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What type of audit evidence are policies and guidelines?
How can an organization ensure the objectivity and impartiality of the internal audit function?
Which two of the following are included in the objectives of the ' Stage 1 initial certification audit ' ?
When monitoring customer perceptions, which analysis is helpful to use?
You are conducting 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.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
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?
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.
(Which of the following two activities can be carried out on-site by an auditor with no human interaction ?)
Select which one of the following statements is true.
A small cleaning services organisation is about to start work on a hospital cleaning 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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