Five Things you should know about ISO 13485

By The Pro QC Quality Assurance Team

1. Why ISO 13485?

ISO 13485 is the global international standard for establishment and maintenance of a documented quality management system in the medical device industry. If a manufacturer has implemented ISO 13485, it will have a foundation upon which to certify for regional medical device regulations such as the EU Medical Device Directive (MDD), the EY Medical Device Regulation (MDR), US FDA 21 CFR 820, as well as other regulations that demonstrate a commitment toward the quality and safety of medical devices.

ISO 13485

2. COVID-19 highlights sanitation requirements.

Manufacturers of medical devices and medical products should consider prevention of risk of contamination of the device during the production process. Sources of contamination come not only from incorrect handling of the devices by people, but also from a list that includes raw materials, airborne particles, and dirty machines, among other things.

On April 16th, the International Organization for Standardization (ISO) published an updated standards list for PPE and Medical Devices, as part of their COVID-19 response effort. These product standards define guidelines for the manufacturers to follow to ensure a proactive role in the fight against the spread of the virus.

3. What is required for ISO 13485 certification?

To ensure medical products will pass certification, here are the key objectives the project should follow:

  1. Define the scope– What is the medical device, and what is its purpose, intended market, classification? What is the collection related ISO product standard, and what are the regional regulations for this product?
  2. Conduct an ISO 13485 Audit & Gap Analysis– This is an audit that determines the level of compliance versus the standards that are being held.
  3. Develop a project plan– After the audit and gap analysis, define a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 requirements and related regional standard implementation.
  4. Develop documentation– Put together the mandatory documentation that includes a Quality Manual, procedures, work instructions and documentation with evidence of proof of implementation.
  5. Develop & conduct training– This is one of the most important steps in this checklist. Provision of training to anyone who will be involved in any stage of the production of the medical device is mandatory. The first training educates the team on applicable requirements of the ISO 13485 standards, including those relevant to regional and product certifications. The next training is to set in place a Quality Management System that provides a standard for complying with work instructions and necessary sanitary procedures, as well as recording of proof of implementation on specific documentation.
  6. Implementation– A period of three to six months is given to implement the new Quality Management System and preparation of documentation to demonstrate compliance.
  7. Conduct an internal audit– The supplier should conduct an internal medical device audit to measure compliance and correct any noted deviations. This internal audit can also be conducted by a third-party auditor, such as Pro QC.
  8. Conduct a management review– If the Quality Management System is not implemented according to ISO 13485 procedure, and does not meet the defined policy and objectives, it must be adjusted to meet the necessary requirements.
  9. Apply for ISO certification– An external audit of ISO 13485 is the final step. This external audit is typically conducted by certification bodies. Based on the readiness of your organization, the certification body will issue the ISO 13485 certificate if you pass, or issue a non-conformance report that will require corrective actions. In the case of a non-compliance, Pro QC can advise and assist the applicant in implementing and validating those corrective actions. Once all non-conformance items are closed, the company can then re-apply for certification.

4. What goes into the external ISO 13485 audit?

When Pro QC goes into a factory to conduct an audit, we have a specific checklist to follow that helps us make sure the manufacturer is following correct procedure. Our technical supervisor comes in to train the on-site auditor (if there is one), to ensure that there is a complete understanding of the ISO 13485 compliance requirements.

5. What are the common pitfalls associated with ISO 13485 certification?

Being ISO 13485 compliant requires being detail oriented. Pro QC has seen a number of common pitfalls in the road toward compliance, including a lack of control for the medical device file (clause 4.2.3), an insufficient record for each medical device or batch that provides traceability (clause 7.5.1), and others. It’s important to follow the steps and ensure you conduct either an internal or external ISO 13485 audit in order to prevent any holdup in manufacturing and shipping your medical devices.

Pro QC is here to help. Please contact us at info@proqc.com, or reach out to one of our offices directly by clicking here.

A free, read-only version of the ISO 13485:2016 standard can be accessed here.

How to keep your supply chain running when you can’t be on the ground?

By The Pro QC Quality Assurance Team

Covid-19 has undoubtedly had a major impact on the supply chain. Over the past few months, factory production has either been completely halted or slowed down considerably in most of the world. But now, as things start to get back on track and we look ahead, how do you get your supply chain back on track and fully functional when nobody can actually visit factories to make sure they’re operating in the way they should be? How do you get a factory audit done?

Under normal circumstances, one of the best ways to make sure your factory-partner is on track, is to go visit the supplier yourself. And when you need to check out a new factory or supplier, it’s an easy-call to get someone into the factory to conduct a supplier verification.

Factory Audit

However, normal circumstances may not apply for some time to come. Despite government restrictions slowly releasing around the world, it’s going to be difficult for many people to get back to travelling and conducting business the way they used to, as health hazards are likely to keep borders closed for a while longer.

Everyone is having to do things a little differently now, but we don’t want that to get in the way of how you keep your business moving. Pro QC can help you keep your company functioning smoothly.

