The most recent version of ISO 9001, ISO 9001:2015, provides a new approach to record and document quality management. This allows organisations to control their documenting processes and deliver the intended results without following the many mandatory procedures of the previous version. One of the essential clauses of this new approach is the quality assurance plan.
What is a Quality Assurance Plan?
In its simplest definition, a quality assurance plan is a document that specifies quality standards, resources, practices, and quality control requirements. It also outlines the sequence of activities associated with a specific service, product, contract, or project.
The primary purpose of a quality assurance plan is to demonstrate how the Quality Management System (QMS) works in a specific case. This document can also be used to meet customer and regulatory requirements to maximise resources in achieving quality objectives and reducing the risk of nonconformity.
What Is Defined in ISO 9001 Quality Plans?
- Objectives: The development of quality objectives is necessary because it defines the strategic purpose and goals of the QMS in an organisation. These objectives may include effectiveness, specifications, utilisation, cost, yield, cycle time, natural resources, and more.
Properly written objectives communicate the purpose of quality systems and create a customer-based culture in a firm. In addition, quality objectives must provide a clear metric for evaluating progress and enable team members to understand the organisation’s value and purpose.
- Steps in the process: This is a quality manual that states a company’s functions and operating procedures. These steps should define the scope of a QMS, outline the requirements of the QMS framework, and point out elements that are not included in the QMS implementation. It should also discuss the organisation’s policies and provide visual documentation of essential processes.
- Allocation of responsibilities: An effective quality management system should include the duties of every individual in the organisation. To achieve this purpose, a company must consider its personnel, resources, equipment, information systems, and other organisational components.
- Documented standards: These are specific standards that involve the procedures, practices, and instructions to be followed in any quality management system.
- Testing parameters: Testing is the process of measuring, examining, or inspecting the performance or properties of an audit process at specific phases.
- A documented procedure: Establishes the changes and adjustments made to a quality plan to continually improve the process.
- Measuring: This provides a way for measuring the accomplishment of quality objectives and goals.
Quality Plan Deployment
Quality assurance plans result from specific legal regulations, strategic organisational policies, and industry standards and are geared towards meeting customer requirements for products and services.
Operating quality plans define a document from a production function showing blueprints, procedures, references to relevant standards, a customer’s order, and work instructions on manufacturing the specific item.
Strategic quality plans are created and deployed in an organisation’s planning process. They become the primary guideline for each department’s quality plan. In some cases, each department or function may build and implement its own operating quality plans.
Need Help Creating a Quality Assurance Plan for Your Company?
In a nutshell, documenting and deploying a quality assurance plan can help an organisation achieve conformance to customer requirements, facilitate traceability, provide objective evidence, and ensure compliance to internal procedures and external standards.
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