International 'Gov't' Type Certification Audit (a.k.a. - Supplier Audit)

Have you ever been through a certification process for another countries 'gov't'?

  • Yes

    Votes: 1 25.0%
  • No

    Votes: 3 75.0%
  • Are you nuts? I'd quit first! (*grin* jk)

    Votes: 0 0.0%

  • Total voters
    4

E Wall

Just Me!
Super Moderator
#1
Has anyone else ever gone through an audit done by a portion of another countries 'Governing Body' (not sure what else to call them) in order to certify your ability to supply them?

We went through one today, and it was interesting. Apparently it was very rough on both the Corporate office and a sister plant. Comparatively we breezed through and even finished early (much to the MR's surprise and delight!). The trickies part was the translatiing, which was done by 2 interpreters, one of them wasn't familiar with ISO which made for awkward moments...but they cleared up after a little discussion.

Anyway. I was just wondering if an of you have gone through similar or not (apparently this process was started 3 years ago!) and to pass along advice to either get an interpreter that has some familiarization with ISO or be very patient and sure what is being asked before you answer.

Hope everyone has a great holiday weekend~
Eileen
 
Elsmar Forum Sponsor
H

HFowler

#2
Eileen,

I have twice gone through audits by China's Center of Boiler & Presssure Vessel Inspection & Research. It is a Division of China State Bureau of Quality and Technical Supervision. I have also visited their facility in Beijing. The purpose of the certification and subsequent surveillance audit was for Type Approval and authority to apply a CT Mark which allowed shipment of product to China.
 

barb butrym

Quite Involved in Discussions
#3
yes...japans defense agency.....

in a nutshell....
not as bad as our own DSCC (defense supply center), and they spoke the language

oops forgot about the Isreal Air Force, again not as eventful as our own DSCC people
 
Thread starter Similar threads Forum Replies Date
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
Sidney Vianna Informational IAF and ILAC Seek Contractor for Establishment of a Single International Organization for Accreditation ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
M Class I - International Registrations EU Medical Device Regulations 3
E Packaging Specifications Mercedes-Benz U.S. International IATF 16949 - Automotive Quality Systems Standard 4
F Mig Welded Components - IMDS International Material Data System RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Medical Device News International exposé of the harm caused by poorly tested medical devices. Other Medical Device Regulations World-Wide 12
Wes Bucey International Manufacturing Technology Show - 10 September 2018 - Chicago (meet up?) Coffee Break and Water Cooler Discussions 6
Sidney Vianna Optimizing Standards for Regulatory Use - International Medical Dev. Regulators Forum Other Medical Device Regulations World-Wide 0
qualprod Which standard to follow, local or international? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
N International / Traceable Standards - Procedures for Calipers, Micrometers, Etc. ISO 17025 related Discussions 2
B ISO 17100 (Requirements for Translation Services) International Translations Other ISO and International Standards and European Regulations 4
S. Moore Where is a good place to get IMDS (International Material Data System) Training? IATF 16949 - Automotive Quality Systems Standard 3
Marc IAF (international accreditation forum) - Mandatory Documents (MD Series) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
Marc "Elsmar 90" International Quality Standard anyone? Other ISO and International Standards and European Regulations 33
F Future Plan for IMDS (International Material Data System) RoHS, REACH, ELV, IMDS and Restricted Substances 5
J International Standards governing Test Method Validations ISO 13485:2016 - Medical Device Quality Management Systems 1
R Determination of IP (International Protection Marking) Rating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
U ISO 9001 Certification for Highly Distributed International Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Calibration Procedure Traceable to National/International Standards (API Q1 9th Ed) Oil and Gas Industry Standards and Regulations 3
M Basic International Standards required for a Manufacturing Industry (Optical Media) Other ISO and International Standards and European Regulations 4
M Differences between international and regional standards (EN, AAMI, CSA...) Other Medical Device Related Standards 6
D International Standards (ISO or MIL) for MTBV Reliability Analysis - Predictions, Testing and Standards 4
automoto International Problem Solving Guide Problem Solving, Root Cause Fault and Failure Analysis 2
AnaMariaVR2 The International Pharmacopoeia (Ph. Int.) WHO US Food and Drug Administration (FDA) 1
I International Sales Legal/Regulatory Gray Area? CE Marking (Conformité Européene) / CB Scheme 3
M FDA Acceptance of ISO 13485 Reports from a Recognized International Program Other US Medical Device Regulations 4
I International Accreditation Board of Bristol, UK ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
Jen Kirley This international consultant thing sure is a ride! Career and Occupation Discussions 13
S IATF (International Automotive Task Force) Rules 4th edition changes IATF 16949 - Automotive Quality Systems Standard 1
P IMDRF (International Medical Devices Regulators Forum)guidance on standalone software Medical Information Technology, Medical Software and Health Informatics 1
jasonb067 Rayong Thailand - Best Hotel and closest international Airport Travel - Hotels, Motels, Planes and Trains 3
J Domestic and International Medical Device IFU (Instructions for Use) Other US Medical Device Regulations 3
E Are non-SI units International? General Measurement Device and Calibration Topics 7
S The days before International Standards - Has ISO done what it was supposed to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D RABQSA International (SUSPENDED) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Icy Mountain Combining ISO9001 and ITAR (International Traffic in Arms Regulations) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Measurement Standards Traceable to International or National Measurement Standards AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B What a mess!!! Nebula Glass International (d.b.a. Glasslam) vs. Wacker Chemicals Quality Manager and Management Related Issues 1
T International Medical Data Storage Requirements Other Medical Device Regulations World-Wide 4
H Painting Quality Requirement International Standard Manufacturing and Related Processes 6
D FDA Cease to Manufacture Order in USA and our International Interests 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
T Are there any International Conferences related to ISO/IEC 27000 series standards IEC 27001 - Information Security Management Systems (ISMS) 1
A Instructions for Use - Best Practice to meet all International Regulations ISO 13485:2016 - Medical Device Quality Management Systems 6
Y NEBOSH International General Diploma Professional Certifications and Degrees 3
A Plaster of Paris Medical Immobilization Cast - International Standards? ISO 13485:2016 - Medical Device Quality Management Systems 6
C International Supplier Audit (ISO9001:2008 + Manufacturing Requirements) Supplier Quality Assurance and other Supplier Issues 4
C National/International Standard For Calibration "As Found" Readings General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom