How to Structure Documentation for Quality Management System Standards

1. How to Structure Documentation for Quality Management System Standards

2. One of the most common misconceptions about QMS is that organisations need a lot of documents and must follow bureaucratic procedures to get certifications. You don’t have to go overboard with your documentation in order to implement processes that meet the management system standards. Most ISO standards, like the ISO 9001, clearly list the required documents. On the other hand, the ISO 10013:2001 provides guidelines for the documentation process and gives an overview of the structure of various QMS document types. Taking points from the recommended structure of the ISO 10013, the following section offers an easy guide to QMS documentation. So, keep reading! Introduction

3. The Documentation Hierarchy for Quality Management System Standards QMS documentation can consist of a variety of documents. Typically, you may need to submit documentation related to your quality policies, manual, work instruction, procedures, records, and quality plans. However, the criteria are flexible and can differ based on the specific ISO standard and the organisation. Here’s an easy way to structure your QMS documentation. 1. Quality policy: The quality policy of your organisation will reflect and declare organisational statements and the commitment to continual improvement and quality. Companies usually use a convenient and short-quality policy for promotional purposes. Furthermore, the policy should clearly define your organisational objectives and quantify the quality goals. 2. Quality manual: The manual structure will depend on the size of your organisation and the complexities of its operations. For instance, if you are a small-medium-sized business owner, you may document the entire QMS in a single manual. However, if you are running a large-scale international organisation, you may require several different quality manuals. Regardless of the size of the manual, it should contain the scope of your QMS, relevant document references, exclusions from the quality standards and a business process model. Depending on your organisation, you can include the quality policy and management system standards objectives in the manual as well. Here’s a brief on the contents of the quality manual. • Title and table of contents • QMS scope • Exclusions from standard • Versioning information and approval • Objectives and quality policy • QMS description • Organisation’s business process model • Responsibilities of all personals • Document and appendix references

4. 3. Quality procedures: There are several ways to convey your quality procedures. For instance, you can describe it through texts or illustrate it with flow charts. Here are the elements quality procedures should include: • Title • Purpose • Scope • Authorities and responsibilities • Lists and descriptions of the records that resulted from the activities mentioned in the procedure • Document control • Description of actions and activities • Appendices if applicable 4. Work instructions: Depending on the extent and completeness of your work instructions, you can refer to it in a procedure or make it a part of the procedure. This documentation typically covers the same structural elements as the procedure. However, work instructions include a more detailed description of activities, containing steps in proper sequence, tools, methods, and processes used to ensure accuracy. 5. Records and forms: Forms and records act as evidence that demonstrates your processes meet quality requirements. Remember the records should clearly demonstrate that your activities have followed the procedures described in the work instructions. Your forms and records should be simple, to the point and compact.

5. Final Thoughts Hopefully, these steps will help you to structure quality management system standard documentation. Remember, these sequences can vary based on specific standards and your organisational objectives. Therefore, if you are unaware of the correct way to structure documentation for QMS, consult with a professional.

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