Is ISO 13485:2016 applicable to distributors of medical devices?

A question I have been asked is: To what extent is ISO 13485:2016 applicable to distributors of medical devices? They import devices and sell them locally as is.

The answer to this question depends on answers to the following questions.

- Are you marketing the medical devices that you sell? What claims do you make in your marketing and can you show verifiable evidence from the manufacturer/supplier that the medical device actually satisfies those claims?
- Are you providing any training regarding installation, set up and configuration, operation or maintenance of the device?
- Are you providing after-sales support of any kind?

- How do you handle and track customer complaints?
- How do you track and handle recalls?
- Do you do any kind of inspection or sampling to ensure that the devices you receive function correctly before shipment or collection of the device?
- Are the medical devices approved for import and sale by you in the country in which you operate?
- What is the medical device classification in your country of operation?
- Are you registered with a healthcare regulator as an importer/distributor? What healthcare laws and regulations are you subject to? How do you demonstrate compliance?

- What due diligence have you conducted to qualify and approve the manufacturer and supplier of your medical devices?
- What technical or professional competence is required or expected of your staff? Do they actually have the required training or experience?

Then...
- To the extent that any of the above apply to you, what processes do you have in place to ensure quality and compliance?
- What records can you show as evidence of quality, consistent conformity with the above answers or compliance with healthcare regulations?

These questions and their answers are all relevant to ISO 13485:2016. I am sure other people in the industry could think of still more questions.

Quality is about time...

by Philip Scalise, an online colleague and acquaintance whom I have met and interacted with on LinkedIn. Philip does Quality System Administration and Development based in Utica in the New York area.

Re-posted with his permission from his LinkedIn post.


People who find QUALITY to be an abstract concept contribute to why it is so. The lack of “common” understanding regarding quality is self-perpetuating. Just as oxygen fuels life it also fuels the flames of confusion. While I am neither a professor nor writer I do have a diverse background in quality and I am one to see things for what they are. Quality is about time, my time and your time. While I understand the traditional definitions of product & process quality and the methodologies utilized to achieve the condition, I need to stress this is not some high minded lofty diatribe, nor do I seek to solicit clientele in its offering. In fact, this is nothing more than a straightforward logical perspective on quality from the common of man. As such I will use every possible practical minded real world example at my disposal to substantiate this point. In the spirit of simplicity I have decided to use time as our least “common” denominator. I will be as direct as possible and not waste any of “our” time.

First let’s understand something. Those who appear not to understand every possible nuance or gradation of quality, in fact do have their own understandings they are just not the same as yours. When an honest person does not understand something we ask questions. Asking questions of people that lack the knowledge or the integrity to admit it is at the very root of this self-perpetuating cycle of misunderstanding. As a result, even more questions come up providing fog and even cover for the smoke and mirrors folks. These are people who use their time to play a shell game with your time. Questions and concerns multiply and grow into a giant sized mass of industry feeding confusion. Once upon a time smart minded business women asked me if I could define quality for her. When I told her I could not, she asked me why not? I explained “if you do not know what quality means to you how can I possibly define it for you?” There are far more people who cannot explain quality than there are those capable of doing so, but make no mistake about it, many of them are doing business just the same. Quality (good quality) is properly defined when things work. Conversely poor quality is defined when things do not work. For example I am writing this right now because of the time I have available while not edging my lawn and waiting for a refrigerator repair person to enter through the front door.

Why not edge the lawn?

Well, it’s about time. You see my WORKS (spelled with an x) lawn and garden tool does not work at the moment. It is a quality tool but it appears the replacement spools sold at area retailers are not. The quality condition of the spools that come with the unit are good quality and worked just fine, however, understanding quality, manufacturing and supply chains as I do, I was not in the least bit surprised to find the replacement spools are not of this same quality condition. It seems, this time, the private labeling business may have been “outsourced” to another organization other than the OEM (original equipment manufacturer). These replacement spools come in a two pack which one might expect to last a few years, but, when I put the first one in it continued to unwind until I lost my patience and threw it away. Trust me Mother Teresa would have done it sooner. When I tried to install the second one I had no chance at all, but this time for far different reason. After spending close to 20 minutes studying the spool with my needle nose in hand, I simply could not find the end of the line to install the damn thing, so I just gave up and came in for lunch when I remembered “do not to open the refrigerator.”

Why am I waiting for a refrigerator repair man?

