Understand The Iso 9001 Qms Documentation Hierarchy

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The international standard known as ISO 9001 is used to describe the specifications for a quality management system (QMS). The standard is used by organizations to show that they can consistently deliver goods and services that meet regulatory and customer requirements. Organizations must develop effective ISO 9001 QMS documentation to create a successful QMS system. ISO 9001 requires documentation with several types of information; however, not all information must be documented as separate documents.

It is adaptable, allowing the organization to choose the size of the documentation and the level of detail documented. Small businesses, for example, can include defined procedures in their QMS manual. The QMS-based ISO 9001 documents might include a variety of documents. Documents such as the Quality Policy, Quality Manual, procedures, work instructions, quality plans, and records are typically included.

A summary of the recommended contents and structure of the several QMS document types is provided in the international standard ISO guidelines for quality management system documentation, which also provides instructions ...
... for effectively dimensioning QMS documentation. The ISO guidelines are taken into consideration; the guidelines are as follows.

Quality Policy: A policy is a declarative statement made by an organization. A Quality Policy should indicate the organization's dedication to quality and continuous improvement. Generally, the ISO 9001 policy is used for promotional purposes and should be shown on the organization's premises and posted on websites, so a simple and understandable Quality Policy is convenient and is the standard practice.

The Quality Policy establishes the quality objectives for which the organization aspires. Organizational quality goals are defined by quantifying the quality objectives.

Quality Manual: The QMS ISO 9001 manual should be personalized as per the organization. The structure and content of the manual can vary based on the organization's size, the complexity of its processes, and the personnel's ability. Smaller companies can document their whole QMS in a single manual. Big organizations, on the other hand, may have multiple quality manuals. The manual often comprises the QMS scope, standard exclusions, references to important ISO 9001 documents, and the organizational process model. The Quality Policy and objectives might also be included in the manual.

Quality procedures: Quality procedures can take several forms and frameworks. They can be descriptive, more structured with the help of tables, more graphical, or any variety of all of these. Also, quality procedures should include the following elements:

• Title – to identify the procedure
• Purpose – describing the purpose of the procedure
• Scope – to describe which components of the operation will be discussed and which ones won't be
• Responsibilities and authorities of all individuals/functions included in any part of the procedure
• Definitions and lists of all records that outcome from the actions described in the procedure
• Document control – Document control procedures should contain the identification of modifications, the date of review, approval, and the version of the document.
• Description of activities – This is the procedure's key section; it links all the other components together and outlines what needs to be done, by whom, how, when, and where. In some circumstances, it's also important to explain "why." The inputs and outputs of the activities, as well as the required resources, should also be explained.
• And, Add-ons may be included if needed.
Work instructions: Work instructions must be included in a procedure or referenced in one. Work instructions, in general, have a similar structure and cover the same aspects as procedures; however, work instructions provide details of actions that must be realized, emphasizing the sequencing of the steps, tools, and methods to be employed, and needed accuracy. Staff training and the employment of competent personnel can help to reduce the requirement for very detailed job instructions. This issue is covered in further depth in Using Competence, Training, and Awareness to Replace Documentation in the QMS.
Records and forms: the organization will need to maintain some proof to indicate that the processes fulfilled the requirements; this is where forms and records are important. A record is what the process owner has specified to demonstrate that the process and activities were carried out by the procedures and job instructions. Forms are blank templates that will be filled in with information to become these records. Make your records and forms more practical by entering the information required briefly and simply manner; do not expect staff to write essays to complete the form and produce the record.
An effective QMS requires dimensioning the documents based on organizational requirements. Furthermore, well-structured documentation will make operations a lot simpler, whereas improper documentation will only cause problems for the business.
Source: https://qms9001consultant.wordpress.com/2022/09/12/understand-the-iso-9001-qms-documentation-hierarchy/