Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a
business, say, over the last 12 months?"
Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our
own products in house."
You: "That sounds like quite a significant change. What has been the impact of that?"
Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced
manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members
of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging
time."
You: "I'm sure. What were the reasons for making the change?"
Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in
demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with
little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices
that made our product uncompetitive."
You: "How did you go about the change?"
The auditor asks to speak to the purchasing manager about the selection of the subcontractor to
manufacture the company's own brand products.
You: "How did you choose a supplier to manufacture your products?"
Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design
drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were
happy with the result and we have used them ever since."
ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?
Put the following steps of a third-party audit into the correct sequence in which they happen.
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only
two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality
Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was
involved in a serious car accident, and the other two managers have had to leave urgently to attend to the
emergency."
The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us
to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in
which he explains why."
Which one of the following would be your preferred answer (as team leader) to the General
Manager's request?
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?