Well, it’s about time, the refrigerator (a samsung) purchased through best buy and whose geek squad has been here multiple times now, is in the “process” of spoiling our food. Unfortunately for us and not for the folks at best buy or samsung, this time, there is no time for them to return for a third time. So this time at an unknown time they will send yet another repair agency because we are short on time. Surely it will be this person’s first time spending time on my time repairing the refrigerator for the third time, so I trust it will not be a good time.

Why will the repair person need to come through the front door?

Well, it’s about time, you see my kitchen is directly off the garage so this time when I opened the door for the repair man so he could roll his tool box into the house to dismantle the unit yet again, well, this time my garage door opener broke. This door opener is only a matter of years old, but here is the thing, you need only hit a button and the door opens along a threaded screw about 10 feet long. Well, as it turns out (yes pun intended) this ten foot long screw is not 10 ft. long? It actually comes in three sections so it can be easily packaged and home shipped as opposed to store bought. This allows the OEM to reach a greater customer base which is great for them, but surely not me! So this time I will need the coupling that is worn down from the multiple times the door has gone up and down wearing down this all important part that the genie door people no long provide. This time I will need more time to invest in the repair or replacement of the unit. Seems this could take some time, but hey, exactly whose time is it anyway…

All that said and in closing allow me to say this about that, when and if you struggle with your understanding of “quality” just recognize that no business on this planet has any such dilemma. They do not struggle with their definition of quality they struggle with yours. If we all woke up in the morning with the very same definition of quality in mind, well, to that my one and only response would be…well, it certainly is about time!

Risk Based Thinking (RBT) in ISO 9001:2015

What is risk based thinking as required in ISO 9001:2015? How do you implement it?

This 17 minute presentation expands on the guidance provided by TC 176.

Six Steps to Creating Your Project Budget

- article by Helena Lui in Quality Digest

Disguised as simple but by no means simplistic, this is a practical, high-view "Project Budgeting For Dummies." The author is a consultant at IBM and an instructor at examspm with a master’s degree in business/commerce from Queen’s University.

Her six steps are:
1. Look through lessons-learned documents
2. Know your cost
3. Roll up individual activity costs (where Lui makes a very important point!)
4. Add contingencies
5. Monitor your progress and resources (where the author makes the point that, "Project budgeting is not a set-and-forget activity, but rather a continuous activity that requires your daily attention.")
6. Communicate changes to stakeholders

It's a quick read which novice and less experienced project managers can refer back to periodically with regard to project finances. Some stakeholders will also find this helpful.

Read the full article here.

Simplify Clarify Control

The banner maxim for my company, tcmc Quality Management Services, is Simplify Clarify Control. This is not just meant to look good as a catchy slogan: it is what I really try to help my clients achieve and the way I operate and do what I do.

Simplify

You simplify by having a standard process for each of the value-adding steps of your core operations, ensuring that these integrate into one system that provides defined products and services.If you can identify busy work that does not add value for your customers, try to eliminate it or minimize the impact on your organization's resources.
As importantly, simplify the work environment and resources by applying 5S:
Sort: sort everything into one of Retain, Return, Rid
Straighten:  a place for everything and everything is in its place.
Scrub: clean everything regularly.
Systematize: have maintenance schedules and systems to keep it this way.
Standardize: create a culture with new habits for keeping things simple.

Clarify

You clarify by ensuring that every value-adding process has assigned roles and responsibilities and that everyone in the organization clearly understands and takes pride in their own roles and responsibilities: who their customers are, who their suppliers are, why they do what they do and why that is important.
Customers and suppliers are not just external to the organization; in fact, for most employees, their customers and suppliers are within the organization itself: who is the first recipient of my work output? That is my customer. Who gives me raw material/components to assemble - whatever I have to add value to by transforming into something for my customer? That is my supplier. How do I get along with my own customers and suppliers? Is there good rapport and mutual respect?

Control

Senior management controls by measuring and monitoring the performance of key, value-adding operational processes, setting SMART objectives that align with the strategic direction of the organization and its stated policies and mission.
SMART objectives are: Specific, Measurable, Attainable, Relevant and Time-bound.

Reap the reward - Quality

If you do the above for your organization - simplify, clarify and control - you should find greater predictability and quality in your products and services, less waste, improved morale and, most importantly, happier customers.

ISO 14001 - What is it? An Overview

My latest training video on YouTube (just 9 minutes long) gives a high level overview of all the requirements in this well-reputed international standard for environmental management systems.

ISO 14001 - What is it?