SOS! My company manufactures engineering parts and assemblies. Can anyone tell me some examples of statutory and regulatory requirements relating to quality.
So far most of them is related to environmental and safety.

Is the compliance to statutory and regulatory requirements need to be mentioned in the quality policy as a commitment by top mgt?

Hi and welcome to The Cove. :bigwave:

It is not so much which statutory and regulatory requirements are related to quality, as which are applicable to your product. We need to know a little more about what type of products you produce in order to help further. It could be that there are no statutory or regulatory requirements relating to your products.

Noe 1 a) of clause 1.1 states that the term product only applies to product intended for or required by the customer.

Should you put it in the quality policy? probably not the detail but 5.3 b) does mention a commitment to comply with requirements so a mention may be appropriate.

I presume that you are referring to section 7.2.1 Determiniation of requirements related to the product.

I use the following for guidance:
Product characteristic or process parameter which affects a product's safety or compliance with regulatory or statuatory requirements.

Regulatory quality can refer to regulations such as medical devices where the quality is obviously potentially a harm to human life. Another example might be the quality of the o-ring that brought down the Challenger might have violated a regulatory requirement. Or parts critical to proper functioning of emission control parts.

Statuatory requirements in quality can refer to an engineered part that would violate a law that is federal, state or local. I don't have any examples that I have run into here.

As to whether it must be part of the quality policy would, for me, depend on the actual products you are manufacturing. If they are critical to meeting a regulatory or statuatory requirement such as emissions control, I would include something to that effect.

An adder to this discussion so far would be that your organization must also determine the statutory requirements of your sell to market. Your company is located in Singapore and if it will be selling products and services in US or European markets you must also meet nationally imposed statutory requirements of these markets.

Thank you for the prompt reply.
My company is manufacturing precision parts and assemblies for vehicles such as ambulance, dump truck, parts for oil and gas industry etc. We make for local and also export to UK, USA, India etc.

We do not do design. Product characteristics pertaining to statutory requirements are already designed into the product. We manufacture and inspect accordingly. So what are the other applicable statutory reqdm that is needed to be addressed?

(Most of the statutory redm are pertaining to safety which is addressed in our EHS manual)

for our practice we mentioned the statutory and regulatory requirements needed in the contract review checklist

Our manual mentioned we will comply with the legal reqm but problem is we are not sure the statutory and regulatory reqdm relating to the quality of the product. Any examples to enlighten me?

Our manual mentioned we will comply with the legal reqm but problem is we are not sure the statutory and regulatory reqdm relating to the quality of the product. Any examples to enlighten me?

Don't mean to be rude, but you should know your product and the statutory and regulatory requirements in your country best. As an example, if you manufacture electrical cables then you should abide by the relevant PSB (or is it Spring now) standards for that particular cable that you manufacture.

Not all products are governed by any regulatory or statutory requirements and it is common practice to state in manuals that you will comply or abide by any statutory or regulatory requirements if any - who knows when they will be introduced or new ones added.

Our manual mentioned we will comply with the legal reqm but problem is we are not sure the statutory and regulatory reqdm relating to the quality of the product. Any examples to enlighten me?

I would suggest getting the lawyers to deal with this one - particularly for the foreign markets.

Also, there are some simple regulatory requirements (i.e., not from statute which has to pass through Parliament / Congress or equivalent) which will require advice from various agencies. E.g., there may be requirements for labelling on packaging material (instructions for use, disposal, safety, etc.) which vary from one jurisdiction to another.

If your company doesn't have the budget / doesn't see the need to involve lawyers, you can start by going to the foreign trade ministry/bureau/agency in your country and getting advice from them.

Remember - the legal requirements will be specific to the products your company provides in the markets which you serve.

Our manual mentioned we will comply with the legal reqm but problem is we are not sure the statutory and regulatory reqdm relating to the quality of the product. Any examples to enlighten me?

Recommend that you retain legal counsel to advise you regarding statutory and regulatory requirements associated to home and abroad markets. Not all S&R requirements are related to quality of the product. Some have to do with who you can sell to.

globalfrienz, to my knowledge there are no statutory requirements relating to quality perse'

As stated quite well in response to your request, your company must determine all the local, state, federal and international standards and mandates that are present in your particular business.

Additionally, these requirements must be considered when quoting potential business even if the customer doesn't call them out in the RFQ. You should appropriately list these requirements and associated costs in your BOE.

I was recently involved with federal requirements involving the transportation of prototype Laser equipment to Canada. We hadn't planned on that level of governmental oversite and justification but the exercise was worth it because we learned a great deal about this subject and now know what is expected of us.

You must know your market place requirements.

Bob

Thank you Bob and all those involved in the discussion.