|
|
S-A-01:2002 - 4.0 Quality System Requirements [revised 2005-01-10]
4. Quality System Requirements
Organizations may structure their quality system documentation in any fashion, as long as all of the ISO 9002:1994, and the additional Measurement Canada requirements are adequately addressed.
4.1 Management Responsibility
4.1.1 Quality Policy
ISO 9002:1994
4.1.1
ISO 9001:2000
5.1, 5.3, 5.4.1
ISO/IEC 17025:1999
4.2.2
Measurement Canada requirement
For the purpose of obtaining Measurement Canada accreditation, the applicant’s policy and objectives shall include a commitment to meeting Measurement Canada’s requirements.
4.1.2 Organization
4.1.2.1 Responsibility and Authority
ISO 9002:1994
4.1.2.1
ISO 9001:2000
5.5.1
ISO/IEC 17025:1999
4.1.5 a), f), h); 4.2.4; 4.9.1a); 4.10.1 and 5.2.5
Measurement Canada requirement
The authority to perform inspections, sampling procedures and to sign and issue inspection certificates shall be documented.
4.1.2.2 Resources
ISO 9002:1994
4.1.2.2
ISO 9001:2000
6.1, 6.2.1
ISO/IEC 17025:1999
4.1.5 a), g), h) and 5.5.1
4.1.2.3 Management Representative *
ISO 9002:1994
4.1.2.3
ISO 9001:2000
5.5.2
ISO/IEC 17025:1999
4.1.5 j)
Measurement Canada requirements
The organization shall notify Measurement Canada of the appointment of the management representative in writing. A formal assessment of any actual or potential conflict of interest shall be performed to ensure that quality is not subordinated to production. Records of this assessment shall be maintained.
4.1.3 Management Review
ISO 9002:1994
4.1.3
ISO 9001:2000
5.6.1, 8.5.1
ISO/IEC 17025:1999
4.1.4
Measurement Canada requirement
Where management review occurs less frequently than annually, the organization shall provide a complete assessment of the adequacy of this frequency period.
4.2 Quality System
4.2.1 General *
ISO 9002:1994
4.2.1
ISO 9001:2000
4.2.1
ISO/IEC 17025:1999
4.2.1
Measurement Canada requirements
For the purpose of obtaining Measurement Canada accreditation, the organization shall clearly state the scope of its accreditation program.
Quality documentation submitted for Measurement Canada accreditation shall include quality system policies and procedures.
Organizations not addressing any element of this standard shall clearly demonstrate why the element does not apply to their application.
Measurement Canada requirements applicable to Weights and Measures *
Subject to exclusions mentioned in section 1.3 of this document, an organization’s quality system documentation shall clearly:
- specify the device types and subtypes selected from Appendix 1 - Device Types and Sub-Types in the Weights and Measures Inspection Certificate Completion Manual that the organization intends to inspect and certify on behalf of Measurement Canada;
- specify the types or categories of fluids measured by the devices (see Appendix 4 - Product Codes in the Inspection Certificate Completion Manual); and
- specify the type of physical standards it will use.
4.2.2 Quality System Procedures
ISO 9002:1994
4.2.2
ISO 9001:2000
4.2.1
ISO/IEC 17025:1999
4.2.2, 4.2.3
Measurement Canada requirement
Applicants shall submit documented procedures addressing all of the program elements contained in ISO 9002:1994 and all of the applicable Measurement Canada requirements.
4.2.3 Quality Planning
ISO 9002:1994
4.2.3
ISO 9001:2000
5.4.2, 7.1
ISO/IEC 17025:1999
4.2.1, 4.2.2 and 4.14
Measurement Canada requirements
Measurement Canada’s legal requirements shall be addressed in the organization’s quality planning.
4.3 Contract Review
4.3.1 General
ISO 9002:1994
4.3.1
ISO 9001:2000
7.2
ISO/IEC 17025:1999
4.4, 4.4.1
Measurement Canada requirements applicable to Electricity and Gas
For the purpose of obtaining accreditation pursuant to the Electricity and Gas Inspection Act and Regulations, an organization providing inspection services for another organization shall ensure that the organization is registered as a contractor, as defined in the Electricity and Gas Inspection Act and Regulations.
4.3.2 Review
ISO 9002:1994
4.3.2
ISO 9001:2000
5.2, 7.2.1, 7.2.2, 7.2.3
ISO/IEC 17025:1999
4.4.2
4.3.3 Amendment to a Contract
ISO 9002:1994
4.3.3
ISO 9001:2000
7.2.2
ISO/IEC 17025:1999
4.4.5
4.3.4 Records
ISO 9002:1994
4.3.4
ISO 9001:2000
7.2.2
ISO/IEC 17025:1999
4.4.2
4.4 Design Control *
The scope of this standard does not include quality system requirements for design control. This subclause is included to align the clause numbering to ISO 9002:1994
|