ISO 15189 Accreditation

Bullet-proof your laboratory accreditation

Keeping your laboratory accreditation (& business) safe
Good laboratory quality systems don’t just cover the things that NATA expects to see, they also support the laboratory management to make the right decisions.  Whether you have laboratory accreditation, GLP or ISO 9001 certification, there are some key strategies that I have seen organisations use to protect their accreditation status and their business:

Say no to work when it is not right (too much, too little, wrong type, wrong client, wrong time)
Train staff members thoroughly before sending them out on their own
Replace departing staff members promptly
Backfill for staff on extended leave
Review their prices regularly
Cultivate ideal clients through suitable marketing
Know the accreditation requirements and how they are meeting them
Have a system in place and follow it
Understand the science and measurement traceability behind the tests they do
Regularly review their operations, make decisions and follow through
Plan changes thoroughly, involving all stakeholders
Use incidents and complaints and internal audits to improve their systems

These organisations have happy employees who know they have a secure job.  Staff know they will be given the time to learn before they have to do, and that there is always someone there who knows more than they do.

When NATA comes visiting, they may be nervous but not afraid.  They will be looking forward to showing the laboratory operations to the NATA assessment team and hoping that all their hard work will be obvious.  The discussions with NATA will be engaging and open, and disagreements handled without animosity.

Keep these practices up so you can celebrate after your next laboratory accreditation assessment.
Laboratory quality systems can help
Most of these issues are alluded to in ISO 17025, especially under “Management Review”.  But […]

By |March 8th, 2018|ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation, Quality systems|Comments Off on Bullet-proof your laboratory accreditation

How Safe is Your NATA Accreditation?

When a lab has their accreditation suspended, it usually comes as a huge shock. But there are warning signs for poor assessment outcomes. You can determine whether there are issues that you should address before NATA comes.

These are some of the things I have observed in laboratories that go on to have a poor assessment outcome or have their accreditation suspended:

Senior technical staff have left and not been replaced.
Business has expanded and they’re getting lots of new contracts but haven’t had time to train the front-line staff.
They are receiving lots of phone calls from customers.
There are technical problems that everyone agrees need to be fixed, but for some reason they never do get sorted out.
Internal audits have not been done for many months: everyone is too busy to be audited.
New NATA requirements, but they haven’t had time to work out how they apply to them.
Their business has expanded, but they haven’t increased the resources for quality management and internal audit.
Their accreditation covers many different labs, some of which they have never seen nor met the staff members.
No one knows where to find a copy of the last NATA assessment/surveillance report.
The laboratory has been chronically short-staffed due to illness or other unavoidable factors.
Last but not least – if you have had the same NATA lead assessor for many years and now a new one is headed your way.

No one of these problems alone means that your accreditation is doomed, but if you are saying “yes” to a few of them, you need to slow right down and take stock.

How to protect your NATA accreditation

Some labs stumble into having their accreditation suspended without a clue […]

By |February 23rd, 2018|Accreditation News, ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on How Safe is Your NATA Accreditation?

Are you wasting time & money on NATA requirements?

The assessment is over, you have ushered the audit team out the door and you already know how you’re going to fix most of those niggly things they brought up.  The assessment team were really helpful and you know it’s going to feel great to get all of these NATA requirements ticked off.

You’re not sure why these issues are important enough to be in the assessment report, but you need to get the response under control so the “Just Do It” approach wins.  You get the assessment report and hold a meeting to decide who will do what, including all the observations and recommendations.  Great work – you’ll have everything fixed and your reply to NATA post haste.

Can I just say whoa?!

When we behave like this we are focussing on one risk: the risk of NATA being annoyed with us for not having a response in time.  What about the other risks?  The real risk to your business presented by the issues the audit team identified?  The risk of wasting time and money on interventions for trivial problems?  The possibility of the same issue coming up in future assessments, which can threaten your accreditation and your reputation.

This is the time to slow down and take a quality improvement approach to each of the issues raised by the auditors. Here’s my step-by-step process to address these findings so that hopefully they never come back to haunt you again.
Understand the problem
Study the finding closely.  Make sure you have understood exactly what the auditors found that is wrong & why it is wrong.  Go and check what they were looking at if you haven’t seen it.  Look up the clause of the standard that they refer to […]

By |June 26th, 2017|ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on Are you wasting time & money on NATA requirements?

The easiest internal audit program ever

I recently discovered there’s a way to do internal audits that takes (almost) no time at all.  I got an invitation to a webinar Freshening Up Your Internal Audit Program featuring a dude who has been around the ISO 9001 certification scene for many decades.  (Aha! I thought.  I’m finally going to learn the secret from a real veteran of internal auditing).

When we got to the secret, I was amazed by the completely different approach to auditing.  This was more than a freshen up, it was radical surgery.  There are no horizontal, vertical, process, observational, or outcome audits: they have all been excised.

This quality manager produces a detailed Compliance Matrix (it’s like a gap analysis with much more detail) and updates it every year (you can get a copy if you make it to the end of the webinar).  And the Compliance Matrix is it.  There is usually quite a vigorous discussion with the ISO auditor when they come, but he manages to get it across the line.

