ISO 9001 Version 2008 Internal Audit Checklist PDF

If your current ISO system works well for you, it may be best to stick with it; redesigning a quality management system from scratch could prove costly and time consuming.

Consider hiring a consultant to perform a gap analysis and guide your transition to the new version, or utilize a template kit to customize prewritten templates to meet your individual needs.

1. Planning
No matter if it is for gap analysis or process audit, this checklist template will assist in making sure all relevant aspects of your management system are assessed. It can provide invaluable insight into potential improvements for quality management processes while simultaneously helping prepare you for third-party ISO 9001 certification audit.

This version of the ISO 9001 checklist has been revised to take account of changes made to the standard, such as its new structure (PDCA management method and greater emphasis on risk-based thinking).

Determine which processes are essential to your business and ensure they remain stable and consistent. Plan additional audits so you can detect changes before they impact customers.

2. Auditing
Preparing your organization for ISO 9001 certification audit requires performing internal ISO 9001 audits. Such audits help identify and address any potential issues, identify areas for improvement, and verify best practices have been put in place.

Audits are a thorough analysis of financial information, typically found within company books, to establish their legitimacy. They usually consist of verifying data accuracy, uncovering any possible instances of fraud and providing a report detailing these findings.

If your current ISO 9001 certificate has lapsed, a consultant can evaluate your existing system and assist in transitioning to the 2015 version of ISO 9001. This version places more emphasis on PDCA management method as well as risk-based thinking; additionally, changes must be made to scope statements which may necessitate additional training of management team members.

3. Reporting
ISO 9001 quality management standard mandates that companies conduct internal audits on their management systems and processes in order to meet customer and relevant legal/regulatory obligations.

The template provided below serves as an ideal foundation for any company looking to implement an efficient and effective quality management system. It includes key elements from the process approach such as customer satisfaction focus and top management commitment while emphasizing continuous improvement efforts.

An ISO 9001 gap analysis is an essential first step to determine any gaps or differences between your existing management system and ISO 9001 requirements, and your implementation project. By conducting this exercise, it will allow you to set realistic budgets, timelines and expectations. SafetyCulture offers an efficient internal audit template so that your results can be recorded effectively.

4. Corrective Action
Corrective action is one of the key components of a quality management system, used to identify problems and develop solutions in order to stop their recurrence.

Correcting issues requires more than simply tossing out an ineffective product or training an employee on a new skill set; you need a comprehensive corrective action procedure with measurable goals and achievable deadlines in place.

Plan for corrective action should include verbal or written communications designed to enhance employee performance, attendance or behavior rather than punish them. A progressive process with less severe measures first before progressing with more serious measures as necessary if these don’t work; furthermore, any successful corrective action process will include debriefing the employees who participated in its implementation to understand where things went wrong and identify any lessons learned.

5. Training
An effective internal audit process is an integral component of an ISO 9001:2015 quality management system. While some revisions to the standard have occurred, most of its requirements remain the same.

Transitioning to ISO 9001:2015 does not need to be a major undertaking – you can keep your existing QMS while updating documentation to comply with its new requirements.

DIY template kit upgrades provide a low-cost and rapid way to bring your ISO 9001 system up-to-date, but this requires both time and resources for proper implementation. Alternatively, consulting firms provide gap analysis and implementation plans, with consultants being hired as needed to determine how much needs changing while also compiling all documentation necessary for compliance.