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Re: Seeking an API Q1 Quality Manual Example - Trying to convert an existing ISO 9000
Hey Cool,
I'm happy to know that the info helped! That's what the Cove is all about.
In terms of how our documents are structured, we're ISO 9001 certified, and API is ISO 9001 based with a handful of special requirements attached, so we just used the typical ISO doc structure:
Tier 1 = QA Manual with the basic policies stated
Tier 2 = Procedures that start fleshing out the policies, especially those that are cross-departmental in nature
Tier 3 = Work instructions that give the job-specific step-by-step directions on what to do
Tier 4: Forms, Logs, Meeting minutes, etc that provide the objective evidence that you did what you say you were going to.
If you're just starting out and you're a smaller company, you may not need the formal structure I described. Some small companies have a short QA Manual and go right to job specific instructions. And those do not need to be written documents. You can take pictures, do videos, or flow charts, depending on how complicated your work process is. I'd make it simple, as long as you can map each section of Q1 to your procedures, (Q1 actually requires that you do that as a part of getting certified) then you'll be fine.
And don't be afraid to call them and ask questions. I have. They can't tell you how to do things, but they can help you understand how they would view a situation. For example, we have a plant in Mexico that makes some parts for us, and they are Q1 certified also. However, because the design control is handled from the US in my plant, they were stressing over the need to have copies of all our design files. A call to API helped us straighten out the issue without havinf to copy design files, and to the satisfaction of the two different auditors that visit us.
Good luck. Feel free to ask any other questions that arise and I'll do my best to help.
Hey Cool,
I'm happy to know that the info helped! That's what the Cove is all about.
In terms of how our documents are structured, we're ISO 9001 certified, and API is ISO 9001 based with a handful of special requirements attached, so we just used the typical ISO doc structure:
Tier 1 = QA Manual with the basic policies stated
Tier 2 = Procedures that start fleshing out the policies, especially those that are cross-departmental in nature
Tier 3 = Work instructions that give the job-specific step-by-step directions on what to do
Tier 4: Forms, Logs, Meeting minutes, etc that provide the objective evidence that you did what you say you were going to.
If you're just starting out and you're a smaller company, you may not need the formal structure I described. Some small companies have a short QA Manual and go right to job specific instructions. And those do not need to be written documents. You can take pictures, do videos, or flow charts, depending on how complicated your work process is. I'd make it simple, as long as you can map each section of Q1 to your procedures, (Q1 actually requires that you do that as a part of getting certified) then you'll be fine.
And don't be afraid to call them and ask questions. I have. They can't tell you how to do things, but they can help you understand how they would view a situation. For example, we have a plant in Mexico that makes some parts for us, and they are Q1 certified also. However, because the design control is handled from the US in my plant, they were stressing over the need to have copies of all our design files. A call to API helped us straighten out the issue without havinf to copy design files, and to the satisfaction of the two different auditors that visit us.
Good luck. Feel free to ask any other questions that arise and I'll do my best to help.