Happy New Year to All
Those of you who have worked with both ISO and NQA systems, Are there similarities between the two? Is ISO superior to NQA? Our company's Quality Program is modeled around NQA-1 '97. What would be the benefits of converting over to ISO?
Thank you

Dan

Which ISO system(s)? ISO 9001 I assume?

Happy New Year to All
Those of you who have worked with both ISO and NQA systems, Are there similarities between the two? Is ISO superior to NQA? Our company's Quality Program is modeled around NQA-1 '97. What would be the benefits of converting over to ISO?
Thank you

Dan
the curse of using acronyms in any field is that confusion can reign when one does not give a proper referent as to WHICH meaning one intends.

Thanks to Marc, we know you are concerned with a nuclear situation, based on a Standard under the aegis of American Society of Mechanical Engineers.NQA-1 - 1994 Quality Assurance Program Requirements for Nuclear Facilities/with Addenda
List Price: $150.00
Description
Order #: A10594
ISBN #: 079182229X
Published: 1994
Product Type: Print-Book
No. of pages: 224
Description:
This part sets forth requirements for the establishment and execution of quality assurance programs for the siting, design, construction, operation, and decommissioning of nuclear facilities. Nonmandatory guidance is provided in the appendices.
Just offhand, I'd say I would feel more secure with a nuclear facility adhering to an industry-specific Standard than to the generic one-size-fits-all ISO9001:2000. I, personally, have only good things to say about ASME Standards.

Citing NQA-1 was the key.

Sorry for being so vague there fellas. Yes, I was referring to ISO9001. We are a small manufacturer/distributor of products used in Nuclear Facilities and applications. We are not a nuclear site. As I had posted back in November I have taken over the role of QA manager and while my first priority is getting the dept. to maintain some sort of effieciency, I'm also trying to look towards the future, short and long term
sorry again

Dan

Sorry for being so vague there fellas. Yes, I was referring to ISO9001. We are a small manufacturer/distributor of products used in Nuclear Facilities and applications. We are not a nuclear site. As I had posted back in November I have taken over the role of QA manager and while my first priority is getting the dept. to maintain some sort of effieciency, I'm also trying to look towards the future, short and long term
sorry again

Dan

I think you'll find that your nuclear customers are (not surprisingly) a bit more stringent than others, and it's conceivable that you might wind up needing both, depending on your customer base. Non-nuclear customers might not be familiar with the NQA-1 requirements, and in ignorance and a blind need to cleave to their own requirments, might expect ISO registration regardless of your NQA-1 compliance.

I think you'll find that your nuclear customers are (not surprisingly) a bit more stringent than others, and it's conceivable that you might wind up needing both, depending on your customer base. Non-nuclear customers might not be familiar with the NQA-1 requirements, and in ignorance and a blind need to cleave to their own requirments, might expect ISO registration regardless of your NQA-1 compliance.
Jim seems to be on the right track here. The key is: "What do your present and future customers expect of you?"

If you really want to select the best system, if any, to maintain registration for YOUR organization, you should survey your customer base to see what meets their criteria.

It may be they don't care about REGISTRATION, if you are compliant. It may be they realize you aren't dealing with nuclear materials directly and that NQA-1 doesn't really apply for the things you make and do.

Depending upon who the customers are, they may not care that much about ISO, either. Why create an additional layer of bureaucracy if none is necessary?

For a transport company I had to implement both.

For the material transported: the IAEA Safety Standards

For the material transporting : ISO 9001.

I used the Safety Standards to make improvements to the 'ISO transport' procedures. That way I had an 'inhouse' continual improvement...

Most customers were in demand of both standards, and for their product (IAEA SS) and for the transport service (ISO 9k).

Have to say there was less room for interpretation in the SS, which I prefer.

Converting to ISO ?....not for me, I rather like to work with straightforward directives...

We have both, ISO 9000 and NQA-1. What we have found is that the ISO program covers things like marketing; proposals; risk assessment which NQA-1 really doesn't. Then when we actually start quality-affecting work NQA-1 kicks in. Later we use ISO for things such as project closeout, customer satisfaction. Again, these are items NQA-1 does not address. Doing this we ensure that we have a quality program that manages all of our processes, not just product quality. One thing to remember is NQA-1 does not really apply until you have a contract and are starting to perform work and ends upon delivery and acceptance of the work product. ISO starts earlier and also continues past delivery.

There are several significant differences between the NQA-1 (1994/1995)/10CFR50 and ISO 9001:2008 quality systems. In general the NQA-1 requirements are specific and in some areas more stringent.

A fundamental difference is in the approach to the system. The ISO requires auditing of the QMS and against the elements of the standard. The NQA makes no reference to a comparison of the QMS back to the standard.

