Modern business is riddled with regulations and components that ensure quality end results for the customer, and for good reason!
This is especially true if you make a product or service that involves people’s health and safety, such as a laboratory. If you are considering starting one in Australia, you’ve undoubtedly heard about NATA certification.
But if you haven’t already, and you are new to this industry, this association is important to be taken seriously as a laboratories.
What is NATA?
NATA (National association of testing authorities, australia), is an organization that according to its website, “Provides a means of determining, formally recognising and promoting the competence of facilities to perform specific types of testing, inspection, calibration, and other related activities.”
In relation to this association, there is also yet another standard that is crucial for every laboratory to follow to maintain high standards and compliance: ISO/IEC 17025. The purpose of this international standard, is to ensure that laboratories operate properly and generate results that are scientifically valid.
So if you are based in Australia, you now understand that NATA and ISO/IEC 17025 accreditation is crucial. However, before thinking of any of these concepts, do you currently have the right systems in place to ensure a good laboratory practice?
This is where a QMS software steps in. It is smart to check the safety of your laboratory process even before you apply for certification from either NATA or ISO, but how can you do so if you lack any protocols and standard operating procedures?
This is why a good QMS is the crucial first step on your journey of legitimizing your laboratory, and maintaining an edge over your competition.
In this article, some tips will be given about how to best achieve NATA certification , and where a good QMS software plays into all of it…
Why NATA laboratory certification is hard without a good QMS software
As mentioned in the beginning of this article, it is impossible to manage your product or service quality without a QMS. Things get especially worse if you are not using a streamlined software and just pen and paper…
The reality is, any legitimate company or laboratory needs a QMS, and this is especially crucial for laboratories.
When it comes to blood testing and other diagnostics that have people’s lives on the line, you want to remove error completely; this is obviously not currently possible, but as close as possible is expected.
With NATA, there are a few mandatory conditions. According to their website:
- The availability of people and other resources required for satisfactory performance of the functions for which accreditation is sought;
- Satisfactory management of people and other resources;
- Satisfactory performance in proficiency testing programs and/or measurement audits or other practical or theoretical tests set by or recognised by the Association and specific to the work to be covered by that accreditation;
- Compliance with any other special qualification, requirement or condition prescribed or authorised by the Board; and
- Past and present conduct including technical and professional skills of the applicant for accreditation which, in the opinion of the Board, are consistent with maintaining the standing, the professional integrity or worldwide reputation of the Association.
When it comes to ISO/IEC 17025 compliance, you will have to purchase the document to get further details on this standard, however some key components are:
- Resourcing: This means attributing the proper amount of money, skills and workers to a particular job, in this case testing.
- Process: ISO wants to track the flow of how an item is tested in the laboratory. This has more to do with the mechanism of how that occurs, and this standard looks at things from a broader perspective.
- Management/Quality control: What is your QMS? How do you manage the results and your employees?
With these mandatory conditions mentioned, it will be difficult to do verification and demonstrate technical competence without measuring quality accurately.
To do so, you are better off using a good quality QMS software.
Establishing a relationship with the accreditation body (NATA)
Now that you have a general understanding of what NATA and ISO/IEC 17025 is, you are better prepared to potentially get accreditation. However, there are some additional things you should do to improve your chances of success.
One of them is establishing a relationship with NATA beforehand.
One way to do this is through getting a preliminary assessment from the association, and showing that you are already prepared. If they already notice your lab is in good condition, and during the verification they see indications of safety and competence, they may give you more of a chance later on.
This is why having a good quality management software is crucial!
If your lab manual, procedures, work instructions, quality documentation and quality records are all clearly understood, laid out, and accessible, you will likely deliver good quality results. The only step after that, is just proving that you truly do get accurate results, based on NATA and ISO standards.
Keeping track of all these components is not easy, and this is why using a software, like Momentum QMS, is the smart move.
Through investing in a good system, you will save money over time with less errors in your testing, and ultimately protect your business from medical malpractice!
And anyone knows that this can be fatal to a healthcare service…
Preparing for the accreditation
If you are using a QMS, you should be able to outline your lab manual, procedures, work instructions, quality documentation, quality records, and more, quickly and clearly.
These documents are crucial when preparing for certification.
However if you don’t already have one, how will you do it?
Keep in mind that having your quality management system laid out clearly is already a big chunk of the battle when preparing, and receiving certification.
You need to be able to competently demonstrate the effectiveness of your testing, and monitor:
- Proficiency testing
- Quality control
- Physical environment of the lab
- Other factors…
Do you think you have these factors under control in your laboratory currently?
If not, you will need to check your quality management system, and make sure that everything is accounted for.
Benefits of NATA certification
As you move forward in your journey to accreditation, you are probably wondering what the actual benefits are as a whole. Is it really that important?
The answer is yes, and here’s why:
- Higher quality, prestige and trust. In Australia, any legitimate testing lab is NATA certified, therefore it is necessary to fit in and have trust in the market.
- Not only will a good QMS save you time and money because of reduced defects and compliance, NATA certification will allow you to outsource certain tasks to third parties in other countries who can work for cheaper. This means more money, and less cost.
Why Momentum QMS is the clear choice for NATA and ISO 17025 certification
So why choose us for your lab certification journey?
Momentum QMS requires no user-license fee, is built with open source technology, provides the tools and techniques necessary to produce valid laboratory results, and in addition to that, makes it easy to comply with ISO/IEC 17025!
A few ways Momentum QMS makes ISO 17025 compliance easy:
- Section 4.1 & 4.2: Management commitment and accountability. Momentum QMS is an integrated platform that is designed to create accountability and traceability.
- Section 4.3: Control all documents that form part of its management system. Momentum QMS has a Document control module that allows users to control documents such as policies, procedures, methods etc. Version control allows you to have complete traceability over previous versions.
- Section 4.7, 4.8: Cooperate with customers, seek feedback. Customer Complaints. Momentum QMS also allows feedback to be collected directly from customers in the form of Anonymous submissions.
- Section 4.9: Control of Non conforming testing or calibration work.
The Deviations module allows for the capture, analysis and resolution of issues. Risk associated with an issue can be assessed and actions can be carried out to close out the issue.
- Section 4.11, 4.12: Corrective and Preventive Actions.
Utilising the CAPA module, issues can be reported and analysed. Investigation teams can be set up, where the root cause is investigated, corrective / preventive actions are planned, carried out and then their effectiveness is measured at the end.
- And many more features…
Now that you know the general aspects of NATA, ISO/IEC 17025 and how a QMS software can help you achieve accreditation, you are one step closer to achieving compliance as a lab.
NATA (National association of testing authorities, australia), is a crucial organization that you must receive recognition from in order to be taken seriously in the Australian medical field. It simply doesn’t suffice in our times to not be verified by an accredited organization, especially when people’s lives are on the line.
In addition to NATA, ISO/IEC 17025 certification is also critical to ensure proper laboratory practices, and scientifically valid results on a global scale. If you expect to do testing for organizations in other countries, ISO certification is critical.
Considering that you read up to this point, you obviously care about certification…
But do you have the right tools?
Let Momentum QMS help you get there. Built without compromise, our software is the right choice to get you prepared for certification, help you pass, and continually improve your testing processes.