The list of ISO 9001 documents according to the latest mandatory requirements

The list of ISO 9001 documents plays a crucial role in the success or failure of the Quality Management System. Therefore, organizations and businesses deciding to adopt the ISO standard need to pay special attention to this content.

A basic list of documents according to ISO 9001 requirements

ISO 9001 is an international standard for quality management, developed by the International Organization for Standardization (ISO). It outlines the fundamental requirements for establishing an effective quality management system within an organization. Below is a basic reference list of ISO 9001 documents according to the mandatory requirements:

Product and service evaluation records.

• Training documents related to skills, expertise, and experience of personnel.
• Records of input factors for product/service design and development.
• Minutes of changes in product/service design and development.
• Records for monitoring and checking documents.

The list of documents according to ISO 9001 requirements

• Standard documents on machinery and measurement equipment
• Reports following monitoring and measurement activities
• Documents evaluating the output of product/service design and development
• Detailed description of the features of the business's product/service
• Description of the conformity of the product based on accepted criteria
• Reports on results of outputs not conforming to standards
• Internal assessment program
• Results after corrective actions
• Records of implementing quality management system reviews
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• Requirements for ISO 9001:2015 documents

When constructing and storing documents according to ISO 9001 standards, it is essential to adhere to principles and processes to ensure transparency, easy management, and accessibility. Here are some important requirements when creating and storing documents according to ISO 9001:

Identify and classify documents accurately

Businesses need to identify the types of documents necessary within the quality management system. These documents may include policies, procedures, forms, guides, technical drawings, etc. Classify them based on their nature, purpose, and significance.

Strictly control documents

Ensure that documents are always controlled and monitored properly. Define processes for creating, approving, reviewing, changing, and discarding documents. Each document should have version information, effective date, and other relevant details."

The documents must be tightly managed.

Storage and preservation of documents

Determine how to safely store and easily access documents. Storage can be in the form of paper or electronic, depending on the nature of the document. Ensure that documents are stored to prevent damage or loss.

Reasonable access and distribution of documents

Provide a means for employees and those who need to use the documents to access them. This can be through an electronic document management system, physical folders, or similar tools.

Original and duplicate documents

Ensure that the originals of important documents are carefully preserved. Copies need to be clearly approved and provide information on the source and status.

Clear classification and notes

For important documents, classification is necessary to determine the level of security, importance, and access rights for each document. Notes related to changes and history of the document should also be clearly documented.

Security of document information

Ensure the security of documents, especially those containing sensitive information. This includes limiting access, encryption (if necessary), and other security measures.

Careful document checking

Before releasing a new document or modifying a document, ensure that it has been checked and meets the requirements of the Quality Management System according to ISO 9001 standards.

Monitoring and evaluation

Regularly monitor and evaluate the storage of documents as well as the effectiveness of applying documents in practice to ensure efficiency and compliance.

Benefits of establishing and storing the ISO 9001 document catalog
Establishing and storing the document catalog according to ISO 9001 standards brings many benefits to organizations and businesses. Here are some key benefits:

Increased transparency and easy information retrieval

The ISO 9001 document catalog helps organizations clearly identify documents related to the Quality Management System. This creates transparency in organizing, building, and storing information.

Efficient data management

The ISO 9001:2015 document catalog helps organizations manage documents more effectively. This includes identifying, classifying, tracking, and controlling important documents.

Avoid loss or confusion

The ISO 9001 document record catalog helps ensure that no documents are lost or forgotten. It also helps users avoid using the wrong document or using an outdated version of the document.

Easy information search and data access

The ISO 9001 document record catalog is established and stored systematically, allowing employees to search for and use documents quickly and easily. This improves work efficiency and saves time.

Proper storage facilitates easier data access.

Aids Compliance with ISO 9001 Standards

ISO 9001 standards require organizations to identify, control, and store documents related to the Quality Management System. Establishing a catalog of document records helps businesses comply with these requirements and prepares them well for audits.

Supports Training and Evaluation Operations

The ISO 9001 document record catalog can be used for training processes and guidance related to work procedures. It also aids in assessing compliance and work performance based on the specified documents.

Facilitates Information Sharing

The ISO 9001 document catalog provides an overview of the available information within the organization. This facilitates easy sharing of information related to the Quality Management System with internal staff, stakeholders, customers, partners, and regulatory agencies.

