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This is the second edition of CSA N299.1, Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 1. It supersedes the previous edition published in 2016.
The CSA N299 series of Standards defines quality assurance program requirements for the provision of items and services for nuclear power plants when specified in the contract between the customer and the supplier.
The most significant updates to this edition include
a) the addition of requirements on dedication in Clause 8;
b) the revision of Annex E to provide guidance on counterfeit, fraudulent, and suspect items (CFSIs);
c) the addition of Annex F to provide guidance on risk evaluation; and
d) the addition of Annex G to provide guidance on records.
This Standard has also been restructured and reordered for better readability.
Users of this Standard are reminded that civilian nuclear facilities in Canada are subject to the provisions of the Nuclear Safety and Control Act and its Regulations.
This Standard defines minimum requirements for a supplier’s quality assurance program (hereafter referred to as QA program) for the supply of items and services to nuclear power plants — Category 1.
1) This Standard does not include a separate implementation guide; instead, relevant guidance is found throughout the Standard as notes, or within the relevant annex (see Annexes B through G).
2) The requirements in this Standard do not restrict or specify the form that suppliers’ programs should take; nor do they specify how to establish such programs. The requirements only specify what these programs cover; they allow suppliers to determine how their programs should be structured in order to suit their own situations and objectives. The onus is on suppliers to develop programs in a consistent and systematic way that allows customers, recognized qualifying authorities, or regulatory authorities to survey and audit the programs.
3) This Standard may provide guidance for nuclear facilities other than nuclear power plants. The operators of these facilities may determine the applicability and suitability of this Standard.
The QA program is aimed primarily at preventing nonconforming conditions by controlling design, production, and verification processes, and by developing corrective actions that
a) ensure items or services conform to specified requirements;
b) maintain control of, and confirm compliance to, quality and customer requirements; and
Note: Typically, customer requirements are found in the contract between the customer and the supplier.
c) readily detect and control the disposition of nonconformances and prevent their recurrence.
This Standard applies to suppliers and subsuppliers when specified by the customer.
Note: Other QA program standards or management system standards may be used provided that the requirements of this Standard are met.
In this Standard, shall is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; should is used to express a recommendation or that which is advised but not required; and may is used to express an option or that which is permissible within the limits of the Standard.
Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.
Notes to tables and figures are considered part of the table or figure and may be written as requirements.
Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.
Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 1