1. An organization can arbitrarily delete the requirements of ISO900 1:2008 when establishing a management system according to its own needs. (x) (only in chapter 7. )
2. The organization must determine the verification personnel, such as inspectors and internal auditors. And train them. (√ )
3. Stable organization, excellent performance and busy work. The top management proposed that the management review of the current year should be conducted together with the next year. (×) (Management review at least once a year)
4. The documents required by the quality management system shall be approved before release. ( √)
5. The quality policy of the organization is decided by the top management. (×) (formulated and officially released by the top management, which is different from confirmation)
6.PDCA method is applicable to all processes. (√ )
7, quality management system documents should be in written form, easy to check when auditing. (×) (Any medium can be used)
8. Statistical techniques are not specified in the ISO 9001:2008: 2008 standard, so organizations do not need to adopt statistical techniques. (×)(8. 1 General Provisions: "This shall include determining the applicable methods including statistical techniques and their application degree". )
9. Personal information of customers should be controlled according to their property. ( √)
10. The organization shall identify the state of the product according to the monitoring and measurement requirements of the whole process of product realization. (√ )
Case topic:
1: during the audit of a factory, it was found that the person in charge of the administrative department had no job responsibilities and no employment standards. I asked the person in charge of the administration department and the management representative, and replied that the administration department was established only after our factory implemented the requirements of ISO900 1:2008 standards, and its director was temporarily changed. Therefore, it was too late to write the employment standards for the heads of administrative departments.
A: There was no administrative department before the implementation, but after the implementation, which means that the system was planned when it was established. However, it does not conform to Article 5.5. 1: "Responsibilities and authorities" and "Top management should ensure that responsibilities and authorities within the organization are specified and communicated", and it is not "regulation and communication" now.
2. When checking the welding section of a machinery factory, the auditor saw several production personnel working nervously, and asked them if they had been trained. The answer is that they are directly assigned to the welder department after entering the factory, and the master teaches them to weld. When I asked the section chief if the welder had been appraised, the answer was no. After I bought it, it worked normally and was put into use.
A: They didn't recognize the "special process", so they didn't confirm the "special process". Because, there is no confirmation. Therefore, the recognition of "people, machines, materials, law and environment" is lacking! Non-compliance with Article 7.5.2 "Process confirmation of production and service provision": When the process output of production and service provision cannot be verified by subsequent monitoring or measurement, so that problems can only appear after product use or service delivery, the organization shall confirm any such process.
3. When the auditor inspected the sales department of a furniture factory, he asked the sales minister if he wanted to identify and evaluate the customer's requirements. The minister replied that no evaluation was needed. The factory has produced dozens of models of furniture, which are selected by operators and customers. After they confirm, they can sign contracts.
A: This question is more complicated. 1) When a customer orders a piece of furniture, it must be appraised and examined as required; 2) If the operator purchases in bulk and has requirements on quality, schedule and quantity, it also needs to be identified and audited; 3) Is it necessary to judge if an individual customer "buys" an inventory finished product at the store? I don't know. I tend to be "judgmental". I suggest that it be stipulated in the relevant documents of the company. In this case, please refer to "7.2.2 Review of Product Related Requirements" "Note: In some cases, such as online sales, it may be impractical to formally review each order. Alternatively, you can view relevant product information, such as product catalogs and product advertisements. " Therefore, they still do not meet the requirements of "7.2.2 Review of Product Related Requirements".
4. The auditor found that the calibration status of the four instruments used in the final inspection was different during the audit of the quality inspection department. Among them, the oscilloscopes numbered QA-00 1, 002 and 003 have calibration certificates and are within the validity period, while the other oscilloscopes numbered QA-004 have no calibration certificates from the metrology department. The engineer at the metering station said that the oscilloscope had been calibrated by the manufacturer before leaving the factory, so we used it directly, and it was not too late to calibrate it after one year.
A: Article 7. 6. "Control of monitoring and measuring equipment" stipulates that "calibration and/or verification (verification) shall be carried out at specified time intervals or before use". Including newly purchased equipment.