[PAS-001] CCMC Product Assessment Service (PAS)

Documented quality system requirements

The quality system documentation must contain the following information:

• the name and location (street address) of the place of manufacture
• a description of the company's quality policies, including quality control (QC) and quality assurance (QA)
• the signature of the manufacturer's authorized officer and the date of signature
• a description of the provisions for keeping the quality manual current, e.g., updates and revisions
• a manufacturing flowchart indicating points of QC and QA, complete with an explanation of the controls at each point, the frequency of controls, and a summary of the manufacturing methods
• a description of the manufacturing specifications and process tolerances
• a list of manufacturer's specifications and QC arrangements for raw materials and equipment
• the inputs to the manufacturing process(es) (i.e., raw materials, raw material suppliers) and the requirements to be met for their acceptance (i.e., incoming material checks, a means to reject non-conforming incoming raw materials, etc.)
• a list of main manufacturing equipment
• the sequence and interaction of the manufacturing and QC processes (i.e., a description of the order and nature of QC checks employed, the intervals at which the checks are performed, a description of how non-conforming products are rejected, etc.)
• a description of the criteria and methods (including monitoring, measurements required and related performance indicators) that are needed to ensure the effective operation and control of these processes
• a description of the measuring equipment (i.e., the type, model and range; their precision and accuracy; the frequency of calibration; any uncertainty associated with the instrument; and the name of the calibration laboratory)
• a description of the resources needed for these processes and the mechanism for ensuring their availability and competence (i.e., staff levels and training, equipment availability and maintenance, etc.)
• reference to the person(s) authorized to perform the quality processes and procedures (used to ensure competence and control of access)
• documentation of the development of and rationale for the processes, limits, measurements, controls and/or indicators that have been established, and the evidence that demonstrates their implementation
• a clear delineation of what constitutes major and minor defects
• records that demonstrate the actions taken when products or processes are identified as non-conforming
• a description of corrective measures for major and minor defects
• a description of how product labelling requirements will be achieved, including a copy of the product label(s)
• a statement that the CCMC will be notified, in writing, when major deviations from specified requirements have been discovered

Installation instruction requirements

The product installation instructions must include the following information (as applicable):

• detailed instructions of all the steps involved in the installation of the system
• a description of the tools and equipment required to install the system
• detailed drawings of the system and all accessories
• a description of the connectors and fasteners used
• a description of storage and handling procedures, including precautions
• a description of on-site QC
• a description of the health and safety safeguards in place for workers
• any other information the manufacturer deems pertinent to the installation

Documented procedures for maintaining the product installation instructions, including version control, must be included in the quality management system.

Technical data sheet requirements

Technical data sheets that include reference to the CCMC assessment must:

• include the assessment number (and in digital format, a link to the assessment on the CCMC registry of product assessments)
• not imply any opinion of the CCMC outside the scope of the assessment
• not contain data that conflicts with CCMC assessments
• use the term "assess" or "evaluate" with respect to the CCMC assessment (not approve, certify, test, verify, etc.)

Website requirements

Websites that include reference to the CCMC assessment must:

• refer to the specific assessment number
• provide a link to the assessment on the CCMC registry of product assessments
• not imply any opinion of the CCMC outside the scope of the assessment
• not contain data that conflicts with CCMC assessments
• use the term "assess" or "evaluate" with respect to the CCMC assessment (not approve, certify, test, verify, etc.)

Product sampling requirements

All products tested for CCMC qualification purposes must be performed on a product that has been sampled following a recognized sampling approach by a recognized sampling organization in order to demonstrate that it is representative of a normally manufactured product and consistent with the manufacturer's documented quality system. Completed sampling must include a report that meets the sampling report requirements below.

Product sampling approach

Sampling requirements can be met by one of the following means:

• sampling from a manufacturing plant or distribution point from multiple lots/batches of regular production product, or
• sampling from a single lot/batch of product where evidence is obtained that the single lot is representative of normally manufactured product.

All samples selected following one of the above approaches must be either taken from the site by the sampling organization and delivered to the testing laboratory, or else marked in such a way as to ensure that the laboratory can confirm that the samples it receives are the samples selected.

Recognized sampling organizations

Sampling must be performed by one of the following organizations:

• the CCMC-recognized laboratory and/or certification body determining compliance with the qualification criteria, or
• an engineer licensed in the jurisdiction of sampling.

Sampling report requirements

A sampling report must be issued by the sampling organization that contains, at a minimum:

• the location, time and date of the sampling
• the sampling approach followed
• the name, organization and contact information of the person performing the sampling
• the name, organization and contact information of the manufacturing/distribution facility
• a description of the samples selected (e.g., colour, dimensions, product names, etc.)
• the number of samples selected, the lot/batch number(s) and the size of the lot(s)/batch(es) from which samples were selected
• the means used to establish chain of custody of the samples to the testing laboratory

Laboratory recognition

All product testing for CCMC qualification purposes must be performed by a CCMC-recognized laboratory.

Recognition is achieved as follows:

Standardized tests

For standardized test methods (that is, where a test method published by a standards development organization exists), the CCMC accepts testing data from third-party laboratories that are accredited to ISO/IEC 17025 for the specified method by the Standards Council of Canada or by a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).

Innovative tests

For testing that follows a procedure that is not published by a standards development organization (e.g., a custom CCMC testing protocol), the CCMC accepts testing data from:

• laboratories that are accredited for test methods that are similar in scope, or
• laboratories from research, government and/or academic institutions that have competence in the relevant technical domain.

The use of a particular laboratory for innovative tests is at the discretion of the CCMC and must be accepted by the CCMC during the qualification process. Testing done without the CCMC's prior acceptance may not be accepted.

Test report requirements

All test reports for CCMC qualification purposes must include the following:

• the name and address of the testing laboratory (if multiple laboratory locations performed testing, all locations should be identified in the report)
• the product sampling report
• the product name(s), which must match the sampling report
• a summary (usually in table format) of testing performed, including, for each result:
  • the test method, edition and any deviations from the method
  • the measured result
  • the stated requirement
  • the uncertainty of the measurement
  • a statement of conformance with the specified requirements
• detailed results for each test method, including:
  • equipment reference and calibration status
  • results for each specimen
  • specimen preparation details
• all information required in the reporting section of the test method
• a record of revision (when applicable), including a clear explanation for each revision

The CCMC requires a single test report summarizing all test data and providing a summary conformance statement with respect to the CCMC qualification criteria (e.g., the product standard).

Conformance statements in test reports

Effective January 1, 2024, all statements of conformance in test reports for CCMC qualification purposes will be based on a simple acceptance decision rule (see ILAC G8:09/2019). However, laboratories must consider the measurement uncertainty for each test (i.e., the value being compared to a requirement), and must clearly indicate in the test report when a requirement falls within the measurand  ±1U, where U is the expanded measurement uncertainty (see ILAC G8:09/2019), for each tested property.

The CCMC may reject a result based on an assessment of the risk (probability and consequence) of possible false acceptance.