Presentation Prepared By:
UNICER
T
Sayem Bin Rashid
ID: BD P152
Organization:
United Certification Services Ltd.
Conference Presentation 1
History of ISO 9001
Origins of ISO 9001
ISO 9001 is a quality management system standard
that was first published in 1987 by the
International Organization for Standardization
(ISO). It was created to provide a framework for
organizations to consistently meet customer and
regulatory requirements, and to continuously
improve their processes and products.
Evolution of ISO 9001
Since its initial publication, ISO 9001 has undergone several
revisions, with the latest version being ISO 9001:2015. The
standard has evolved to be more flexible and adaptable to
different industries and organizational structures, while still
maintaining its focus on customer satisfaction and continual
improvement.
Requirements of ISO 9001
Quality Management System
ISO 9001 requires the implementation of a quality management
system (QMS) that meets the needs of the organization and its
customers. The QMS should be documented, implemented,
maintained, and continually improved.
Leadership
Top management must demonstrate leadership and commitment
to the QMS by establishing policies, objectives, and processes
to achieve them. They should also ensure that the QMS
achieves its intended results and is continually improved.
Requirements of ISO 9001
Planning
ISO 9001 requires that the organization plan and implement
processes to address risks and opportunities, quality objectives, and
the QMS. The planning process should be documented and updated
as necessary.
Support
The organization must provide resources, including human
resources, infrastructure, and work environment, to support the
operation and monitoring of the QMS. They should also ensure
that people are competent, aware, and involved in achieving the
QMS objectives.
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Requirements of ISO 9001
Operation
ISO 9001 requires that the organization plan, implement, and
control the processes needed to meet the requirements for the
provision of products and services. This includes design and
development, production, service delivery, and control of
externally provided processes, products, and services.
Performance Evaluation
The organization must monitor, measure, analyze, and evaluate
the QMS and its processes to demonstrate conformity and
effectiveness. They should also evaluate customer satisfaction,
internal audits, and management review.
Context of ISO 9001
ISO 9001 is a standard for quality management systems that was first published in 1987 by the International
Organization for Standardization (ISO). It is designed to help organizations ensure that they meet the needs of their
customers and other stakeholders while meeting statutory and regulatory requirements related to their products or
services.
Benefits of Implementing ISO 9001
Implementing ISO 9001 can provide a number of benefits for
organizations, including improved customer satisfaction, increased
efficiency and productivity, better communication and decision-
making, and a competitive advantage in the marketplace.
ISO 9001 Certification
Organizations can obtain certification for ISO 9001 by
undergoing an audit by a third-party certification body. This
involves demonstrating that they have implemented a quality
management system that meets the requirements of the
standard.
ISO 9001 and Other Standards
ISO 9001 is one of several standards developed by ISO related
to quality management systems. Other standards include ISO
14001 for environmental management and ISO 45001 for
occupational health and safety management.
Process of Implementing ISO 9001
Step 1: Establish a Quality Management System (QMS)
The first step in implementing ISO 9001 is to establish a
Quality Management System (QMS). This involves identifying
and documenting all the processes and procedures that are
necessary to ensure the quality of your products or services. The
QMS should include a quality policy, objectives, and
procedures for managing documents, records, and
nonconformities.
Step 2: Conduct a Gap Analysis
The next step is to conduct a gap analysis to identify any
areas where your current processes and procedures do not
meet the requirements of ISO 9001. This will help you
identify areas for improvement and develop an action plan
to address any gaps.
Process of Implementing ISO 9001
Step 3: Develop and Implement an Action Plan
Based on the results of the gap analysis, you should develop an
action plan to address any gaps and implement any necessary
changes to your processes and procedures. This may involve
training employees, updating documentation, or making
changes to your production processes.
Step 5: Continual Improvement Step 4: Monitor and Measure Performance
Finally, ISO 9001 requires organizations to Once you have implemented the necessary changes, you should
continually improve their QMS. This involves monitor and measure the performance of your QMS to ensure
setting new objectives, monitoring performance, and that it is effective. This may involve setting up a system for
making changes to processes and procedures as collecting and analyzing data, conducting internal audits, and
needed to ensure ongoing quality improvement. reviewing customer feedback.
Industries to Implement ISO 9001
ISO 9001 is a globally recognized standard that can be
implemented in any industry, regardless of size or sector. The
standard is designed to help organizations improve their quality
management system, enhance customer satisfaction, and increase
profitability. Here are some of the industries that can benefit from
implementing ISO 9001:
1. Manufacturing: ISO 9001 can help manufacturing companies
improve their production processes, reduce waste, and enhance
product quality.
2. Healthcare: ISO 9001 can help healthcare organizations
improve patient safety, enhance the quality of care, and streamline
their operations.
Industries to Implement ISO 9001
3. Information technology: ISO 9001 can help IT companies improve their
software development processes, enhance customer satisfaction, and
increase profitability.
4. Construction: ISO 9001 can help construction companies improve their
project management processes, enhance quality control, and reduce costs.
5. Hospitality: ISO 9001 can help hospitality organizations improve their
customer service, enhance the quality of their facilities, and increase
customer loyalty.
THANKS
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