CAN3-Z299.4-85 (R2006) - Quality Assurance Program - Category 4
This Standard specifies minimum requirements for a supplier's quality assurance program - Category 4. The supplier is responsible for planning and developing a program which provides objective evidence that contract requirements are met and which detects and dispositions nonconforming products or services.
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.
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;
Evidence or registration by a recognized authority should be considered to fulfill this responsibility.
(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;
(iii) the quality assurance program standards applied to customer-supplied products or services;
(iv) the regulatory requirements that apply to the products or services;
(c) to carry out surveillance and audits as and when required to ensure that the supplier is conforming to the Standard;
(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.
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 produce objective evidence that products and services meet contract requirements;
(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.