API Q1 Validation in Europe

M

mkerton0120

#1
Hi :bigwave:
Does anyone know of a european API inspector/representative that can validate/mongram a QMS system to API Q1 ninth edition. The QMS system is being set up at a UK division. I have looked at the API web site and just about all other continents are covered but no mention of Europe! Any assistance/contacts appreciated.

Rgds
mark
 
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Sajith

Starting to get Involved
#2
M

mkerton0120

#3
Sajith
thanks for info, ive already got the conformity matrix and the QMS is looking good, but we all know what auditors are capable of;).

Rgds
Mark
 
D

DP561

#4
Mark,

I'm new here and in the UK. Did you get any more info with regards to your question. Have you had an audit yet?
 
M

mkerton0120

#5
Hi DP561
welcome to the uk! I am in the same situation as yourself. Q1 managment system to put in place from nothing, procedures, manual,training etc. i am also going for API 6A monogramming at the same time along with other specs in the future. I have not had an audit as yet as i am working alone! I planned for 3 months to do the procedures but looks like im going to run approx 3 weeks late due to other factors.
I have had contact from API directly who will audit your system, cost is dependant on the size of the company API Q1 also includes ISO 9001. There are auditors in the UK that will help you prepare but it will cost you.
API have been really helpful. If you complete your conformity matrix when your ready and send it to them they can advise. The conformity matrix is a really good tool to use to keep you on the right track.
I believe they are more rigorous now than compared to the past but it is in their interest also to point you in the right direction. My advice is get in touch with API directly for a quote and they will assist you all they can.

Rgds
mark
 
D

DP561

#6
Hi Mark,

Thanks for your fast reply. I've started keeping this forum open all day as it is such a good source of info.
I'm brand new to this area, my company employed the services of a consultant last year who produced 'something' in line with the API 8th edition (even though the 9th edition was published). Needless to say, I archived everything and started from scratch.
We have registered with API and have bought the 9th edition and I am slowly going through it now. I say slowly as the 'jargon' is all new to me.
I downloaded a copy of the conformity matrix and intend to start using it. When I am ready with everything and send it off to API, will they advise on any areas that need more work prior to them organising an audit, or do they just arrange an audit without any feedback on the matrix?
Regards,
Dave.
 
M

mkerton0120

#7
DP561
API will review your matrix and advise as they request you send a copy of the completed matrix prior to the auditing.
I found it much easier to base my quality manual by section so it is much easier to cross check against the conformity matrix.
for example : My Quality plan for control of documents is given the number QP 423 which refers to section 4.2.3 of API Q1, and the forms and work instruction also refers to this number ie F -423-001 etc. This make life a lot easier when tracking your documents at the start.
Theres also a lot of assistance on this forum just alter your search criteria and i found lots of good advice.


Rgds
Mark
 

lawcch

Involved In Discussions
#8
hi, everyone

It is a tough job if you want to start from a stretch. I am a consultant helping a company with the facility to get API 6A/ 6D.

There are many things you need to know and implement before you can start to do the API monogram audit, you need to have a QMS compliant to API Q1 system in place and fully implemented for at least 4 months. therefore, it is recommended that you need more time and efforts to do the API Monogram Licensee program as it requires organisation to have QMS based on API Q1 standard to be fully implemented. Then we can look at the detail requirements as per applicable API Spec. product standard or service standard.

You need to have all the relevant records as specified in API Q1 and API Spec 6A/6D.
Therefore, you need to know the real technical stuff here before you can implement the whole system as an overview.
creating master list for almost all the records and SOP documents or Quality Manual make life easier for reference and control.
your records can be in electronic copies and not only in hard copies.

All records related to QA/ QC must be signed off and dated. You have to define who is preparing , reviewed and approved.

Where possible, you must have a overall processes work flow in flow charting diagram to reflect all the 4 elements within the QMS processes: Management responsibility and leadership, resources management, product realisation (or valve manufacturing / valve maintenance servicing processes and Monitoring, measurement and improvement.

regard, Lawrence
 
#9
Sajith
thanks for info, ive already got the conformity matrix and the QMS is looking good, but we all know what auditors are capable of;).

Rgds
Mark
hello can you help me to fill API Q 1 Conformity matrix?
I need help about this its first time for me
If you have complete form it can be help me
thanks in advance
 
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