001 in manufacturing concern? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
smryan SVHC (Substances of Very High Concern) Declaration List Update Notices RoHS, REACH, ELV, IMDS and Restricted Substances 3
S Level of Concern only applicable to Medical Device software? IEC 62304 - Medical Device Software Life Cycle Processes 3
somashekar Supply Chain Oversight is the FDA's Next Area of Concern Other US Medical Device Regulations 0
S Medical Device Software Level of Concern Determination 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 23
P Level of Concern anomaly - FDA Guidance Document Conflicts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
F Level of Concern for 892.2050 - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Software Validation - Splitting the Level of Concern on multiple software parts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G First time flyer - My big concern other than crashing is air sickness! Coffee Break and Water Cooler Discussions 41
Q Management Review Meetings - Auditor issued an Area of Concern regarding our method ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 85
T To Whom it may concern... Imported Legacy Blogs 0
L Software Documents in 510(k) submission (Moderate Level Concern) Other US Medical Device Regulations 1
J FDA classifying all PACS software devices as Moderate Level of Concern? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9

Similar threads

Top Bottom