API Q1 Quality Manual / ISO 29001 - 7.3 - The need for "Control Features"

V

ValveNerd

#1
Hello all,

I'm trying to make a Q1 manual so my company can get 6D approval at our factory in china. Problem is we don't do design and development but according to Q1 we need "control features" for it.

How do I address this in my Q manual?

There is an old post with a sample Q1 manual I have seen here: (elsmar.com/Forums/showthread.php?t=11885&highlight=api)

Could I use the same text from that manual and then address the fact that we outsource D&D but we use the following XYZ procedures in order to verify / validate the designs we have bought?

And to what detail do I have to go into in explaining that. Can I just say "we perform the following tests on X% of new designs until we have determined the design works for to suit the needs of our customers, and that any changes to the design will receive the battery of tests and records of the changes will be kept".

Does that work? :confused:

thx!
 
Elsmar Forum Sponsor
V

ValveNerd

#3
Re: API Q1 Quality Manual / ISO 29001 - 7.3

Read that one. It's dealing with the fact that I don't actually our company doesnt actually do the D&D which must be controlled as per Q1. Rosie is helping me out, she's on all these Q1 posts!
 
V

ValveNerd

#5
Re: API Q1 Quality Manual / ISO 29001 - 7.3

oh jeez can't they slowdown with these changes already?! Thx for the heads up.
 
P

pipethredr71

#6
Re: API Q1 Quality Manual / ISO 29001 - 7.3

i am trying to obtain an API qi monogram cert. for our company. we will be under spec 7-1. how/ where could i find an example of a quality manual of another 7-1 company? im trying to keep it as short and sweet as possible. also ive seen where you can purchase template software of a QM.any thoughts, knowledge, or previous experience about this would be greatly appreciated : )
 
M

mani.venkatesh

#7
Re: API Q1 Quality Manual / ISO 29001 - 7.3

May be, I can be of some help to specific queries about writing an API specific QM
 

Stijloor

Staff member
Super Moderator
#8
Re: API Q1 Quality Manual / ISO 29001 - 7.3

May be, I can be of some help to specific queries about writing an API specific QM
You can post an example of an API specific Quality Manual. ;)

If not possible, you can refer possible "queries" to your profile....

Stijloor.
 
T

tbsajeev

#9
Re: API Q1 Quality Manual / ISO 29001 - 7.3

Hi

I joined a oilfield company recently and they assigned me to devolop quality management system in accordance with apiq1 to get monogram right as well iso 9001/29001 certification for the company. I have the idea about the manual but can anybody assist me in the level 2 documentation. Please tell how i have to deal with control feautues?

sajeev
 

Stijloor

Staff member
Super Moderator
#10
Re: API Q1 Quality Manual / ISO 29001 - 7.3

Hi

I joined a oilfield company recently and they assigned me to devolop quality management system in accordance with apiq1 to get monogram right as well iso 9001/29001 certification for the company. I have the idea about the manual but can anybody assist me in the level 2 documentation. Please tell how i have to deal with control feautues?

sajeev
Welcome to The Cove! :agree:

Well, what you just decribed, takes a heck of lot more than just composing "The Manual" and "Level 2" documentation. I strongly recommend that you attend formal training in the understanding and implementation of the mentioned quality management system standards. We can help, but without a decent understanding of what this takes, I am afraid that you are going to be faced with a lot of difficulties.

Any thoughts?

Stijloor.
 
Thread starter Similar threads Forum Replies Date
H Updating Quality Manual to API Q1 Service Industry Specific Topics 6
F Quality Manual Updates - ISO 9001:2015 and API Q1 9th Editition Quality Management System (QMS) Manuals 14
S What is the difference between an API Q1 and API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 5
S Sample Quality Manual which complies with API Spec Q1 Ninth Edition Oil and Gas Industry Standards and Regulations 17
C API Q1 Quality Manual Example - Trying to convert an existing ISO 9001 QMS Oil and Gas Industry Standards and Regulations 30
D API 5CT Compliant Quality Plan for Manufacturing Manufacturing and Related Processes 0
J Add API Q1 & Q2 to Quality Management System Standards Oil and Gas Industry Standards and Regulations 1
K Quality Asssurance in an API Manufacturer Manufacturing and Related Processes 1
I Contingency Plan that meets requirements of API Q1 Quality Management System Other ISO and International Standards and European Regulations 3
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
U API License Agreements Oil and Gas Industry Standards and Regulations 2
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
R American Petroleum Institute - Becoming an API Auditor Professional Certifications and Degrees 2
B There is an estimated date of release of API Q1 10th edition? Oil and Gas Industry Standards and Regulations 8
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
lanley liao The validity of API Spec Q1 certificate Oil and Gas Industry Standards and Regulations 2
R [ASK] API Q1 Ninth Edition, Section 5.4.5 Oil and Gas Industry Standards and Regulations 4
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
S API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
S API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 10
S API spec Q1 9th edition - Castings & Forgings Oil and Gas Industry Standards and Regulations 4
N API spec Q1 9th edition Oil and Gas Industry Standards and Regulations 2
lanley liao How to understand the term 3.1.21 'Servicing' and the clause 5.7.1.2 'Servicing' of API Spec Q1? Oil and Gas Industry Standards and Regulations 19
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
M API Spec. Q1, 8th Ed. Section 7.5.2 vs. Q1, 9th Ed. Section 5.7.1.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
A API Spec Q1 9th Edition # Re-audit - Disputing with API AARs Oil and Gas Industry Standards and Regulations 1
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
K Supplier re-evaluation (API Q1) Manufacturing and Related Processes 8
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
S Can we integrate both ISO 9001:2015 and API Q1 Management System Standards Quality Management System (QMS) Manuals 11
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12

Similar threads

Top Bottom