ISO 9001 System Launch and Confirmation
As you are launching and implementing your ISO 9001 management system, it might be a good idea to review, confirm, and if needed, update some key activities and artifacts that were created along the way. Take some time to consider the full extent of the management system that has now been implemented along with the results of your internal audit and management review as you complete this exercise. Once your reviews and updates are complete, but sure to update any needed documentation.
Note that these reviews are optional and not required by ISO 9001. Most of this information will be reviewed during your management review meeting and you can certainly wait until that time if desired. Take action as you see fit.
Also, you need to complete your initial internal audit and management review activities before auditors arrive to complete your ISO 9001 certification audit. Plan and execute accordingly during your ISO 9001 system launch.
Confirm and Update Context of the Organization (Strategic Plan)
In a previous article we discussed strategic planning activities, or what ISO 9001 calls context of the organization, and provided some guidance on how to address this clause. Remember that context of the organization as it applies to strategic planning requires two different activities:
- Determine and monitor the external and internal issues relevant to the organizations purpose and strategic direction, and
- Determine and monitor the interested parties relevant to the quality management system.
In addition to satisfying these requirements, we recommend that you continue with strategic management activities by completing a SWOT analysis and a strategic plan for the organization. As we discussed in our article on context of the organization, formal strategic planning isn’t required by ISO 9001 if you satisfy the stated ISO 9001 requirements. As you review your organizational context also consider any revisions that might be needed for the quality objectives.
As part of the organizational context, take a quick look at the quality management system scope during your ISO 9001 system launch to ensure that it is still relevant and appropriate. Make any changes as needed and update appropriate documentation.
Confirm and Update Quality Objectives
It’s also probably been a while since you defined your quality objectives. It would be a good idea now that you are going live with your ISO 9001 management system, to pull those objectives out and make sure they are complete, appropriate, and ready to start implementing. We posted an article a while back that helps explain what ISO 9001 is looking for with quality objectives and how to document and implement them.
Confirm and Update Risk Assessments
Considering any updates and changes to the strategy, objectives, and organization, review and update your risk assessment and risk management activities which we discussed in a previous article.
As you complete this review, determine new risks and opportunities to the organization and changes to previously identified risk or opportunities. It also wouldn’t be a bad idea to start working on risk mitigation actions soon, if you haven’t already done so.
Confirm Awareness & Communication Activities
As you execute your ISO 9001 system launch, confirm that communication activities throughout the organization have and continue to reinforce those areas of ISO 9001 where awareness and communication is required. These activities fall under the general support processes defined by ISO 9001 in section seven of the standard. Communication activities can also satisfy some of the leadership requirements in section five.
Take some time to review any communication plans that might exist and make any necessary updates. Verify that communication activities completed to date have appropriately addressed the ISO requirements. Consider the effect that communication activities have had within the organization, and whether desired results have been achieved. Remember that communication should always be an ongoing process and that your really can’t over communicate. It is always a good idea to document communication activities.
Confirm Monitoring & Measuring Activities
One final confirmation step is to ensure that all monitoring and measurement activities have been initiated and that appropriate data and information is being generated and collected. Verify that all personnel responsible for collecting and documenting monitoring and measurement information fully understand the measurement processes and how and where to report the data.
Also verify that all effort and tasks associated with execution of business or quality objectives are correctly implemented and understood as you complete the ISO 9001 system launch.
Initial Internal Audit and Management Review Meeting
Let’s shift gears and look at a couple of mandatory key process activities. While the above review and confirmation activities where generally optional, completing your initial internal audit and management review are not.
Initial Internal Audit
All registrars will require you to complete a full internal audit prior to your stage one certification audit. Follow your internal audit process to complete this activity. If you made the decision to utilize employees as internal auditors, you need to ensure that they have completed all necessary audit training and meet your established competency requirements prior to executing the audit. If you are utilizing external contractors to complete the audit, identify and qualify the appropriate resource to add them to your Approved Provider List (APL).
This initial audit should cover all elements within the ISO 9001 standard that apply to your organization along with all processes associated with your management system. This full audit will establish a good baseline for planning and executing future audit activity and identify any significant deficiencies within your new management system. Note that while the audit itself must be completed prior to your ISO 9001 certification assessment, you do not necessarily need to address and close nonconformity corrective actions prior to the audit. The audit report should be completed, the nonconformities captured within your corrective action system, and corrective actions should be assigned and in-process. One exception to this is if your audit identified a major nonconformance or significant deficiency or gap in the management system. This should be adequately resolved prior to your stage one assessment.
While there are no specific ISO 9001 requirement mandating that this audit to be completed at this time, most ISO 9001 registrars will require evidence of a completed full internal audit during the stage one assessment. In addition, it just makes sense to complete this assessment to verify that the management system has been effectively implemented and is operating in full compliance to the ISO standard and your established process requirements.
One issue with completing an internal audit shortly after implementing and launching the management system is the lack of documented evidence to be reviewed and audited. If possible, allow the management system to run for a period time to generate some records and measurables. If time is of the essence, you might need to get creative and find ways to assess the effectiveness and compliance of processes within the management system.
Initial Management Review
As with your initial internal audit, your ISO 9001 registrar will require a completed management review prior to execution of the stage one assessment. This should be executed following the initial internal audit as audit results are a required input to management review.
Follow your established management review process to schedule, plan, execute, and document a formal management review meeting. Since your management system is relatively new there probably won’t be a significant amount of data and information to review at this time. Report and review what information is available and note in the management review report or meeting minutes where data is currently lacking. Use this first review to complete any needed training on the management review process with all team members and meeting participants. Where data and information aren’t yet available, review and discuss the viability and appropriateness of establish measure and metrics for the management system.
While there is no specific ISO 9001 requirement mandating that this management review to be completed at this time, most ISO 9001 registrars will require evidence of a completed review during the stage one assessment. In addition, it just makes sense to complete this activity to verify that the management system has been effectively implemented and identify where changes and improvements are needed.
It has probably taken several months at least to develop all the different process and documents associated with your management system. During this time, things within the system and your organization have most likely changed, so it would be a great idea to review and confirm some of the key elements within you ISO 9001 system during this ISO 9001 system launch. Make updates as needed and be sure to revise any needed documents and records accordingly. Also, be sure to complete your initial internal audit and feed the results of the audit into your first management review meeting. As always, be sure to document both activities along with their outputs and results.