When writing a quality management system procedure, it is important to ensure the procedure meets quality assurance requirements. This includes considering elements such as process and quality control, error prevention and correction, documentation of procedures and results, customer feedback, training and communication.
Quality procedures are the backbone of any organisation striving to maintain its quality standards. They provide an instruction manual for employees and other stakeholders on how they should do their activities to ensure that the expected outcomes meet or exceed customer requirements. Quality procedures should be comprehensive, clear, and easy to follow in order to ensure consistency within operations.
ISO 9001 procedure definition
ISO 9001 is the International Organisation for Standardisation’s standard quality management systems. An integral aspect of a QMS is the writing of processes and procedures. ISO 9001 defines a process as a “specified way to carry out an activity or a process”.
Process and procedure structure
Quality management involves a hierarchy of documentation, from policies at the top to the minutiae of records, forms and SOPs at the bottom. Procedures sit in the middle of the hierarchy, providing information on how to enact the processes established in a quality management system and setting the structure for work instructions below.
The purpose of a QMS procedure
The purpose of a QMS procedure is to create product and service consistency by mapping out the steps required to perform a specific process. Businesses using a quality management system need to create standard procedures to ensure the process is completed in line with best practices every time.
The 6 mandatory ISO 9001 procedures
- Control of Documents
- Control of Records
- Internal Audit
- Corrective Action
- Preventive Action
- Control of Non-Conforming Products
ISO 9001 QMS procedure structure
Quality management procedures can be written as a descriptive narrative, a table, an infographic, a flow chart or a combination of two or more of these elements.
Quality management procedures should include the following sections:
Description: Identify the procedure
Example: Control of Documents
Description: Explain the reasoning behind the procedure
Example: To provide a standard process for controlling quality management documents
Description: Detail which elements the procedure will and won’t cover
Example: Which documents will and won’t be covered, which employees and contractors are involved and which aren’t
4. Responsibilities and authorities
Description: The responsibilities and authorities of any employees, contractors, management and other stakeholders involved in the procedure.
Example: Which departments and staff members are in charge of each element of the procedure
5. Definitions and records
Description: Define any terms and list any records which will be used as part of the procedure
Example: Provide definitions of what is meant by “documents” or “employee”
6. Document control
Definition: The tracking of different versions of documents, review dates, changes and approvals.
Example: File naming conventions
7. Description of activities
Description: The main body of the procedure, the description of activities provides a detailed list of “who, what, when, where and, when needed, why” along with the resources and activity output information
Example: Who is responsible for document filing and when should the filing system be updated
8. Appendices (Optional)
Definition: While not mandatory, appendices can be included if required to provide additional context or information
Example: Graphs or reports
How to write a procedure for an ISO 9001 quality management system
Documenting your processes and procedures is one of the most important aspects of an ISO 9001 quality management system.
The process of developing quality management system procedures begins with identifying the process that needs to be detailed in the document. The purpose of the quality management system should also be clearly stated to provide direction for those who will follow the steps outlined in the procedure. The steps should then be described in detail, including any roles or resources required for completion. Finally, indicate any quality control measures that need to be taken when executing the procedure. These could include verification steps like inspections or tests based on the set quality objectives.
Match with business process context
- Establish internal stakeholders and their needs
- Establish external stakeholders and their needs
- Determine what quality management risks are involved in the process and what items in the procedure will minimise those risks
Establish process scope
- Select core processes to document and create procedures for.
- Understand the limits of each procedure and define the scope clearly in order to avoid ambiguity.
- Ensure consistent and high-quality delivery to the customers.
- Collect information regarding outcomes, inputs and outputs, responsibilities and measurements
- Use flow charts to map your current process and design your new process
- Ask yourself the five Ws and one H:
- Why is the procedure necessary?
- Who will be involved in the procedure?
- What supplies or equipment will be needed?
- Where will the procedure take place?
- When will it take place?
- How will the procedure take place (what tasks and methods are involved)?
- Define how the procedure will be measured/assessed
- Define the required frequency of the procedure
- Ensure your procedure aligns with other documents and processes
- Ensure your procedure uses the appropriate structure (see “ISO 9001 QMS procedure structure above)
- Write the procedure to a standard that can be understood by intended users
- Write the procedure in a way that is clear and unambiguous to avoid potential non-conformances
- Avoid cluttering the procedure with unnecessary information
Review and approval
- Have the appropriate management personal review and approve the procedures
- The assigned reviewer should be detailed in the QMS. For example, a procurement manager may be responsible for reviewing purchasing procedures.
Educate and communicate with employees
- Communicate any changes to ensure everyone involved is aware of the new procedure
- Create or update training and documentation, with comprehensive instructions for those working on the quality procedures
- Conduct assessments or audits to ensure team members are correctly trained and are following the new procedures
Who writes the QMS procedures?
By following these steps when writing a quality management system procedure, you will be able to create an effective document that meets quality assurance requirements. The quality management process should also be reviewed regularly in order to maintain high standards and remain compliant with quality control regulations.