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S-A-01:2002 - 4.0 Quality System Requirements [revised 2005-01-10]


4.9 Process Control *

ISO 9002:1994
4.9

ISO 9001:2000
6.3, 6.4, 7.5.1, 7.5.2

ISO/IEC 17025:1999
4.12, 5.3, 5.4, 5.5, 5.8, 5.9

Measurement Canada requirements

The applicant's documentation shall address, as a minimum:

    a) the control of processes for the receipt of devices, parts or components of devices;
    b) the calibration or adjustment of devices;
    c) the handling, cleaning, packaging, storage, delivery and preservation of devices;
    d) the final inspection (as defined in this document) of devices, including the inspection of devices by sampling; and
    e) the retrieval of devices for the purposes of inspection.

4.10 Inspection and Testing

4.10.1 General *

ISO 9002:1994
4.10

ISO 9001:2000
7.1, 8.1

ISO/IEC 17025:1999
5.4

4.10.2 Receiving Inspection and Testing

ISO 9002:1994
4.10.2.1, 4.10.2.2, 4.10.2.3

ISO 9001:2000
7.4.3, 8.2.4

ISO/IEC 17025:1999
4.5, 4.6, 5.5, 5.8

4.10.3 In-process Inspection and Testing

ISO 9002:1994
4.10.3

ISO 9001:2000
8.2.4

ISO/IEC 17025:1999
4.9, 5.5.9, 5.8.3, 5.8.4, 5.9

4.10.4 Final Inspection and Testing *

ISO 9002:1994
4.10

ISO 9001:2000
8.2.4

ISO/IEC 17025:1999
5.4.7, 5.9, 5.10.1

Measurement Canada requirements

For the purpose of obtaining Measurement Canada accreditation, the organization shall ensure that, for the purpose of final inspection, only Measurement Canada approved devices and components are tested, verified or certified.

Measurement Canada requirements applicable to Electricity and Gas

When a supplier is not manufacturing or assembling devices under a recognized quality management system, the organization performing the inspections shall ensure that particular device types are manufactured under controlled conditions by performing 100 % inspection. Once a confidence level has been established, the organization may inspect subsequent shipments of that device type using a modified sampling plan.

Prior to verifying or reverifying electricity and gas devices, accredited organizations shall:
    a) confirm that contractors are registered; and

    b) include the contractor's registration number on the inspection certificate.

Organizations shall send copies of inspection certificates to Measurement Canada upon request.

Should contractors not be registered, the accredited organization shall direct contractors to Measurement Canada for registration.

Measurement Canada requirements applicable to Weights and Measures

The quality management system documentation shall include device evaluation and inspection procedures that assess the overall compliance of devices to the Weights and Measures requirements including device configuration or setting, installation and performance.

4.10.5 Inspection and Test Records *

ISO 9002:1994
4.10.5

ISO 9001:2000
7.5.3, 8.2.4

ISO/IEC 17025:1999
4.12.2

Measurement Canada requirements applicable to Weights and Measures

For the purposes of traceability under the Weights and Measures Act and Regulations, a certificate of inspection shall be completed for every device that is certified for use in trade. The certificate shall be designed as stipulated by Measurement Canada (for guidelines regarding certificate format refer to Appendix 5 of this document). In addition, accredited organizations shall send a copy of certificates to the local Measurement Canada district office at least once a week, but no longer than 10 days from the date of their issue. Where there are no certificates issued within a 10 day period, then a nil report must be sent.

Inspection certificates shall be issued to the device’s owner or to the person in possession of the device at the time the inspection service is provided and in accordance with the bulletin on inspection of scales that are affected by differences in acceleration due to gravity.

Measurement Canada requirements applicable to Electricity and Gas

For the purposes of accreditation under the Electricity and Gas Inspection Act and Regulations, certificates, when required, shall contain the information stipulated in section 21 of the Electricity and Gas Regulations.

4.11 Control of Inspection, Measuring and Test Equipment *

4.11.1 General

ISO 9002:1994
4.11.1

ISO 9001:2000
7.6

ISO/IEC 17025:1999
5.4, 5.5, 5.6

Measurement Canada requirements

The organization shall identify the necessary measuring apparatus or test standards used to perform final inspections. These shall be certified as prescribed in the applicable act.

Accredited organizations shall provide clear instructions to their recognized technicians to verify the conditions of a borrowed or rented test standard and to ensure that the Measurement Canada calibration certificate is valid. A copy of the calibration certificate for those borrowed or rented test standards shall be maintained by the accredited organization.

