Non API products need to comply to API Q1?

#1
Hi all. Need advise on this and hope friends over here will be able to help.

My company has API Q1 certificate and understand that for API manufacturing or repairs, we need to comply to API Q1 Quality Management System.

However, we also do manufacturing for non-API products for general industries. Thus will like to know if :-

1) for non-API manufactured products, do we also need to comply to API Q1 requirements?

2) for non-API products, are we able to purchase from raw materials from suppliers who did not submit the API vendor qualification questionnaire?
 
Elsmar Forum Sponsor

jmech

Trusted Information Resource
#2
This is a question that you should ask APIQR to ensure that they interpret it the same way as you do and to ensure that your scope is clear enough.

Generally, APIQR will expect you to conform to API Q1 requirements (including supplier qualification) for all products intended for use in the oil & gas industry. For example, if you make a valve intended to be used in oil & gas applications, you need to meet all API Q1 requirements for that valve, regardless of whether it is an API 6A valve or not or whether it is API monogrammed to any standard. However, if you also build valves for water utilities (not oil & gas industry related), you should be able to exclude these from your API Q1 registration scope and then you would not have to meet any API Q1 requirements (including supplier qualification) for these water valves.

If you want to exclude any products from your Q1 registration scope, I recommend being very clear with APIQR about it and getting their approval for the exclusion. As well, you will likely need to demonstrate that your system is effective at applying the correct requirements for in-scope and out-of-scope products (for example, your system is set up so that you will only use vendors that you qualified per API Q1 for any materials incorporated in your oil & gas products).
 
#3
Hi Jmech,

Your understanding is correct. There are products that we manufacture which are not intended for Oil & Gas industry.

Thanks for your advise and will check with APIQR. Appreciated.
 

lanley liao

Involved In Discussions
#4
Hi, Guys,
I think that Jmech is very right. I have encountered a question that the API asks the auditor to audit the non-API products in the audit report, unless which is not the sope of your QMS registered.
 
Thread starter Similar threads Forum Replies Date
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 25
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
J API Q1 - Control of Non-Conforming Product - Use-As-Is or Repair Dispositions Oil and Gas Industry Standards and Regulations 2
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 29
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
D IATF 16949 SI 10, External non-accredited lab IATF 16949 - Automotive Quality Systems Standard 4
M Selling non-CE marked devices for evaluation EU Medical Device Regulations 4
L "Shelf-Life" Class I Non-Sterile Products Expiration Date? CE Marking (Conformité Européene) / CB Scheme 3
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
N How to find column number for the last non-empty column? Using Minitab Software 0
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
3 Non-conformance Register vs Corrective Action Register ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
G Competent Authority non-EU Manufacturer EU Medical Device Regulations 7
F Non conforming locked? Manufacturing and Related Processes 13
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
G Not accepting a non conformity during an audit General Auditing Discussions 11
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 4
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
G Team to analyze a non conformance Customer Complaints 26
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
P Ppk results shown as asterisk after the transformation of Non-normal data Using Minitab Software 4
I When is necessary to have RoHS declaration on non-electrical parts? REACH and RoHS Conversations 1
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1

Similar threads

Top Bottom