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NEW QUESTION # 249
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
According to Scenario 6, the audit team required DC's top management to submit corrective action plans within two weeks. Is this action acceptable?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions) states:
* The auditor can set a reasonable deadline for corrective actions.
* 10 to 60 days is a best practice timeframe for the auditee to respond.
* The auditee must propose corrective actions, but the audit team has the authority to set the deadline
.
A 7-day deadline (A) is too short, and the audit team-not the auditee-determines the timeframe (B).
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions)
NEW QUESTION # 250
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
Answer: D,F
Explanation:
According to the ISO 9001:2015 standard, clause 4.1 requires organizations to determine the external and internal issues that are relevant to their purpose and that affect their ability to achieve the intended outcomes of their quality management system. Clause 6.1 requires organizations to plan actions to address the risks and opportunities associated with these issues. These actions must be integrated into the quality management system processes and evaluated for effectiveness.
In this scenario, the General Manager of the pharmaceutical organization has shown a lack of understanding and involvement in the process of identifying and addressing the external and internal issues that affect their quality management system. The General Manager has relied on the legal compliance expert, who is not an employee of the organization, to guide them on this process. The General Manager has also admitted that they did not document these issues, which is contrary to the requirement of retaining documented information on the context of the organization. The General Manager has also delegated the responsibility of determining and planning the actions to address the risks and opportunities to the Technical Manager, who is absent due to COVID-19.
Based on this information, you can respond to the General Manager's suggestion by taking two options:
B: I would ask for a different guide instead of the legal compliance expert: You can request to have a different guide who is an employee of the organization and who is familiar with the quality management system processes and the external and internal issues that affect them. The legal compliance expert may not have the necessary knowledge and authority to answer your questions or provide you with the relevant evidence.
C: I would look for evidence that the actions resulting from the risk assessment had been taken: You can verify whether the organization has implemented and evaluated the actions to address the risks and opportunities associated with the external and internal issues. You can look for evidence such as records of risk analysis, action plans, monitoring and review results, and improvement measures.
These two options would help you to assess the conformity and effectiveness of the organization's quality management system with respect to the requirements of clauses 4.1 and 6.1.
NEW QUESTION # 251
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: "What risks and opportunities have the business identified?"
QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review." Narrative: The QSM shows you the latest management review record and points to the following table:
You: "How is the business planning to address these risks and opportunities?" QSM: "The MD said that they already knew about them so it was not necessary."
Answer:
Explanation:
Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
6.1.2 (a)
Actions to address risks and opportunities not planned.
"The organization shall plan actions to address risks and opportunities." Step-by-Step Reasoning:
* Clause 6.1.1 - Determining Risks and Opportunities:
* Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
* Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
* Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
* Requirement: The organization must plan actions to address identified risks and opportunities.
These actions should be integrated into the QMS processes to ensure continuous improvement.
* Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
* Correct Options Selected:
* Clause 6.1.1 with the nature of the problem as: "Several risks and opportunities have not been determined."
* Clause 6.1.2 (a) with the nature of the problem as: "Actions to address risks and opportunities not planned."
* ISO 9001 Requirements Not Fulfilled:
* For 6.1.1:"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
* For 6.1.2 (a):"The organization shall plan actions to address risks and opportunities."
NEW QUESTION # 252
You are carrying out an audit to ISO 9001 at an organisation which offers consultancy services on the implementation of ISO 9001 quality management systems to manufacturers of cosmetics.
You are interviewing the Technical and Quality Director (TQD), who manages a team of biochemists responsible for providing ISO 9001 consultancy services to customers.
You: "How do you ensure your team's competence concerning regulatory and ISO 9001 requirements?" TQD: "We subcontract a part-time lead consultant who has years of experience working as a biochemist in the cosmetics industry. She is responsible for ensuring the team's competency." You: "Do they retain any documented information on the individual competency of each consultant?" TQD: "No. The lead consultant is a dedicated individual with lots of contacts in the sector. We rely on her decision on the consultants' competency. She says that she thought that it was not necessary to keep documented information; however, after the event two weeks ago, which could not be solved due to the lack of documentation, she may consider in the future to plan which information we may need to keep." You: "How does the organisation enable the consultants you employ to maintain updated their competence on ISO 9001 and regulatory requirements?" TQD: "As I said before, we leave that up to the lead consultant. She tells us when we need to employ more young consultants and when changes are introduced in the applicable regulations. Our regular survey shows that customers are quite satisfied with our consultants; last year's objective of customer satisfaction was achieved. We gave a salary increase to consultants when they knew that the objectives had been achieved." You decide to raise a non-conformity.