4.11.2 Control Procedure *

ISO 9002:1994
4.11.2

ISO 9001:2000
7.6

ISO/IEC 17025:1999
5.3, 5.4.1, 5.4.5, 5.5, 5.6

Measurement Canada requirements applicable to Electricity and Gas

For the purposes of obtaining accreditation pursuant to the Electricity and Gas Inspection Act and Regulations, the organization shall ensure that newly acquired and existing measuring apparatus and test standards are calibrated in accordance with section 7 of the Electricity and Gas Regulations and certified by the President of Measurement Canada prior to use.

Measurement Canada requirements applicable to Weights and Measures

For the purposes of obtaining accreditation pursuant to the Weights and Measures Act and Regulations, the organization shall ensure that test standards are calibrated as prescribed in section 56 of the Weights and Measures Regulations:
    a) have a valid verification and designation certificate issued by Measurement Canada; and

    b) are verified by Measurement Canada at the prescribed intervals or more frequently where verification is necessary to maintain the accuracy of the test standard.

Standards such as thermometers, pressure measuring instruments, test weights and other standards used by recognized technicians to inspect devices used in trade shall be monitored for accuracy at the frequency determined by Measurement Canada (i.e. ice point test performed on electronic thermometers) and quality records of results shall be maintained.

4.12 Inspection and Test Status

ISO 9002:1994
4.12

ISO 9001:2000
7.5.3

ISO/IEC 17025:1999
5.5.12, 5.8, 5.9.2

Measurement Canada Requirements

For the purpose of obtaining Measurement Canada accreditation, the organization shall:
    a) establish and maintain a system for seals, tags, labels or other means on the devices that indicate the status of the inspection and final acceptance;

    b) control status indicators including the authority for applying and removing tags, stamps or other physical means of indicating the inspection status; and

    c) seal devices which have passed inspection in the manner prescribed in the Electricity and Gas Inspection Act and Regulations and the Weights and Measures Act and Regulations and as set out in the applicable Notice of Approval issued by the Minister.

Measurement Canada requirements applicable to Electricity and Gas Seals

The accredited organization shall use a seal that shows its identity, and the year of verification. Devices shall be sealed in the manner described in the applicable Notice(s) of Approval issued by Measurement Canada.

Measurement Canada requirements applicable to Weights and Measures

Seals, initial inspection markings and verification indicators shall be accepted by Measurement Canada prior to use by the organization. The organization shall ensure that appropriate controls, including accounting controls, are in place in order to safeguard inspection certificates, seals, marks and stickers from being misplaced or misused. Requirements for seals, markings and indicators can be found in Appendix 4.

Organizations seeking accreditation to perform inspections pursuant to the Weights and Measures Act and Regulations shall:
    a) affix a verification indicator; and

    b) mark devices with the appropriate initial inspection markings.

In the case of a device with a non-compliance that cannot be corrected for any reason, a rejection (warning) tag accepted by Measurement Canada shall be attached to it with a seal in a prominent location. This applies to subsequent inspections and reinspections only. See Appendix 3.

Inspection certificates shall be numbered and controlled from the point of issuance to recognized technicians to their filing upon return to the office. Inspection certificates may be generated electronically at the time of inspection.

Processes shall be implemented to ensure that inspection markings and verification indicators (stickers) approved by Measurement Canada are used only on devices certified on behalf of Measurement Canada.

4.13 Control of Nonconforming Product

4.13.1 General

ISO 9002:1994
4.13.1

ISO 9001:2000
8.3

ISO/IEC 17025:1999
4.9

4.13.2 Review and Disposition of Nonconforming Product

ISO 9002:1994
4.13.2

ISO 9001:2000
8.3

ISO/IEC 17025:1999
4.9

4.14 Corrective and Preventive Action

4.14.1 General

ISO 9002:1994
4.14.1

ISO 9001:2000
8.5.2, 8.5.3

ISO/IEC 17025:1999
4.10, 4.11

4.14.2 Corrective Action

ISO 9002:1994
4.14.2

ISO 9001:2000
8.5.2

ISO/IEC 17025:1999
4.10

4.14.3 Preventive Action

ISO 9002:1994
4.14.3

ISO 9001:2000
8.5.3

ISO/IEC 17025:1999
4.11
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    Created: 2004-06-03
Updated: 2005-06-23
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