CSA N299.1-16

Preface

This is the first edition of CSA N299.1, Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 1.

The CSA N299 series of Standards defines a consistent set of quality assurance program requirements for the provision of items and services for nuclear power plants.

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. The Canadian Nuclear Safety Commission (CNSC) can therefore impose additional requirements to those specified in this Standard.

The CSA N-Series Standards provide an interlinked set of requirements for the management of nuclear facilities and activities. CSA N286 provides overall direction to management to develop and implement sound management practices and controls, while the other CSA Group nuclear Standards provide technical requirements and guidance that support the management system. This Standard works in harmony with CSA N286 and does not duplicate the generic requirements of CSA N286; however, it may provide more specific direction for those requirements.

The following people made valuable contributions to the development of the seed documents for the N299 series of Standards: G. Cairns; L. Colligan; A. Galati (COG); N. Gaudani (COG); S. Harris (Ontario Power Generation); P. Karsten (Bruce Power); W. Kettle (Ontario Power Generation); J. Lopez (Bruce Power); M. Pletosu (Ontario Power Generation); D. Rowland (Bruce Power); and M. Small (Ontario Power Generation).

This Standard was prepared by the Subcommittee on Quality Assurance Program Requirements for Supply of Items and Services for Nuclear Power Plants, under the jurisdiction of the Technical Committee on Management Systems for Nuclear Facilities and the Strategic Steering Committee on Nuclear Standards, and has been formally approved by the Technical Committee.

0 Introduction

0.1 Background

The CSA Z299 series of Standards (referred to collectively as "CSA Z299") was selected by Ontario Hydro and AECL in the 1970s as the quality assurance standard for the procurement of items and services for their nuclear facilities. As a result, the CSA Z299 Standards were embedded in the design bases of all nuclear power stations and some utility-owned nuclear facilities licensed in Canada, and continue to be used. These Standards were initially developed from Ontario Hydro quality standards and contained many of the requirements that were in force at that time. When the CSA N286 series of Standards were developed in the late 1970s, they referenced CSA Z299 as the recommended quality assurance standard for items and services. CSA Z299 was a commercial standard used broadly both nationally and internationally, and it was the pre-cursor to development of the ISO 9000 series of Standards. With the development of ISO 9001 in 1994, ISO 9001 became the commercial quality standard that was generally adopted by industry. CSA Z299 was no longer supported by the Technical Committee in charge of CSA Z299, and it was eventually withdrawn.

Internationally, there have been mixed approaches to creating industry-specific QA standards, such as augmenting ISO 9001 or creating completely new standards. CSA Z299 has not been issued since 1985 and needed to be updated to reflect current needs. To fulfill this need, nuclear utilities have developed, through a joint COG project, a set of graded standards that align with the withdrawn CSA Z299 series so that the impact to the design basis and content transition to the new standards is minimized. These graded standards were used as the seed documents for the new N299 series of Standards, which incorporates operating experience and current best practices and harmonizes, to the extent possible, with other standards (both national and international).

0.2 Category series

This is the first in a series of four standards for the four quality assurance program categories (Category 1 to Category 4).

This Standard was developed in response to industry need for a quality assurance standard for items and services supplied to nuclear power plants.

1 Scope

1.1

1.1.1

This Standard defines minimum requirements for a supplier's quality assurance program (hereafter referred to as "QA program") for existing nuclear power plants - Category 1.

Notes:
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 E).

2) This Standard may be used by other nuclear facilities.

1.1.2

The QA program is aimed primarily at being preventive by controlling design and production processes, as well as inspection and test verifications, and developing corrective actions that

a) ensure items or services conform to specified requirements;

b) maintain control and verify 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.

1.2

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.

1.3

1.3.1

The requirements of this Standard apply to the control of the use of software employed in the operation of process, production, inspection, and test equipment.

1.3.2

This Standard does not apply to the design, use, development, or coding of analytical software. Note: When a QA program is needed for these aspects, then a standard written specifically for them should be used.

1.4

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.