Structure of QMS documentation

The structure of the documentation of the quality management system, created according to the ISO 9001standard, is a hierarchical system of interrelated documents. Some of these documents are explicitly stipulated in the standard, the other part is implied. The structure of the quality system has a "constant" component defined by the standard and a "variable" component depending on the specific organization.

A "constant" component of the QMS documentation structure:

• Quality policy;
• Quality objectives;
• Quality Manual;
• Mandatory quality system procedures;
• Quality records.

The "variable" component of the structure in the standard is named as follows – "…the organization shall maintain documented information to support the operation of its processes" (4.4.2 ISO 9001:2015). As a rule, these documents include various plans, maps or process diagrams, work instructions, reporting forms, contracts, regulatory documents, invoices, etc. It can be assumed that almost all the documentation of the organization is "variable" component.

ISO 10013:2021 standard ("Quality management systems — Guidance for documented information") provides some recommendations on the structure of QMS documentation and the content of QMS documents. Therefore, it is better to focus on the existing documentation system in the organization when compiling the structure of the QMS documentation. This structure should be supplementing with the necessary levels and documents required by the ISO 9001:2015 standard.

Quality policy and quality objectives

The quality policy is one of the strategic documents of the organization. This document defines the basic principles of operation and development of its quality management system. As a rule, the quality policy is a declarative document. Each declaration stated in the policy should be "decomposed" into specific goals, plans and actions for the implementation of these declarations. There is a direct link between quality policy and quality objectives.

Quality objectives – it is a document in which an organization sets out results that it wants to achieve. Quality objectives should be aimed at the implementation of policy declarations. Objectives have specific indicators that can be measured and achieved in limited periods of time.

The quality policy and quality objectives are usually singles documents. Quality objectives may be included in the policy. The quality policy will have two parts in this case – open and closed. The open part is the declarations, and the closed part is the specific and measurable goals of the organization.

Quality Manual

ISO 9001:2015 standard doesn't required to have quality manual, but these document can help an organization to structure and manage its quality system. The quality manual is a document describing the entire quality management system of an organization. It sets the rules of quality system, how it is organized, what structure it has, what is the structure of the quality system documentation. The ISO 9000:2015 standard defines the Quality Manual in the following form: "Quality manual – specification for the quality management system of an organization." This means that the quality manual should contain a description of the implementation of the ISO 9001:2015 requirements in an organization.

 

Documented procedures

In accordance with the requirements of ISO 9001:2015 (point 7.5.1), the organization's quality system must be documented. As a rule, the documentation of the quality system is carried out in the procedures of the quality system. The minimum set of procedures to be developed in the organization is determined by the requirements for documented information.

In most cases the set of procedures includes:

• Documented information management - it is intended for the formalization of the organization's documentation support. This procedure regulates the issues of creation, analysis and verification of documents before their official use in the organization, updating and revision of documents already used in the organization, rules for the designation of documents and identification of any changes in existing documents. In addition, it is necessary to clearly define the rules for the distribution of documents in the organization and the rules for the withdrawal or explicit identification of outdated documentation. The procedure must also reflect the rules of identifying and handling external documents, for example, regulatory documents, standards, customer contracts, etc.;
• Quality records management – this procedure can be a part of documented information management procedure or can be a single procedure. It regulates the course of action for handling documentary evidence of the quality system. The quality records management procedure should contain rules for identifying records and record management tools (for example, you can make records on paper, you can in an electronic system), the procedure for storing, protecting and restoring quality records in case of damage. In addition, it is necessary to determine the terms of storage and the course of action for the withdrawal and destruction of quality records;
• Nonconforming products management - this is a procedure that determines who and how should act if nonconformance arise in the course of the organization's work. As nonconforming products in the standard means not only products, but also services and other work results. For example, the result of the work of the contract department is a contract. It is necessary to determine in the procedure which nonconformities may arise in the contract, and how to act when nonconformities are detected;
• Internal audits procedure - It is necessary to determine the course of action for organizing internal audits, requirements for auditors, methods, criteria, frequency and scope of audits in this procedure. Also, it is necessary to determine the list of the documentation that is being developed during the audit and the procedure for processing the audit results;
• Corrective actions procedure - this procedure should regulate the course of action for carrying out work to eliminate nonconformance related to the organization's products (services), processes and quality system. The procedure for carrying out corrective actions should include the analysis of identified nonconformance, the establishment of the causes of their occurrence, the development of actions to eliminate nonconformance, recording the results of the actions and the analysis of the results of the actions;
• Preventive actions procedure – This procedure allow you to realize the requirement of ISO 9001:2015 about risk-base thinking. This procedure should define actions to prevent the occurrence of nonconformance. It is necessary to define in the procedure the methods for determining possible nonconformance, the course of action for developing actions to prevent the occurrence of nonconformance, the procedure for recording the results of actions taken and analyzing the results of performing preventive actions.

 

Process maps

There is no direct requirement of the ISO 9001:2015 standard that process maps or other documents representing processes be created in the organization. But the requirements of sections 4.4.1 and 8.1 of this standard say that the organization should define all its processes and ensure the necessary process management. It is impossible to fulfill these requirements without documentation. One of the options for documenting processes is to create a process map (flowcharts or process algorithms).

A process map is a document that defines the purpose of a process, its main results and characteristics, as well as the sequence of operations or actions of the process. Therefore, the process map represents the process execution technology. It can be presented with different levels of detail depending on the purpose.

Process maps can represent administrative management processes, resource management processes, control, monitoring and measurement processes. One of the varieties of the process map is a technological map that representing technological (production) processes.

Process maps can be drawn up in the form of documented procedures.

Quality records

The ISO 9001:2015 standard doesn't have a term "quality records". But this term is assumed. The standard talks that the organization "shall retain documented information". It means to register quality records. Quality records are a special type of quality system documentation. The singularity of this type of documentation is that these documents confirm the fact of performing an action. They change their status at the time of registration of this fact. For example, an empty form intended for registration of control results is an ordinary document of the quality system. As soon as the control results are entered into this form (the form is filled in), this form becomes quality records.

The ISO 9001:2015 standard defines the minimum composition of quality records that must exist in an organization. This set of quality records can be expanded by the organization itself if necessary.