ISO-9001-Lead-Auditor 試験問題を無料オンラインアクセス

What is a combined audit?

• A.Two or more auditing organizations cooperating to audit a single auditee.
• B.Two or more management systems audited simultaneously at several auditees.
• C.Two or more management systems audited together at a single auditee.

Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to general principles of sampling procedure, did the audit team select a valid sample for electrical services?

• A.No, the selected sample size is low compared to the population, as for a population from 13 to 52 the minimum sample size should be 5.
• B.No, the selected sample size is high compared to the population, as for a population from 13 to 52 the minimum sample size should be 10.
• C.Yes, the selected sample size is proportionate to the population.

During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.
There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions.
Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.
Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.

• A.There were no receipt inspection records of the incoming materials.
• B.The external provider asked for the contract details to be verbal only.
• C.There was no documentation which provided evidence of any monitoring of the external provider.
• D.The auditee trusted the external provider because of a long-standing relationship with them.
• E.The auditee required the outsourced products on an urgent basis before the completion of the paperwork.
• F.The auditee did not retain documentation on the selection and evaluation of the external provider.

You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for
25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.
What would you do?

• A.Plan to miss lunch and review as many as possible.
• B.Plan to review as many as possible and see if you can extend the audit duration by one day.
• C.Extend the audit until 1.00pm and ask for a quick lunch later.
• D.Plan to review less than 25 cases.

During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?

• A.We will add this to our external issue register, assess its associated risk, and plan action to address that risk.
• B.We will look for a local company to provide this service.
• C.We will select one sample, which we will send to an external laboratory and will use it as our internal standard.
• D.We will have the results on one out of ten of our routine production samples double-checked by an external local laboratory.