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Does a raw materials distributor need to be certified to ISO 13485:2016 in order to best do business with medical device manufacturers and OEM's? Should they be?

(TL;DR) Not in my opinion. Not as long as you transition your 9001:2008 system into a 9001:2015 certified program that is true to the standard and taken seriously within your organization.

M. Vincent and ISO 13485

When I was considering adding ISO 13485 to our ISO 9001 certification back in 2011 I asked these questions on a couple of LinkedIn groups that focused on ISO 13485, and ISO for small business. Results were mixed. Most members associated with larger companies said it didn't matter, that 9001 was good enough. Small business owners, though, were less sure. Any chance of losing business is frightening to a small business. If you don't have a big budget to do unlimited market research, you tend to err on the side of caution.

That is what I did. I recommended that we do what some of our competitors were doing and get 13485 certified. Working with a consultant, we identified the additional documentation we'd need to maintain and came up with a procedural change that would allow us to show an auditor we were differentiating "medical materials" from the metals we sell to the aerospace and general machining industries. Now, after much thought and asking of our customers I've decided that ISO 13485:2015 isn't appropriate for our company.

Changes to the standards

With the issue of 9001:2015 and 13485:2016 the two standards have, in some ways, gone in different directions but in others have come together. I think ISO 9001:2015 is a big improvement over 9001:2008. As far as our business goes, it brings every benefit we gained from 13485:2003 certification into the 9001 certification.

The following are just a couple of things I think are important changes that effect raw materials suppliers. They would lead to having to take non-applications on requirements that are essential to the heart of 13485. Doing so would make a 13485 certification way to watered down to mean anything. Changes to 9001, though, have made dropping 13485 an easy thing to do.

13485

  • Lining itself up more with regulatory bodies like the FDA. This is meaningful to the medical device industry, but not so important to raw material suppliers.
  • Requiring risk management in the purchasing process to be proportionate to the risk associated with the medical device. This is an important change, but suppliers like us have to treat all material purchases as equally important. Our only risk is buying the wrong product, or buying from a shady supplier. We can't rightfully assign proportionate risk to what our customers do with the materials we purchase and then sell to them. End usage is rarely shared with us, so how could we know that one's use is more 'important' than another's?
  • Requirement to document a procedure for the validation...of computer software. Another very important addition, but this implies that the software effects the quality of the product. This is very true within the medical device industry, but not in a raw materials distribution. We have to make sure that our software works to complete our process map (including record control), but it doesn't have the opportunity to directly change the product itself.

9001

  • Incorporating risk management (in place of the dreaded Preventive Action requirement). This was a requirement of 13485:2003 that we followed and included individually in every one of our processes. It is one of the most important benefits our business gained. The thought that goes into formalizing risk management can, and should, bring the whole purpose of your business into focus.
  • Eliminating exemptions in favor of non-applications (and requiring justification for every non-application). This might seem like just a change in wording, but I think it's a very effective change. Allowing exemptions also allowed for a very generic "we don't do that, so it doesn't apply" sort of blanket statement that covered whole chunks of the standard at one time. Justifying non-applications individually forces us to take a look at the entire system as a whole. How does each non-application effect every other aspect of the system? It's a good question to consider, and one that can take auditing and improvement to a new level. The more you have to think about every 'cog', the more you can see the system as a whole.
  • Requiring auditable consideration of "interested parties". This means that if you know you have a medical device company as a customer, you better consider every aspect of 13485 that effects their perception of your products and services. I take this to mean that a thorough integration of all relevant requirements of 13485 are built into your 9001 system. We know we sell metals for surgical and implant use. We will continue to keep our standards in line with our customer's expectations.

What's the conclusion?

