ISO 9001:2021, What's New?

Industri Pariwisata - Quality management systems (QMS) have long been the foundation of success for organizations around the world. The ISO 9001 standard, as the main reference for QMS, has been evolving to adapt to changes in the business landscape and the increasingly dynamic needs of customers. Now, with the advent of ISO 9001:2021, we are entering a new era in the world of QMS.

The new standard not only refines the existing framework, but also introduces significant changes that focus on improving the effectiveness, efficiency, and competitiveness of organizations. These changes touch on various aspects of QMS, from structure and terminology to a sharper focus on customers, risk, and leadership.

In this article, we will dive deeper into the key changes in ISO 9001:2021, uncover their impact on organizations, and provide guidance for preparing a successful implementation. So, get ready to enter a new era of QMS with ISO 9001:2021!

Changes in ISO 9001:2021

ISO 9001:2021 is the latest quality management system (QMS) standard published by the International Organization for Standardization (ISO). This standard replaces the previous standard, ISO 9001:2015, which has been in use for over 10 years.

The changes in ISO 9001:2021 can be categorized into three, namely:

Structural changes

The structure of ISO 9001:2021 has been changed to a process model, which places more emphasis on the PDCA (Plan-Do-Check-Act) cycle. This process model can help organizations improve the effectiveness and efficiency of their QMS.

The most significant structural change in ISO 9001:2021 is the shift from a document-based approach to a process-based approach. In a document-based approach, organizations need to document all processes and procedures required to meet the standard's requirements. In a process-based approach, organizations need to identify and manage the processes required to meet the needs and expectations of customers.

A process-based approach has several advantages, including:

• Improved effectiveness and efficiency of the QMS

• Improved flexibility and responsiveness of the QMS

• Improved understanding and communication of the QMS

Terminology changes

Some of the terminology used in ISO 9001:2015 has been changed in ISO 9001:2021. These changes are intended to align this standard with other ISO standards.

Some of the terminology that has been changed in ISO 9001:2021 includes:

• "Document" replaced with "documented information"

• "Processes and procedures" replaced with "processes"

• "Responsibility" replaced with "authority and responsibility"

These changes in terminology are intended to align ISO 9001:2021 with other ISO standards.

Focus changes

ISO 9001:2021 places more emphasis on a focus on customers, risks, and leadership. These changes are intended to help organizations meet the needs and expectations of their customers, as well as improve their competitiveness.

ISO 9001:2021 places more emphasis on a focus on customers, risks, and leadership.

Customer focus

ISO 9001:2021 emphasizes the importance of organizations understanding the needs and expectations of their customers. Organizations need to identify their customers, understand their needs and expectations, and measure customer satisfaction.

Risk focus

ISO 9001:2021 emphasizes the importance of organizations managing risks that can affect the achievement of objectives. Organizations need to identify and assess risks, and take action to mitigate those risks.

Leadership focus

ISO 9001:2021 emphasizes the importance of the role of leadership in QMS. The organization's leadership must demonstrate commitment to QMS and create an environment that supports the implementation of QMS.

Impact of Changes in ISO 9001:2021 on Organizations

Changes in ISO 9001:2021 can have positive impacts on organizations, including:

Improvement of effectiveness and efficiency

The new process model can help organizations to improve the effectiveness and efficiency of their QMS in the following ways:

• Improving understanding and communication about QMS

With a process-based approach, organizations need to identify and understand the processes required to meet the needs and expectations of customers. This can help organizations to improve understanding and communication about SMM throughout the organization.

• Improving coordination and cooperation between processes

Process models can help organizations to identify and manage interrelated processes. This can help organizations to improve coordination and cooperation between processes, which can improve the overall effectiveness and efficiency of the QMS.

• Improving the effective use of resources

With a process-based approach, organizations can identify and measure the use of resources for each process. This can help organizations to improve the effective and efficient use of resources.

Improved competitiveness

ISO 9001:2021 places a greater emphasis on customer focus, risk, and leadership. These changes can help organizations to improve their competitiveness in the following ways:

• Better understanding of customer needs and expectations

With a process-based approach, organizations can better understand customer needs and expectations. This can help organizations to meet customer needs and expectations, which can improve customer satisfaction.

• Managing risks that can affect goal achievement

With a risk-based approach, organizations can identify and assess risks that can affect goal achievement. This can help organizations to mitigate those risks, which can improve their competitiveness.

• Improving the leadership role in QMS

The leadership of an organization needs to demonstrate commitment to QMS and create an environment that supports the implementation of QMS. This can help organizations to improve their competitiveness.

Improved customer satisfaction

ISO 9001:2021 places a greater emphasis on customer focus. These changes can help organizations to improve customer satisfaction by:

• Improved communication with customers

With a customer-focused approach, organizations can improve communication with customers. This can help organizations to understand customer needs and expectations, so that they can meet customer needs and expectations.

• Improved customer requirement fulfillment

With a requirements-based approach, organizations can improve customer requirement fulfillment. This can help organizations to improve customer satisfaction.

Overall, the changes in ISO 9001:2021 can have a significant positive impact on organizations. Organizations that implement ISO 9001:2021 can improve their effectiveness and efficiency, competitiveness, and customer satisfaction.

Tips to prepare for the implementation of ISO 9001:2021

ISO 9001:2021 is the latest quality management system (QMS) standard published by the International Organization for Standardization (ISO). This standard supersedes the previous standard, ISO 9001:2015, which has been in use for over 10 years.

The changes in ISO 9001:2021 can have a positive impact, but they can also be challenging. It is important to prepare well for implementation.

Here are some tips for preparing for ISO 9001:2021:

1. Understand the changes

The first step is to understand the changes that have been made to ISO 9001:2021. These changes can be categorized into three:

• Structural changes

• Terminological changes

• Focus changes

The most significant structural change is the shift from a document-based approach to a process-based approach. In the document-based approach, organizations need to document all processes and procedures. In the process-based approach, organizations need to identify and manage the processes that meet customer needs and expectations.

Terminological changes include:

• "Document" is replaced by "documented information"

• "Processes and procedures" are replaced by "processes"

• "Responsibilities" is replaced by "authority and responsibility"

Focus changes include:

• Focus on the customer

• Focus on risk

• Focus on leadership

2. Conduct a gap analysis

After understanding the changes that have been made, organizations need to conduct a gap analysis to identify the differences between their current QMS and the requirements of ISO 9001:2021. This gap analysis can help organizations to determine the steps that need to be taken to meet the standard's requirements.

Gap analysis can be conducted internally or by a consultant. If internally, form an audit team with ISO 9001:2021 knowledge and experience.

3. Develop an implementation plan

After the gap analysis, organizations need to develop an implementation plan that includes the objectives, timeline, and resources required to meet ISO 9001:2021 requirements. The plan will help organizations to manage the implementation of their QMS effectively.

The implementation plan must be realistic and achievable. Organizations need to consider factors like size, complexity, and resources.

Here are some things to consider when developing an implementation plan:

• Implementation objectives

• Implementation schedule

• Required resources

• Responsible parties

• Progress measurement

By preparing well, organizations can increase their chances of success in implementing a QMS.

Visit the ISO website to learn more about ISO 9001:2021

To learn more about ISO 9001:2021, visit the ISO website. The website provides comprehensive information about the standard, including requirements, implementation guidance, and additional resources.

Contact a quality consultant for help with implementing ISO 9001:2021

If you need help implementing ISO 9001:2021, you can contact a quality consultant. Quality consultants can help you understand the standard requirements, conduct a gap analysis, and develop an implementation plan.

What are you waiting for? Contact a trusted business consultant today.

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