Sets the Foundation for Improvement

ISO 9001 documents and records help businesses identify areas for improvement within the organization, allowing them to establish suitable improvement processes.

Some Non-Mandatory but Necessary Documents when Applying ISO 9001

Procedures identifying the context of the organization and interested parties (Clauses 4.1 and 4.2) Procedures for addressing risks and opportunities (Clause 6.1) Procedures for competence, training, and awareness (Clauses 7.1.2, 7.2, and 7.3) Procedures for maintaining equipment and measurement devices (Clause 7.1.5) Procedures for document and record control (Clause 7.5) Sales procedures (Clause 8.2) Procedures for product design and development (Clause 8.3) Procedures for the provision of production and services (Clause 8.5) Procedures for incoming goods inspection (Clause 8.5.4) Procedures for managing nonconformities and corrective actions (Clauses 8.7 and 10.2) Procedures for monitoring customer satisfaction (Clause 9.1.2) Procedures for internal business reviews (Clause 9.2) Procedures for management review (Clause 9.3)

Considerations When Preparing an ISO 9001 Document Catalog

Requirements for ISO 9001 documents may vary based on the organization's context and the standards' requirements. To ensure proper compliance with ISO 9001 clauses, businesses should refer to the official standard documents and seek support from experts in the field of quality management.

Additionally, organizations need to continually maintain and enhance the process of creating and controlling documents according to ISO 9001:2015. This ensures that documents are prepared carefully, are effective, and information is stored and accessed easily, while maintaining the integrity and security of critical information. Improvement measures may include optimizing processes, ensuring sufficient instructional materials and resources, applying information technology to enhance record management, and training employees on effective document control procedures.

Simple and Easy Document Control Guidelines

The document control process is a crucial stage in the Quality Management System, ensuring that documents and records related to the organization's activities are stored, accessed, and protected reliably. Here are the steps of the Document Control Process according to ISO 9001:2015:

Step 1: Identify and Classify Records

Initially, organizations need to identify and classify various types of documents. These may include quality documents, technical documents, personnel records, production process records, customer records, and other records related to the organization's activities. Identifying and classifying documents helps organizations gain an overview of the quantity and type of records they need to manage.

Step 2: Identify the Origin and Store Records

Next, the organization needs to identify the origin of each document and decide how to store them. The origin of the document can be internal to the organization or external, such as from customers, suppliers, or government agencies. The organization should establish a clear document storage system, including determining storage locations, classification systems, and security measures.

Step 3: Establish the Document Control Procedure According to ISO 9001:2015

After identifying and storing records, the organization needs to implement a document control procedure to ensure integrity, easy access, and security of information. Firstly, the organization should establish a detailed and clear document control procedure. This procedure should describe specific activities, responsibilities, authorities, and instructions for implementing document control.

Step 4: Train Employees

The organization should provide training for employees on the ISO 9001:2015 document control procedure. This training helps them understand the procedure, regulations, and requirements of ISO 9001:2015 related to document control. Employees need guidance on ensuring the integrity of records, efficient storage, and retrieval of information.

Training Employees for Proper Document Storage Awareness

Step 5: Establish Recording and Monitoring System

Organizations should set up a recording and monitoring system to ensure that the ISO 9001:2015 document control process is implemented correctly, and related activities are accurately recorded. Monitoring may include the use of forms, records, reports, and periodic evaluations.

Step 6: Ensure Compliance and Continuous Improvement

Organizations need to ensure that document control activities adhere to the prescribed procedures and the requirements of ISO 9001:2015. Additionally, organizations should regularly assess and improve the document control process according to ISO 9001:2015 to ensure effectiveness and alignment with organizational requirements.

Step 7: Internal Assessment and External Verification

Organizations should conduct internal assessments and external audits to ensure the effectiveness of the document control process. Internal assessments can involve checking document control activities, reviewing procedural compliance and security measures, and evaluating employee satisfaction with the process.

External verification can be performed by independent certification bodies or external audit agencies. These organizations will evaluate the organization's document control process and confirm its compliance with ISO 9001:2015. Results from external audits provide feedback and an assessment of the effectiveness of the document control process.

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