Where to Start to Implement ISO 9001

[siewkingbee]

Re: Design to be included or excluded?

Dear all,
Hi! I am very new to this forum... hope to get your feedback.
We are a trading company on skin care products. We do not do formulation on the ingredients of the skin care products however we design the lable for the bottles and packaging for the products according to customer's requirement.
Our scope of certification is sales of skincare product...
Do we consider design as part of our process so to include 7.3 element in our quality management system?

Need your urgent reply now.... Thanks so much....

 

[AndyN]

Re: Design to be included or excluded?

Dear all,
Hi! I am very new to this forum... hope to get your feedback.
We are a trading company on skin care products. We do not do formulation on the ingredients of the skin care products however we design the label for the bottles and packaging for the products according to customer's requirement.
Our scope of certification is sales of skincare product...
Do we consider design as part of our process so to include 7.3 element in our quality management system?

Need your urgent reply now.... Thanks so much....

Welcome to the forum. This is a topic which is often discussed. Two key questions to help give you an answer are:-

What does your customer contract with you to do? Design the labels, for example?
Do you offer the service of label design and have a process in place now?

If the answer to these is NO, then you can exclude design. You've also indicated that your scope is 'sales of skincare products', however you say you design labels - can you be clearer for us on what you actually do?

 

[Kees Kraaijeveld]

Re: Design to be included or excluded?

Dear all,
Hi! I am very new to this forum... hope to get your feedback.
We are a trading company on skin care products. We do not do formulation on the ingredients of the skin care products however we design the lable for the bottles and packaging for the products according to customer's requirement.
Our scope of certification is sales of skincare product...
Do we consider design as part of our process so to include 7.3 element in our quality management system?

Need your urgent reply now.... Thanks so much....

If you design/develop a new product it is yes. However I think that you should consider to see this as part of your production process. When you clearly set the responsibility for the decision points in this process there is no difference between development and production. For example: when you check and register if the input for the design complies with customer wishes (and regulations and your own standards) then this is exactly the same step as when you verify the inputdata for your production. Actually design is a process that needs to be considered like all other processes as a number of steps where after every step you check if you did everything the right way . So you may call it production if only you follow the basic ISO 9001 steps to assure that you do it right the first time.

 

[siewkingbee]

Re: Design to be included or excluded?

We import skincare material in bulk and send the bulk material to our out-source contractor. they will pack into smaller bottles and return the packed bottles to us.
We design the labelling as well as packaging of the bottles...
so we include 7.3 design in our quality management system?

 

[siewkingbee]

Re: Design to be included or excluded?

for me actually the design of the label is considered part our our services, right? I know we are selling the skincare product but at the same time, the packaging and labelling of the product is designed by us based on a few input from the client... so the conclusion is include or exclude 7.3 design & development?
I don think in ISO 9001 it clearly specifies what is considered as in desigining and development... either i exclude or include 7.3... i should still have a procedure to indicate my process of reviewing and approval...right??

 

[siewkingbee]

Re: Design to be included or excluded?

labelling and packaging of bottles... we import the skin care product in bulk and request an outsource to pack

 

[AndyN]

Re: Design to be included or excluded?

Welcome to the forum. This is a topic which is often discussed. Two key questions to help give you an answer are:-

What does your customer contract with you to do? Design the labels, for example?
Do you offer the service of label design and have a process in place now?

If the answer to these is NO, then you can exclude design. You've also indicated that your scope is 'sales of skincare products', however you say you design labels - can you be clearer for us on what you actually do?

If you answer these questions, you have your answer...

 

[John Broomfield]

Re: Design to be included or excluded?

We import skincare material in bulk and send the bulk material to our out-source contractor. they will pack into smaller bottles and return the packed bottles to us.
We design the labelling as well as packaging of the bottles...
so we include 7.3 design in our quality management system?

siewkingbee,

Yes, include your existing design process.

You'll probably find it already conforms to clause 7.3 if you look closely enough.

John

 

[Sidney Vianna]

Re: Design to be included or excluded?

We import skincare material in bulk and send the bulk material to our out-source contractor. they will pack into smaller bottles and return the packed bottles to us. We design the labelling as well as packaging of the bottles...
so we include 7.3 design in our quality management system?

According to this "official" interpretation, you must.

 

[AndyN]

Re: Design to be included or excluded?

According to this "official" interpretation, you must.

Sidney, I didn't read they designed the packaging - only that they design the label...hence my questions.

Saying they "We design the labelling as well as packaging of the bottles" could mean two things...only one of which is a preservation/packaging design responsibility.