Updated 2023
What is ISO 9001?
ISO 9001 is a globally recognized standard for quality management systems (QMS) that provides organizations with a framework for ensuring consistent delivery of products and services that meet customer and regulatory requirements. The 5.4 management planning section of ISO 9001 is an essential component of the standard that helps organizations develop an effective QMS.
5.4 Management Planning
The management planning section of ISO 9001 includes requirements related to the development and implementation of a quality management system, and it involves four sub-sections:
Quality Objectives
Quality Management System Planning
Responsibility and Authority
Management Review
Let’s dive into each of these sub-sections in more detail.
Quality Objectives:
Quality Objectives:The first sub-section of the 5.4 management planning section of ISO 9001 requires an organization to establish quality objectives that are measurable, consistent with the quality policy, and relevant to the product or service being provided. These objectives must be communicated throughout the organization, and progress toward achieving them should be regularly monitored and evaluated.
Setting Clear Quality Objectives
Setting clear quality objectives is crucial for any organization because it provides direction and focus for the QMS, helps ensure that everyone in the organization is working toward the same goals, and ensures that the QMS is aligned with the organization’s strategic objectives.
Quality objectives are specific, measurable goals that an organization sets to achieve quality performance in its products, services, and processes.
These objectives must be consistent with the quality policy and relevant to the product or service being provided. They are a crucial component of the 5.4 management planning section, as they provide direction and focus for the organization’s QMS.
Examples of quality objectives that an organization can set include:
Reduce Product Defects:
A manufacturer can set a quality objective to reduce the number of product defects in its manufacturing process. The objective can be to reduce defects by a certain percentage, such as 10%, within a specified time frame.
Improve Customer Satisfaction:
A service provider can set a quality objective to improve customer satisfaction by increasing the number of positive customer feedback received. The objective can be to increase the number of positive customer feedback by a certain percentage, such as 20%, within a specified time frame.
Reduce Lead Time:
A logistics company can set a quality objective to reduce the lead time between order placement and delivery of products. The objective can be to reduce lead time by a certain number of days, such as three days, within a specified time frame.
Increase Productivity:
A software development company can set a quality objective to increase productivity by improving the efficiency of its development process. The objective can be to reduce the time taken to develop a software feature by a certain percentage, such as 20%, within a specified time frame.
Communicate the Quality Objectives
Once an organization has set its quality objectives, it must communicate them throughout the organization to ensure that everyone is working towards the same goals. This can be achieved through various means, such as company-wide meetings, email communications, or posting objectives in common areas.
Monitoring and evaluating progress toward achieving quality objectives is also crucial.
This allows the organization to track its performance and make necessary adjustments to its QMS to ensure that it remains aligned with the organization’s strategic objectives. Regularly monitoring and evaluating progress towards quality objectives also helps to identify areas for improvement and promote continuous improvement within the organization.
Quality Management System Planning:
The second sub-section of the 5.4 management planning section of ISO 9001 requires an organization to plan the QMS, including identifying the processes needed for the QMS and their interactions and determining the resources required for the QMS. Additionally, the organization must establish quality objectives and plans for achieving them.
Examples of QMS planning activities that an organization can undertake include:
Process Mapping:
An organization can use process mapping to identify the processes required for the QMS and determine their interactions. Process mapping involves creating a visual representation of all the processes involved in delivering a product or service, identifying the inputs and outputs of each process, and understanding how they are interconnected.
Resource Planning:
An organization can determine the resources required for the QMS by analyzing its current resource capacity and forecasting future demand. This analysis can help the organization identify any resource gaps that need to be addressed, such as hiring new staff, investing in new equipment or technology, or outsourcing certain activities.
Quality Objective Planning:
An organization can develop plans for achieving quality objectives by breaking down the objectives into smaller, more manageable tasks, assigning responsibility for each task to specific individuals or teams, and setting deadlines for completion. These plans can be reviewed regularly to ensure that progress is being made toward achieving the quality objectives.
Planning the QMS ensures that an organization is adequately resourced and has the necessary processes in place to deliver products and services that meet customer and regulatory requirements.
It also helps ensure that there is a clear plan for achieving quality objectives, which helps the organization continually improve its performance.
Examples of QMS 5.4 Management Planning
For example, a software development company may plan its QMS by mapping out its development process, identifying the inputs and outputs of each stage, and analyzing the interactions between stages. The company may determine that it needs to invest in new development tools or hire additional developers to improve efficiency and reduce lead times. The company may also set quality objectives, such as reducing the number of bugs in its software by a certain percentage, and develop plans for achieving these objectives by identifying specific areas for improvement, assigning responsibility for improvement tasks, and setting deadlines for completion.