To complete the non-conformity report, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.
Answer:
Explanation:
Explanation:
Non-conformity Report
ISO 9001 Clause Number:
7.2
Nature of problem:
Documented information is not retained on the necessary competence of consultants with respect to relevant regulatory and ISO 9001 requirements.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain appropriate documented information as evidence of competence." ISO 9001:2015 places a clear requirement on organisations to ensure that persons doing work under its control that affects performance and conformity are competent, and that this competence is demonstrated and evidenced.
Relevant ISO 9001 requirements
* Clause 7.2 - Competence requires the organisation to:
* determine the necessary competence of persons doing work under its control,
* ensure that these persons are competent on the basis of appropriate education, training, or experience, and
* retain appropriate documented information as evidence of competence.
In the scenario:
* Competence decisions are entirely delegated to a subcontracted lead consultant.
* No documented information is retained to demonstrate individual consultant competence.
* A recent event could not be resolved specifically due to the absence of documented competence records, which directly confirms non-fulfilment of Clause 7.2.
* Reliance on customer satisfaction results or the personal judgement of a consultant does not replace the ISO 9001 requirement for objective evidence.
Why other clauses are not applicable:
* Clause 7.1 relates to provision of resources, not evidence of competence.
* Clause 7.3 relates to awareness of quality objectives, not competence records.
* Statements such as "consultants are not aware of customer satisfaction objectives" or "persons necessary are not determined" are not supported by the scenario evidence.
ISO-aligned conclusion:
The organisation has failed to retain documented information as evidence of competence for consultants providing ISO 9001 and regulatory consultancy services. This is a clear and justified nonconformity against ISO 9001:2015 Clause 7.2.
NEW QUESTION # 253
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were told to dismiss most of the complaints because of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
You raised a nonconformity against clause 8.5.1 of ISO 9001.
Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.
Answer: A,D,F
Explanation:
The nonconformity was raised against ISO 9001:2015 Clause 8.5.1 - Control of production and service provision. This clause requires organisations to carry out production and service provision under controlled conditions, including:
* the use of suitable infrastructure and equipment,
* the availability and use of appropriate monitoring and control, and
* the prevention of nonconforming outputs being delivered to customers.
In this scenario, the evidence shows a systemic failure in operational control, not isolated human error.
Explanation of the selected evidence:
E). The organisation failed to control the laundry operations in 5 shops adequately.
Clause 8.5.1 requires consistent control of service provision. The fact that 80% of complaints come from five specific shops demonstrates a lack of effective operational control in those locations.
G). The organisation failed to maintain all of its equipment to an adequate standard.
Clause 8.5.1 requires suitable infrastructure for service provision. Management acknowledged that equipment in these shops is old and cannot currently be replaced, meaning it is not being maintained at a level necessary to ensure conformity of service.
H). Some equipment used was not suitable for the laundry process.
The poor cleaning outcomes and high complaint levels directly indicate that the equipment is not fit for purpose, which is a clear breach of the requirement to provide suitable resources for controlled service provision under Clause 8.5.1.
Explanation of why the other options are not appropriate evidence for Clause 8.5.1:
* A relates to strategic planning and investment decisions, not directly to operational control.
* B and C relate to inspection activities, which were not evidenced in the scenario.
* D and F relate to complaint handling behaviour, which would align more closely with Clause 9.1.2 (customer satisfaction) or Clause 10.2 (nonconformity and corrective action), not Clause 8.5.1.
ISO-aligned conclusion:
The nonconformity is justified because the organisation is continuing to provide services using unsuitable and inadequately maintained equipment, resulting in repeated service failures in multiple locations. This demonstrates a clear failure to control service provision as required by ISO 9001:2015 Clause 8.5.1, supported by evidence E, G and H.
NEW QUESTION # 254
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