20210386, Gaye Gülüm Şimşek

WHAT IS A QUALITY MANAGEMENT SYSTEM?

In the most simple terms, a quality management system such as ISO 9001 is a clearly defined
set of business processes. Together with the relevant documentation, it defines your
commitment to creating products and services in accordance with pre-defined standards. A
good QMS should include detailed information about processes and responsibilities within
an operational environment.
An effective QMS ensures that your business delivers to a consistently high standard,
together with a plan to continually measure and improve every aspect of the business
operations, within the appropriate regulatory framework.

WHAT IS ISO 9001?

ISO 9001 is the internationally recognized Quality Management System (QMS) standard that
can benefit any size organization. Designed to be a powerful business improvement tool, ISO
9001 Quality Management certification can help you to:
 Continually improve, streamline operations and reduce costs
 Win more business and compete in tenders
 Satisfy more customers
 Be more resilient and build a sustainable business
 Show you have strong corporate governance
 Work effectively with stakeholders and your supply chain

The customers tell that they receive significant business benefits from ISO 9001 including:
WHAT IS ISO 9001:2015 (CURRENT VERSION)?
ISO 9001:2015 is the current version of the ISO 9001 standard which outlines the
requirements an organization must maintain in their quality system for ISO 9001:2015
certification. ISO 9001 is explained in detail above. It is the most recent version of the
standard which included several changes from ISO 9001:2008 including:
 Adaption/adoption of the new ISO structure (Annex L) to align with other standards
including ISO 14001, ISO 45001, etc.
 Enlarging the relationship between organizations and quality management systems
 ISO 9001:2015 promotes a process approach in order to produce the sought after quality
outcomes
 Presents requirements for quality performance in the organization’s strategic planning
 Greater emphasis on top level management for ownership of the QMS
 Less prescriptive requirements compared to previous versions
 The main focus is on customer satisfaction
 Straightforward terminology throughout the standard
 STANDARTS CONTENTS APPLICATIONS

Provides definition and concepts. Explains how All industries including software
ISO 9000 to select other standards for a given business. development

Engineering and construction

firms, manufacturers that
Quality assurance in design, development, design, develop, install and
ISO 9001 production, installation and servicing. service products.

Companies in the chemical

process industries that are not
Quality assurance in production and involved in product design or
ISO 9002 installation. after sales service.

Small shops, divisions within a

firm, equipment distributors
that inspect and test supplied
ISO 9003 Quality assurance in test and inspection. products.

QMS-guidelines for performance improvements,

The aim of the standard is the improvement of
the performance of an organization and the
satisfaction of customers and other interested
ISO 9004 parties. All industries

WHAT IS THE DIFFERENCE BETWEEN ISO 9001:2015 AND ISO

9001:2008?
1. Identify both external and internal issues
The new ISO 9001 standard now requires organizations to identify all issues both within
and outside the organization that are relevant to its context and that can help to achieve
the intended outcomes of its management system.
2. Greater emphasis on leadership than management
ISO 9001:2015 certification requires management to have direct involvement and
ownership of the process and to ensure that the QMS is achieving its intended results
and drive continual improvement within the organization.
3. Focus on organizational planning
This is a new requirement which obliges organizations to identify those risks and
opportunities that have the potential to impact (negatively or positively) on the
operation and performance of their QMS.
4. Evaluation of resources
Organizations need to take into account both internal and external resource
requirements and capabilities to implement, maintain and improve its QMS.
5. Open-communication with customers.
There is now a requirement that these processes must include, where relevant,
communicating with customers in relation to the handling or treatment of customer
property and specific requirements for contingency actions.
6. Identifies the ‘what’ ‘how’ and ‘when’ of the monitoring and measurement.
ISO 9001:2015 certification now requires organizations to monitor information relating
to the degree to which their needs and expectations have been fulfilled.
7. Improvement
An additional requirement for organizations to address is the ‘consequences’ of
nonconformities, which is recognition that not all of its processes and/or activities will
represent the same level of risk in terms of the organization’s ability to meet its
objectives.

The following table is a brief summary of a number of important changes to the terminology
compared with ISO 9001:2008.

ISO 9001:2008 ISO 9001:2015

Products Products and services

Documented information
Documentation, quality manual,
documented procedures, records,
instructions

Work environment Environment for the operation of

processes

Monitoring and measuring equipment Monitoring and measuring resources

Purchased product Externally provided products and

services
Supplier External provider
ISO 9001 STRUCTURE
ISO 9001:2015 introduced new structure of the standard:
 Scope
 Normative references
 Terms and definitions
 Context of the organization
1. Understanding the organization and its context
2. Understanding the needs and expectations of interested parties
3. Determining the scope of the quality management system
4. Quality management system and its processes
 Leadership
1. Leadership and commitment
2. Policy
3. Organizational roles, responsibilities and authorities
 Planning
1. Actions to address risks and opportunities
2. Quality objectives and planning to achieve them
3. Planning of changes
 Support
1. Resources
2. Competence
3. Awareness
4. Communication
5. Documented information
 Operation
1. Operational planning and control
2. Requirements for products and services
3. Design and development of products and services
4. Control of externally provided processes, products and services
5. Production and service provision
6. Release of products and services
7. Control of nonconforming outputs
 Performance evaluation
1. Monitoring, measurement, analysis and evaluation
2. Internal audit
3. Management review
 Improvement
1. General
2. Nonconformity and corrective action
3. Continual improvement
WHY SHOULD YOU CHOOSE ISO 9001 AS YOUR QMS?
ISO 9001 is internationally recognised and one of the most popular quality management
systems. It is possible for a business to implement a QMS and for a disconnect between
policy and procedure to still remain across the operational capacity. This is not the case with
ISO 9001.
No other standard has the history of ISO 9001. The certification can be traced back to the
World War II era, and has undergone continual revision on the world-wide stage. Created by
the international standards agency it has become the world’s best-known quality
management system.

