Free PECB ISO-9001-Lead-Auditor Exam Dumps Questions & Answers

The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.
Which one of the following answers would you accept as a ' correction ' from the Purchasing Manager?

• A.  I do not accept the nonconformity. Anything I may ask my employees to do will be seen as another piece of evidence that complying with ISO 9001 requirements is a bureaucratic valueless burden.
• B.  During those weeks, as I was on holiday, the production manager should have signed those purchase orders. As a correction to this particular nonconformity, I will ask him to sign them.
• C.  I will sign all the purchase orders now. It will take some time to print them since they are on a backup disk, but I will get them done before the end of the audit.
• D.  All products related to those purchase orders have already been successfully used during the first quarter of 2020, therefore there is no need for correction. We will only take corrective action.

You are leading a team that is auditing a fruit juice manufacturer (ORANGE+), which markets its products in bottles of 0.5 and 1 litre. It is 4 pm, and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the closing meeting. The closing meeting was scheduled for 5 pm.
ORANGE+ has two manufacturing lines: M1 is a clean room for manufacturing and bottling the juices, and M2 is for packing and labelling the filled bottles in packets of 50 bottles each to be sent to retailers.
Auditor 1 audited the two manufacturing lines.
You: "What findings would you report?"
Auditor 1: "I have one issue. Earlier today, in the morning in M1, I observed a batch of 'sugarless orange juice' being filled into bottles with the label 'standard orange juice' on them." You: "How would you write the non-conformity?" Auditor 1: "Some bottles from a batch of 'sugarless orange juice' were labelled as 'standard orange juice'." What information would you add to this text to complete the non-conformity report? Select six.

• A.  The place where the bottles with the wrong label were found.
• B.  Composition of both sugar and sugarless juices.
• C.  The description of the ISO 9001:2015 requirement not being complied with and the clause number.
• D.  Name of the supervisor and of the workers who were responsible for the bottling process.
• E.  If any of the ORANGE+ procedures for bottling and labelling products were not being met.
• F.  The regulatory requirements that apply to the juice being bottled.
• G.  The signature of the M1's supervisor accepting the non-conformity.
• H.  The grade of nonconformity (major or minor).
• I.  The date on which the evidence was identified.
• J.  Batch number audited.

Knowledge and skills are requirements of the auditor ' s competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

• A.  Requirements of ISO 9001
• B.  Organisation ' s invoicing and profits of the last 5 years
• C.  Requirements of auditee ' s interested parties other than customers
• D.  Organisation ' s market sector
• E.  ISO 19011 Audit principles
• F.  Organisation ' s processes

You are auditing an organisation that has been certified to ISO 9001 for 10 years. The organisation is a privately owned, multi-site car tyre fitting company. You are auditing one of the sites.
You have confirmed with the Workshop Supervisor that tyre batch numbers shall be recorded in the Work Schedule. You have sampled recent Work Schedule records and written the following in your audit notes:
No batch numbers for tyres fitted to customers' cars were recorded in the Work Schedule for job numbers 1/5,
1/16, 2/2, 2/7, 3/2, 3/5, 3/7 and 3/9. 15 jobs completed over the past five days were sampled. The Workshop Supervisor and the Tyre Fitter were aware of this missing information in the records, but no action had been taken.
You decide to raise a non-conformity.

Correct Answer:

Explanation:
ISO 9001 Clause Number:
8.5.2
Nature of problem:
Tyre batch numbers have not been recorded in the Work Schedule.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain the documented information necessary to enable traceability." This is a traceability issue. The organisation requires tyre batch numbers to be recorded in the Work Schedule, but sampled records showed that batch numbers were missing for multiple completed jobs.
ISO 9001 clause 8.5.2 Identification and traceability requires the organisation to control unique identification when traceability is required and retain the documented information necessary to enable traceability.
Clause 7.2 competence and clause 7.3 awareness are not the best fit because the evidence shows the Workshop Supervisor and Tyre Fitter were aware of the missing records. The issue is the failure to retain required traceability information.

Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation ' s improvement actions and the auditor asks to see the most recent management review meeting minutes.
The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.
Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.

• A.  An enhanced customer satisfaction survey score than in the previous year.
• B.  Removing expensive external providers from the database.
• C.  Outsource more processes to external providers
• D.  An increase in the number of quality staff.
• E.  A quality objective to achieve lower reject rates by quality control.
• F.  The certification body auditor reporting fewer nonconformities.
• G.  Automate the fabrication process to increase profitability.
• H.  Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.