Running Head: MEDICAL NEEDS 1 MEDICAL NEEDS 4 MEDICAL NEEDS Institution Affiliation Student Name Date There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017). Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time. Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing. Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for. Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that. Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987). Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products. Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service. Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017). To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model. References Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge. Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109. Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge. Medical Needs Quality Assurance Integration Connie Farris Colorado Technical University Project Performance and Quality Assurance (MPM357-1902A-02) Jason Lewis Running he.

1. Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a
huge part in the development of a business. Some of these
dimensions are equally reinforcing and push business to do
better and move to the next level. However, product service or
good can rank high in one of the dimensions and rank low in
another dimension. For medical Needs business to give better
results they should focus on building in these dimensions,

2. (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all
the medical devices that the doctors prescribe to any patient.
They should plan in such a way that all products are available in
the required time.
Features: Medical Needs should have products or services that
supplement their core functioning. Medical Needs can provide a
free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products
on the stipulated time and the right quantities, with this, they
will receive the benefit of reliability which every customer is
looking for.
Conformity: Just as Medical needs stated regarding a provision
of vendors in all areas and ensuring that all medical products
are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing
durable products and services. They should try not to fail
customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs
of the customers. They should offer fast services, courteous
services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is
very important for Medical Needs to ensure that their products
have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business.
Medical Needs should listen to their customer’s plea and
perception towards their services and work towards bettering
the services according to the customer’s perception, (Ross,
2017).
To achieve quality gains, the managers need to perceive things
in a different outlook. For any upcoming business, it will be
necessary to perform these eight dimensions to ensure that their
business picks up and moves to the next level. Medical Needs
have a classified goal which is going to be achieved along
implementation of the eight-dimensional model.

3. References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in
Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of
quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and
readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance

4. (MPM357-1902A-02)
Jason Lewis
Running head: MEDICAL NEEDS QUALITY ASSURANCE
INTEGRATION 3
MEDICAL NEEDS QUALITY ASSURANCE INTEGRATION
3
Abstract
Medical Needs is in the process of setting up
business in Nashville and Memphis Tennessee. This company
will provide any medical device the doctor prescribes for the
patients, with an extensive line of medical products available.
They are hoping to be securely established by the fall of next
year. A risk analysis has been performed and the stakeholders
requested a quality analysis to ensure all the materials used will
meet FDA QS regulations and ISO 14971 device quality system
requirements This will include all vendor materials and the
equipment used to manufacture the devices in both locations. In
the next few weeks we will cover all aspects needed to complete
this step of the preparations to open these businesses.
MEDICAL NEEDS QUALITY ASSURANCE INTEGRATION
3
Table of Contents
Abstract2
Plan Quality Management Week 14
Outline4
Quality Planning4
Quality Improvement6
Quality Control8

5. Quality Assurance8
Perform Quality Management Week 29
Perform Quality Assurance Week 310
Control Quality Week 411
Control Quality Week 512
References:13
Plan Quality Management Week 1Outline
Quality Assurance is among the most important tasks that
Medical Needs can undertake. Medical Needs Company wants
to set-up a business in Memphis and Nashville. The company
provides medical devices prescribed by the doctor to patients.
The company have already performed a risk analysis so that
they can ensure that all materials used meet ISO 14971 and the
FDA QS regulations.
Medical Device Quality Management System commonly known
as QMS involves structured processes and procedures which
cover all aspects of product labelling, distribution, design,
clinical data storage, risk management, complaint handling, and
supplier management.Quality Planning
To start with quality management systems (QMS) ought to
integrate strategic organization objectives into manufacturing
processes. From this system there are four major deliverables,
these are; management controls, design controls, process and
production controls, and corrective and preventive action. The
management control is used to provide adequate resources,
making the necessary adjustment, and ensuring they are
effective, conducting quality audits, conducting management

6. reviews and establishment of functioning quality system. Design
control deliverable is used to identify design inputs, verifying
design inputs, and validating system design, the process and
production controls is aimed at developing adequate processes,
monitoring and controlling medical manufacturing processes,
and verifying all the processes results. In addition, this
deliverable will enable the development of production processes
so as to ensure that the medical device conforms the
specifications (Pate, 2016).
The initial and first stage in the development of a great quality
management project will be to determine the quality
management mechanisms that are employed by Medical Needs.
The company will have a well-established quality management
technique that it has been using to determine the manufacturing
quality of the devices i.e. The Total Quality Management
technique.
Successful companies like Google have stated that customer
satisfaction has direct impact on the success of the company.
Medical Needs Company has already created an environment
that supports a quality culture and requires a systematic and
structured process. To implement the selected project, the
company has started off by performing risk analysis. In here the
company is aimed at identifying some of the critical success
factors. One of the reasons for this is to assist the company in
meeting the company objectives. Some of the customer success
factor which are employee satisfaction, customer satisfaction,
product quality, and process improvement. In addition, risk
analysis will assist in monitoring and tracking the organization
progress. Also, with risk analysis, it will help in identifying the
customer groups which are vendors, suppliers, employees,
customers, and volunteers.
Lastly with risk analysis it shows Medical Needs readiness to
the selected project as it will aid in developing an improvement
plan and SMART goals which includes leadership development,
process improvement, staff development, and performance
management (ISO, 2017).

