PECB ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam
The ISO 9001 clause 5.1.1 states top management shall demonstrate leadership and commitment with respect to the quality management system.
In the context of the ISO 9001 management system certification, select the one correct description of top management ' s responsibilities.
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?
You are conducting a Stage 2 audit at an organisation that services refrigeration equipment for a large customer base. The scope of certification is “Provision of refrigeration equipment maintenance and repair servicesâ€. You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs.
The Managing Director adds that the ISO 9001 requirements for the competence of personnel extend to both sub-contract and full-time staff.
You then asked 2 of the sub-contract engineers what they could do to contribute to the effectiveness of the quality management system, they replied stating that “we are not really sure as we have not been told how we could contributeâ€. The Managing Director added that this is not applicable as they only use sub-contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.
Which clause in ISO 9001 has not been fulfilled in this instance?
You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more
important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff
are now required to be ' multi-skilled ' . You ask to see plans for the multi-skilling training and are shown plans that look
comprehensive, and include both ' on the job " training and internal and external training courses.
The records indicate that several staff required parts of their training to be repeated one month after the first training was
provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff
members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a
corrective action.
Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?
Select the two most appropriate audit trails from the following.
Who assigns a guide to assist the audit team?
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above
nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
In the context of a third-party audit, match the event with the responsibility for conducting it.
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:
According to scenario 1, AL-TAX determined the factors that could hinder their processes from achieving the planned results and implemented preventive actions. This means they employed:
The following are stages of an audit, put them in the order they would be conducted.
An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.
During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001.
Which one of the evidence statements would support this finding?
