Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards

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QAIntern9

#1
Hello! I am a college student working as a QA intern this summer with no experience in a manufacturing environment or with quality control.

I am working for a mid-size company that has a goal of obtaining ISO-9001 certification for the first time in the next 3-4 years. They currently employ a full-time Quality Director (my dad) and another quality empoyee at another plant location.

For the past three weeks I've been trying to learn the ISO standards and think of preliminary ways that they might apply to our company (where I have a whopping three weeks experience). :frust:

My dad pointed me here to Elsmar Cove to do some reading, and I am so thankful for the wealth of information, healthy debate, and years of experiential wisdom at my fingertips.

As I've tried to understand what QA is all about, I've pieced together my thoughts in a document attached below. I would greatly appreciate any comments, correction, kudos, tips, tricks, and insights you might have to help me achieve a better general understand the purpose and applications of QMS/ISO standards. :thanks:
 

Attachments

#2
Daddy's a smart man.

Do you have a copy of ISO 9001:2008? If not, you need to get it and read it. The questions will be plenty, even for those of us that have been doing this for a long time.
 

Kales Veggie

People: The Vital Few
#3
Nice job.

Somethings to think about and expand on in your cliff notes:

- process approach
- PDCA cycle
- processes and their interactions
- measuring process performance through metrics
- driving continuous improvement through setting objectives and tracking process metrics
- (not in the ISO 9001 standard) maturity of these processes

ISO 9001 is just one ISO standard. There are 1000s of ISO standard, so be specific when you mention ISO.
 

SmallBizDave

Involved In Discussions
#6
The overall tone of your paper is right on and your opening sentence is especially impressive. Many companies never get this. I've seen companies that are certified to ISO9000 or AS9100 or other related standards and their quality system does nothing to improve quality. Likewise, it is possible to have great quality without getting certified to any standard.

Certification provides credibility to your customers that you take quality seriously. The key will be to build your system in a way that meets the standard AND improves quality. The standard provides great flexibility to implement processes in a way that provides value to your business. If you find yourself implementing a process or form ONLY to meet a requirement of the standard there is probably a better way to implement it that provides better value.

I used a consultant to help design my first system but discussion boards such as this can go a long way toward getting your questions answered to make sure you're headed in the right direction. Focus on implementing quality processes to solve real problems within your company and you'll have a great system.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
As I've tried to understand what QA is all about, I've pieced together my thoughts in a document attached below.
The best piece of advice that I can offer you is an epiphany I had several years ago and many organizations struggle with the concept.

The quality system is NOT the system of the quality department, but, instead, the quality component of the BUSINESS PROCESSES of the organization. The sooner an organization understands that and make everyone in the organization co-accountable to the conformity of goods and services and customer satisfaction, the better.

Even ISO TC 176 SC 2 WG 24 saw the light :tg:
In the ISO 9001:2015 Committee Draft they now state:
Top management shall demonstrate leadership and commitment with respect to the quality management system by

c)ensuring the integration of the quality management system requirements into the organization?s business processes;
:agree1:
 
C

CarolinaQ

#9
I so agree with Sidney! The QMS should NOT be considered something the Quality Manager or the Quality Department owns - it needs to be embraced by the business process owners (and the whole team, actually) as "how they do business". A company needs to identify and understand its processes (inputs, outputs, controls, etc.), and have process owners that accept and drive ensuring their processes meet their QMS requirements. To be truly successful with your QMS, it can't be treated as "seperate entity". Good luck!

And, thanks for the excerpt from the 2015 draft - like seeing that!
 

Ninja

Looking for Reality
Trusted
#10
I always just figured people put the verbal pause in the wrong place...

Quality management system is not a system that manages quality (Quality-management ... system)

Quality management system is the system that Management (those of any quality) use.

It is the Quality(<--adjective, not noun) Managers who build a productive and effective system. and one would hope that the folks up top have some beneficial qualities.

Writing the same words over and over...I can't seem to say the emphasis correctly through the keyboard...I hope that made sense up above...:cfingers:
 

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