At what stage do you review new product statutory / regulatory requirements?

[Andrews]

At what stage do you review the statutory / regulatory requirements required for any new product ? Is it during the pre-contract (quotation) stage or the contract review (during order acceptance ) stage?

What are the points you review during quotation and points reviewed during order acceptance stage.

 

[JodiB]

Personally, I wouldn't quote for a product without knowing exactly what I was dealing with, so I would review the req's at quotation stage. Why waste time preparing a quotation that may turn out to be invalid?

At any rate, you must review req's and determine that you can meet those req's prior to accepting the contract.

 

[johnnybegood]

5.1 Management Commitment, requires Top management to communicate to the organization the importance of meeting customer as well as statutory and regulatory requirements. What it meant by statutory and regulatory here and what objective evidence do I need to fulfil this.

 

[Graeme]

johnnybegood said:
... What it meant by statutory and regulatory here and what objective evidence do I need to fulfil this.

A statutory requirement is a law that you, your company or your product must comply with.

A statutory requirement is a government regulation that you, your company or your product must comply with. A regulation often implements a law, in much the same way that a procedure implements a policy.

Failure to comply with a law may result in a criminal penalty, and failure to comply with a regulation may result in a civil or administrative penalty.

What laws or regulations apply depend on where you are geographically located, and where your product is sold or used. That is all something that top management (or more likely the company lawyers) have to determine. Laws and regulations usually contain information about required records, or that information may be elsewere.

I work in a regulated industry (an airline) -- statutory and regulatory requirements are a way of life, and are always above the QMS and other company policy. Also, international treaties that apply are treated as statutory requirements.

 

[CarolX]

how did you?

johnnybegood said:

5.1 Management Commitment, requires Top management to communicate to the organization the importance of meeting customer as well as statutory and regulatory requirements. What it meant by statutory and regulatory here and what objective evidence do I need to fulfil this.

My question....

What have been the ways any of you have addressed OSHA regs? Is the safety policy sufficient to show management commitment?

Thanks,
CarolX

 

[ralphsulser]

We have just been certified (last week) to ISO 14001. We have a EHS Manager who is responsible fot this system.
Does this meet the statutory, and regulatory requirements?

 

[jalarson]

HELLO,

FIRST POST, I AM WITH AN ENGINEERING CONSULTANT COMPANY AND AS FAR AS STATUTORY/REGULATORY REQUIREMENTS WOULD I BE INCLUDING SOFTWARE LICENSING?

JALARSON

 

[Randy]

Ralph...No

Jalarson...Yes

Andrews...At the beginning of the planning process of product realization. Look at issues directly related to the product, the making of the product and the delivery of the product. There may be some requirements that are not specified in contracts or customer specifications that can effect the realization process and ultimately customer satisfaction.

 

[Kim bentley]

5.1 management commitment

I'm attaching a copy of a procedure i would like your opinion on how it stands up to the new standard. I hope this attachment makes. not sure how it works.

 

[Dearl]

I would have to agree with Lucinda. I want to know what I am working with before hand.