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.

Which one of the options is the correct response by the auditor?

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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 following audit trails would be the most appropriate to follow?

Select the two most appropriate audit trails from the following.

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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: "IO 9001 for one year. It provides service 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.

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You have been nominated audit team leader of a third-party audit.

Which of the following could be the two most relevant objectives of this audit?

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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:

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DRAG DROP

In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.

To complete the table, click on the blank section you want to compete so that it is highlighted in red, and then did on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section.

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Richtige Antwort:

Explanation:

In the context of a third-party audit, the activities and the parties responsible can be matched as follows:

Review the organization’s processes:

This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.

Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.

Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.

Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1. These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.

Based on the description of the image you’ve provided, here’s how the activities match with the responsible parties in the context of a third-party audit:

Review the organization’s processes: This activity is typically the responsibility of the Audit Team. They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.

Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives

are met.

Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization’s management system is found to be in compliance with the standard.

Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.

These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit’s governance and integrity.

Which two of the following auditors would not participate in a first-party audit?

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DRAG DROP

The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.

To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the appropriate record from the option listed. Alternatively, drag and drop the appropriate record to the requirement of clause 8.4 that applies.

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Richtige Antwort:

Explanation:

The following table shows the possible matching of the records to the requirements of clause 8.4:

Table

Requirements

Records

Define product requirements

Product specification

Criteria for selection

List of requirements to be met by the external provider

Evaluation of potential external provider

External provider questionnaire

External provider selection

Approved external provider list

Communicate requirements

Purchase order

Monitoring of performance

External provider delivery times and quality issues

Comprehensive and Detailed = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:

Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement. Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence o this requirement.

Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.

Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.

Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.

Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.

Reference: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO 9001 for 1 year. It provides services to ten, small rural hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).

At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider recommending suspension of the organisation’s certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.

Which two actions should you take in the context of the audit?

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A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical."

Which one of the following options is the reason why you did not accept this action taken?

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