Planning the QMS
Planning the QMS is an important component of ISO 9001’s management planning section. Organizations must identify the processes required for the QMS and determine their interactions, determine the resources required for the QMS, and establish quality objectives and plans for achieving them. By planning the QMS, organizations can ensure that they are adequately resourced, that the necessary processes are in place to deliver products and services that meet customer and regulatory requirements, and that there is a clear plan for achieving quality objectives.
Responsibility and Authority:
The third sub-section of the 5.4 management planning section of ISO 9001 requires an organization to define and communicate responsibilities and authorities within the QMS. This includes defining roles and responsibilities for all personnel who impact the QMS and ensuring that everyone is aware of their responsibilities.
This sub-section is important because it helps ensure that everyone in the organization understands their role in the QMS and knows what is expected of them.
This can help improve accountability and ensure that the QMS is implemented consistently throughout the organization.
Defining and communicating responsibilities and authorities within the Quality Management System (QMS) is a critical aspect of ISO 9001’s management planning section. This sub-section requires an organization to define roles and responsibilities for all personnel who impact the QMS and ensure that everyone is aware of their responsibilities.
Examples of activities an organization can undertake to define and communicate responsibilities and authorities within the QMS include:
Developing Job Descriptions:
An organization can develop job descriptions that clearly outline the roles and responsibilities of each employee in the QMS. This helps ensure that everyone understands their role in the QMS and knows what is expected of them.
Training and Awareness Programs:
An organization can provide training and awareness programs that help employees understand their responsibilities and authorities within the QMS. These programs can also help employees understand the importance of the QMS and their role in delivering quality products and services.
Communication Channels:
An organization can establish communication channels that ensure that everyone is aware of their responsibilities and authorities within the QMS. For example, regular team meetings, newsletters, or a company intranet can be used to communicate updates and changes to the QMS.
Defining and communicating responsibilities and authorities within the QMS is crucial because it helps ensure that everyone in the organization understands their role in the QMS and knows what is expected of them. This can help improve accountability and ensure that the QMS is implemented consistently throughout the organization.
Examples of Assigning Responsibilities and Authorities in the QMS
For example, in a manufacturing company, the QMS may involve several departments, such as engineering, quality control, and production. Each department would have its specific responsibilities and authorities within the QMS. The engineering department may be responsible for designing products to meet customer and regulatory requirements, while the quality control department may be responsible for inspecting products to ensure they meet the required specifications.
The production department may be responsible for assembling products according to the design and specifications provided by the engineering department. By defining and communicating responsibilities and authorities within the QMS, everyone in the organization would understand their role in ensuring that quality products are delivered to customers.
Defining and communicating responsibilities and authorities within the QMS is an essential component of ISO 9001’s 5.4 management planning section. Organizations must define roles and responsibilities for all personnel who impact the QMS and ensure that everyone is aware of their responsibilities. By doing so, organizations can improve accountability and ensure that the QMS is implemented consistently throughout the organization, which can lead to the delivery of quality products and services to customers.
Management Review:
The fourth and final sub-section of the management planning section of ISO 9001 requires an organization’s top management to review the QMS at regular intervals to ensure that it remains effective and relevant. This includes reviewing the QMS’s performance against quality objectives, making necessary changes to the QMS, and ensuring that it continues to meet customer and regulatory requirements.
Management review is critical because it provides top management with a comprehensive overview of the organization’s QMS and ensures that any necessary changes are made to keep the QMS relevant and effective.
The management planning section of ISO 9001 is an important aspect of the standard that helps organizations develop an effective QMS. By setting clear quality objectives, planning the QMS, defining responsibilities and authorities, and conducting regular management reviews, organizations can ensure that their QMS is aligned with their strategic objectives, meets customer and regulatory requirements, and continues to deliver consistent, high-quality products, and services.
This detailed set of qms management requirements has vast implications for any organization seeking ISO 9001:2015 compliance or registration. Senior management must steer the organization away from high risks and toward clearly stated, consistently measured, and carefully analyzed quality objectives. By using quality objectives, top management can keep the organization focused on what is most mission-critical to the company and its customers, ensuring improving results that deliver real, demonstrable quality throughout the organization.
How Core Can Help
If you’re interested in becoming ISO 9001 certified and are unsure about where to start, consider partnering with Core Business Solutions. We understand that some businesses need to get certified quickly to meet deadlines. With Core Business Solutions, getting ISO 9001 certified is simple. Using a web-based platform and expert consulting, we give you the tools to complete your certification using four steps within four months. Our experts will work one-on-one with your business to help you create a plan that will result in improvement.
If you’re looking for other certifications, we do that too! From AS9100 to ISO 13485, we will help you understand how a standard applies to your business so you can achieve certification efficiently. We can even support you through an integrated management system if your business needs multiple certifications. To find out how Core Business Solutions can help your business get certified or to learn more about our services, contact a member of our team today.
