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QUESTION 1: Why are there two manuals (IATF 16949:2016 and ISO 9001:2015)? Two manuals instead of one manual makes it much more difficult to read and understand the requirements.
ANSWER: The IATF and ISO were not able to reach a licensing agreement to publish IATF 16949 in an integrated document. In order to not further delay the launch of the new IATF 16949 standard, the IATF decided to publish in a two-manual format. Prior to release, the IATF did confirm with international accreditation organizations that other industry sectors use a two-manual format model to define their sector specific requirements, and auditing with the two-manual model, while not optimal, is effective. The IATF maintains strong cooperation with ISO by continuing the liaison committee status ensuring continued alignment with ISO 9001.
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QUESTION 2 : Why are the two manuals (IATF 16949:2016 and ISO 9001:2015) so much more expensive than the ISO/TS 16949 version?
ANSWER: Without the co-licensing agreement between ISO and the IATF for the integrated format of IATF 16949, the IATF was not able to negotiate a discount for the ISO 9001:2015 standard.The IATF kept the price of the automotive specific content consistent with prior pricing. Essentially, the difference is the full list price to ISO for their publication of ISO 9001
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QUESTION 3: What should be done if translation errors are discovered in the IATF 16949 standard?
ANSWER:The IATF uses a defined process for managing translations of the standard, including “cross-checking” the translation to ensure accuracy. If an organization, or a certification body, identifies what is believed to be a translation error, they should contact either the IATF member industry association or the Oversight Office supporting their certification body. |
QUESTION 4: What is the scope of clause 4.4.1.2 (Product Safety)? Many organizations focus on regulatory/statutory requirements of the product and do not believe they have product safety-related manufacturing products or processes.
ANSWER: This clause focuses on product and manufacturing process characteristics that affect the safety performance of the final assembly. These characteristics may not be directly addressed in regulatory/statutory requirements, but may be defined by the customer. |
QUESTION 5: Is the intent that responsibilities be assigned to the function (e.g. Quality), a specific title (e.g. Quality Director) or a named individual (e.g. Bob Smith)
(Clause: 5.3.1 Organizational roles, responsibilities, and authorities —supplemental)?
ANSWER: Responsibilities are assigned to the role/position (i.e. specific title, Quality Director) within the organization. Although individuals may have those responsibilities in their roles, the responsibilities remain with the role (e.g. Quality Director). Therefore, top management will assign the responsibility and authority to the role, not to the individuals by name. |
QUESTION 6: Are MSA studies required for each instrument or device? (Clause: 7.1.5.1.1 Measurement system analysis)
ANSWER: No. A complete statistical study on each single piece of equipment is not required.
Instruments with the same characteristics (e.g. measurement range, resolution, repeatability, etc.) can be grouped and a sample instrument (representative of the gauge family) can be used for the statistical study. |
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QUESTION 7.1: When can the equipment manufacturer be used to calibrate inspection and test equipment? If an accredited laboratory exists but is very remote and/or expensive and the inspection or test equipment manufacturer is nearby and available can they be used (even if they are not accredited to ISO/IEC 17025)? (7.1.5.3.2 External laboratory)
ANSWER: The inspection or test equipment manufacturer developed the methodology to maintain and adjust the equipment to meet calibration requirements as part of the design and manufacture of the inspection or test equipment. Therefore, the original equipment manufacturer of the inspection. The organization shall obtain customer approval before using any original equipment manufacturer for calibration services.
QUESTION 7.2: If the organization has inspection, measuring and test equipment in the final assembly and test area, is it considered an internal laboratory? (7.1.5.3.2 External laboratory)
ANSWER : No. In-line measurement and test equipment used in any part of the manufacturing process or assembly process is not considered to be an internal laboratory.
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