Instructions for writing ISO 9001 procedures - 6 mandatory ISO procedures

Applied widely in organizations and businesses globally, ISO 9001 establishes fundamental requirements for an effective quality management system. An integral part of ISO 9001 is identifying and designing processes suitable for the organization. In this article, let's explore the 6 mandatory processes of ISO and guidelines for writing ISO 9001 procedures with KNA.

6 MANDATORY PROCESSES OF ISO 9001

Document Control Process

• The document control process is one of the 6 mandatory processes of ISO 9001. It ensures that documents related to the quality management system are managed, updated, and distributed efficiently. This process includes steps such as:
• Identifying and establishing the document file structure.
• Determining document control requirements.
• Managing versions, copies, and revisions of documents.
• Verifying and approving new or modified documents before distribution.
• Record Control Process
• The record control process ensures that records related to quality management, such as inspection records, reports, and certificates, are maintained and controlled accurately.

Guidelines for writing ISO 9001 procedures include:

• Identifying and establishing the record file structure.
• Managing the storage, preservation, and classification of records.
• Ensuring the integrity and readiness of records.
• Verifying and approving records before long-term storage.

Compilation of 6 ISO 9001 Processes

Internal Audit Process

The Internal Audit Process is one of the 6 mandatory processes of ISO 9001. This process ensures that activities and procedures within the quality management system are operating efficiently and comply with ISO 9001 requirements. The process includes:

• Defining the scope and schedule for internal audits.

• Planning internal audit activities.
• Conducting internal audits and collecting relevant information.
• Evaluating audit results and identifying weaknesses and necessary improvements.
• Reporting audit results and proposing corrective actions.
• Inspection and Testing Process
• The Inspection and Testing Process ensures that products, services, or production processes comply with quality requirements.

Guidelines for writing ISO 9001 procedures include:

Identifying inspection and testing requirements for products, services, or production processes.
Establishing methods and standards for inspection.
Conducting inspection and testing activities according to the plan.
Evaluating inspection and testing results.
Handling and reporting inspection and testing results.
Complaint Handling Process
The Complaint Handling Process ensures that customer complaints are received, processed, and resolved reasonably and promptly. This process includes:

Receiving and recording complaint information from customers.
Identifying and classifying complaints by severity.
Conducting investigation activities and handling complaints.
Evaluating complaint resolution results and suggesting improvements.
Notifying and resolving complaints with customers.
Control of Nonconforming Products Process
The Control of Nonconforming Products Process is one of the 6 mandatory processes of ISO 9001. This process ensures that products not meeting ISO 9001 quality requirements are handled accurately and effectively.

Guidelines for writing this ISO 9001 procedure include:

• Identifying and recording nonconforming products.
• Evaluating the severity of nonconforming products.
• Managing the handling of nonconforming products, including inspection, assessment, and decisions on repair, reuse, or other corrective actions.
• Ensuring that activities related to handling nonconforming products are carried out according to relevant procedures and regulations.
• Recording the results of nonconforming product handling and suggesting improvements.

GUIDELINES FOR WRITING ISO 9001:2015 PROCEDURES

Writing ISO 9001 procedures requires detail and clarity to ensure a clear understanding of each step and responsibility related to each process. Below are some suggestions for writing procedures effectively:

How to Write a Simple ISO 9001:2015 Procedure

Describe the Steps and Activities in Detail: Use clear, understandable language and avoid unnecessary complex terminology when describing the steps and activities in the procedure.

Define the Scope and Objectives of the Procedure: Clearly specify the scope and objectives of the procedure to identify the activities to be performed and the expected outcomes.

Identify Detailed Steps: Analyze the necessary steps to execute the procedure in detail and determine the interactions between them.

Clearly State Responsibilities and Roles: Clearly define the responsibilities and roles of each department or individual involved in the procedure. This ensures transparency and clear accountability.

Specify Requirements and Standards: State the requirements and standards that the procedure needs to adhere to. This ensures that the procedure is executed according to specific requirements, guaranteeing quality.

Determine Performance Indicators: Propose performance indicators to evaluate and monitor the effectiveness of the procedure. These indicators may include execution time, error quantities, customer satisfaction, etc.

Identify Evaluation and Improvement Mechanisms: Determine mechanisms to evaluate the effectiveness of the procedure and establish improvement measures. This may involve internal audits, reviewing test results, customer feedback collection, and continuous improvement actions.

List Supporting Documents: Enumerate and describe important supporting documents, forms, or tools within the procedure. This ensures that individuals implementing the procedure have the necessary information and use supporting documents accurately.

Ensure Compliance with Legal Regulations: Ensure that the procedure complies with legal regulations, privacy rights, and information security. This involves updating the procedure based on new regulations and requirements, as well as ensuring the protection of crucial information and privacy rights of customers and stakeholders.

Evaluate and Update the Procedure: Assess the effectiveness of the procedure and update it over time. Use feedback from customers, performance evaluations, and other information to identify improvement opportunities and enhance the procedure.

The above is a guide on how to write an ISO 9001:2015 procedure and the 6 mandatory processes of ISO 9001. For specific support, please contact KNA CERT at the hotline: 0968.038.122 or Email: salesmanager@knacert.com.