When does ISO require work instructions. I have in my quality manual that "Work instructions are written where the absence of such would affect the quality of the product or service." Is this sufficient enough considering we are a contract manufacturing company and can't get too specific about work instructions?

Thanks for the help!

As a general rule work instructions are required when the final product quality can be compromised if the work were performed differently.

Just think about that new bicyle you put together without following the assembly manual, or that home theater system you connected and the system did not function correctly.

Remember ISO does not tell you how to run your quality system. It does tell you what elements must be included, what procedures must be created and what records must be generated.

Work Instructions should be created when quality can be compromised if the work were performed differently. If you standard your operations the theory is that the outcome will be the same 99.9% of the time.

When does ISO require work instructions. I have in my quality manual that "Work instructions are written where the absence of such would affect the quality of the product or service." Is this sufficient enough considering we are a contract manufacturing company and can't get too specific about work instructions?

Thanks for the help!

Whenever and however you feel they are necessary, in my opinion.

The organization must decide which processes need specific work instructions. The only requirement is there are 6 minimum procedures required by ISO9001:2000. You will need to look at processes that could affect the outcome of your product(s) to your customer(s), and define them as required.

When does ISO require work instructions. It doesn't

I have in my quality manual that "Work instructions are written where the absence of such would affect the quality of the product or service." Is this sufficient enough considering we are a contract manufacturing company and can't get too specific about work instructions? If you think so, yes

Thanks for the help!

As stated by others, it's your decision or not to use work instructions or whatever else you wanna call something that provides guidance or gives direction on how to perform a task to achieve product conformity.

When does ISO require work instructions. I have in my quality manual that "Work instructions are written where the absence of such would affect the quality of the product or service." Is this sufficient enough considering we are a contract manufacturing company and can't get too specific about work instructions?

Thanks for the help!

If by 'contract mf' you mean that you get different jobs in, and some of them might require specific Work Instructs and some might not, one way of being clearer would be to assign responsibility for deciding that to one or more specific roles. Eg, the workshop supervisor/foreman decides when WIs are needed for a particular job. Is that done before work starts? when quoting? etc.

Then, instead of simply regurgitating words from the Standard, you're being clear about how & when you decide this.

Thank you, Thank you, Thank you!!!! I am so glad you posted this and there have been some great responses. I have been searching for these answers for a while now! This has helped ME out greatly!

:thanx:

Thank you, Thank you, Thank you!!!! I am so glad you posted this and there have been some great responses. I have been searching for these answers for a while now! This has helped ME out greatly!

:thanx:

Please let others know about this great resource. :bigwave:

Stijloor.

Hi,
WI that describe the actual production work to be done could be generic for the most common type of contract work you do. You didn't say what business you are in but let's say if it's electronics you could write a WI for board assembly , or cleaning, or SMT line setuo, and so on, which would not be specific to a specific PO but still make sure your work processes are controlled and uniform.
There is another type of WI or some call it SOP, that complement and provide greater detail to a top level procedure. Say you don't want a procedure to be overly lengthy and hard to read /follow, you write a general procedure in which you define what needs to be done and complement it with a WI or SOP that provides the nitty gritty of how to do what the procedure says.
Just my 2 cents
Willy

Hi,

Work instructions can be generic (Process specific) or item specific. It depends on the complexicity of your process

T S Rao

Just to add in clarifying requirements of ISO regarding work instructions.

ISO 9001 Clause 7.5.1 states:
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
a) The availability of information that describes the characteristics of the product,
b) The availability of work instructions, as necessary...


The use of the highlighted words suggest that ISO 9001 allows any company to identify for themselves those activities that will need to be written.:bigwave: