5 Tips to maximize results with validation consulting services
Management reviews play an integral part in preparing for ISO 17025 accreditations. These are not auditing or report-back meetings but a management evaluation of how much the systems in place fulfill their function. It is an opportunity for the top-level management to get involved in the systems development process and hence evaluate the overall readiness of a quality management system.
This step is crucial to the accreditation process since it defines the lacking’s and also improves leadership buy-in on various changes made or being made. Here are 5 steps to make sure you get the most out of these reviews
5 Tips to maximize results with validation consulting services
Table of Contents
Set the details of the review:
Just like other meetings, management reviews should be set in advance. To begin with, fixing when the review will take place is important. A set schedule is necessary to make sure everyone is aligned on the progress of things. These meetings could be quarterly or even monthly but there should one a year at least.
Next, setting an agenda is important. This allows everyone to fully understand what the purpose and flow of the review are. Also, along with the agenda, you can also circulate the details of your documentation in terms of the QMS modifications, calibration template, reporting structures, etc. so that everyone involved has access to documentation beforehand for basic review.
Take minutes:
Writing down the minutes of the meeting is absolutely important. This makes it easy to list action items and to keep everyone aware of the happenings of this meeting post the review.
Minutes are also required as documented information under the ISO standards and should be provided to third-party auditors. If reviews are not documented, it may impact your accreditation.
Examine the evidence:
This is the most important part of the review. As a laboratory, the most important document in process management is the calibration database. This database is a control measure to ensure that all your machine calibrations are in place as per standards.
With the implementation of a calibration database, business processes change. Hence, the leadership must be aligned on the documentation and changes in the process via a presentation of the process in the review meeting. Apart from this, evidence of appropriate changes includes reviewing of policies, incident management systems, register of legal requirements, etc.
Trend and process monitoring:
To continue improving management systems, an analysis of trends in technology and business processes is necessary both internally and externally. This is where validation consulting services can also step in to help you identify the practice trends and validate or suggest changes to better equip you for accreditation.
In trend analysis you can look at the needs of potential clients, legislation and regulatory compliance needs, changes to product or services, customer satisfaction, non-compliance management, and corrective measures in place.
Reporting:
Once the management reviews are completed the minutes or parts of them must be distributed to all appropriate staff members. This report must include any decisions made around opportunities for business improvements, changes to management systems, revisions in KPIs, amendments to plans or budgets, and even changes in resourcing for management system implementation.
This report is essential to align all stakeholders and is also necessary from the perspective of 3rd party accreditation audits.
The accreditation process is daunting and requires lots of minute steps to ensure smooth processing. To make sure you don’t face any issues in accreditation, get in touch with the experts at Cal Lab Access today. These ISO accreditation experts help you with validation consulting and understand the different steps of the process and put all systems in place to achieve and maintain ISO certification.