In my opinion it is much easier to add the ISO requirements to an existing NQA system than to try to modify an ISO Quality Management System (QMS) to meet the NQA requirements.

From what I have seen, most nuclear quality manuals repeat (parrot) the requirements of the NQA ands ISO standards in the Quality Manual and then explain how these requirements are applied in the procedures. I don't like this "old school" approach but it is what the customer expected and implied was required to quote on new jobs. We ended up with a 59 page quality manual that is not read by anyone but the customer's quality representative.

There are several ISO requirements that are different or not in NQA standard. I added the following items to our NQA-1 customer approved quality manual and have passed two subsequent ISO audits along with our own internal analysis.

5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4.1 Quality Objectives
5.4.2 QMS Planning
5.5.2 Management Representative
5.5.3 Internal Communication
6.1 Provision of Resources
6.2 Human Resources
6.2.2 Competence Training and Awareness (some differences here)
6.3 Infrastructure
6.4 Work Experience
7.3.1 Design and Development Planning (some diff from Design Control)
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7Control of design and development changes
7.4.1 Purchasing Process
7.4.2 Purchasing Info
7.4.3 Verification of Purchased Product
7.5.4 Customer Property
7.6 Control of monitoring and measuring equipment
8.2.1 Customer Satisfaction
8.2.2 Internal Auditing
8.2.3 Monitoring and Measuring of Processes
8.4 Analysis of Data
8.5.1 Continual Improvement

The NQA-1 has some unique requirements such as Qualification of Inspection, Test, Special Process, and auditing personnel, Indoctrination, commercial grade dedication, 10CFR21 Reporting, and QA records.

I will eventually put all of this together along with a tutorial on a web site so that others can get a look at the entire process.

In my case I was given only 6 months to make the changes from an ISO to NQA-1 QMS and to implement the changes. Usually you need 12-24 months. We passed the audit with about 20 minor findings, all tied to recent changes that were not fully implemented. Three months later we received a full approval and have quoted on several projects.

In my case I was given only 6 months to make the changes from an ISO to NQA-1 QMS and to implement the changes. Usually you need 12-24 months. We passed the audit with about 20 minor findings, all tied to recent changes that were not fully implemented. Three months later we received a full approval and have quoted on several projects.

Thank you for your information. You talk about passing audits and full approval. What sort of audit, and approval from whom? Your customer? Just wondering, thanks.

There are different requirements which are dependent upon your product or service, the standards invoked by the order, your organization, and your relationship with the nuclear material or nuclear material handler.

I should have been more clear about the specific application I was addressing.

The posting applies to suppliers and subtier suppliers of "safety related" products to the nuclear power industry. A safety related part or system, is one that if defective, can cause or contribute to causing a safety related incident such as one which prevents the safe shutdown of the reactor.

For a more precise definition go to the NRC reading room and look up 10CFR Part 50 and 21. The NQA-1 can be purchased from ASME.

The suppliers and sub tier suppliers must have quality systems which meet certain standards as invoked by the utility or purchaser. These are usually some combination of 10CFR50, NQA-1, and 10CFR21 among many other specifications.

Who Audits? Our customer audits us, we audit our suppliers

Now, each level is responsible for invoking the requirments in the quotes and purchase orders and for auditing their suppliers to the nuclear requirements. Next the NRC reserves the right to audit everyone in the supply chain.

Suppliers must show historical evidence of compliance to the requirements. When no supplier is available a process called "Commercial Grade Dedication" is used. Here you take a normal commercial grade product and perform at least one of four possible types of analysis. The analysis must conclude, with objective evidence, that the part will function properly as required. In a sense you are taking on the liability and relieving the supplier of the reporting responsibilities.

Approval? Comes from the customer who is confident, after the audit, that the company has been, is, and will contiue to be compliant. Now the company must then audit the sub-tier suppliers. Each time a company gets a new customer they will be audited by that customer.

There is no accredidation body, like the ISO, but there are some people out there that provide consulting and system auditing.

There are two organizations NIAC.org (suppliers) and NUPIC.com (utilities)

Type of Audit
You can look at the latest NUPIC audit (Rev 14) included here. It has some additional requirements but should give you an idea.

jgrumelot's postings are very helpful. To turn and ISO program into an NQA-1 program in six months is truly a challenge - congrats! My only feedback is to remember that ISO is a customer centric standard vs. NQA-1 which is a safety standard. That makes the focus and the level of detail much greater. I have found that it isn't so much as there are changes that need to occur in a program, but the level of rigor. In ISO the level of rigor is driven by the organization (or the customer if in some other regulated environment), whereas in the NQA-1 world the regulators drive the level of rigor. Again thanks jgrumelot for your insights.