QUALITY MANAGEMENT SYSTEM (QMS)
IMPLEMENTATION
WORKSHEET
The simple guide to putting in place a QMS
that benefits your company and customers
Quality Management System (QMS)
PAGE 01
Implementation Worksheet
Implementing a QMS in your company comes with a lot of benefits. First and
foremost, you’ll be able to meet the requirements of your customers, retain
their loyalty, and most likely attract new customers to your products. This QMS
implementation worksheet will walk you through what you need to put in place
in the company to achieve this.
Before Getting Started: Specify the rationale and
objective of QMS in your company which includes:
Maintain and accomplish compliance with the requirements of the QMS
standards
Ensure that there is consistency in quality management processes across
the company
Enhance the level of accountability among staff such that they can contribute
to the management of quality, safety, and risk
Improve audit trail and records/evidence keeping of how quality processes
are managed
Measure KPI’s/benchmarks
Company-wide implementation of the QMS
Improve systems for managing quality, safety, and risk
Train staff on the benefits and effective use of the QMS
PAGE 02
Project Planning Phase
Appoint a quality manager: Select a member of the management team
responsible for overseeing and reporting on the QMS and promoting it in the
company.
Define quality objectives and policy: Outline the company’s commitment to
quality and guide the processes used to ensure product quality.
Establish the product scope: Define the customer requirements and an
undertake an internal analysis of your company’s ability to meet those needs.
Establish the Software Development Lifecycle (SDLC) for the project:
Include all processes necessary for the QMS and the sequence and
interaction between these processes.
High-Level planning: Define the high-level processes necessary for the
development of the QMS.
Low-level planning: Provide more detailed instructions to meet the overall
strategy.
PAGE 03
System Development Phase
Gather customer requirements: Determine the actual customer requirements
for the project to ascertain what they expect from your company.
Assign resources: Ensure that adequate resources, in terms of personnel
and infrastructure, are in place and documented.
Analyze system requirements: Identify potential risks and performance
expectations.
Design the system architecture: If you’re using external components, an
appropriate acquisition strategy should be in place.
QMS development: Document and maintain the implementation process to
be used during the project.
Delivery: Ensure that the delivery conditions for your products that are put in
place by the company are met.
Customer support: Collect and retain actual customer satisfaction data
relating to your products and offer them more support through phone calls,
emails, and FAQs on your company’s website.
PAGE 04
On-Going and Irregular Activities Phase
Risk analysis: Ensure that adequate risk management activities are
performed in the company.
Document management. Track, manage, and store each document before
distribution to be sure that they are available where and when needed.
Quality assurance: Perform regular assessments of both the processes used
during the development of your company’s products and the products itself.
Validation and verification: Perform validation and verification activities to
ensure that the company’s product is correct and meets the quality standard
requirements.
Audit: Every year, the company should prepare and conduct an audit in order
to meet up with the annual surveillance by the regulatory bodies such as ISO.
Problem resolution: Any problems detected in the company’s production
process should be identified and recorded, and the root cause diagnosed so
as to prevent future recurrences.
Change request management: A documented procedure should be in place
to address change requests.
Acquisition: Follow an appropriate, QMS acquisition process throughout
company operations.
PAGE 05
Tips for successful implementation:
Establish a shared vision and clear reason for implementing quality
systems: Communicate this vision and mission to staff from the Directors,
CEO, and senior management, and at all levels.
Appoint a ‘super-user’: This is an expert in using the QMS and the go-to
person in the company.
Formulate and implement a communication strategy: This should explain:
the purpose of the QMS and what it should be used for
how to get support to use the system
how the system will benefit the company and its clients
Establish a project group: This group will be chaired by a management
representative to oversee and be held accountable for the implementation of
the system.
Continuous training and development: Develop a project plan and training
program for staff.
