A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO 9001 for one year. It provides services to
10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated
trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager
(DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff."
You: "I see. It really shouldn't affect the QMS so the audit can progress as normal."
DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is."
You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?"
DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office."
As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions
or ask staff members about their processes. You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
Which of the following misconceptions about ISO 9001 was present in scenario 1?
Select which one of the following statements is true.
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important
customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit
team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager,
quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the
warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"
Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and
the other two managers have had to leave urgently to attend the emergency."
Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message
from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."
Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
In the context of a third-party audit, match the event with the responsibility for conducting it.
Which one of the following documents addresses audit time calculation for third-party certification audits?
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?
Even though past audits have highlighted a consistently large number of nonconformities within an organisation's design team, the organisation has not varied the frequency or duration of audits on its audit plan.
The decision for whether this situation is acceptable or not should be governed by which of the following?
Which two of the following may be changed once a Stage 2 certification audit has commenced?
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?