With people on the ground in over 88 countries, Pro QC leverages not only extensive global ground-spread, but also extensive knowledge of local suppliers and existing relationships with many factories around the globe. We leverage our expertise across industries, with specialized teams set to help you manage quality control on everything from medical devices and medical personal protective equipment to automotive components to electronic chips to socks and other softgoods and apparel.

Our true talent, however, lies in how we manage our own chain of disciplines – we can help you handle everything from supplier development and supplier audits to everything related to meeting vendor compliance standards. And you don’t even need to be on an aircraft to visit your supplier.

With it becoming increasingly difficult for anyone to actually physically visit factories due to health concerns or local government regulations, Pro QC decided to take our skill set one step further. We created a remote supplier verification service, which enables us to leverage our factory relationships and simultaneously continue to conduct a supplier verification through a remote audit.

With a 24-hour turnaround, we request very specific photo evidence of factory floors and certifications from the suppliers, and also utilize our existing relationships with contacts in individual regions to assess the legitimacy of the vendor and how they are working to get a genuine, good quality product across to our clients.

As Covid-19 continues to throw new curveballs at all of us, Pro QC wants to make sure your essential products and services continue to be manufactured at the highest quality and delivered in the fastest speed possible. We are constantly innovating our third-party audit capabilities and increasing our remit of light-touch audits that can be conducted remotely.

Get in touch with us to find out more about how we can help lend our quality services to keep your business moving in these unprecedented times.

Making Sure Your Personal Protective Equipment Suppliers are Verified

By The Pro QC Quality Assurance Team

With the critical importance of personal protective equipment and a rising number of scams worldwide, Pro QC recently launched a quality assurance and quality control solution specifically for the medical device and PPE segment. This could not be an ordinary service, as the environment in which it was launched has been far from ordinary. Here’s a little about what we’ve learned, and how we’ve tweaked it along the way, to help you better verify suppliers

Medical PPE

Where does our demand come from?
Most of our inquiries so far have come from China, Turkey, and Cambodia – a hint that suppliers are ready to take on the challenge of getting PPE production back on-line, efficiently.

Getting around travel restrictions

We launched a remote service to help identify high-risk suppliers, as travel restrictions have been a major challenge for much of the auditing process. The remote service has been extremely successful – it gives us the flexibility to schedule audits for the next day, and coupled with the tight regulations on supplier submissions of photo evidence, we have reduced risk of fake photos being sent in by the factories. Our in-office product certificate validations are able to quickly identify potentially fake or invalid certifications.

Scams are difficult to spot

Many factories selling PPEs are registered FDA (for the United States), or CE (Europe) compliant, as Personal Protective Equipment – however, the fine-print specifies these items are not for medical purposes. The factories will try to sell the product to the client as medical devices, but the packaging will not reference medical use, as they are not intended for that purpose either.

Additionally, despite the fact that governments are encouraging medical PPE manufacturers to return to working functionality (and most of these, especially in China, are running smoothly), we do warn clients that many non-experienced factories are purchasing PPE production equipment to set up small face-mask producing operations. These are usually non-compliant, so fall squarely into the scam bracket.

Is this service going to go away after COVID-19 is over?

We estimate the need for medical PPE equipment will be part of our “new normal” for a long time to come. What we’re here to do is make sure we can help clients identify manufacturers trying to sell them the wrong product – for example, face-masks for industrial (for chemical factories) and medical face-masks are quite different. The standard used for particles allowed to penetrate the mask surface, as well as the production and sterilization needs under specific environmental conditions, are dissimilar for industrial and medical purposes, but certain manufacturers will illegally try to sell it as the same product. Pro QC wants to ensure clients avoid these situations.

A Sticky Situation

Pro QC recently had a client who came to us with a rush purchase order for 500,000 medical face-masks. A supplier had quoted them US$0.62 per unit for KN95 masks. The current market price for KN95 masks is around $1.90, so the pricing seemed suspiciously low. Our clients needed to get back to their customers with a final quote on the per price masks within 24-hours.

We took on the challenge and were able to schedule a remote supplier verification for the next day. The supplier submitted photo evidence as requested, and since the masks were being sent to the US and Germany, they also submitted relevant FDA and CE registrations.

On closer inspection, we found that while the supplier’s FDA registration was verified in the FDA Establishment Registration & Device Listing, we found that the masks they were verified for were for industrial – rather chemical lab purposes, and would not have been suitable for use in any medical context. The CE registration was marked in the official registry as “Fake or Invalid”.

As the situation was high-risk – it would have been a great loss to our client if they had purchased from this particular supplier, as the masks would have effectively been garbage-on-delivery – our team quickly delivered the report the same day the verification checks were conducted. (Our usual practice is within 24-hours of assignment completion).

When the client called Pro QC to personally thank the team for catching a potentially catastrophic decision in its tracks, we were pleased to have been able to help.

Pro QC’s teams are located around the world and have significant experience in working with suppliers across the medical PPE Industry. Get in touch if you need us to work with you to prevent supplier-fraud, and have your medical PPE supplies delivered as quickly and hassle-free as possible.

