Experience with APIQR dual registration to ISO 9001/API Q1

G
#1
Has anyone had any experience with APIQR dual registration to ISO 9001/API Q1,if so please give me a call,cos I am struggling with among other things Field Nonconformities
 
Elsmar Forum Sponsor
G
#3
APIQR = American Petroleum Institute Quality Registrar.More detail is available at the API web site www.api.org. Basically they are offering dual accreditation to ISO and API Monogram Program (ISO9001/API Q1) with only one audit annually whereas normally you would require two (one per standard). Thanks in advance for any assistance you can give.
 
Q

Qualiman

#5
gmac:

I am not really an expert in API topics, but trying to give some help let me give you some opinion.

I have a client related to valves and is working in the monogram program that you mentioned. He has to comply with 2 main programs: API Spec. Q1 and API Spec 6D.

As far as I understand Q1 is a "selection" of ISO 9001, which includes 4.1,2,3,4,5,6,10,13,14 and finally 4.15, and probably those items are not fully followed as ISO 9001 establishes. They are using (at API) the 6th. edition of Q1.

The other spec (6D, is about the requirements to be fullfilled by any product using the "API monogram" and contains information about: types and class of valves, materials, Tests, identification, calibration, personnel qualification, records and storage/handling.

I'm trying to get the 6D standard to have the complete information.

I hope this information will give you some help.

QQQQQualiman
 
G
#6
qualiman
if you are sourcing API 6D you may also want tolook at the API guide to spec Q1, I believe it is free from API, this clearly shows the correlation of Q1 to ISO 9000, Q1 includes all the elements of ISO plus a little bit more. We are presently looking at obtaining licences for API 8C/4F/6A/16A/16C & 16D, which all have thier own particular requirements as regards material/inspection etc.Thanks for your reply.

[This message has been edited by gmac (edited 02 March 2000).]
 
Q

Qualiman

#7
gmac:

I became confused when I used the checklist taken from API website, which was used to change from 5th to 6th edition of Q1. That list just mentioned the points I listed in my last post. I will try to get the official Q1 spec. I'm sure you are right and it includes all ISO 9001 chapters and a little beat more.

Qualiman
 
G
#8
If you contact API direct Phone 202-682-8064
and explain you are seeking registration they will send you a package which includes API Q1 and the guide, in our case there was no charge for this service, alternatively you can request a registratin quote via the API website
 

Confussed

Involved In Discussions
#9
API Q1 has a lot more shalls, it seems ISO went soft then API went strong. The API Q1 checklist is not set up to the specification. They couldn't keep it simple. API is not that difficult to achieve these days no more than ISO. I find supplier audits find more than either ISO or API. They need to keep the cash flow going.

The 7th edition of API Q1 is good.
 
Thread starter Similar threads Forum Replies Date
N Any experience with Registrars that deny Certification to a Registrant? Registrars and Notified Bodies 4
BeaBea Registrars with VAR (Value Added Reseller) experience Registrars and Notified Bodies 6
Q Experience with Adobe Sign Document Control Systems, Procedures, Forms and Templates 3
S Experience working with TUV SUD or Rheinland, and/or BSI Registrars and Notified Bodies 5
C Experience with Agile PLM (Product Lifecycle Management Software) software from Oracle? Document Control Systems, Procedures, Forms and Templates 3
Gamula Product-Lifecycle-Management Experience Medical Information Technology, Medical Software and Health Informatics 9
D Experience with De Novo applications Other US Medical Device Regulations 8
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 4
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
T Training and experience - How do I document my experience and training Career and Occupation Discussions 5
D AEA (Aerospace Experience Auditor) Challenges - Finding availability of AEA for witness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
QIE Anyone have experience with BPA Quality (QMS system based on Office365/Sharepoint) Quality Assurance and Compliance Software Tools and Solutions 1
Rameshwar25 Min working experience for IATF 16949 third party auditor IATF 16949 - Automotive Quality Systems Standard 5
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
1 ISO Registrar with waste water treatment experience Registrars and Notified Bodies 1
A Anyone have experience with Transmille calibrators General Measurement Device and Calibration Topics 1
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
C IATF 16949:2016 New CSR (CQI´s) - Share your experience IATF 16949 - Automotive Quality Systems Standard 1
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
W Problems with our new Auditor (a Ph.D. with four months experience) ISO 13485:2016 - Medical Device Quality Management Systems 25
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Moncia Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L How to get more Auditing Experience Career and Occupation Discussions 11
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
D What is your experience with FDA using "mixed load" i EO sterilization Other Medical Device Related Standards 1
P CQE Work Experience - New to Industry Professional Certifications and Degrees 1
S Any experience on filling form, FDA 3654 for the DICOM standard? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
K SSBB Qualifications and Experience Requirements Professional Certifications and Degrees 2
S IRCA Lead Auditor Certificate based upon Work Experience ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
A MDS software - Does anyone have experience with iPoint? RoHS, REACH, ELV, IMDS and Restricted Substances 8
P Experience / advice for integrating API Q1 9th with a WCM program Oil and Gas Industry Standards and Regulations 5
D Experience with Notified Body - ITC from Czech Republic for Medical Devices Registrars and Notified Bodies 15
J Experience with Licensale Submission Portal for Medical Devices Other Medical Device Regulations World-Wide 1
D Any experience with the SME/AME/Shingo/ASQ Lean BOK/Certifications? Lean in Manufacturing and Service Industries 2
N Willing to share my experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
M Offered Management Position - Limited Experience - Any Concerns? Quality Manager and Management Related Issues 13
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
B Japan PAL QMS Audit Experience Other Medical Device and Orthopedic Related Topics 5
D Minimum requirements/experience/qualifications to be head of quality Career and Occupation Discussions 6
J Does anyone have experience in submitting TSE Dossiers to EDQM? EU Medical Device Regulations 1
I Validation Software Experience? (Valgenesis, etc.) Quality Assurance and Compliance Software Tools and Solutions 1
Colin Anyone with Experience of BS EN 1090? CE Marking (Conformité Européene) / CB Scheme 7
D Any experience with Target Corporation Audit of Factories Supplier Quality Assurance and other Supplier Issues 1
P MDD position on Final Inspection/Release Employee Experience/Training EU Medical Device Regulations 1
SteveK Technical Files Sections ? Have you the experience asks a NB? CE Marking (Conformité Européene) / CB Scheme 5
R Does any one have experience on Xinco software? Document Control Systems, Procedures, Forms and Templates 2
M Pursuing AEA (Aerospace Experience Auditor) Certification Professional Certifications and Degrees 2

Similar threads

Top Bottom