How to Write an ISO 9001 Quality System Procedure

Organizations that are ISO 9001 certified adhere to an international standard of business procedures that give them credibility and legitimacy. Earning ISO 9001 certification does not come without work, however. Organizations must establish a range of procedures to gain ISO certification. This includes a quality system procedure, which serves as a road map for ensuring quality across the organization.

Instructions

1. Draft a list of quality objectives for your organization. These objectives should represent specific goals related to quality that your organization must meet. For example, if your organization is a product manufacturer, your objectives can specify the quality expectations for each product.

2. Describe the quality management team in place for your organization. Before you jump into the specific quality procedures, explain who will be responsible for upholding these procedures. Identify each individual by title and explain his responsibilities as they relate to quality management.

3. Compose specific steps related to each objective you identified. For example, if your first objective is to produce interactive, engaging simulations to train members of the military, outline how you will do this as it relates to quality. You might establish several review processes with subject-matter experts and technical editors to ensure the simulation is technically accurate. Specify how you will achieve each objective step by step.

4. Describe how you will maintain files and records within the organization. In order to maintain a successful quality system, you need to have a specific set of procedures that deal with record-keeping and documentation. A configuration manager might be responsible for this task. List a step-by-step description of how the configuration manager or other individual will store important documentation, update files and maintain different versions of documents.

Tips & Warnings

• An ISO-9001-compliant quality system procedure is one of many documents that you must establish to gain certification. This document will relate to many other ISO-required documents, which will touch on subjects such as preventive and corrective action as it relates to quality and control of records and other documents.

References

• ISO; Introduction and Support Package: Guidance on the Documentation Requirements of ISO 9001:2008; October 2008
• ISO; Taking the First Steps Toward a Quality Management System; July-August 2004

Resources

• Read this Article in Spanish