Manufacturing Medical Devices during COVID-19? Know this…

By The Pro QC Quality Assurance Team

COVID-19 has turned up a number of challenges for the entire world, the global marketplace notwithstanding. However, one of the most pressing demands on the supply chain at present is a need for medical devices to help hospitals cope with enormous numbers of coronavirus patients. But how do parties ensure they are getting a quality product?

Inevitably, the coronavirus has posed several quality challenges for medical devices as well as medical products – due largely to the rising number of scams as people try to take advantage of the urgent need for quick production. At Pro QC, our auditors and inspectors have found several cases where the marketed product is not what it claims (e.g. industrial masks proclaiming to meet medical standards) or, in a worst case, not being produced at all.

Medical Device

Under normal circumstances, top producers for medical devices were China, Hong Kong, Taiwan, South Korea, India, and Vietnam. The main exporters in USD value terms were the United States, Germany, Netherlands, Mexico, China, Belgium, Ireland, Japan, Switzerland, and France.

However, with coronavirus lockdowns and major supply chain disruption ongoing around the world, exporting medical devices from countries such as Italy, France, Spain, the UK, and Belgium is almost impossible. While China has typically been first in terms of number of medical device shipments, it has only been fifth in terms of value for that particular market – this is an important note as despite the fact that China is opening up in terms of production, the likelihood of scams in the market is higher there as producers have not typically been as well versed in medical equipment production.

So, alternatives include looking at countries including Vietnam, Taiwan, South Korea, Germany, Hong Kong, Japan, Thailand, Singapore, Mexico, Brazil, Malaysia, and Sri Lanka.

However, medical devices and medical supplies are one of the most stringently regulated products on the market. Not only is it imperative to ensure the supplier is legally registered and has a declaration of conformity for its medical device product, but also that the product complies with market regulations (i.e. The FDA, CE, etc.).

Whether you’re new to medical device procurement, or an old hand, given the unusual COVID-19 circumstances, Pro QC recommends starting at the very beginning to get started: check in with your local customs agents regarding the medical device import process, and make sure you are fully informed before taking next steps.

Make sure any supplier you engage with provides you with relevant certificates for the market you intend to supply to. For the EU and UK market this is the ISO 13485 certificate, business license and CE certificate for the product you intend to purchase, and for the US market, you will need an ISO 13845 or GMP for Medical Devices certificate, FDA factory registration certificate, FDA product registration certificate, and business license for the product.

We know that in this critical period of COVID-19 sometimes the speed of the purchase has a life and death criticality and speed of procurement is of utmost importance. If this is the case, we suggest to conduct a COVID-19 Supplier Verification. If we identify the supplier as low risk, you can then proceed onto next steps in the procurement process; however, we do not recommend you continue to engage with a high-risk supplier. In certain instances, Pro QC might even be able to conduct a remote audit to speed up the decision making.

Ensure the supplier confirms that they are able to export to your market, and make sure everything is confirmed in writing through contract and email. In this time of coronavirus it may not be possible to meet the supplier in person, so we suggest you conduct a face-call over a zoom chat or face-time in order to make sure you are dealing with a knowledgeable manufacturer, and not a scam-artist. Again, Pro QC can help with remote audits or verifications if necessary.

After making a purchase, we highly recommend conducting a product inspection of your medical device. This can either be a first-article, in-process or pre-shipment inspection and Pro QC is specialized in each worldwide. This will minimize risk and raise any red flags as to the product quality and whether the medical products have the relevant certificates from their supplier.

Above all, make sure you keep yourself well informed and up to date on constantly changing rules and regulations regarding shipments for medical supplies.

Pro QC is experienced in COVID-19 Supplier Verifications and Audits. Get in touch with us to see how we can work with you to get urgent medical device shipments well on their way to market.

 

To Avoid Fake Suppliers, Keep This Checklist Handy

By The Pro QC Quality Assurance Team

Last week we discussed avoiding fake suppliers and scammers when sourcing medical personal protective equipment (check out that article here: Avoid Fake Suppliers of PPE & Scams).

This week we’re taking you through the checklist you should have on hand when investigating a supplier for sourcing any product. Any of these points should raise red flags as to the authenticity of a supplier.

Fake or Real

  • The website design looks unfinished, there are many spelling errors
  • The ‘About Us’ and ‘Contact Us’ sections of the website do not contain the full company details: registered company name, address, phone number, and email)
  • The website indicates that the manufacturer is selling several categories of branded products, all listed on a single page
  • The website domain name contains the words ‘genuine’, ‘replica’, ‘original’
  • The website domain name is linked to anything stating an offer or discount
  • There are no return policy, terms & conditions, or privacy policy stated on the website
  • The price of the products offered by the supplier are too low compared to average market prices
  • The manufacturer does not appear on a Google Map search, or it does appear but has been added very recently
  • There is no official registration for the company name in the country it is in

If you are in any sort of doubt, and need help to spot a scam, Pro QC can help. Get in touch with us today to find out more.