By The Pro QC Quality Assurance Team

What is the EUVFTA?

Signed into effect by the European Parliament and Vietnam at the end of June 2020, the EU-Vietnam Free Trade Agreement (EUVFTA) is both a trade agreement and an investment protection agreement that offers opportunities for trade, jobs and growth for both signatories.

According to the official European Union documentation, the agreement effectively tackles the following points:

• Eliminates 99% of all tariffs between the EU and Vietnam
• Reduces regulatory barriers and overlapping red tape
• Ensures protection of geographical indications
• Opens up services and public procurement markets
• Ensures the agreed rules are enforceable

The EUVFTA will not only protect labor rights and environmental concerns, but also aims to protect certain traditional European foods and goods from imitation through increased standards, regulations – and indisputable legal enforcement of these.

Key products being exported from the EU for example, include dairy – the 20% tariffs will drop to 0% over a five-year period. Other examples of rates that will fall to 0% over seven years are vehicles with current 78% tariffs, wine with current 50% tariffs, pharmaceuticals with current 8% tariffs, and chocolate with current 30% tariffs.

The opportunity for Vietnam exporters, according to Global Risk Insights, is a gateway into a US$18 trillion market. For EU investors looking at Vietnam, the move signifies an opportunity capitalize further on projects beyond traditional investment into heavy manufacturing and oil and gas. Sectors such as agriculture, pharmaceuticals and automobiles stand to gain in the long run.

So, what’s the Context?

Although the deal offers greater perks for European buyers, the US-China trade war and ongoing tensions between the two countries, have also spurred a deeper interest in Vietnam from US companies as well. Another element that has come into play more recently is the fact that Vietnam was able to control the impact of Covid-19 quite well, and with ardent screening and testing, managed to keep the country’s supply chains up and running efficiently. As a result, Vietnam has been one of the great resources for medical supplies and medical PPE for the rest of the world through this time.

Pro QC has been active in Vietnam for a couple of decades, and we have seen an uptick in business heading that way, with companies increasingly looking for alternatives to China over the past 12-18 months.

But what are the Challenges?

The most obvious challenge is of course, that Vietnam is not China.

While Vietnam does have relatively low costs for manufacturing and increasingly liberalized trade and investment policies, as well as a stable political system, which stand in its favor, unlike China the country depends on foreign inputs for production. It also has a much lower population, and Vietnam’s labor force is only 7% the size of China’s, which limits its ability to attract a larger number of firms looking for competitiveness with Chinese manufacturing. Another key point is that Vietnam has been successful with textiles, footwear and electronics, but it has yet to tackle electronics in the same way that China has done so successfully.

On the plus side, many of Vietnam’s factories are Chinese, Japanese and Korean owned, which means the logistical infrastructures are in-place to meet demand in the same way as it would be in the native countries of the owners. This makes Vietnam an interesting growth story to follow, especially as the EUVFTA really kicks into action.

Pro QC is well established throughout Vietnam, and we are here to answer any questions you might have on manufacturing there.

By The Pro QC Quality Assurance Team

What is ISO 9001:2015?
If you want to indicate that your organization has a functional quality management system, ISO 9001:2015 is the certification you need. The official ISO.org website says the steps a company takes to demonstrate its ability to consistently provide quality products and services that meet customer and applicable regulatory requirements, combined with the company’s aim to enhance customer satisfaction through the effective application of the system, are the core tenets of the certification.

ISO 9001:2015 is applicable to any organization of any size – whether it offers manufactured goods of any kind, or services.

Why do we need an ISO 9001:2015 certification?

The certification tells customers that the goods manufactured, or the services offered by the company they are looking to potentially be a client of, adhere to the best practices laid out by the official ISO 9001 quality management system guidelines.

It is very much a global standard, so anyone will recognize it anywhere in the world.

So how do you prepare for ISO 9001:2015 certification?

Getting an ISO 9001 audit is imperative to working through the journey toward being certified.

There are six key steps to achieving the ISO 9001 certification:

1. Understanding the ISO 9001 – classroom training on the standard and documentation review
2. ISO 9001 audit – conducted by a third-party audit company to complete an on-site gap analysis and suggest an action plan
3. Preparation of documentation – based on the results of the ISO 9001 external audit, the third-party audit company works with the team on necessary documentation and next steps
4. ISO 9001 implementation – committing the entire organization to effective uptake of a quality management system that adheres to the certification standard
5. ISO 9001 audit – as part of the requirements for the ISO 9001:2015, an internal audit review is required annually to demonstrate continued effectiveness of implementation of the quality management system at the company
6. ISO registration – before an organization can apply for an ISO 9001:2015 standard, evidence of consistency within the quality management system is required for up to six months; this is verified through a third-party audit

The process to complete the necessary steps can take up to nine months if starting from scratch. Proving consistency and verifying this through a specific audit is imperative to the process.

What are the challenges to getting ISO 9001 certified?

Preparing for the ISO implementation is often the hardest part of the process – aligning the company and having everyone fully onboard, defining the technical requirements, collating relevant documentation, and communicating the procedures to the entire company are just some of the challenges. Many organizations assign an internal representative or champion and often outsource the audit and facilitation to a third-party auditor who is familiar with the certification process and can provide unbiased advice to drive changes more successfully.

The ISO 9001:2015 quality management system is a core building block of an organization’s foundation. This means that each and every member of the team needs to be on board throughout the process and ensure that nobody flips back into old or bad habits. To ensure quality management system consistency is maintained, a third-party auditor can ensure quality management system gaps and the associated corrective action plan are managed to completion. This approach can help to ensure that ISO 9001 certification is just around the corner for your organization.

If you are looking for help with a customized plan for reaching ISO 9001 certification, Pro QC can help.

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.

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 16^th, 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.

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.

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.