7. The technique is mainly focused on achieving the best
quality for devices used in the health care facility. This comes
at a price in the long run because the quality of those devices is
already pre-defined ergo improvement is never achieved. The
level of quality leads to a saturation point since no
advancements are applied to the development process of the
devices. Therefore, the company may find its devices to be
outdated as new approaches/ methodologies to manufacturing
are not be implemented using the Total Quality Management
Technique (Juneja, 2019).
As a result, the company would use addition or change of
the technique used to aid in the improvement of the quality of
devices as explained next.Quality Improvement
While trying to find a middle ground that will enable the
company makes the best decision when it comes to quality, it is
paramount to discuss some of the techniques that can be applied
in performing the process; Six Sigma, ISO, and Lean (Westgard,
2005).
Among the tools that can be applied to quality management
process, the Six Sigma is one of the best methods to do it. The
technique involves the change of several small aspects of a
product in order to improve its overall quality. It targets
manufacturing devices that are error free. This is accomplished
through a quantitative process that takes note of the number of
defected products in a batch of production. To achieve the
standards set by six sigmas, there are certain levels of the
production quality that are tested for and appropriately reacted
to depending on the scores achieved. This include changes in
the process of manufacturing, improving the design, or just
small obvious changes. Depending on the level of quality
required, six sigma works to give the most out of the standards
set i.e. it is more or a quantitative than qualitative process.
Another great tool used for quality management is ISO
9000. This generally depends on the set standard quality of
devices. Once the standard is achieved, the quality of
production is said to be up to standard. ISO can be applied to

8. individual processes or the whole system of processes to
improve the product that is being made. Specific ISO standards
that should be met by a device/ machine produced are checked
against the product, areas that should be improved are
identified, and appropriate steps are taken to ensure continual
improvement.
Finally, the last technique to be mentioned is Lean. Lean is
more of a quality improvement strategy that a company could
take. The technique employs removal of any waste that could be
in a process through careful identification of areas in the
process/ product that does not have any value whatsoever.
Additionally, the process of quality management through lean
takes the shortest time possible i.e. 3 months; after which the
company experiences a drastic change e.g. in inventory, space
allocation, the timing of processes, or produced units per unit of
time. In this case, the project will aim to combine several
implementations of quality management techniques to come up
with the most qualified strategy.
Taking ISO and Lean will give the company an edge in
achieving high quality (standard) devices in its stock and at the
same time ensure that the acquisition of inventory is done in an
appropriate manner i.e. without any wastage. Lean and ISO also
ensure continual improvement in quality by regularly checking
for any vulnerabilities that may exist in the products. Further,
the company could benefit from ISO and Lean implementation
since it can continue with the quality improvement process over
time i.e. it is not a one-time thing.Quality Control
In this scenario, the company wishes to open two
additional branches ergo the quality management task. Quality
control will ensure that steps taken in establishing quality
management techniques continue even after the process is
finished. The use of ISO and Lean as management tools allows
for regular audits to be done on the process as well as the
products in stock. With a set-up audit, the company can easily
improve as advancements are discovered over time.Quality
Assurance

9. This is the process of testing and maintaining quality over time.
The set standards for devices are defined in the ISO 9000
manual. Therefore, every device being bought for the
organization must pass the needed minimum requirements as
stated. Depending on the changes that may come up, the
standards are revised, and effective improvements adopted as
soon as possible.
In conclusion, it is evident that quality management for the
health care business is crucial to the business. Further, several
techniques that the process can be undertaken have been
discussed i.e. Lean, ISO, and Six Sigma. Medical Needs
adoption of ISO and Lean ensures the process follows quality
standards that have been set for the healthcare industry, as well
as quick, waste removal steps, are taken to improve both the
process and the devices used.
Perform Quality Management Week 2 TBD

10. Perform Quality Assurance Week 3 TBD
Control Quality Week 4 TBD

11. Control Quality Week 5 TBD
References:
ISO. (2017). Guidelines for quality management system
documentation. Geneve: International Organization for

12. Standardization Press.
Juneja, P. (2019) Comparison of Six Sigma and Total Quality
Management. Retrieved from
https://www.managementstudyguide.com/six-sigma-and-total-
quality-management.htm
Pate, S. (2016). The global quality management system:
improvement... by Suresh Patel, (Quality management
consultant) . Productivity Press: Productivity Press.
Westgard, S. (2005) Quality Management Cocktail ISO, Lean,
and Six Sigma. Retrieved from
https://www.westgard.com/guest30.htm