I know this is a very superficial examination. It's going to take a long time and a lot of audits before the full effect of these changes are fully integrated into all of our systems. I do think, though, that the question of whether or not a raw materials distributor needs to be certified to ISO 13485:2016 (if they want to remain a valuable supplier to the medical device industry) can be answered with a fairly certain "no". ISO 9001:2015 is so improved that it covers all quality concerns of a distributor without an unnecessary burden of redundant record keeping. As long as a non-manufacturing distribution company takes 9001:2015 seriously, and implements it intelligently, their quality system should fulfill the expectations of their customers.

I'm looking for...

What do you call that highly refined grade of stainless steel that all your medical device customers ask for? If you're like us, and most people in the business, you call it "316 LVM" and never really think about it. At least not until a customer print calls for something like "316L ASTM F138" or "Implant Grade 316". Then you might get out your books, search Google, check the specs and mill test reports, and make sure that what you're buying or selling is just what they need. And chances are you've got it right. But why all the names? What should it really be called?

There's only one definitive answer to that, but before I reveal that magical answer let's first look at the path we take to get there.

"316 LVM"

This is by far the most common way of referring to it. It's a bit misleading, though. The 'VM' stands for "Vac Melt', so you would think that this is simply 316L that has been vacuum melted. You'd be sort of right, but not really. It is vac melted, but it's not 316L. 316L has a UNS number of S31603. That's the low carbon version of S31600 (what you would know as common 316 stainless). What we're talking about is UNS S31673. Seventy numbers away. Considering each UNS number is a specific chemistry, you don't need to know the particulars to see that they're not the same thing. Same 316 family, true, but little differences can mean a lot when metal is going to be left inside your body.

"'Medical', 'Surgical', or 'Implant' Grade Stainless"

This alloy is used for all of those things, but these terms are meaningless beyond that. A number of stainless steels are used in the medical industry. Never buy anything called 'surgical stainless' or 'implant grade' without specifying exactly what alloy you need.

"ASTM F138"*

Now we're getting closer. ASTM specifications lay down the industry accepted 'law' on what a product should be, and what it should be capable of. Just as "AMS" specifications are important to the aerospace industry, the ASTM "F" series of specs include a number of specifications that are particular to the medical market. ASTM F138* sets requirements exclusively for this one alloy and calls it "Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" right in the header. This is what ties the UNS number (which is for reference only) to the 'medical grade' that you require.

But what about the "VM"?

Interestingly enough, vacuum melting is not required. Nowhere in the specification does it mention or refer to vacuum melting. You can do whatever you want to the steel to get it to the standards of ASTM F138 *. The only way anyone knows how, though, is through an initial vacuum melt and then a remelt.

I'll get more into remelting techniques in another article (it's really fascinating), but the short story is that first the alloy is melted in a process called Vacuum Induction Melting (VIM) and then is either remelted using Vacuum Arc Remelting (VAR) or Electro-slag remelting (ESR). Done correctly, either method of remelting will get you to a product that is considered safe enough to implant into the human body.

Order it by name

So whether you call it 316 LVM', '316L Vac Melt', 'Medical grade stainless', or 'Implant Grade Stainless'...what will always get you what you need is "UNS S31673 certified to ASTM F138".

And don't forget...

ASTM F138 has specific tensile and yield requirements for what it calls "Annealed", "Cold worked", and "Extra-hard". These terms might not mean what you think they do. In this case they aren't referencing a process, they're setting what you might normally think of as a "type". In the spec it's referred to as a "Condition" and is included in the information that 'shall' be named in inquiries and orders. It's always safest to include, at least, a minimum tensile strength on your purchase order. Better yet, refer to a min-max range on your request for quote and again on your PO. It's what the pros do.

 

*ASTM F139 for sheet product

430FR "Solenoid Quality" stainless steel rod is specifically formulated and treated to be used as the inner shaft of a linear solenoid.

Solenoids are, at heart, simple machines. You can make one yourself using copper wire, a drinking straw, a battery, and any magnetic metal. You can even use an ordinary nail for the shaft (or armature, as it is known). Coil up the wire around the straw, put the nail inside and attach the two loose ends of the wire to a battery. That's it. Watch the nail move in and out of the straw as the electrified wire creates a magnetic field that attracts or repels the shaft.