Now I wasn’t quite ready to adopt this approach whole-heartedly, but there were some great lessons in the webinar that I’d like to share with you:
There is no right way to do internal audits
The ”tell me, show me” or process method used by certification and accreditation bodies is not mandatory.  Many of us are married to the belief that observational process audits are the only “proper” kind of audit (you know, the ones we learn about in the NATA/SAI/Lloyds internal audits courses). I know I was for many years and I love auditing that way because it suits my curious nature and visual learning style.

However, if you follow the requirements trail for internal audits, it leads you back to […]

By |June 15th, 2017|Internal Audit, ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation, Quality improvement|Comments Off on The easiest internal audit program ever

10 Tips to Avoid NATA Paper Warfare

Some lab / quality managers enjoy corresponding with NATA and arguing the point with them.  But most of us don’t.  Other labs inadvertently get caught up in three, four or even more rounds of correspondence with NATA following an assessment.  It can be frustrating and time consuming.  You seem to be talking at cross purposes at times and you may even start to wonder if the NATA staff were actually at the same assessment as you were!

After an assessment you need to get the follow-up over and done with as quickly as possible so you can turn your attention to more significant issues.  It’s not that NATA is not significant, but that many of the issues they find are compliance issues with no immediate impact on your output or business security. In the normal run of business they would be prioritised much further down the list.  So we need to minimise the amount of time spent dealing with these issues, whilst managing the risk of having a poor NATA assessment in the future.

Here are my key steps to stay out of the mire:
Be a good host
Before the assessment, make sure everyone knows who is who on the assessment team: who the technical assessor is, who are the NATA staff members and what the difference is.  If you don’t know much about the technical assessor you can google them to find out a bit more about their background. This gives you an opportunity to establish rapport right from the start and have good open lines of communication. This is small task that can make things run a lot smoother.
Stick like glue
Do not leave any assessor or NATA staff member alone to interview junior staff members.  […]

By |April 1st, 2017|ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on 10 Tips to Avoid NATA Paper Warfare

Supervision or Teamwork?

NPAAC has produced four revisions of the Requirements for the Supervision of Pathology Laboratories document in the past 6 years.  Each of these drafts has been met with dismay by any pathology laboratory wanting to determine their most effective organisation structure and to foster a culture of teamwork, continual improvement and learning amongst all of their staff.

What follows is my quick review of the draft that was circulated in October 2016.
Supervision Requirements
S3.2 Requires full time on-site supervision to direct the operations of a pathology laboratory. The person can only supervise one category G laboratory.

S3.3 Every test must be covered by an APP with the relevant scope of practice.

The effect of these two provisions together is that there will be a lot of very bored pathologists and/or Clinical Scientists working in pathology laboratories trying to find something useful to do while they meet the full-time supervision requirements. Oh no, wait –we already know that there are not enough pathologists or Clinical Scientists to fill these roles anyway.  Where are these highly qualified, but somehow lacking in ambition staff going to come from?  Who has tried to find a full-time Immunologist lately?

How will NATA staff, encountering non-compliant organisations, insist on them meeting a requirement that they know is impossible for pathology laboratories to meet?
Risk management and handling clinical incidents
S1.6 This is repetition of what is in ISO 15189. I cannot understand why NPAAC insists on repeating things that are already in an international standard for medical laboratories.

S1.7 Again, this is repetition of one of the most fundamental requirements in any quality system.  There is nothing in this that is not already covered in ISO 15189.
Supervision Requirements for Category B Laboratories
S3.6 Specifies how many days of supervision […]

By |January 4th, 2017|ISO 15189 Accreditation, NATA Accreditation|Comments Off on Supervision or Teamwork?

3 Secrets for a successful audit program

At this time of year many of us are surveying the wreckage of our laboratory internal audit programs, wondering if we can fit in a couple more before the end of the year and reign in the backlog.  Rest assured that you are not alone!

This is a good time to review your approach to the audit program and see how you can shake it up a bit.  Think about what determines the success of your audit program. Is it whether every single audit that was on the schedule was completed on time? Or is it whether your senior management are happy with the outcomes and control of risks?
Don’t confuse purpose with objectives
The purpose of an audit program is to do audits.  If you only focus on the purpose, you will just keep on doing audits, producing reports and piling up a lot of minor non-conformances.  This is when we can get demotivated and disenchanted.

Take a look at your laboratory’s objectives and think about how the audit program could support them.   If your organisation wants to become more efficient, then your audit program should be aiming to identify process improvements that can save time or resources in producing test results.  This will inform what approach you take to audits – you may move away from looking for compliance to adopt a process approach.

If your organisation is new to accreditation and just wants to meet NATA’s (or ISO) requirements, then auditing for compliance with the criteria documents can be a priority.  This is also a great way for staff to learn about the requirements. But avoid getting stuck in this type of auditing for too long, as it rarely leads to any real improvements.

When the customer […]

By |November 17th, 2016|Internal Audit, ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on 3 Secrets for a successful audit program