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CQI 17

CQI-17 soldering system evaluation form and question catalog.

It should be used for soldering process audits.  

You can obtain relevant manuals and forms on this subject from AIAG's website.

3.4. Handling classified information

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Custom Edit Documents

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Multiple scope in one certification

Our company is certified for meeting ISO 13485 requirements for the scope of design, development, manuafcture and sales of product for brand A. Our Parent company has requested to get certified for their brand (i.e Brand B) with the scope of manufacture aand sales of products. Would this be treated as a spearate certification and would require both stages of audits? or can be integrated with existing one as an extension of scope

Recovery

ISO 22301 does not prescribe how recovery needs to be performed, so organizations can implement recovery as best fits their needs.

The preference for fully automated recovery versus human intervention step by step would depend on various factors such as the criticality of the systems or data being recovered, the complexity of the recovery process, and the resources available.

Fully automated recovery processes can be faster and more efficient in certain situations, especially for routine or well-defined recovery scenarios where human intervention may introduce delays or errors. Automation can also help ensure consistency and reduce the risk of human error during the recovery process.

However, in some cases, human intervention may be necessary to make critical decisions, assess the situation, or address unforeseen issues that automated systems may not be able to handle. Human intervention can also provide a level of oversight and control that may be necessary for certain recovery scenarios.

Zeiss CMM Users

I do not know where the person you were talking to got the information that this is against the AS9100 requirements because those requirements do not go into this much detail on how you manage the organization, they only give a structure on what needs to be included.

In fact, in AS9100 clause 8.5.2 it talks about using acceptance media as part of the identification and traceability, and gives examples of electronic signatures and passwords as being acceptable. This is how you will be controlling the approval in your CMM area. Again, the standard does require that you control changes and access for production processes, but this is what you will be doing.

Repackaging of a medical device

ISO 13485 is not specifically mentioned anywhere in the MDR, but the term quality management system is extended. However, Article 8 states that "Devices that are in conformity with the relevant harmonized standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to conform with the requirements of this Regulation covered by those standards or parts thereof." In the list of harmonized standards published in the Official Journal of the European Union, the only standard related to the quality system is ISO 13485. That is why manufacturers and distributors are expected to have introduced ISO 13485.

Contract Review Scope

For medical devices, all contracts must be reviewed to be sure that all requirements from the MDR point of view are settled. Whether all contracts will be reviewed depends primarily on whether they are critical parts or parts that can be purchased/acquired anywhere. For critical parts, it is important to be sure that the supplier will inform you of any changes in their product that could affect the quality of the final medical product.

Intermediate checks Testing Lab

You said you had an internal Audit. I can’t tell if this was a third-party consultant on your behalf or the accreditation body, assessing you for accreditation. If it was an accreditation body, you must comply with their technical requirements for traceability and measurement uncertainty.

To meet ISO 17025 requirements as a testing laboratory, you must ensure your method is valid for the purpose, and reliable by meeting all the technical requirements including:
1. Verifying that the equipment used has the performance specification required (eg resolution/gauge units), 
2. Proving through experimentation that the method is valid –i.e. accurate to the extent required.
3. Having metrological traceability through an unbroken chain of calibrations.

Accuracy is a qualitative description that you need to represent as Uncertainty. This has two quantitative components, being bias (a measure of trueness due to any systematic error) and a quantitative measure of the spread of results (a measure of precision due to random error of measurement).

From what you shared, it seems the Auditor's findings are valid. You said:

Based on the repeatability of the final reading in MPA for (UTM) i made 1.5x expanded uncertainty as my UCL/LCL

You must take both systematic and random errors into account. Not just repeatability (random error) and you need to show that the MU estimate is acceptable. (e.g. it cannot be smaller than the machine uncertainty. You need the standard uncertainty of each contributing device as a percentage (relative) and then represent the final expanded uncertainty in the units.

he insisted to have calibration of slip gauge.

Yes to ensure metrological traceability this is required. There are times when you can achieve this with an in-house secondary calibrator device, providing traceability to an externally calibrated device. The external calibrations must always provide the MU of the unit tested and reported.

For more information, have a look at a previously answered question at https://community.advisera.com/topic/measurement-uncertainity/

The ISO 17025 toolkit document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure/

The ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results is available from https://ilac.org/publications-and-resources/
The article: What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/

Procedure for document and record control

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