To verify compliance with ISO 9001:2015 section 4.4.2, you will need to evaluate how well your quality management system (QMS) maintains and retains documented information. This documentation is crucial for ensuring processes are well-supported and consistently carried out as planned.

1. Maintaining Documented Information (Part a):

First, review how your organization documents information necessary for the operation of your processes. This includes developing and keeping documents such as process maps, work instructions, standard operating procedures (SOPs), and any other resources that provide guidance on how each process should be conducted. During your evaluation, check if these documents are easily accessible to the relevant personnel and if they are written in a clear and understandable manner, tailored to the needs of the users.

Examine the process for creating and updating these documents. Ensure that there is a systematic approach in place, including a defined procedure for revising and approving updates to documentation as processes or requirements change. This will often involve a designated person or team responsible for documentation control, ensuring that only the most current versions are in use.

2. Retaining Documented Information (Part b):

Next, assess how you retain documented information that provides confidence in the execution of processes as planned. This involves checking records such as logs, checklists, audit findings, and performance data that demonstrate activities have been executed according to the documented procedures. The retention policy should specify the duration for which records are kept, how they are stored, and the method of disposal once they are no longer needed.

Evaluate if there is a clear system in place to categorize, store, and retrieve these records to ensure they are available when needed, whether for internal review, audits, or continual improvement activities. Effective record-keeping practices help verify that processes are being correctly followed, providing a basis for trusting that the QMS is functioning as intended.

3. Verification and Improvement:

To conclude your evaluation, ensure there is an established routine for regularly reviewing both active documentation and retained records. This might involve internal audits or management reviews where the adequacy and effectiveness of documentation practices are assessed. If gaps are found, develop an improvement plan to address them, which could include further training for staff, enhanced document control procedures, or upgrades to your record-keeping systems.

By thoroughly analyzing your documentation practices in these ways, you can determine compliance with ISO 9001:2015 requirements, ensuring your QMS is both robust and reliable in supporting and verifying process operations.