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. "
This scenario presents a number of audit trails to different ISO 9001 requirements.
Which three of the following requirements would be relevant audit trails for this scenario?
Which two of the following may be changed once a Stage 2 certification audit has commenced?
During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.
If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.
This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.
The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).
If you had been the auditor, which one of the following actions would you have accepted?
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
The audit team members were selected based on their knowledge of the legal and other regulations that TD is subject to. Is this acceptable?
During an ISO 9001 audit of an electric cable manufacturer, you are reviewing the customer file for XYZ Construction in the Sales Department. This contract specifies that the installation configuration of the cable runs should meet national fire safety standards for Category A. You ask to see the test results for the specified configuration but are told that they are not available as they have never produced Category A cable before.
When interviewing the Technical Director, you ask about the tests for XYZ Construction. He advises that the order was never reviewed technically but shows you test results that satisfy Category B, which is less stringent.
You discover that he had a meeting with the customer to request approval of a Category B configuration. He provided the minutes of a meeting at which the customer agreed to accept the new test results subject to an agreed discount on the contract price.
Select the two statements for which there is evidence of a non-conformity to ISO 9001.
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: " I would like to begin by looking at the cleaning controls. "
MM: " We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside. "
Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
You decide to raise a non-conformity.
Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization. Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?
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. "
Administration officer: " Our quality manager, before leaving, left a written message about ' NC2 ' . He declares that the
correction and corrective action have been already implemented and has attached some documents to the message as
evidence of these actions. Therefore, he expects that ' NC2 ' will not be included in the report. "
Which one of the following would be your preferred answer to the Quallty Manager ' s request?
You are preparing an audit plan for a third-party ISO 9001 audit of organisation ABC that extracts lithium from mines in Bolivia.
ABC’s head office is in Lima, Peru, and it outsources all processes related to Production, Maintenance, Procurement and Human Resources to local Bolivian companies. ABC personnel manage in Bolivia only the Planning function.
Your plan starts in Lima, then you decide to go to Bolivia and fly back to Lima to audit the Quality Function and Top Management and conduct the closing meeting.
What would be your best decision when planning the audit in Bolivia?