Just as all digital data is stored and transmitted in ones and zeroes, ons and offs, linear solenoids begin with such simplicity. The armature is either moving in or out based on whether or not current runs through the wire. It moves in one direction or another based on the polarity of the magnetic force. Imagine the possibilities of that simple motion, though. Digital data can be used simply to tell you what time it is, or it can be used to beat humans on 'Jeopardy'. Solenoids can be used to lock the door of your car, or they can be used to control a person's blood flow through a kidney dialysis machine. Or to play beautiful music on the new Steinway Spirio grand piano.

Any magnetic metal will work in a solenoid for demonstration purposes, but for a real-world application the choice of metal alloy is very important. 430F and 430FR stainless steels are used most often in the solenoids we use in our daily lives.

The ASTM A 838 standard covers "free-machining ferritic stainless soft magnetic alloy produced or supplied expressly in cold-finished bar form for use in magnetic cores and other parts requiring a high permeability, low-coercivity stainless steel".1 The spec defines two chemical compostions as "Alloy Type 1" and "Alloy Type 2". Type 1 corresponds to 430F and Type 2, 430FR. Generally our customers ask for "430F" or "430FR Solenoid Quality" and then refer to the ASTM A838 type. It's interesting, though, that A838 does not specifically name one type or another as 430FR. When ordering material, it's best to insure you specify the 'type' and also, the 'grade' within the type. 'Grade' refers to the annealing and drawing processes. Both have an important effect on the consistency of magnetic properties.

430FR has became the 'go to' alloy of the two. It's increased silicon content makes it slightly harder and more able to withstand the repeated impact solenoiods are subject to. When properly annealed, at the mill or after your parts are machined, it has very stable bar to bar magnetic properties. Combined with it's ease of machining, these characteristics have made 430FR the alloy we've chosen to stock for job shops that are machining solenoids.

Our 430FR round bar is certified to ASTM A 838, Alloy Type 2 Grade 1. It is produced by the finest DFARs compliant mills, including Carpenter and Schmolz + Bickenbach.

If it's 430F that you need, we also stock a good range of round bar sizes.

Short Facts:

  • The higher percentage of silicon in 430FR (compared to 430F) ups the electrical resistivity, hence the 'R' in 430FR.
  • ASTM A 838 only covers material between .250" and 1.625" diameter. This is because anything larger or smaller cannot hold the specified low coercivity when mill annealed.
  • The specification also states that if material is supplied from different heat lots, it must not only be identified separately, but must be packaged separately.
  • To avoid confusion, it is stated in A838 that all purchase orders must refer to the Alloy Type and Grade when ordering.
  • There is 430FR and 430F in the metals distribution network that isn't certified to A 838, but instead covered by ASTM A 582. This material can be used for any purpose.
  • "Soft Magnetic" is the term used for metals that can be quickly magnetized and demagnetized. Metals that hold magnetism for a long period of time are called "Hard Magnetic".
  • The "F" in 430F and 430FR refers to 'free-machining'. It forms small chips when it's machined. These fall away from your tools so the waste metal doesn't clog up your machine.

1 ASTM International

Tungsten is known as one of the toughest elements in nature due to its density and high melting point. Coming from the Swedish language meaning "Heavy Stone", Tungsten was discovered in 1781 and was originally used by the Chinese to make and color porcelain. Today, Tungsten is produced as powder, and then pressed and sintered into near net shapes. Parts are then machinable and have physical properties similar to high grade steel.

Tungsten is 50 percent heavier than lead and twice the weight of steel. Typically, this heavy metal is used to increase strength, hardness, elasticity and tensile strength. Additionally, Tungsten is most often alloyed with Copper, Nickel and Iron for various applications. Some applications that Tungsten is used for include ordinance components, high temperature tooling, radiation shielding, aircraft components, jewelry and brain sensor implants. This small sample of applications shows the versatility and dependability of Tungsten as a metal alloy. 

