ISO 9001:2015 Clause 6.2 is titled "Quality Objectives and Planning to Achieve Them." This clause focuses on setting quality objectives for your organization and planning how to achieve them. In essence, it's about defining what you want to accomplish regarding product and service quality and how you intend to do it.
Breakdown of Clause 6.2
Quality Objectives: You must establish specific, measurable, achievable, relevant, and time-bound (SMART) quality objectives. These objectives should be aligned with your organization's overall mission and vision and should contribute to enhancing customer satisfaction and the performance of your quality management system (QMS).
Alignment with Organizational Goals: Quality objectives should be consistent with your organization's quality policy established in ISO 9001 clause 5.2. They should support the organization's mission, vision, business goals, and strategic direction.
Commitment to Continuous Improvement: This clause promotes a commitment to continual improvement. Quality objectives should reflect a desire to enhance product and service quality, increase operational efficiency, and meet or exceed customer expectations.
Planning and Resource Allocation: Organizations must develop plans detailing how they intend to achieve their quality objectives. This planning includes identifying the necessary resources, responsibilities, timelines, and actions required to attain those objectives.
Monitoring and Measurement: Quality objectives should be measurable and linked to relevant performance indicators and metrics. This clause emphasizes the importance of ongoing monitoring and measurement to assess progress toward these objectives.
Communication and Engagement: Effective communication of quality objectives throughout the organization is essential. Employees at all levels should understand these objectives and be engaged in working toward their achievement.
Accountability and Responsibility: By assigning responsibilities for quality objectives, this clause ensures that individuals or teams within the organization are accountable for their achievement. This fosters a sense of ownership and commitment.
Adaptability: The clause emphasizes the need for organizations to review and, if necessary, adjust their quality objectives as circumstances change. This adaptability ensures that objectives remain relevant and achievable.
ISO 9001:2015 Clause 6.2.1 Detailed Requirements
ISO 9001:2015 Clause 6.2.1 specifies detailed requirements for establishing and maintaining quality objectives within an organization's quality management system (QMS).
Let's break down each requirement:
Consistency with the Quality Policy (6.2.1a): Quality objectives should align with the organization's quality policy. This means that the objectives should support and reinforce the commitments made in the quality policy, ensuring that the organization's actions are in harmony with its stated quality intentions.
Measurability (6.2.1b): Quality objectives should be measurable, meaning they must be expressed in quantifiable terms. Measurability enables the organization to track progress and assess whether the objectives have been achieved.
Applicable Requirements (6.2.1c): Quality objectives should consider applicable requirements. This includes legal and regulatory requirements, as well as any specific industry standards or customer expectations that are relevant to the organization's products and services.
Relevance to Conformity and Customer Satisfaction (6.2.1d): Quality objectives should be relevant to the conformity of products and services. In other words, they should address areas where the organization needs to ensure that its products and services meet the required standards and specifications. Furthermore, quality objectives should also focus on enhancing customer satisfaction, as this is a fundamental goal of the ISO 9001 standard.
Monitoring (6.2.1e): The organization must establish a system for monitoring the progress toward achieving these quality objectives. This involves regularly collecting data and performance indicators that provide insight into whether the objectives are being met.
Communication (6.2.1f): Quality objectives should be communicated throughout the organization. Everyone in the organization should be aware of these objectives, their significance, and their role in achieving them. Effective communication ensures that all employees are aligned with the organization's quality goals.
Updating (6.2.1g): Quality objectives should be subject to regular review and updates. If circumstances change or if it becomes evident that certain objectives are no longer relevant or achievable, they should be modified to reflect the current organizational context.
Documented Information (6.2.1h): The organization is required to retain documented information on the quality objectives. This documented information serves as a record of the established objectives and their associated details, such as how they align with the quality policy, how they are measured, and how they are monitored.
This clause ensures that quality objectives are not just vague intentions but are well-defined, quantifiable, and consistently aligned with the organization's quality policy and applicable requirements. These objectives are actively monitored, communicated, and reviewed to drive continual improvement within the organization's quality management system. The documented information provides a record of the objectives for future reference and auditing purposes.
ISO 9001:2015 Clause 6.2.2 Requirements for Planning to Achieve Quality Objectives
ISO 9001:2015 Clause 6.2.2 outlines the requirements for planning to achieve an organization's quality objectives. It specifies the key elements that must be determined during the planning process. Let's break down these requirements:
What Will Be Done (6.2.2a): This refers to defining the specific actions or tasks that need to be carried out to achieve the quality objectives. These actions can include process improvements, changes in procedures, or any other measures that contribute to meeting the quality objectives.
What Resources Will Be Required (6.2.2b): Determining the necessary resources includes identifying the materials, equipment, human resources, and any other assets or support required to accomplish the planned actions effectively. Resources may encompass personnel, technology, funding, and infrastructure.
Who Will Be Responsible (6.2.2c): Assigning responsibilities is crucial for accountability. It involves designating individuals or teams responsible for carrying out the planned actions. Each task should have a clear owner who is accountable for its completion.
When It Will Be Completed (6.2.2d): Establishing a timeframe is essential for goal setting and tracking progress. It involves setting deadlines or milestones for each action or task, ensuring that they are completed within a defined timeframe.
How the Results Will Be Evaluated (6.2.2e): This addresses the methods and criteria for evaluating the results of the planned actions. It involves defining the metrics, indicators, or evaluation processes that will be used to assess the effectiveness of the actions in achieving the quality objectives.
Specifically, this clause requires the organization to have a structured approach to planning. It ensures that achieving quality objectives is not left to chance but is carefully considered and well-documented. By addressing what needs to be done, what resources are needed, who is responsible, when it will be completed, and how results will be evaluated, the organization can effectively plan, implement, and monitor actions that contribute to quality improvement and the fulfillment of its quality objectives. This planning process is a fundamental aspect of achieving continual improvement within the quality management system.
ISO 9001:2015 Clause 6.2 Quality Objectives and Planning to Achieve Them
ISO 9001:2015 Clause 6.2 focuses on setting clear, strategic quality objectives aligned with an organization's mission and vision. It emphasizes continuous improvement and requires well-defined plans, resource allocation, and ongoing monitoring to ensure these objectives are met. The clause promotes a results-oriented approach to quality management.