written by Maree Stuart
As we head into the silly season, we’re delighted to present:
The MAS Management Systems 12 Days of a Lab Christmas!
On the fifth day of Christmas, we did our management review
with our business planning session.
Huh? You mean we can do a management review not just to tick the accreditation or certification box?
That’s right! Accreditation and Certification standards are not written just to please auditors. They are sensible sets of quality management principles that help to ensure things like accuracy, reliability, trust and business success.
We see so many labs and other businesses rushing to get a management review done just before their external audit. This is often on top of the regular business planning and management meetings activities that are done throughout the year.
Management reviews – are you doing them properly?
Once you’ve completed your assessment visit, you may feel like you can take a deep breath and rest on your laurels for a while.
And this is absolutely true. You certainly can do this.
For at least a couple of hours.
Because once you’ve waved goodbye to your NATA assessment team and closed the door, that’s not the end. It’s the start of another cycle.
You can consider this phase ‘maintenance and monitoring’. Of course, it’s business as usual because you’re still carrying out the work that serves your clients. Plus, there may be one or two things that the assessment team picked up that you’ll need to action.
But during this ‘live’ phase of your business, you need to be monitoring and reviewing trends in your system and responding to any issues or opportunities from this monitoring and trend analysis work. And an important part of that process is the management review.
Why should you do a management review?
No doubt you’ve read the section in the standard about management reviews. For your reference, in ISO 17025 it’s clause 8.9 or clause 4.15 in ISO 15189 (makes great reading if you can’t sleep…).
If your lab holds accreditation to ISO 17025 or ISO 15189, a management review is mandatory.
We’ll talk about inputs and outputs shortly. Essentially, what you’re looking for is anything that needs to change or improve and allocating resources for those things.
Remember, the standard doesn’t say HOW you should conduct your management review. It just says that you should. It’s up to the lab and management to decide when and how often this should take place and the format.
The key is ensuring that you act upon any decisions in a timely manner and documenting this action.
What is a management review?
The standard requires that labs review their management system at pre-planned intervals. This isn’t an audit. It’s not about reporting back or reporting measurements.
This is a tactical and strategic planning opportunity to evaluate the extent to which the management system fulfils its functions and goals.
You’re aiming to systematically evaluate the overall performance of your lab and its quality management system.
But just to be clear, this isn’t something you should be doing because NATA or your certification body requires it. Ensuring the lab’s management system is suitable, adequate, and effective is simply good business practice. And a management review should allow you to identify shortcomings and find the resources you need.
What do the standards actually require?
While section 8.9 covers management reviews in general, clause 8.9.2 contains a list of information.
This list of 15 items is what must be covered as part of the management review. But if you look closely, they could well be topics discussed in other meetings like business planning and management reviews.
The items in 8.9.3 are not additional topics to discuss. But your records do need to show that decisions and actions have been taken in relation to each of those 15 items. In particular, you should be aware of things like effectiveness and resources. And don’t forget about the interaction between section 8.5 and this section.
What do you need to look at?
Whilst there is a laundry list of things to cover in a management review, they boil down to four key factors to consider:
- Suitable – do the processes and operations you have in place facilitate and support the lab’s activities?
- Adequate – are all the requirements of the standard being met? Is the lab complying with regulatory and contractual requirements?
- Effective – is the management system accomplishing the stated purpose of producing the intended or expected results?
- Efficient – examine the relationship between the resources and the results being achieved.
Just because the standard doesn’t talk about financial performance doesn’t mean you can’t look at this in your management review. The “list” is the minimum and not the only things that can be discussed.
Management reviews don’t have to be a one-off meeting covering everything. It can done over several meetings with inputs from different levels within the lab. Assign responsibility for the review to a senior staff member (most likely the lab manager or quality manager). They can conduct a final review meeting after going through all the contributions.
Remember, if you do a big annual internal audit, completing this before the management review means you can include those inputs.
This is also an important and valuable process that will reap benefits for your business.
However, if you need help with any of it, we’re right here for you.
Maree is a highly experienced consultant and facilitator with years of practical, hands-on experience both with NATA and within the lab environment. She’s been on both sides of the table and brings that expertise to benefit your business.
Call Maree on 0411 540 709 or email firstname.lastname@example.org to arrange a confidential, obligation free discussion about how we can help your business to work better and smarter.
Remember, you don’t have to do this alone!