ISO 9001 System Release
Now that you have all your processes defined and documentation approved, it is time for you ISO 9001 system release and “go live”. Rather than just pushing the button and hoping everything works, you might want to turn this new system on in a planned and controlled manner. Consider a “soft-launch” approach that allows you to test parts of the system while making changes and improvements where needed.
Soft Launch / System Pilot
Now that you have approved and released your processes and documents, you have an opportunity to “pilot” or exercise the management system prior to a hard and final launch. This soft-launch provides an opportunity to test drive the management system and allows you to determine and discover certain aspects of the system that aren’t working as designed or desired.
Information gained during this activity should be used to define and implement changes and improvements prior to the official system launch. If the management system you have developed over the past weeks and months introduces numerous new processes, methods, systems, and tools to the organization, then we strongly recommend that you take a period of time to exercise the system before your official launch.
Piloting your management system can help with the following:
- Evaluate, troubleshoot, and improve unknown processes,
- Test and verify process performance,
- Verify roles, responsibilities, and competencies,
- Complete and verify training activities,
- Check and improve linkages between different processes,
- Assess and modify process measures and metrics,
- Execute communication activities about the management system and leadership principles,
- Test facilities, equipment, environment, and other infrastructure,
- Develop and document organizational knowledge,
- Verify the effectiveness of established documentation (procedures, forms, records, etc.),
- Other assessment, execution, documentation, or verification activities.
Please note that this pilot activity is completely optional and if your feel that your management system and associated processes are robust and ready to go, then there may not be much value in piloting the system and you are certainly welcome to move forward with a hard system launch.
If you do decide to soft-launch and pilot the system, consider the duration of this activity and what you want to accomplish. Perhaps the pilot period will be indefinite and last until certain goals are attained. Define how your will collect any data and performance information needed and how it will be evaluated and used. What is the scope of the pilot? You don’t necessarily need to launch and exercise all aspects of the system during this activity. You can limit the pilot to just specific processes that you feel need to be evaluated and improved.
You can run a pilot on draft documentation or, as we discussed back in our previous article, you can go ahead and complete a formal release of documentation. You can also use this pilot run to complete any needed on-the-job training or training verification activities to ensure roles and responsibilities are understood and personnel are competent. Be sure to properly document all training activities per established procedures.
Management System Launch
Whether you completed the system pilot or not, you need to formally launch the system and make it officially active. This ISO 9001 system release means that all management system processes are released and implemented for use throughout the organization. Processes that are already released and active don’t require any additional action, however, any process documentation that has not yet been approved and released must be released at this point.
One of the key aspects of this launch is that it establishes the official “go-live” date for all your processes and associated records. This will establish the time boundary for management system records and activities, which will be especially important during audits. This date will provide a limit or boundary for the records that auditors can request and inspect during certification assessments. You are welcome to share records beyond this date that are relevant and compliant if you desire, but you aren’t required to do so. Any activities, actions, or records beyond this date don’t need to meet the requirements of the ISO 9001 management system processes and auditors can’t hold you accountable for actions and documentation prior to your launch date.
As you launch your management system, remember to:
- Approve and release all management system processes and associated documentation,
- Ensure that all training is complete and competencies have been met. On-the-job training and effectiveness verification activities can be on-going at the time of launch,
- Clearly communicate the system launch and ensure that all employees are aware of the need to adhere to the established system and processes,
- Verify that all personnel are aware of core management system information including the quality policy, quality objectives, customer focus, etc.,
- Provide all resources necessary for the effective implementation of the management system,
- Ensure that top management is engaged and participating in the management system while meeting the ISO 9001 Leadership requirements,
- Activate and execute all system measurement and monitoring activities,
- Generate and retain all required process documentation in the form of records.
You don’t necessarily have to roll the entire management system out at a single specific point in time. You can implement different processes and documentation over a period of time as they are completed and ready for use. Some ISO 9001 processes are dependent on others, so be sure to account for this during in your implementation plan. This approach would certainly be possible if you released and exercised some processes during the system pilot activity described above. It would still be a good idea to identify a specific “go-live” date in which the entire management system is considered fully implemented and use this date as your line in the sand with auditors.
As you initiate your ISO 9001 system release, expect some chaos and be prepared to put out some fires and address operational issues. Investing time and effort towards your planning activities and actions to review, approve, and test your processes and documentation will significantly reduce issues experienced during your system launch.