10 CFR 50 Appendix B: A Clear Guide to the 18 Criteria

10 CFR 50 Appendix B is the regulation. NQA-1 is the standard people actually build
their quality assurance programme from. Suppliers new to nuclear work routinely confuse the two, and
the confusion is expensive, because the regulation is what binds you and the standard is only one
accepted way of satisfying it.

What 10 CFR 50 Appendix B requires

Its full title is Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing
Plants. It sets out eighteen criteria, numbered I to XVIII, that a quality
assurance programme must satisfy. It is short — a few pages — and it is deliberately
written as criteria rather than as a method.

Read that list next to ISO 9001 and the family resemblance is obvious. Read it carefully and the
differences are the point: procurement document control, control of special processes and inspection
and operating status are all called out as criteria in their own right, which tells you where the
regulator’s attention sits.

How NQA-1 relates to 10 CFR 50 Appendix B

Appendix B says what a programme must achieve. It does not say how. ASME NQA-1 is the consensus
standard the industry wrote to fill that gap, and its structure maps onto the eighteen criteria
closely enough that most nuclear QA programmes are written to NQA-1 and cross-referenced back to
Appendix B.

The link is made formal by the NRC through Regulatory Guide 1.28, which endorses
specified editions of NQA-1 as an acceptable means of complying with 10 CFR 50 Appendix B, subject to
stated exceptions and clarifications.

Here is the detail that catches people out. RG 1.28 Revision 6 extends NRC endorsement to
NQA-1-2017, NQA-1-2019 and NQA-1-2022. ASME’s current published edition is NQA-1-2024. Being
on the newest ASME edition therefore does not automatically mean being on an NRC-endorsed one, and
that gap is real: it is not an error in either document, it is simply the lag between a standards body
publishing and a regulator endorsing.

This is the practical reason our guide to
which NQA-1 edition binds you insists that the answer
comes from your licensing basis, contract or customer flow-down rather than from ASME’s catalogue.

The endorsement is conditional, not blanket

RG 1.28 endorses NQA-1 “subject to the exceptions and clarifications” the NRC sets out.
A programme that says “we comply with NQA-1” and stops there has not addressed those
conditions. Read the regulatory guide alongside the standard, and record in your programme document
how each exception is handled.

What 10 CFR 50 Appendix B means for a supplier

Most organisations meeting 10 CFR 50 Appendix B for the first time are not licensees. They are
suppliers, and the regulation reaches them through the purchase order rather than directly. Three
consequences follow.

• You inherit the criteria that apply to what you supply. A supplier of
  safety-related valves lives inside criteria III, VII, VIII, X, XI, XV and XVII in a way a training
  provider does not. The scope discussion happens with the customer, in writing.
• 10 CFR Part 21 comes with it. Part 21 requires the reporting of defects and
  noncompliances associated with basic components, and it reaches suppliers and consultants, not just
  licensees. It carries individual as well as corporate obligations, which is not true of most quality
  regimes.
• Commercial items need dedicating. Nothing bought off a commercial catalogue
  arrives with Appendix B pedigree. Turning it into something usable in a safety-related application is
  the discipline of
  commercial grade dedication,
  and it is where suppliers new to nuclear spend most of their learning curve.

Where to start with 10 CFR 50 Appendix B

1. Establish scope in writing. Which criteria apply to what you supply, agreed with
   the customer, before any documentation is written.
2. Find the binding edition. Which NQA-1 edition does the licensing basis, contract
   or flow-down invoke — and is it one the NRC has endorsed for that application?
3. Read RG 1.28 with the standard. The exceptions and clarifications are part of the
   compliance case.
4. Write the Quality Assurance Program document first. Auditors read it first, and
   everything else references it.
5. Cross-reference every procedure to a criterion. A traceability matrix from
   Appendix B criterion to NQA-1 requirement to your own document is the artefact that makes an audit
   short.
6. Stand up Part 21 and commercial grade dedication early. Both take longer than
   expected and both are scrutinised hardest.

What an ISO 9001 system already gives you, and what it does not

Most organisations approaching 10 CFR 50 Appendix B for the first time hold ISO 9001. It is a
genuine head start, and being precise about how much of one prevents both over-confidence and wasted
rebuilding.

The honest summary is that an ISO 9001 certificate supplies perhaps half the management system and
none of the nuclear-specific disciplines. Treat the overlap as reusable and the remainder as the real
scope of work.

The DOE route is a different regulation

Not every organisation encountering nuclear quality assurance is inside the NRC’s remit. Work for the
Department of Energy runs under 10 CFR 830 and DOE O 414.1 rather than under 10 CFR 50 Appendix B, with
its own criteria and its own endorsement of NQA-1. The disciplines are recognisably the same family,
and the documents that invoke them are not interchangeable — so establish which regime you are in
before writing a quality assurance programme that cites the wrong one.

Frequently asked questions

How many criteria are in 10 CFR 50 Appendix B?
Eighteen, numbered I to XVIII, from Organization through to Audits.

Does an ISO 9001 certificate satisfy 10 CFR 50 Appendix B?
No. ISO 9001 is a genuine head start on document control, records, audit and corrective action, but it
does not reach design control at nuclear depth and has no concept of commercial grade dedication.

Is NQA-1 mandatory?
Appendix B is the requirement; NQA-1 is an accepted means of meeting it, endorsed by the NRC through
Regulatory Guide 1.28 for specified editions and subject to exceptions. Your contract or licensing
basis is what makes a particular edition binding on you.

Which NQA-1 editions does the NRC currently endorse?
RG 1.28 Revision 6 endorses NQA-1-2017, NQA-1-2019 and NQA-1-2022, with exceptions and clarifications.
ASME’s current published edition, NQA-1-2024, is newer than the endorsed set.

Does 10 CFR 50 Appendix B apply to small modular reactors?
The Appendix B framework applies to the licensing of production and utilization facilities, and SMR
developers and their supply chains are working inside it. ASME states NQA-1 applies to all large light
water reactors and to future advanced reactors including SMRs.

Where this leaves you

Keep the two documents in their proper places and most of the confusion disappears. 10 CFR 50
Appendix B is the regulation, with eighteen criteria and no method. NQA-1 is the method, endorsed for
specified editions and subject to the NRC’s exceptions. Your contract or licensing basis is what makes
a particular edition binding on you, and it will not always be the newest one ASME has published. Get
those three facts written down at the start of a programme and every later argument about scope,
edition and evidence becomes a short one.

References

• 10 CFR Part 50, Appendix B — Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, on the eCFR.
• NRC Regulatory Guide 1.28, Revision 6 — the NRC’s endorsement of NQA-1 editions, with exceptions and clarifications.
• ASME NQA-1 — the standard’s catalogue entry.

More on nuclear quality assurance

• 10 CFR 50 Appendix B — you are here
• NQA-1 and which edition binds you
• Commercial grade dedication
• NQA-1 software quality assurance
• The graded approach in NQA-1

All of these are covered by the NQA-1 Toolkit, or start with the free ISO templates.