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?
ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that
machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.
Which six elements should be included in the nonconformity report?
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 one of the following documents addresses audit time calculation for third-party certification audits?
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?