CSA N299.2:19 Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 2.
3 Definitions The following definitions shall apply in this Standard: Authority having jurisdiction (AHJ) — the organization having jurisdiction over the design, procurement, fabrication, installation, testing, operation, inspection, maintenance, and decommissioning of a nuclear facility. Authorized distributor — a distributor authorized by a manufacturer to conduct transactions and distribute an item within the terms of a distribution agreement. Note: Other distributor(s) are considered unauthorized distributors/brokers. [Source: Adapted from SAE AS6496] Batch (or volume or lot) — an identifiable collection of items, or quantity of material, of a single type, grade, class, size, or composition produced in the same facility under essentially the same conditions and at essentially the same time. Business — an organizational entity with accountability to implement some or all of the requirements of this Standard. Calibration — comparing two instruments, measuring devices, or standards, one of which is of known accuracy. Note: It is done to detect, correlate, report, or eliminate by adjustment any variation in accuracy of the instrument or measuring device of unknown accuracy. Characteristic — any distinct property or attribute of an item, process, or service that can be described and measured to determine conformance and nonconformance to specified requirements.
Configuration management — a process that
a) establishes consistency between design requirements, physical and operational configuration, and documentation and records;
b) maintains configuration management element consistency from initial conception to cessation of operations;
c) maintains alignment of safety and design analysis with item configuration;
d) facilitates safe operations; and
5 QA manual
The supplier shall
a) prepare a QA manual approved by top management; and
b) submit the QA manual and the subsequent revisions to the customer for evaluation, unless otherwise agreed to in writing by the customer.
5.2 QA manual contents
A supplier’s QA manual shall address the requirements of this Standard and include as a minimum, but
not limited to, the following:
a) the business name, facility location(s), scope of the items or services covered by the QA program, and revision date;
b) what QA program standards or specifications it is intended to satisfy;
c) the revision history;
d) a table of contents for easy location of information;
e) the supplier’s identification on each page;
f) the page number on each page;
e) supports changes.CSA N299.2 pdf download.