ISO 9001:2015 Clauses 6.2 & 6.3 – Quality Objectives and Planning for Change in Your QMS
ISO 9001:2015 Clauses 6.2 and 6.3 help organizations establish measurable quality objectives and manage changes within their Quality Management System (QMS) in a structured way. Clause 6.2 focuses on setting achievable goals aligned with the quality policy, assigning responsibilities, allocating resources, and monitoring results. Clause 6.3 ensures that any changes to the QMS are planned, risk-assessed, and implemented without compromising system integrity. This guide explains both clauses with practical examples and best practices, helping organizations improve performance, adapt to change effectively, and achieve continual improvement with Maxicert’s expert guidance.
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Introduction
Establish meaningful goals for your business with ISO 9001:2015. Dive into Clauses 6.2 and 6.3 to learn how to set measurable quality objectives and manage changes effectively. Discover how strategic planning ensures your QMS drives both customer satisfaction and organizational success. These clauses encourage organizations to translate their vision into actionable, trackable outcomes while ensuring smooth adaptation to changes without compromising quality. With Maxicert’s ISO certification expertise, businesses can confidently align their objectives with long-term strategies and implement structured change management processes that strengthen performance and resilience.
6.2 Quality Objectives and Planning to Achieve Them
Quality objectives are clear and measurable goals set by an organization to improve product and service quality. They align with the quality policy and help meet customer needs. The organization plans what actions are needed, who is responsible, and when to complete them. These objectives are regularly monitored, communicated, and updated to ensure continuous improvement.
6.2.1 The organization shall establish
Quality objectives at relevant functions, levels and processes needed for the quality management system. The quality objectives shall:
- Be consistent with the quality policy;
- Be measurable
- Take into account applicable requirements
- Be relevant to conformity of products and services and to enhancement of customer satisfaction
- Be monitored
- Be communicated
- Be updated as appropriate.
The organization shall maintain documented information on the quality objectives.
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
- what will be done,
- what resources will be required;
- who will be responsible,
- when it will be completed;
- how the results will be evaluated.
By following the requirements in 4.3, 4.4 the scope and processes of the QMS have been identified and you will have established your quality policy per 5.2. In order to put this policy into effect, top management needs to establish clearly defined objectives that your organization can aim for. This does not need to be carried out personally by top management but the responsibility is still theirs.
It is important that these objectives are not vague but address what’s important to you and your customers.
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Basis for Setting Quality Objectives
An organization can develop quality objectives on the basis of the results of the identification and prioritization of risks. Planned risk treatment actions are essentially quality objectives. The development of quality objectives shall be taken into account development directions identified in the quality policy.
The objectives need to be realistic and related to achievable outcomes, such as:
- meeting the requirements (customer, regulatory and other) for products and services,
- meeting the planned schedule,
- identifying opportunities for improvement, and
- identifying new market opportunities.
Relevance Across the Organization
This clause also requires that relevant objectives (e.g., process performance, continual improvement) are established at appropriate parts of your organization (e.g., human resources, production, sales). It is important that you and your people are aware of how they contribute to the achievement of the quality objectives.
The organisation may have an objective of 100% on-time delivery. However, in order to meet that objective it might have to set a more specific objective relating to meeting daily planned schedule requirements. This, in turn, might generate an even more localized objective of decreasing turnaround time for fitting all components for an assembly job.
Measurable Quality Objectives
Quality objectives need to be measurable. They should be based on analysis of the current status of a product or process, with the intent of improving the outcome in a manner that can be measured.
At the service delivery/customer interface or at the production line, objectives can be very simple and direct, as shown by these examples:
- A transport organization running a bus service might set an objective for the percentage of buses that will run to the scheduled timetable within set limits.
- At a production location, the objective output per hour with maximum acceptable reject level can be set.
- In a hairdressing salon, for the times when all available staff are busy, one person can be assigned to greet new customers. The objective here might be that “customers entering the shop are to be welcomed within one minute and their requirements ascertained”.
At higher levels in the organization, objectives can get more complex.
For example, in the case of the hairdressing salon, the owner/manager could set a further objective of having sufficient staff available to meet peak demand times. This might require planning, employing temporary staff, training them, and so forth.
Review and Documentation of Objectives
6.3 Planning of Changes
When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4). The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
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Key Focus in Managing Change
A key focus in dealing with any change is to minimise the impact on conformity of product and services to requirements and to ensure the integrity of the QMS. Changes can occur in a number of ways.
Identification of the Need for Change
The identification of the need for a change can occur in any number of ways. The need for change may come from:
- external sources (e.g., changes to product or service based on customer feedback, supplier of new material, new IT system for customer interface), or
- internal sources (e.g., identified problems with processes or products or changes as part of an internal improvement initiative, see 10).
Reactive Changes
When things go wrong with the delivery of a service or a product or with the processes of the QMS there may also be a need for a change i.e. a reactive change. It may be too late to prevent the provision of the service or the delivery of the products but the issue should be identified and analysed to determine what changes are needed to prevent reoccurrence or what action is needed to mitigate the problem — see 8.5.6., 8.7 & 10.2.
Importance of Analysis and Trending
Analysis and trending of results and data is important in determining possible changes, which should be planned.
Planning Changes Properly
All changes should be planned and assess the changes and the possible impacts on the QMS.
When planning changes to the quality management system the organization should address the risks (see Clause 6.1) associated with these changes on the issues outlined in this section of the standard from a) to d).
Conclusion
Clauses 6.2 and 6.3 of ISO 9001:2015 are intrinsically linked, forming the backbone of strategic QMS management. Clause 6.2 gives your organization a clear direction by requiring measurable, communicated objectives that are aligned with your quality policy. In turn, Clause 6.3 provides the framework to navigate the journey toward those objectives by ensuring that all necessary changes are planned, proactive, and risk-assessed. By treating quality objectives not as mere paperwork but as living goals, and by managing change as a planned, strategic activity, your organization can maintain the integrity of its system, enhance customer satisfaction, and ensure continuous improvement. With Maxicert’s guidance, organizations can turn these requirements into practical actions, ensuring goals are realistic, well-communicated, and adapted to evolving business growth.
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FAQ
Quality objectives are clear, measurable goals set by the organization to improve its products, services, and customer satisfaction. They help turn the company’s quality policy into practical actions that support continual improvement and business success.
Effective quality objectives should follow the SMART approach—they should be Specific, Measurable, Achievable, Relevant, and Time-bound. They should also align with the organization’s quality policy, be regularly monitored, and updated when necessary.
Top management is responsible for establishing quality objectives and ensuring they align with the organization’s strategic direction. However, employees across different departments also play a key role by understanding their responsibilities and contributing to achieving these objectives.
Organizations should plan QMS changes by evaluating the purpose of the change, potential impacts, required resources, and responsibilities. A structured approach helps maintain QMS integrity, minimize risks, and ensure product and service quality are not affected during the transition.
