scope:

General

This Standard specifies minimumr equirements for a supplier's QualityA ssurance Program-Category 3. The supplier isr esponsible for planning andd eveloping 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.

The supplier shall identify and provide or update thsep ecial controls, measuring and test equipment, and skills required to assure product or service quality.

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.

This Standard may be applied to products produced for inventory(i e, 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 parto f or is incorporated into products osr ervices 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.

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 thew ork starts, which shall includea n evaluation of

(i) the Quality Assurance Manual and the quality assurance program implementation;

Note: Evidence of registration by a recognized authority shouldb e considered to fulfill this responsibility. 

(i) 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;

(i¡) the quality assurance program standards the supplier is required to meet as well

(iii) traceability according to Clause 3.5.11;

(¡v) the quality assurance program standards applied to customer-supplied products

(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

(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 accordingto CAN342395 or equivalent;

(d) to certify that customer-supplied products or services comply with specified requirements and that theya re consistent with the quality requirementso f 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 requirementsw here document submittal is required before start of them work.

Note: When a recognized authority has registered a quality assurance program for products produced to inventory, submittal requirementst o customers before the work startms ay not be included in the registration. The customer should resolve this with the supplier.

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 thec ustomer before the award of the contract which productsw ill be supplied from inventory and to demonstrate that the quality assurance program was implemented for the productsa t the time theyw ere 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 ors ervice shall be met.