Previous requirement:

3. Requirements/Supplements

a) QM officer:
the term “QM officer” denotes a central contact person who is responsible for the operational issues of the QM system within the respective scope. […]

Change of requirement:

3. Requirements/Supplements

All employees of a company are to be qualified according to the tasks assigned to them. Depending on the respective scope of the QM system, the size of the company, legal or customer-specific requirements, special qualifications may be necessary. Among them the following are included:

a) QM officer: central contact person responsible for the operational issues of the QM system within the respective scope. […]

Previous requirement:

3. Requirements/Supplements

[…]

The change status (calibration status) must be attached to the test equipment such that it cannot be detached and must be recorded (e.g. EDP system).

If, due to the size of the test equipment, a fixed marking (e.g. sticker on the test equipment) is not possible/applicable, then some other unambiguous marking method must be used for this test equipment in this case (e.g. coloured dot, ink ribbon or something similar).

If requested by the customer, the technical data and records of test equipment shall be provided.

Change of requirement:

3. Requirements/Supplements

[…]

The change status (calibration status) must be attached to the test equipment such that it cannot be detached and must be recorded (e.g. EDP system).

If no marking (e.g. sticker on the test equipment) is possible/applicable due to the size of the test equipment as well as the surface condition and/or the conditions of use, then some other unambiguous marking method must be used for this test equipment (e.g. coloured dot, ink ribbon or something similar). According to the selected marking method, the assignment to the calibration status shall be verifiable.

If requested by the customer, the technical data and records of test equipment shall be provided.

Previous requirement:

3. Requirements/Supplements

Complete verification of traceability to the next higher standard must be provided, for instance by accredited bodies (accredited calibration laboratories).

The accreditation (ISO 17025) and the corresponding approvals of the external laboratories must be documented with proof of validity.

Traceability is part of ensuring the accuracy and precision of the measurement and is regulated by law. The measuring instruments and measuring standards must be calibrated. The calibration process is effected using a standard.

The unbroken chain goes in ascending form (calibration hierarchy) from the working standard, to the reference standard, via the national standard to the primary standard.

Change of requirement:

3. Requirements/Supplements

Complete verification of metrological traceability shall be provided for all measuring instruments used to assess conformity.

In this context, it must be adhered to that:

• Traceability certificates from internal calibration laboratories without accreditation are recognised if this is carried out according to the specifications of ISO/IEC 17025 or DAkkS.
• External calibration laboratories used must have/prove that there exists a valid accreditation according to ISO/IEC 17025 for the corresponding measurement parameter.
• If there is demonstrably no accredited laboratory for the specific calibration, verification of traceability must be provided by means of a factory calibration certificate. The specifications of ISO/IEC 17025 or DAkkS must be taken into account here.

PLEASE NOTE:
If an accredited laboratory exists but is very far away and/or very cost-intensive, the manufacturer of the measuring and test equipment located closer may be deployed, even if this manufacturer is not accredited according to ISO/IEC 17025.

Justification: Measuring and test equipment manufacturers also develop the methodology for compliance and adjustment of their measuring and test equipment as part of their design and manufacture to ensure compliance with the respective calibration requirements. Therefore, the manufacturer of the measuring and test equipment is generally qualified to calibrate the equipment they have designed and manufactured.

However, the organisation shall obtain the approval of the client or internal customer before deploying the manufacturer of the measuring and test equipment for calibration services.

Question:

Which elements of the VDA volume “Quality-related costs” should be given special consideration with regard to the requirements of questions 05.1 to 05.4?

Answer:

The requirements of questions 05.1 to 05.4 are to be defined (described) in the respective QM system. The principles of the VDA volume “Quality-related costs” are to be taken into account.

Quality cost reporting is a management-oriented approach for recording, cataloguing and condensing the relevant cost types into reportable key figures, which can be presented by the responsible organisational units of the company (in accordance with the described procedures according to question 05.1), if necessary.

In the context of the description, it must be noted that not all cost types can be clearly recorded due to a lack of delineability. Corresponding delimitations (exclusions) are to be clearly presented in the documentation of the QM system.

Question:

In section 02.3*, under 3rd Requirements/Supplements, all employees within the QM system/scope are required to have free access to process descriptions/process standards. Which employees specifically need to be guaranteed access to the relevant process descriptions/process standards?

Answer:

All employees involved in ensuring the quality of the process, product or service must have unhindered access to the relevant process descriptions/process standards. This also includes temporarily deployed employees such as students, interns, employees of external companies and temporary workers.