There are three reasons why the ISO 9001 standard has developed this reputation for
delivering real results:
1. Credibility
The independent certification process that requires a third party to assess the organisation
against the required standards, ensuring that a high level of quality assurance is consistently
achieved.
2. Universality
Because the standard can be applied across a wide variety of business sectors, it has been
applied to vast numbers of companies. With such a wide reach it has become the simple way
for procurement teams to rate companies.
3. Success
When ISO 9001 is implemented in a business it creates results, drives efficiency and gives
business a framework for continual improvement. Its reputation is based on a consistently
high level of return on investment, making it an extremely attractive proposition for
business.
And of course, ISO 9001 is a pre-built QMS that reduces the load on high-level directors and
authorities within the business. Rather than having to construct an entire approach from
first principles, this standard allows businesses to simply make the decision and accelerate
towards the end goal of certification and a better operational structure.
HOW ISO9001 HELPS?
Client Expectation
 It helps you to identify present customer needs and identify and assess future
requirement
 It helps you to measure client satisfaction

Compliance
 Helps you ensure all regulatory requirements are met for your products and services
• Requires you to communicate regulatory requirements to your employees and interested
parties

Improvement
• It makes you assess risks and identify opportunities for your business
• It makes you continually examine opportunities for improvement
• You need to put in place the operational controls to effectively manage and measure your
performance

Reputation
• Demonstrates your commitment to quality products and services
• It is the most widely recognized international management system standard • Helps
safeguard the quality of your products and services

Engagement
 Requires you to identify al internal and external stakeholders relevant to your Quality
Management System and their needs
 Requires you to communicate the quality policy and ensure that the workforce
understands how they contribute to it
 You are expected to show how you meet customer requirements and regulatory and
statutory requirements

BENEFITS
Client Expectation
• You focus on planing ahead to make sure you have the right resources and knowledge in
your organization
• Helps you to build a resilient organization for the long term
• Helps you to deliver better products and services
• Increase in customer satisfaction and repeat business
Compliance
• Gives confidence to interested parties that relevant regulations and compliance obligations
are being met
• Protects your reputation
• Reduces likelihood of fines and prosecutions which allows you to focus on winning
business
Improvement
• Lower operational costs
• Reduce waste and increase efficiency • Improve your bottom line

Reputation
• Improved reputation and stakeholder satisfaction
• A competitive advantage to grow your business
• Win more high-value customers, and achieve improved customer retention with better
customer service

Engagement
• Internal and external communication is improved
• Business with a motivated and engaged workforce are more likely to remain compliant and
avoid penalties or fines

ISO 9001 CERTIFICATION

The ISO 9001 is a basis for certification. The ISO doesn't certify enterprises itself.
Numerous certification bodies exist. They are accredited to certify quality management
systems as compliant with ISO 9001 requirements. Usually the certificate is issued for
three years, and each year the certification body provides an supervision audit. Other
standards of ISO 9000 family are not certified.
The certification system has an important flaw. The certification body has a business
interest in issuing certificates. If the organization fails during the audit, it can choose
another certification body. Therefore, over years the certification bodies became to
approach to the audit in more flexible way. This in long term decreases the value of ISO
9001 certificate. The certification bodies that keep high standards have less customers
and therefore they can bye forced to leave the market.
PROBLEMS RELATED TO THE QUALITY MANAGEMENT SYSTEM
The problems related to the functioning of quality management systems can be divided into
three categories. The first one are the weaknesses of the ISO 9001 standard. The second
group are practical irregularities which appear at the stages of implementation,
improvement and certification of the quality management systems. The last category
consists of real or potential threats in company’s surroundings.
DRAWBACKS OR DISADVANTAGES OF ISO 9001
Following are the drawbacks or disadvantages of ISO 9001 QMS:
 Stakeholders do not have adequate understanding of ISO 9000 certification process. It
requires training to implement it successfully.
 It is expensive to establish quality management system (QMS).
 It requires heavy emphasis on documentation.
 Period to achieve ISO certification is very lengthy and requires months of efforts.
 Standard is prone to failure when company is interested in certification before quality.

TOP TIPS ON MAKING ISO 9001 EFFECTIVE

 Top management commitment is key to making this a success .
 Keep staff informed of what’s going on, create a team or assign a champion, as this will
increase motivation. This could include a well communicated plan of activities and
timescales.
 Think about how different departments work together to avoid silos. Make sure the
organization works as a team for the benefit of customers and the organization.
 Review systems, policies, procedures and processes you have in place – you may already
do much of what’s in the standard and make it work for your business.
 Speak to your customers and suppliers. They may be able to suggest improvements and
give feedback on your service.
 Train your staff to carry out internal audits. This can help with their understanding, but it
could also provide valuable feedback on potential problems or opportunities for
improvement.
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https://the9000store.com/what-are-iso-9000-standards/what-is-iso-9001/