Report the CB... Certification Audit (IATF 16949) not to ISO 17021

Coury Ferguson

Moderator here to help
Trusted Information Resource
#1
In the event that a CB doesn't really perform a Certification Audit (IATF 16949) by the standards of 17021, what actions can you take with the CB?

1. Notify the ANAB

2. Contact the CB

3. Request a Witness Audit

What actions can be taken? I really don't want to go into details. But, I am not sure how in the world our company received IATF Certification, knowing what I know about the company I work for.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
A ISO/TS 16949 - Sharing Certification Audit Report (NCR's) with the Customer IATF 16949 - Automotive Quality Systems Standard 8
S Internal Audit Closure Certification Report - FDA Requirements US Food and Drug Administration (FDA) 5
N CQC (China Quality Certification) did not issue an Audit Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K IEC 62133 Test Report for Lithium Battery Certification IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Corrective Action Report (CAR) for CB (Certification Body) required? Registrars and Notified Bodies 8
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
U FSC Due Diligence System (DDS) summary report... Sustainability, Green Initiatives and Ecology 0
S Post Market Surveillance Report (PMSR) for Medical Devices EU Medical Device Regulations 6
Zafortner EU Manufacturing Incident Report (MIR) version 7.3 ISO 13485:2016 - Medical Device Quality Management Systems 9
S Customer audit report review and approval ISO 13485:2016 - Medical Device Quality Management Systems 3
P 21 CFR 58 GLP Periodic Study Phase Inspection Report Other US Medical Device Regulations 0
D DOD First Article Test Plan & Report Manufacturing and Related Processes 4
A Report on handling customer property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M MAUDE Report Medical Device Related Regulations 4
M Clinical evaluation report training EU Medical Device Regulations 3
J PSUR encompassing PMS Report? EU Medical Device Regulations 5
M Who should quality representative report to? ISO 13485:2016 - Medical Device Quality Management Systems 5
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
D License annual renewal - What changes to report to HC? Canada Medical Device Regulations 1
S Consolidated Analysis Report for Moulding Process Manufacturing and Related Processes 1
placebo_master Verification Protocols - when to implement them (and when to skip in lieu of a report) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A TGA - Annual Report or Periodic Safety Update Report? Other Medical Device Regulations World-Wide 0
C API Q1 internal audit report Internal Auditing 3
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
X Sample SOC2 audit report (or a redacted one) IEC 27001 - Information Security Management Systems (ISMS) 0
E Calibration/Verification Report Durometer ISO 17025 related Discussions 2
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 6
S Submit to Health Canada with only MDSAP report? Canada Medical Device Regulations 5
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 18
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
R Not every INCIDENT report will lead to a corrective action EU Medical Device Regulations 7
M Sponsor name presented in the test report EU Medical Device Regulations 4
P MedWatch Report from a hospital due to a quality issue US Food and Drug Administration (FDA) 5
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 4
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
M Documents to be included in 1.3 Material check in PPA report APQP and PPAP 4
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
B Biological evaluation plan and report Other Medical Device Related Standards 7
C 21 CFR 803 malfunction detected during packaging - report? Other US Medical Device Regulations 1
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0

Similar threads

Top Bottom