Ridiculously Underqualified and Need Some Guidance

greatwhitebuffalo

Involved In Discussions
I believe this is called a gap analysis. There might be a useful framework for it around here somewhere.
I suppose that's right, I found completing the exercise from scratch to be hugely beneficial in helping to understand what all the mumbo jumbo in the standard was actually talking about. Reading that thing for the first time just left me overwhelmed and confused. Getting down to the meat and potatoes of the intent was the biggest hurdle, and of course that continues whenever I have a new auditor with a different perspective.
 

Gwerner

Registered
I found myself in a similar position some years ago, but I was charged with implementation of the system. What helped me understand in practical terms how we complied with the standard was to make tables with the standard's requirements on the left, compliance in the middle (yes / no column) and evidence of compliance on the right (how we comply). This table also helped guide me through our first audits. Some quality manuals are set up in a similar fashion, with the clauses listed and how the company complies. Take it slow and one day it will "click". This forum has been an invaluable resource.
This is very helpful! Thank you!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Also, the context of the organization. What do you do that provides value so customers pay your mortgage on your house? Prepare to die on that hill.
 

FRA 2 FDA

Involved In Discussions
My answer is not from the perspective of a knowledgeable professional but from a person who was in a similar situation not that long ago. As @Golfman25 said, come here often and read. I devoted an hour a day to just combing through the forums and reading the threads diligently. I learned so much that I probably wouldn't have thought to ask (until it was too late, anyway) and I also avoided some instances of falling prey to common misperceptions/mistakes/pitfalls. You'll find a lot of really useful information here if you just come and read in a wandering, not very purposeful way. Good luck!
 

Nadaabo

Involved In Discussions
I work as office manager for a small machine shop and was put in charge of quality management. As an absolute beginner, but a relatively intelligent individual, where can I start with training? We are ISO 9001:2015 Certified, and I'd like to keep it that way!
@Gwerner , This is pretty exciting! congratulations! When I was moved from production to QA, I tried to read books and what nots. I finally decided to go to the local college and take a continuing education course on ISO9001. These are also offered by your registar as well. Best thing I ever did. They go in detail into each section to understand the intent of the standard and get ideas on how to implement it properly. The teachers are usually very knowledgeable in their field so you get pretty good examples from the industry. I also found that I can chat with them even after the class and they support and explain everything sometimes even after the class is over.

I would also read the quality policy manual (QPM). The ISO standard is the "thou shalt" document, states what a company needs to do to be compliant to ISO9001:2015. "Say what you do"
The QPM is the policy stating that the company follows the standard's requirements and point to specific processes or procedures as proof.
Then there are the lower tiered documents that you would be familiar with. The operating procedures/ SOPs/etc. These tell you how the company does the work. "Do what you say"

Good luck! we're all here to help.
 

Rob_Kellock

Involved In Discussions
All the above is good advice, but personally I am a fan of face-to-face training. 2 days of uninterrupted training in the standards and their implementation will give you a great starting point. And that's why I wouldn't do the same training online - it's all too easy to receive an important work call and mute the trainer while you take it. With those two days under your belt, reading the standards and any other resources will help reinforce and build on that initial training.
 

qusys

Trusted Information Resource
I work as office manager for a small machine shop and was put in charge of quality management. As an absolute beginner, but a relatively intelligent individual, where can I start with training? We are ISO 9001:2015 Certified, and I'd like to keep it that way!
In my opinion you need to have a plan for training about ISO 9001, quality tools, auditor training and stuff like that, also ojt with other expert personnel in your current QMS. You need a competences gap assessment with HR and based upon it, understand how to proceed, also taking into consideration the related activities you will support.
 

mattador78

Quite Involved in Discussions
I work as office manager for a small machine shop and was put in charge of quality management. As an absolute beginner, but a relatively intelligent individual, where can I start with training? We are ISO 9001:2015 Certified, and I'd like to keep it that way!
In 2018 i was told put my hand up and take two steps forward if i wanted to get off shifts and get a pay rise. Despeite following my former military mantra of never volunteer i caved. I found this place within a few weeks and Ive not looked back.
As ive already seen advised on here if you are already certified read your QMS and previous internal and external audits to see where you lie and what exemptions you may have from certain clauses. Get hold of the standard if you dont have one and there should be some gap analysis on here where you will be able to fill in the blanks youself as you educate yourself. Also cant stress enough if you need audit a process you are not familiar with walk through it with the operator or process owner, nothing worse than never doing the job then telling someone whos done it for years with no issues that there is a problem iwth how they do it. You are coming from the paperwork office side so that is where your strengths will lie, the production side is where you will need to intergrate yourself. I came from the other way around.
 
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