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' XYZ ' has already sent to you a list with all documented procedures and work instructions related to the services provided to ' ABC ' (a quality manual is not included in the list).
To complete the audit planning which additional information would you ask to XYZ to submit? Select four.
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged
steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality
Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
Which of the following options for the best description of the nonconformity?
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.
Scenario 4 mentions that Anne received a document that contained the audit scope, criteria, duration, and the limits to the audit engagement. What did Anne receive in this case?
You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is ' internal auditing ' .
When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.
You: " I have noted that many of the older files contain non-conformances that have not had any corrective action taken. "
Quality Manager: " Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed "
You: " Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable. "
Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.
Select one course of action you would now take from the options.
Which of the following is a responsibility of a guide in an audit?
(Select one option which defines the purpose of a second-party audit 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 are carrying out an audit to ISO 9001 at an organisation which offers consultancy services on the implementation of ISO 9001 quality management systems to manufacturers of cosmetics.
You are interviewing the Technical and Quality Director (TQD), who manages a team of biochemists responsible for providing ISO 9001 consultancy services to customers.
You: “How do you ensure your team’s competence concerning regulatory and ISO 9001 requirements?”
TQD: “We subcontract a part-time lead consultant who has years of experience working as a biochemist in the cosmetics industry. She is responsible for ensuring the team’s competency.”
You: “Do they retain any documented information on the individual competency of each consultant?”
TQD: “No. The lead consultant is a dedicated individual with lots of contacts in the sector. We rely on her decision on the consultants’ competency. She says that she thought that it was not necessary to keep documented information; however, after the event two weeks ago, which could not be solved due to the lack of documentation, she may consider in the future to plan which information we may need to keep.”
You: “How does the organisation enable the consultants you employ to maintain updated their competence on ISO 9001 and regulatory requirements?”
TQD: “As I said before, we leave that up to the lead consultant. She tells us when we need to employ more young consultants and when changes are introduced in the applicable regulations. Our regular survey shows that customers are quite satisfied with our consultants; last year’s objective of customer satisfaction was achieved. We gave a salary increase to consultants when they knew that the objectives had been achieved.”
You decide to raise a non-conformity.
To complete the non-conformity report, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
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