PECB Related Exams
ISO-9001-Lead-Auditor Exam
The PECB ISO-9001-Lead-Auditor exam is ideal for professionals seeking to:
The PECB ISO-9001-Lead-Auditor exam assesses your knowledge across seven key domains:
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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:
The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?
The following are stages of an audit, put them in the order they would be conducted.

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product
packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is
responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: " Good afternoon. "
OD: " Good afternoon. "
You: " What responsibility do you have concerning the SWIFT database? "
OD: " I maintain it. If anyone wishes to propose an update to the database, they send me an email with
details of their proposal. I then either process the database update myself, or I send the request to the
consultant who designed the database 20 years ago. The necessary software changes are made, and the
amended software is immediately released to users. "
You: " Would you explain how the software amendments are controlled? "
OD: " Of course. I personally update every computer myself. "
You: " Do you inform the database users of the changes? "
OD: " No I don ' t. They find out for themselves by using the software, or they come to see me if they have
any questions. "
You: " How do you ensure that the database users use the latest version? "
OD: " That ' s easy, I update every computer myself. "
You: " During the audit, I noted there were several versions of SWIFT in use (you refer to your audit
notes). "
OD: " I know. That ' s because some versions work better than others, and depending on user needs and
experiences, we allow users to revert to using an earlier version if they find it works better for them. "
Based on the scenario, which two of the following statements are true? There is evidence of
nonconformity with a requirement defined in ...