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NEW QUESTION # 140
Match the process descriptions below to the process names:
Answer:
Explanation:
Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
NEW QUESTION # 141
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?
Answer: C
Explanation:
Clause Reference - ISO 9001:2015 Clause 8.6 (Release of Products and Services):
ISO 9001 requires that products and services are not released to the customer until:
All planned verification activities have been completed.
Acceptance criteria have been met.
Any necessary approvals have been obtained.
In this scenario:
The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.
This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.
Option Analysis:
A). A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.
B). Release of the product without acceptable test results has been accepted by the customer for Project DK:
Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.
C). Products for Project DK have been released before product approval through the quality control process:
Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.
D). The untested product was not recalled until the galvanic efficiency of the anodes was verified:Incorrect.
The issue is not about recalling the product but about releasing it without completing the required tests.
Recalling the product is not mentioned in the scenario.
Why C is Correct:
The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.
This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO 9001 compliance.
Key ISO 9001 Reference:
Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.
NEW QUESTION # 142
An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.
During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO
9001.
Which one of the evidence statements would support this finding?
Answer: B
Explanation:
According to clause 10.2.1.b of ISO 9001:2015, the organization should evaluate the need for action to eliminate the causes of nonconformities, in order to prevent their recurrence. This means that the organization should identify and address the root causes and contributing factors of the nonconformities, and implement appropriate corrective actions that are effective and proportional to the impact of the nonconformities. In this case, the evidence statement that supports the finding of nonconformance is C, because it shows that the organization did not take effective actions to prevent the recurrence of the spelling errors in the print run, which resulted in repeated customer rejections and dissatisfaction. The other options are not directly related to clause 10.2.1.b, although they may indicate other nonconformities or weaknesses in the organization's QMS.
For example, option A may relate to clause 7.2 on competence, option B may relate to clause 8.6 on release of products and services, and option D may relate to clause 7.1 on resources. References: ISO 9001:2015, [ISO
9001 Auditing Practices Group Guidance on Nonconformity and Corrective Action], ISO 9001 Clause 10.
Improvement - ISO-templates.com
NEW QUESTION # 143
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
Answer: D,F
Explanation:
* D. I would look for evidence that the actions resulting from the risk assessment had been taken.
* According to ISO 9001:2015, Clause 6.1.2 requires the organization to plan actions to address risks and opportunities. The organization must integrate and implement these actions into its quality management system and evaluate their effectiveness. The auditor should seek evidence that the organization has assessed the risks and taken appropriate actions.
* B. I would ask to audit the Technical Manager by phone.
* As the Technical Manager is responsible for this process and is absent due to illness, it is reasonable to attempt to contact him to obtain accurate information. This ensures that the audit process is not unduly delayed and that the information is obtained from the appropriate person.
* A. I would not accept the legal compliance expert answering the question.
* While the legal compliance expert might not be the best source for technical details, outright rejecting their input is not appropriate. It is better to first verify if the expert can provide relevant information.
* C. I would delay the audit until the return of the Technical Manager.
* This would be an inefficient approach. Contacting the Technical Manager by phone is a more practical and reasonable option.
* E. I would ask for a different guide instead of the legal compliance expert.
* The guide's role is not necessarily to answer technical questions but to facilitate the audit. Since Jack is already familiar with the situation, replacing him may not add value.
* F. I would ask the consultant to leave the meeting since he is not an employee of the organization.
* This is inappropriate and could disrupt the audit process. There is no rule in ISO 9001 preventing a consultant from assisting in the audit if authorized by the organization.
Why Not the Other Options:
NEW QUESTION # 144
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization 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.
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
NEW QUESTION # 145
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