QUALITY MANAGEMENT SYSTEM
PRE-COURSE ASSIGNMENT
ISO 9001:2015
Auditor / Lead Auditor
Training Course
Pre-course Assignment
for
Student Name: Cherrieson Faltado
Date of course: 25-29 November 2024
Venue: Virtual Training
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QUALITY MANAGEMENT SYSTEM
PRE-COURSE ASSIGNMENT
ISO 9001:2015
Students are expected for this QMS Auditor / Lead Auditor training course of IRCA to have
knowledge in the following:
a) Management systems
The Plan, Do, Check, Act (PDCA) cycle
The core elements of a management system and the interrelationship between top
management responsibility, policy, objectives, planning, implementation,
measurement, review and continuous improvement.
b) Quality management
The fundamental concepts and the seven quality management principles (see ISO 9000):
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence-based decision making
- Relationship management.
The relationship between quality management and customer satisfaction.
c) ISO 9001
Knowledge of the requirements of ISO 9001 and the commonly used quality management terms
and definitions, as given in ISO 9000, which may be gained by completing an IRCA Certified QMS
Foundation Training course or equivalent.
This pre course evaluation is aimed at helping student develop and re-enforce this essential
knowledge including an understanding of ISO 9001 and its application within an organization. The
case study organization will be given to each students together with this Pre-course Evaluation.
Students are expected to study this organization’s Quality Manual in advance so they can quickly cope
to the concept of the auditing process.
This evaluation forms an important and integral part of the training process, and will contribute
towards the continuous assessment of your performance throughout the course.
Assignment Instructions:
A copy of ISO 9001 and case study company’s Quality Manual will be included in the students
handouts. Study the standard and answer the pre-assignment questions. (For further reference obtain
copies of ISO 9000 and ISO 9004 during the training course - these are not provided by the training organization).
After you have answered these questions you should then read through the case study company
Quality Manual for you to develop a general understanding of the type of company, the nature of its
business activities and the relative size of its operation, and then answer assignments A and B.
Submit this pre course assignment with your answers on the first day of this training course.
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QUALITY MANAGEMENT SYSTEM
PRE-COURSE ASSIGNMENT
ISO 9001:2015
Pre-course assignment A: Answer the following questions:
1. Describe the impact of quality to the organization. (1 point)
The quality is important to an organization. Having a good quality management system in a
company will lead to the improvement of product and business operations.
2. Give three ways on how top management can demonstrate leadership and commitment with
respect to the quality management system. (3 points)
In our company, our Top Management is knowledgeable, very hands-on and supports the
QMS, even the other management systems. They ensure the employees are informed
with the objectives and targets, educated and encouraged the employees to understand
and comply with the company policy and applicable laws.
3. Describe the fundamental concepts of;
a. quality (1 point)
Quality is to ensure the excellence of products and services.
b. quality management system (1 point)
Quality Management System is a systematic approach to ensure that an organization
functions well.
4 Why does organization needs to understand the needs and expectations of interested parties?
Interested parties have significantly impact the quality of products and services. It helps
the
organization to make their products and services better, improve satisfaction, increase
level of
trust/relationship.
5. Give two ways on what they must understand the needs and expectations of interested parties. (2
points)
The organization must understand the needs and expectations of their interested parties
to check if the company QMS is aligned/consistent with the needs and expectations of
interested parties. For Interested Parties Satisfaction.
6. What are the benefits of applying process approach in a quality management system? (2 points)
There are numerous benefits of applying PDCA approach in a QMS but the main benefit of this
approach is to continually improve company processes.
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QUALITY MANAGEMENT SYSTEM
PRE-COURSE ASSIGNMENT
ISO 9001:2015
Assignment B
Identify what quality management principle each activity describes best. Choose the letter.
a) Customer focus b) Leadership c) engagement of people d) Process approach
e) improvement f) Evidence base decision-making g) relationships management
Activities Principle
Organization maintain processes by accepting contribution of C
individual knowledge, skills and experience as an essential resources.
Company ABS encountered production over capacity due to internal F
miscommunication and will not be able to meet their customer
requirements. To avoid it, they required and seek other company who
can support their requirement and be able to share business
opportunities.
Analyze customer requirements, define the processes that A
contribute to the achievement of a product which is acceptable to
the customer and keep these processes under control.
The organization ensures and take responsibility to control outsourced G
processes in conforming with all customer, statutory and regulatory
requirements
Where the customer provides no documented statement of A
requirement, the organization confirm it with the customer and if
appropriate provide their documented statement of requirement and
ask the customer for acceptance for a go/no go decision.
Recognize individual accomplishments of the people and adopt reward C
system to motivate them to work efficiently and effectively.
A key performance indicator is set to determine the quality B
management system meets the standard’s requirements.
The organization plan processes and verify, validate, monitor, measure, D
inspect and test activities specific to the product and the criteria for
product acceptance
Helping the supplier in calibrating his measuring instruments, using A
master instruments of the organization.
The design manager is present at the site to make required changes D
in the pressure controls based on the actual reading.
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QUALITY MANAGEMENT SYSTEM
PRE-COURSE ASSIGNMENT
ISO 9001:2015
Assignment C. Answer the following questions.
1. When planning for QMS, give 4 purposes in determining the organization’s risks and
opportunities that need to be addressed?.
1. To identify risk / hazard that could potentially affect the business, workplace and
employees.
2. To enhance the organization’s ability to make better decisions
3. To achieve the company mission and vision, objectives and targets.
4. To provide quality products and services to interested parties.
2. What do the organization need to determine when planning to achieve its quality objectives?
The top management must ensure that the organization follows a process to determine what
actions to be taken and resources required, target dates, responsible people, and how it will
be evaluated.
3. Give at least two ISO 9001 standard’s requirements for monitoring and measuring resources.
The organization shall determine and provide the resources needed to endure valid and
reliable results when monitoring or measuring is used to verify the conformity of
products and services to requirements.
The organization shall retain appropriate documented information as evidence of
fitness for purpose of the monitoring and measurement resources.
4. When organization do apply determined controls to externally provided processes, products and
services?
In our company, we determine the controls to be applied to our externally provided
processes, products and services.
. - We have a standard process for managing our subcontractors.
- An assessment is being conducted to ensure that they are compliant with our policy and standards –
inspection, audits, performance evaluation, etc.
5. The organization shall take appropriate action based on the nature of the nonconformity and its
effect on the conformity of products and services. This shall also apply to nonconforming
products and services detected after delivery of products, during or after the provision of
services. Give 4 ways on how organization deal with nonconforming outputs.
In our company, findings were acted upon by each department / vessel. Also, we do internal
audits, inspections and management review.
.
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