• (0)
    ISO-9001-blog

    ISO 9001 Blog

    Making the best out of ISO 9001 Quality Plan

    The new version of ISO 9001 has a new approach to documents and records (see also New approach to document and record control in ISO 9001:2015) and this opportunity should definitely be seized. Without so many mandatory procedures as the previous version of the standard, requirements for documenting processes to ensure they deliver intended results can be approached differently. One of the aces up our sleeve is the Quality Plan.

    Why Quality Plan?

    The primary intention of the Quality Plan was to demonstrate how the QMS (Quality Management System) is applied to a specific case, for example, when the company is conducting more complex processes or some processes that need additional information. It was also used to meet statutory, regulatory and customer requirements, to optimize use of resources in meeting quality objectives, to minimize the risk of nonconforming to the requirements and many other purposes. The beauty of Quality Plan is that it can contain a great amount of important information in simple and systematic form and be more useful than conventional procedures.

    How to create one?

    The first step, of course, is to determine what will be covered with the Quality Plan and this will depend on several factors:

    • The processes and quality characteristics that are particular to the specific case, and will therefore need to be included
    • The requirements of customers or other interested parties (internal or external) for inclusion of processes not particular to the specific case, but necessary for them to have confidence that their requirements will be met
    • The extent to which the quality plan is supported by a documented quality management system

    Once the scope is determined, the person responsible for the Quality Plan should be appointed. The quality plan should be prepared with the participation of people who are involved in the specific case, both within the organization and, where appropriate, external parties. Their help can be crucial in creation of the quality plan that really meets the needs of the organization.

    Since the form of the Quality Plan is not prescribed by the standard, it may be created and used in any way that the organization finds suitable. This means that it can have different input elements, such as the requirements of the specific case, risk assessments on the specific case, resources needed, information on the needs of other interested parties who will use the quality plan, and more.

    What should it contain?

    The quality plan should indicate how the required activities will be carried out, either directly or by reference to appropriate documented procedures or other documents (e.g., project plan, work instruction, checklist, and computer application). Where a requirement results in a deviation from the organization’s management systems, this deviation should be justified and authorized.

    A quality plan is a document, or several documents that, together, specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract. Quality plans should define:

    ISO 9001:2015 Quality Plan: How to make the best of it?

    • Objectives to be attained (for example, characteristics or specifications, uniformity, effectiveness, aesthetics, cycle time, cost, natural resources, utilization, yield, dependability, and so on)
    • Steps in the processes that constitute the operating practice or procedures of the organization
    • Allocation of responsibilities, authority, and resources during the different phases of the process or project
    • Specific documented standards, practices, procedures, and instructions to be applied
    • Suitable testing, inspection, examination, and audit programs at appropriate stages
    • A documented procedure for changes and modifications to a quality plan as a process is improved
    • A method for measuring the achievement of the quality objectives
    • Other actions necessary to meet the objectives

    Let’s put it to work

    The presentation of the quality plan may have any of several forms, for example a simple textual description, a table, a document matrix, a process map, a work flow chart or a manual. Any or all of these may be presented in electronic or hard-copy formats.

    If created correctly, the Quality Plan will provide all necessary information for effective execution of processes in a form that is the most suitable for its end users. Good Quality Plans will give an overview of all activities to be conducted within the process, documents related to certain activities, persons responsible for the activities and so on. Having such document can significantly decrease the number of nonconformities within the process and avoid writing long procedures with too many information.

    Click here to see a free preview of the Quality Plan template.

    Advisera Strahinja Stojanovic
    Author
    Strahinja Stojanovic
    Strahinja Stojanovic is certified as a lead auditor for ISO 13485, ISO 9001, ISO 14001 and OHSAS 18001 standards by RABQSA. He participated in implementation of these standards in more than 100 SMEs, through creation of documentation and performing in-house trainings for maintaining management system, internal audit and management review.