ISO 9001 Documentation: What You Need to Know and Follow

This article presents all the key documentation requirements that businesses need to understand and meet to achieve the ISO 9001 certification.

Most businesses consider the documentation requirements of the ISO 9001 certification to be very complex and time-consuming to meet. They become doubtful about achieving the certification for this one reason. However, this article tries to put an end to all those doubts and confusions. It explains the detailed and exhaustive documentation requirements in a few simple sections so that it becomes easy to understand for businesses. Also, the documentation has undergone a major change in the latest version of the standard i.e., ISO 9001: 2015. Now the requirements are quite comprehensible and flexible compared to the earlier versions. It means the businesses have their take on what crucial processes to document and how, and what they do not need to document. The following section mentions the documents that your business needs to maintain and the ones you need to retain for the ISO certification.

Documents to Maintain and Retain for the ISO 9001 Certification

Documents to Maintain

The following are the vital documents that your organization needs to maintain i.e., they are subjected to change when the business grows, adapts new processes, and expands its products or services. The documented information that they should maintain for successful implementation of the ISO 9001 certified QMS are:

• Scope of the Quality Management System (QMS) - It means the areas or processes of your business that should be covered by the QMS. You should determine it based on the internal as well as external factors that influence the quality of your products/services, purpose and abilities of your business.

• Information or data required to carry out the operations and processes related to the QMS.

• A quality policy, which is a declarative statement made by your business stating its commitment to quality assurance and continual improvement.

• A set of quality objectives, which underlines what your organization strives to achieve to meet the customer requirements and keep up their satisfaction levels.

• A quality manual that fits with your organization and QMS. In the manual, the scope, relevance document references, your business processes, quality policy, and objectives are included. Depending on the size of your organization or the vastness of your processes, you can have one or multiple quality manuals.

You should maintain the above documents because they are referred to and used by the staff to carry out quality management processes and meet the purpose of QMS.

Documents to Retain

There is a comprehensive list of documents that an organization needs to retain to make the QMS functional and make it compliant with ISO 9001. These requirements vary with the type of organizations and their business processes. However, these documents or records are not subjected to any change unlike the previous set of requirements. They are:

• General requirements of the products or services
• Records of information regarding the designing, development, and maintenance of products/services
• Records of the training provided and skills and qualifications required in the employees to undertake the processes of QMS
• Records of the calibration methods and measuring equipment used for assessing the quality performance
• Records of customer requirements regarding the products or services
• Records of the review of products/services requirements
• Records of change management in the organization following the QMS implementation
• Records of the nonconformities identified in the products or services
• Records of the nonconformities in the QMS against the set criteria
• Results or reports of the internal audits
• Detailed records of the management reviews and meetings
• Results of the corrective and preventive actions

Key Takeaway

For both sets of requirements, some extent of flexibility is permitted. The businesses can determine what and how exactly they should document depending on their processes, objectives, goals, customer requirements, and types of products or services they provide. Many of these are basic documentation necessities for a business and so are already created and maintained or retained by organizations. However, for achieving the ISO 9001 certification, they need to arrange all the documents precisely and make them uniformly available to the staff. That is the actual challenge to the organization which they can easily meet by consulting with some experts in the ISO certification field.