Preface
This is the second edition of CSA Standard CAN3-Z299.3, Quality Assurance Program-Category 3. It supersedes the previous edition issued in 1979.
This is the third most comprehensive of the following series of four quality assurance program Standards:
CAN3-Z299.1, Quality Assurance Program-Category 1 ;
CAN3-Z299.2, Quality Assurance Program-Category 2;
CAN3-Z299.3, Quality Assurance Program-Category 3;
CAN3-Z299.4, Quality Assurance Program-Category 4.
Each Standard in the series is less comprehensive than the one above it. The table of contents and matrix comparison show the decreasing requirements by clause. The matrix will assist users when cross-referencing or upgrading from one CAN3-Z299 Standard to another.
When contractually required to produce a product or provide a service to one of the CAN3-Z299.2, .3, or -4 Standards, suppliers should consider the benefits to them of implementing the applicable additional requirements of the higher category Standards.
The objectives of these Standards are:
(a) to provide a customer with assurance that a quality product or service will be supplied; and
(b) for the supplier to assume responsibility for achieving the required quality and then demonstrating that it has been provided.
The selection of any one Standard does not change the contractual requirements to produce a product or provide a service of the required quality. Specifying a more comprehensive Standard does, in general, provide the customer and the supplier with greater assurance, supported by documentary evidence, that the quality requirements will be met, providing that the quality assurance program is implemented and is effective.
For selecting and implementing the most appropriate of the CAN3-Z299 series of Standards, the use of CSA Special Publication CAN3-Z299.0, Guide for Selecting and Implementing the CSA CAN3-Z299 Quality Assurance Program Standards, is recommended. Although not mandatory, the guidelines in CSA CAN3-Z299.0 provide examples and explanations and suggest means for satisfying the requirements of this Standard.
For some products or services, specifying a more comprehensive Standard may not lead to a higher degree of assurance. Selection of the appropriate Standard should be made by considering the parameters that are inherent in the product or service.
These Standards were prepared to reduce to four documents the numerous and seemingly different quality assurance program standards applied to many products or services. The premise was adopted that although there may be minor variations in individual quality assurance programs, standard fundamental practices can be established for each quality element. Therefore, the requirements are neither product nor service oriented and are appropriate for purchasing products or services in many industries and businesses. Nevertheless, the supplier’s quality assurance program must suit the supplier’s operation.
This Standard was prepared by the Technical Committee on Quality Program Standards under the jurisdiction of the Standards Steering Committee on Management for Quality and Reliability and was formally approved by these Committees.
It has been approved as a National Standard of of Canada by the Standards Council of Canada.
Scope
1.1 General
1.1.1
This Standard specifies minimum requirements for a supplier's Quality Assurance Program - Category 3. The supplier is responsible for planning and developing a program aimed primarily at controlling inspection and test verifications which
(a) assure that products or services conform to specified requirements; and
(b) readily detect and control the disposition of nonconformances.
1.1.2
The supplier shall identify and provide or update the special controls, measuring and test equipment, and skills required to assure product or service quality.
1.1.3
Planning and descriptions are essential for stating what has to be done to complete the activities, listed in Clause 3.4, which verify that products or services meet specified requirements.
1.1.4
This Standard may be applied to products produced for inventory (ie, for future sale to unidentified customers), in which case submittals to customers before the work starts do not apply. However, objective evidence shall be available to show compliance with this Standard, except for those requirements where submittal of data is required before start of the work. This shall be resolved with the customer before purchase.
1.1.5
(a) The requirements of this Standard shall apply to the control of the use of computer software employed in design analysis and in the operation of process, production, inspection, and test equipment.
(b) Computer software that forms part of or is incorporated into products or services shall be subject to final acceptance inspection and testing according to this Standard.
Note: This Standard does not apply, however, to the design, development, coding, and configuration management of computer software. Where this is required, the CSA Q396 Series of Standards on Software Quality Assurance Programs is recommended.
1.2 Customer's Responsibilities
The customer's responsibilities are
(a) to evaluate and select suppliers based on their ability to meet specified requirements by the time the work starts, which shall include an evaluation of
(i) the Quality Assurance Manual and the quality assurance program implementation;
Note: Evidence of registration by a recognized authority should be considered to fulfill this responsibility.
(ii) the Inspection and Test Plan(s);
(iii) other required facilities, Plan(s), and resources;
(b) to specify in the tender and contract
(i) the scope of and requirements for the work;
(ii) the quality assurance program standards the supplier is required to meet as well as any specific ones to be included in subcontracts;
(iii) traceability according to Clause 3.5.11;
(iv) the quality assurance program standards applied to customer-supplied products or services;
(v) the regulatory requirements that apply to the products or services;
(vi) documentation to be delivered to the customer and retained by the supplier and the retention period;
(c) to carry out surveillance and audits as and when required to ensure that the supplier is conforming to the Standard, such audits being conducted according to CAN3-Q395 or equivalent;
(d) to certify that customer-supplied products or services comply with specified requirements and that they are consistent with the quality requirements of the final products or services or to advise the supplier that nonconformances have been suitably dispositioned; and
(e) to evaluate the supplier's quality assurance program as it relates to products produced for inventory (stock) and to resolve with the supplier at the time of the initial evaluation those standard requirements where document submittal is required before start of the work.
Note: When a recognized authority has registered a quality assurance program for products produced to inventory, submittal requirements to customers before the work starts may not be included in the registration. The customer should resolve this with the supplier.
1.3 Supplier's Responsibilities
The supplier's responsibilities are
(a) to satisfy the requirements specified in the contract;
(b) to develop, implement, and maintain the quality assurance program specified herein;
(c) to submit, update, and resubmit the quality assurance program documents required by Clauses 3.3 and 3.4;
(d) to provide customer access to the applicable premises or working area for the purpose of quality surveillance and audit; and
(e) to identify for the customer before the award of the contract which products will be supplied from inventory and to demonstrate that the quality assurance program was implemented for the products at the time they were produced.
1.4 Regulatory Authority Requirements
The requirements of all Federal, Provincial, Territorial, and Municipal Acts, Regulations, Bylaws, and their referenced Codes that apply to the product or service shall be met.
