What system to use? Foundry in Malaysia seeking US Business

K

Keith_1975

#1
hi fellas, just a quick question. We are a foundry in Malaysia and are looking to deal with some american companies now our problem is that alot of the companies require some form of QC system in place, but from my little knowledge of this subject and the little research ive done ive found a fair amount of systems avalible and ive heard some bad reports over the qs9001 system in regards to not having anything to do with what the company does but more on paperwork, so my question is, what would be the best system to have if i wanted to deal with american companys ( most interest has been from auto industry or suppliers for the auto industry ) and knowing that we ourselves are a foundry. The other thing to remember is that being in Asia its a well know fact that you can buy qs9001 so i would like to stay away from that

Thanks for your time
 
Elsmar Forum Sponsor
W

wendy p

#2
Choosing a system

Hi Keith, this won't answer your question, but is just to let you know you are not alone. I am also in the dillema of finding the best system for our organisation (local government). After much searching on the internet I have found:

ISO9000:2000
Six sigma
Business Process Re-engineering
Baldridge - which is more of an assessment tool!?!
Investors in People
Systems Thinking

So far I have determined that ISO will be the way to go. However, if there is anyone else out there in a government organisation using something else, I would love to hear from you.



Wendy
 
J
#3
Keith,

First of all, welcome to The Cove. You have come to the right place. This is one of the most knowlegable (sp) and giving bunch of people on the web. Now on to your question.

If your looking at automotive, then QS-9000 is the current system. However I would suggest you look at ISO-9001: 2000 which is a good place to start. Also try to get a copy of TS16949 which is the new international automotive standard currently under development.

I am curious though. You stated:

"...our problem is that alot of the companies require some form of QC system in place."

Howare you currently controlling quality? Or are you refering to having a "Registered" system?


You also stated:

"...ive heard some bad reports over the qs9001 system in regards to not having anything to do with what the company does but more on paperwork."

While any formal quality system can increase the paperwork somewhat, there are good ways to hold it to a minimum and many benefits to be gained. QS-9000 requires a couple of processes (APQP and PPAP) that can be difficult to learn, but provide a structured and disciplined way to control your processes.
I would suspect that you will find that you have been doing a lot of the the things whitout even knowing it.

In the meantime bring your questions here. It's an excellent place to find answers. (sometimes lots of different ones.)

Good luck
James
 
J
#4
Wendy,

I think you are on the right track. I would suggest that you look at anything related to the service industry. After all, that is what goverment is (or, at least, should be):vfunny:

James
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
James,

Nice hearty endorsement of the Cove and its contributors!! Thanks!!

Keith and Wendy,

I'm with James on this one. Look at your respective industries and determine which System Standard best fits your needs. If you are aiming at the Auto Industry, then you will need to select one of the automotive tailored standard. Do you homework and look forward into the future. For instance, how long will QS9000 remain an active guideline? Is there a better choice, perhaps? If service oriented, would following the Baldridge Criteria help focus your program creation (note: you may win an award, if you're lucky, but you wont have a certificate or be registered)? Also, be careful about Six Sigma: it is a tool and not a system guideline. If you are creating a system, build it around organizational, customer, and system needs, not a tool.

From my perspective, Systems Thinking is the most expansive of all system creations. It is mostly a philosophy, but there are several books written on how to create a Quality Program/System (also note that you will not receive any type of Registration Certificate). It will take several years to create correctly (Dr. Kano estimates at least 3 years), but the rewards are of a much grander scale. Consider your organizations long-term plans/goals and the short-term requirements (i.e. you might be in a situation where you have less than a year to create and deploy a registered QS system and as such, might have to do interim work or risk plant closure).

No quick answers, folks, but as James noted, tell us more about the problems you face and drop us a line.

Regards,

Kevin
 

Atul Khandekar

Quite Involved in Discussions
#6
Keith,

I don't have much to add to the two excellent posts from James and Kevin here. Maybe first you can try to find out what your prospective customers require. If it's automotive, most probably they may ask you to certify to QS9000.

Paperwork is certainly involved but, no job is complete unless paperwork is done !

The other thing to remember is that being in Asia its a well know fact that you can buy qs9001 so i would like to stay away from that
Well..

All the Best!
-Atul.
 
R

Richard Flexton

#7
Local help !

Try contacting Partners-In-Quality Consultancy Sdn Bhd. 603-444-6812. They provide training and software to help with the process. They are approachable and while no consultant is cheap they are very good value and will undoubtedly save you in the long run - they will also help with "genuine" registration. I know several companies in Malaysia who have used them.
 
Thread starter Similar threads Forum Replies Date
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
D EQMS - When the internet or system might not be available ISO 13485:2016 - Medical Device Quality Management Systems 7
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 10
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
H Pedicle screw system Conformity Assessment Other Medical Device Related Standards 2
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7
K ISO 15223-1 Sterile barrier system - The 3-layer symbol EU Medical Device Regulations 1
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Starting an ISO 41001:2018 Facility management system Other ISO and International Standards and European Regulations 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
S CQI-23 - Molding System Assessment - Control of part weight IATF 16949 - Automotive Quality Systems Standard 5
D Classification of Syringe (nozzle) of needle free injection system. EU Medical Device Regulations 8
T Correct MSA study for an automated camera system which makes attribute inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
J Medical System with non-medical device and FCC US Food and Drug Administration (FDA) 5
B Include cost of quality (and other wastes) in an ISO 9001 system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 6
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 7
S Maintaining Equipment Records - We use a manual system ISO 17025 related Discussions 1
R Bottom up approach versus system level ISO 14971 - Medical Device Risk Management 2
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
Sidney Vianna Informational List of ISO Management System Standards Other ISO and International Standards and European Regulations 0
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
S Computer System Validation of Bioinformatics Pipeline Qualification and Validation (including 21 CFR Part 11) 5
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19

Similar threads

Top Bottom