This Standard specifies minimum requirements for a supplier's quality assurance program - Category 1. The supplier is responsible for planning and developing a program which assures that each management, design, and technical responsibility for quality is integrated and executed effectively. The program is aimed primarily at being preventive by controlling design and production processes as well as inspection and test verifications which
(a) assure that products or services will and do conform to specified requirements; and
(b) readily detect and control the disposition of nonconformances and prevent recurrence.
The contractual requirements, resources, and schedule shall be completely reviewed by the supplier at the earliest practical time. This includes identifying and providing or updating the special controls, production processes, measuring and test equipment, and skills required to assure product or service quality.
Planning and procedures are essential for specifying how activities affecting quality such as those listed in Clause 3.4 shall be performed and controlled.
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.
(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.
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.
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.
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.