2019 Resolutions for Your Management System

The turning of the calendar to a New Year is traditionally the time when we stop and reflect on the coming year and changes that we may want to make. This is always a good time to take a look at your laboratory's management system and to assess whether improvements are in order. 

Laboratories making the change to ISO/IEC 17025:2017

For laboratories that have not yet made the change to the 2017 version of ISO/IEC 17025:2017, now is the time to start planning for the changes. Don't wait until your assessment is looming and then rush to make the required updates to your system. 

Where do you start?

The first step is to conduct a gap analysis. A gap analysis is conducted by looking at the requirements of the new standard and comparing them to your current management system. You note wherever there is a change or addition required to your current quality manual, policies or procedures.

You can quickly get up to speed on the 2017 version of the standard with the ISO/IEC 17025:2017 What's New or Different course. For help with doing the gap analysis, the webinar, Gap Analysis as a Tool in the ISO/IEC 17025:2017 Transition will take you through the steps of doing a gap analysis specifically on moving to the 2017 standard and will provide you with some useful tools and tips.

For CALA accredited laboratories, a gap analysis needs to be submitted prior to your first assessment to ISO/IEC 17025:2017.

Once you have identified the gaps in your management system, set a schedule for tackling the changes. Ensure you assign responsibilities and set deadlines for drafts, reviews, etc. 

Pay particular attention to the areas that were causing some issues during the assessments in 2018 to the revised standard. These include:

• implementing risk-based thinking
• ongoing assessment of risks to impartiality
• understanding whether you are making statements of conformity, and, if so, that you have documented decision rules
• completing an internal audit against the revised management system prior to your assessment

Also make a plan for communicating changes to your staff and set up any required training. CALA's ISO/IEC 17025:2017 Highlights of Changes for General Staff course is the recommended course for getting your staff up to speed on the new requirements of the standard. 

Start implementing the changes. You can gradually implement the changes over time, or do a quick switchover to the revised requirements. If you have planned your updates, you can choose whichever method works best for you instead of being forced into a quick change mere weeks ahead of your assessment. 

Laboratories already assessed to ISO/IEC 17025:2017

You have made the change to the revised standard, but have you made the most out of the changes to your management system? The reports from assessments to the 2017 standard carried out during 2018 indicate that most laboratories that were assessed were still in the early stages of implementing the new or changed requirements. For example, risk based thinking was being considered but laboratories may not have fully implemented the concept. Some additional communication, training, or even updates to the management system may be required to embrace the new approach to the management system that comes with the 2017 revision and to use those changes to your best advantage.

What is your plan for moving your management system forward? Some suggestions for 2019:

• Plan additional training and communication on the revised standard. Whenever there are major changes it is always a good idea to do follow-up sessions ensure everyone affected has made the required changes and understands any impacts to their work. 
• Look at the major changes and assess whether you need to work on integrating these further in your management system. The one that is causing the most concern is risk-based thinking. Remember that risk-based thinking is primarily a proactive activity. If you are not looking at the risk associated with work in the future, you may not have fully implemented risk-based thinking. If you need help on risk-based thinking, check out the course Risk-Based Thinking in ISO/IEC 17025:2017.
• Start planning for your next management review. Be sure to incorporate the new requirements for the review from the 2017 standard. Plan a comprehensive look at how the revisions are working in your management system and whether changes are required.
• Take a look at your Internal Audit. Are your auditors familiar with the 2017 standard and able to audit against it? Are your audit procedures aligning with the revised requirements? And, most importantly, if there are any areas where you did not have evidence of conformance during your first assessment, are you auditing those areas to ensure you are complying before your next assessment? For example, the requirements for complaints have changed, but most laboratories did not receive complaints between updating their management system and the assessment, so there was no objective evidence that the new requirements were being followed.

Take some time now to plan out what you want to accomplish with your management system this year. Putting a plan in place is the first step to achieving your goals for the upcoming year.

Happy New Year!