DRAG DROPYou are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM)You: "Would you tell me about your management review process?"QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?"Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.The Quality Manager then gives you the previous management review record, which took place one year before the latest review.You: "Are there any other review reports in the last two years?QM: "No, these are the only ones."
Answer(s): A
Nonconformity reportISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.
DRAG DROPWhistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
The quality system failed to control the laundry services provided for customers in five shops. The equipment used was not capable of consistently producing the required service.
DRAG DROPBelow 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).
Quality management principles:Customer focus = Increased revenue and market shareEngagement of people = Enhanced trust and collaboration throughout the organisation Improvement = Enhanced drive for innovationEvidence-based decision-making = Increased ability to demonstrate effectiveness of past actionsAccording to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization's objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards. Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.
DRAG DROPMatch the process descriptions below to the process names:
Match the process descriptions below to the process names:The process by which the accuracy of test equipment is checked against a known standard. = CalibrationThe process by which a product or service is visually examined to determine conformity to requirements. = EvaluationThe 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.= MeasurementAccording 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.
ISO 9000:2015 - Quality management systems -- Fundamentals and vocabulary
Select the term which best describes the quality management system process of modifying a non- conforming product to bring it within acceptance criteria.
Answer(s): B
According to the ISO 9000:2015 - Quality management systems -- Fundamentals and vocabulary, correction is defined as "action to eliminate a detected nonconformity". A nonconformity is defined as "non-fulfilment of a requirement". Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:·Concession: permission to release or use a nonconforming product, service or process ·Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence ·Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation
ISO 9000:2015 - Quality management systems -- Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera
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