Self-Certication - Distributing Steel - 3 People - Need advice

J

Joseph Otis

#1
My company is a small (1-3 people) distributing steel. We manufacture nothing, and we process using outside vendors. I have heard that a company might "self-certify" by conforming with ISO requirements and then simply "declaring" their compliance. Can you help me - or point me in the direction of some authoritative source on the subject of Self-ceertification.
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
#2
There are a lot of different opinions on self-certification. The bottom line is self-certification is only your word that you comply. Some companies may 'accept' this and some may scoff. You might be better to use the phrase 'compliant' rather than 'self-certified'.

Is it a good idea? I can't see any drawback.

I can't direct you to any specific source of information - I don't know that there are any 'experts' on self-certification. Nor am I aware of any specific criteria to 'self-cetify'. Maybe one of the others can help you out on this.
 

Randy

Super Moderator
#3
All you really need to do is show a continuing system of internal audits, preventive and corrective action, all the required documentation, and an adherehance to your policy and plan....Then a signed letter by your senior management that you conform to whatever the standard is.

You should also be willing to let a customer perform an audit if they wish.

My recommendation is to hire a qualified "3 party auditor" to perform an independent audit to verify conformance. The auditor should be willing to supply you with a document stating that in his/her opinion that you conform to the standard (only if you really do that is).

Check the Registrar Accredidation Board
(www.rabnet.com) for qualified auditors that are for hire.
 
Thread starter Similar threads Forum Replies Date
M Online/self-paced ASQ CRE Exam Prep Reliability Analysis - Predictions, Testing and Standards 1
H Is CE valid in Switzerland for self certified products? CE Marking (Conformité Européene) / CB Scheme 5
R EUDAMED - IVDD self-declared devices EU Medical Device Regulations 1
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
Z COVID-19 Antigen Test Kit (Self-test) Registration in Peru Other Medical Device Regulations World-Wide 0
F Self Evident Inspection Method ISO 13485:2016 - Medical Device Quality Management Systems 11
F Self-test minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
F Medical cart self certification EU Medical Device Regulations 1
M IATF 16949 SI # 10: Integrated self-calibration of measurement equipment- Needs for explanation IATF 16949 - Automotive Quality Systems Standard 2
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
A Self-training or Self-studying ISO 13485:2016 - Medical Device Quality Management Systems 8
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Control-self assessment Internal Auditing 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
E HONDA HAA QAV-1 Self Assessment General Auditing Discussions 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 7
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
M Notified Body Involvement with Self Declared Products EU Medical Device Regulations 7
S Help: Need Control Self Assessment Questionnaire for HR Departmental Functions Process Audits and Layered Process Audits 0
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 12
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N MDD Class I Medical Device Self Declaration Articles/Supplementary Documents EU Medical Device Regulations 1
A Self-study plan to improve fluency in English speaking, writing After Work and Weekend Discussion Topics 3
Crusader Interval for Self-Calibrating Measurement Device? Calibration Frequency (Interval) 15
T Transition Time for Self Declared IVDs EU Medical Device Regulations 3
Z IVD Self Test Pregnancy - Assessment Route? EU Medical Device Regulations 5
S Anyone know the self-selection study for home use medical device Other US Medical Device Regulations 2
D Off-Label Self Promotion - What to do EU Medical Device Regulations 3
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
S Creating goals and objectives with targets and measurables for self-evaluations Management Review Meetings and related Processes 2
C Help with Risk/Benefit Analysis Self-help Device for Diabetics ISO 14971 - Medical Device Risk Management 3
B Self Contained Biological Indicators as internal PCD Other Medical Device Related Standards 2
T Self Declaration for CE Class I, Non-Invasive Medical Device EU Medical Device Regulations 10
R Self-Certification Is Not a Real Thing - an IAF article Registrars and Notified Bodies 13

Similar threads

Top Bottom