Want to get a quote on Tungsten? Click here.

What is the DFARS Specialty Metals Clause?

The Defense Federal Acquisition Regulation Supplement, better known as "DFARS", is an enormous and far-reaching document. As part of the even larger 'Federal Acquisition Regulations' it covers things like how a Department of Defense purchasing contract is written, negotiated, awarded, and paid for. It's an important set of guidelines designed to protect the political interests of the United States. DFARS is aimed at keeping money and quality control in the hands of our friends, and away from threats to US interests.

For instance, you are probably aware that Cuba has been recommended for removal from the list of states that sponsor terrorism. That list is contained within DFARS clause 252.209-7001 "Disclosure of Ownership or Control by the Government of a Terrorist Country".

In our industry, the supply and fabrication of metals, we're concerned with one single clause; DFARS, 252.225-7014 "Preference for domestic specialty metals". This clause was added in 1973 and amended as the world around us has changed. It provides specific rules about what's considered a "specialty metal", and which countries those metals must be melted in.

The Purpose of this DFARS clause.

Sometimes it seems like this clause can get in the way of fulfilling your customer's order or finding the lowest price on metals. At that point you're probably viewing it as 'government red tape' and wondering why it is even important.

The purpose of the specialty metals clause, (and the spirit of its forefather, the "Buy American Act") is to insure that in the worst of times we have an adequate industrial base to make the defense of our country, and our allies, a reality.

That makes paying more for domestic titanium a little easier to swallow when you're tempted to maximize profits by using Chinese titanium.

What is a "Specialty Metal"

The clause lists both base and alloying elements and what quantity of these elements can be incorporated into steel and the other "specialty" metals. Unless you have an ASTM or AMS specification or a mill test report in front of you, however, it can be confusing as to what specific alloys it applies to. You could read the clause whenever you need to buy an alloy, or you can use this list as a general guideline to the DFARS compliant alloys M. Vincent & Associates sells.

Stainless Steels

  • All 300 and 400 series stainless
  • 15-5 PH stainless
  • 17-4 PH stainless
  • 13-8 MO stainless

Titanium

  • Commercially pure grades 1, 2, and 4
  • 6AL-4V (Grade 5)
  • 6AL-4V ELI (Grade 23)

Nickel Alloys

  • Nickel 200, 201, & 205
  • Nickel Alloys 400, 405 and K-500 (Monel® family of alloys)
  • Nickel Alloys 600, 601, 625, 718, & X-750 (Inconel® family of alloys)
  • Nickel Alloys B-2, C-22, C-276, & X (Hastelloy® family of alloys)

Cobalt Chrome Alloys

  • MP35N
  • L605
  • CoCr20Ni15Mo7 (ASTM F1058, Conichrome®, Elgiloy®, Phynox®)
  • 28Cr-6Mo (ASTM F1537, BioDur® CCM Plus®)

Other Alloys

  • Nitinol
  • Invar®
  • Kovar®
  • Zirconium


Note that DFARS doesn't apply to the copper alloys we sell. It's a common practice of machine shops to include a "DFARS Required" statement on all purchase orders. If DFARS doesn't apply to the purchase, we may ask for an exception before the purchase order is accepted.

M. Vincent & Associates Can Fulfill Your Requirement for DFARS Compliant metals.

Our DFARS relevant alloys are melted in the United States, Germany, Sweden, France, Italy, Slovenia, and the United Kingdom. We do not purchase materials from China or other countries that are not on the list of qualifying countries. We feel that this insures that our customers get the best quality alloys. It means that when you buy from us, you can rest assured that you'll receive materials that won't come back to haunt you later.

UPDATE: Japan and Slovenia have been added as "Qualifying Countries" as of August 2016.