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NEW QUESTION # 124
An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.
To complete the sequence, 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.
Answer:
Explanation:
Explanation:
To certify an organization's ISO 9001:2015-based Quality Management System (QMS) for the first time, the correct sequence of activities would be:
* Establish the management system (already in place).
* Supplier audit
* Internal audit
* Management review
* Initial certification audit - stage 1
* Initial certification audit - stage 2 (already in place).
This sequence follows the typical path for preparing and ensuring that a QMS is functioning as required, leading up to certification.
NEW QUESTION # 125
Which one of the following is not an ISO 9000:2015 quality management principle?
Answer: B
Explanation:
According to the ISO 9000:2015 quality management principles document1, risk-based approach is not one of the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on. The seven quality management principles are:
* Customer focus
* Leadership
* Engagement of people
* Process approach
* Improvement
* Evidence-based decision making
* Relationship management
Therefore, risk-based approach is not a quality management principle under ISO 9001:2015.
References: ISO - Quality management principles
NEW QUESTION # 126
You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on, and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." After further auditing, you have gathered additional evidence. Match the following statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.
Answer:
Explanation:
Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
F # 5.2.2.c
8.4.3.a - No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:
"The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider."
7.2.b - The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience."
10.2.2 - No documentation is retained for rejected materials:This relates to corrective action documentation.
Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..."
10.2.1 - The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause
10.2.1 discusses actions such as containment or segregation for nonconforming outputs:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..."
6.2 - Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:
"The organization shall establish quality objectives at relevant functions... The quality objectives shall be measurable..."
5.2.2.c - The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:
"The quality policy shall be... available to relevant interested parties, as appropriate." References:
ISO 9001:2015, Clause 8.4.3 - Information for external providers
Clause 7.2 - Competence
Clause 10.2.2 - Corrective action documentation
Clause 10.2.1 - Nonconforming outputs
Clause 6.2 - Quality objectives
Clause 5.2.2 - Communicating the quality policy
NEW QUESTION # 127
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 does not require an organization to hire external consultants for the implementation of a Quality Management System (QMS). Clause 7.2 (Competence) states that an organization must ensure that personnel are competent based on education, training, or experience. However, it does not mandate hiring an external consultant. The organization can choose to develop internal competency or seek external assistance at its discretion.
Additionally, Clause 5.1.1 (Leadership and Commitment) specifies that top management is accountable for the effectiveness of the QMS, including ensuring sufficient resources and competent personnel. Hiring an external consultant is an option, not a requirement.
Reference:
ISO 9001:2015, Clause 7.2 - Competence
ISO 9001:2015, Clause 5.1.1 - Leadership and Commitment
NEW QUESTION # 128
Match the process descriptions below to the process names:
Answer:
Explanation:
Explanation:
A white background with black text Description automatically generated
NEW QUESTION # 129
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