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Do we need an SOP for ISO 9001?

#1
Hello,
I'm new to both the Cove and the quality management field so I am hoping to get some input from the experts here.

I'm trying to get ISO 9001 for my company and one of the many advices I have gotten from talking to other quality managers from different ISO accredited companies is that we need to have proper procedures (I assume that requirement comes from Section 8.5 of ISO 9001:2015).

Currently my company has a "quality control manual" that outlines the responsibilities of each department and we have work instructions that provides the general steps for each incoming product to be made. We don't really have a formal "SOP Document" but do we need to make them for each department to satisfy ISO's requirements?

We don't have anything that would instruct the employees how to do their job per say, most of the people here have been working in their dept for 10+ years so they primarily know what to do via experience. The work instructions provides basic steps, like the sequence of steps but nothing too detailed.

Pardon my lack of understanding, I know my current level of understanding is very basic so I appreciate any insight and feedback.
 
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indubioush

Quite Involved in Discussions
#2
You need to set up processes at your organization that meet the requirements of ISO 9001. Some of these processes must be documented to comply with ISO 9001. The amount (quantity, detail) of procedures you need depends on many factors including the size and type of your organization. Since you are just starting to scratch the surface, you probably will need a consultant to help you implement your quality system. Where are you located? I might be able to help you.
 
#3
You need to set up processes at your organization that meet the requirements of ISO 9001. Some of these processes must be documented to comply with ISO 9001. The amount (quantity, detail) of procedures you need depends on many factors including the size and type of your organization. Since you are just starting to scratch the surface, you probably will need a consultant to help you implement your quality system. Where are you located? I might be able to help you.
Thank you for the offer, my company is a medium sized company (approx 65 employees) in the Los Angeles area. While I wish I could hire a consultant, my top management is not giving me a budget for one unfortunately.
 

indubioush

Quite Involved in Discussions
#4
I thought you might be in California. Maybe because of the "Westside." I'm in the SF Bay Area. I can still be a free resource to you. I will PM you.
 

Big Jim

Super Moderator
#5
Hi Teddy,

Need to have written procedures according to ISO 9001:2015?

NO!

ISO 9001:2015 did away with the term procedure and didn't replace it with anything.

What is required is that you be able to show that you understand the requirements of ISO 9001:2015 and be able to explain how you meet them. Written procedures may help with that, but it is up to you, the organization to determine if you want them and if so to create them.

Over documentation was a pitfall of earlier times in ISO 9001 history. Do all you can to keep from falling into that pit yourself.
 

indubioush

Quite Involved in Discussions
#6
To clarify, ISO 9001 does require "documented information." This is typically in the form of procedures and records. However, fully agree that any documentation needs to be value added for the organization. It is possible to comply with ISO 9001 with only policy documents and forms (that become records).
 

Big Jim

Super Moderator
#7
To clarify, ISO 9001 does require "documented information." This is typically in the form of procedures and records. However, fully agree that any documentation needs to be value added for the organization. It is possible to comply with ISO 9001 with only policy documents and forms (that become records).
You need to have another look at the standard. More than one. First of all read the appendix about what documented information is where it explains that documented information can be retained documented information and retained documented information. Maintained is documents. Retained is records.

The standared doew say that you need to retain and maintain the documented information required by the standard as well as any retained or maintained documented that the organization chooses to.

No where in the standard is there a requirement to maintain documented information for any procedures unless the organization chooses to do so.

Common practice may include having a quality manual (and I recommend one) and that you have some written procedures, but the standard does not require it! Be careful how much you decide to document or you will be overcome with overdocumentation as happened in the past.

Don't mislead the newbe.
 

Tagin

Trusted Information Resource
#8
I'm trying to get ISO 9001 for my company and one of the many advices I have gotten from talking to other quality managers from different ISO accredited companies is that we need to have proper procedures (I assume that requirement comes from Section 8.5 of ISO 9001:2015).

Currently my company has a "quality control manual" that outlines the responsibilities of each department and we have work instructions that provides the general steps for each incoming product to be made. We don't really have a formal "SOP Document" but do we need to make them for each department to satisfy ISO's requirements?
Documentation of processes/procedures does relate to 8.5, but also to 7.5.1b ("documented information determined by the organization as being necessary for the effectiveness of the quality management system"). I look at 7.5.1b as taking a 'risk-based' approach to documentation. If your product or service is fairly simple to produce, your staff has low turnover, etc., your documentation needs may be minimal for those processes. But where complexity comes into play, or there is too much to expect staff to reliably remember, etc., then more detailed process documentation, job aids, flowcharts, whatever, could be appropriate. You may also have customer or regulatory requirements for documentation in some areas.

At this early point, it would help to do a gap analysis. This would be where you list the clauses in one column; e.g.,
4.1
4.2
4.3
4.4.1
4.4.2
etc.

In the next column, write down how you currently address the requirements in that clause. This will give you a good perspective on where you need to address shortcomings, and spend your efforts.

I'd also say that's very useful to wrap your head around the PDCA concept of improvement. The structure of the standard describes this kind of big feedback loop, which is intended to promote continuous/continual improvement. It is shown in 0.3.2, but more typically I've seen it with PLAN as clauses 4-6, 7 straddles PLAN/DO, 8 as DO, 9 as CHECK, and 10 as ACT. Once you understand that PDCA structure, it will hopefully become more clear why the standard is organized as it is.
 

indubioush

Quite Involved in Discussions
#9
I agree with you, Big Jim. Procedures are not required; however, most companies decide that some procedures are necessary to support their quality system processes. A procedure can be a one-page flow chart. A procedure can be an appendix to a form that explains how to fill it out.
 
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