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IMSM: Certifying Medical and Laboratory Quality with ISO

Michael Bright | Founder & Managing Director | IMSM
Michael Bright | Founder & Managing Director | IMSM

Business growth requires more responsibility and accountability, but it also comes with the opportunity to experiment with new ideas, and incorporate better processes and technologies- that will help your customers achieve their goals. While some businesses innovate by overhauling processes to exterminate redundancy, others seek for certifications, patency, and trademarks as a form of validation; one of which is ISO Certification. The process of gaining ISO certification is, in itself, a way to improve your business. This makes it critically important to choose the right service provider, such as IMSM; they can help you every step of the way in obtaining your ISO certification hassle-free, and cost-effectively with long-term support. Their experienced IRCA-qualified assessors have a flexible approach that will help you to produce a set of procedures tailored to your business objectives.

Did you know ISO Certification can help you to identify risks, improve employee performance and place your brand in the spotlight for clients, investors, and stakeholders? This enables them to locate your company whenever they have a need for partnerships, products or services –including medical devices, clinical diagnosis, and others because they are sure to gain extra quality that meets their desire.

ISO certification is a merit-based seal of approval from a third-party body showing that a company runs to one of the international standards developed and published by the International Organization for Standardization (ISO). These standards are set rules of excellence across many industries. IMSM gives businesses that exhibit effectiveness and quality in various specialities ISO certification.

IMSM has a rich portfolio of over 25,000 organizations, leading in various industry sectors, who obtained their ISO certification through the guidance of their qualified and experienced IRCA assessors. IMSM also assist medical and clinical laboratories in obtaining their ISO certification, which is awarded to those organizations that demonstrate competency and diligence in fulling the legal and internationally standardized requirements set out for medical and clinical laboratories, amongst other industry niches. The company has a simplified, yet comprehensive approach to ISO certification designed to fit around the laboratories’ client’s business requirements and schedule. This approach is based on five key principles that enable a trouble-free journey in elevating the clients’ reputation:

  • Fixed fees, with no unexpected or hidden charges
  • Flexible Nature of ISO implementation as per the client’s business requirement
  • A highly qualified assessor is assigned to work one-on-one with the clients
  • Implementation of ISO framework based on the organization’s existing system
  • Provides full implementation to enable a trouble-free experience for ISO certification

IMSM’s Founder & Managing Director, Michael Bright, understands that the clients’ journey often begins with answering the question—What does success look like? Thus, he aligns IMSM’s business solutions with the client’s set criteria for success, regardless of what it may be.

To date, the company has supported over 5,000 organizations in attaining and maintaining ISO Standards in every industry. As for the business, IMSM is forever proud of its associations with the Chartered Quality Institute, the American Society for Quality and a five-star recognition from the European Foundation for Quality Management.

Let’s learn about IMSM’s operations in supporting its client’s journey to ISO certification.

Inception of IMSM

IMSM is an expert company, with 25 years of experience in demystifying and simplifying the route to ISO compliance. It is an international consultancy specializing in ISO standards with offices branched out in California, Chicago, and New York, typically in the SME market. “We have followed many of the critical developments in the world of standardization and, fortunately, have been able to play our part, via our incredible team, in shaping standards in several industries,” adds Michael.

Initially, IMSM’s CEO, Michael—ran several businesses before forming IMSM. When he was faced with a need to comply with a quality standard (previously BS5750), he knew that there ought to be a straightforward way to achieve it rather than the costly (both in time and money) routes that were available back then. Thus, at present, the company’s mission is aligned with similar objectives.

Michael is now approaching thirty years in the industry, and he finds himself fortunate to be supported by a loyal and professional team whom he continues to work with throughout the U.S. and further afield in Europe and Asia to improve IMSM’s standing in the market, client experience and overall expertise.

Key Services to ISO Certification

IMSM works across more than thirteen international standards. The ISO 13485:2016 (Medical Devices) standard is one particular area of expertise which applies to a range of businesses in the MedTech industry.

“We have continued to leverage our straightforward, consultant-led approach to implementing these standards,” says Michael. Clients at IMSM can tap into the significant experience held by its consultant team. Being qualified auditors, they hold a wealth of experience in the regulatory world, ranging from FDA to HIPAA. The company pairs this with additional standards that add value to healthcare clients, such as ISO/IEC 27001:2022 (Data Security).

Simplifying the Process of ISO Certification

IMSM ensures that the clients are satisfied with its services by leveraging the experience and personality of its consultants. This way, clients get clear direction, support, and the expertise required to get through the implementation and certification process.

“It is too easy (and unfortunately frequently seen) to hand over templates and come back in a few months. But we are there throughout the whole process and provide that needed leadership and hands-on support,” adds Michael.

IMSM has started and remained mostly as SME experts. However, given the success of its approach, the company has demonstrable experience with more significant concerns. All of this provides IMSM with a unique insight into how certification and regulations impact businesses as a whole. “Most importantly, we can take these learnings to continually optimize and simplify the process for our clients,” adds Michael.

Providing Assistance

IMSM recognizes that businesses always look at their internal resourcing and can often feel that they are up against a wall. In response to the dilemma, IMSM acts as a fractional resource there- taking the hands-on responsibility for maintaining the various standards for the client and working with them on an ongoing basis. It ensures that they not only remain compliant but also continue to gain value from holding these standards. The company operates with great agility in this field and can easily and quickly create a support package for our clients.

In addition, the company works closely with the client’s needs and helps identify the best digital tools to use. IMSM has been at the forefront of things like remote auditing and remote consultancy for quite a while now.

Words of Wisdom

To the budding entrepreneurs who desire to venture into the industry, Michael advises, “For me, it has always been about the customer—anticipating and, occasionally, reacting to their needs. We have to be an advocate at all times for our customers and the increasing regulatory frameworks they’re required to abide by. My team and I are, therefore, always putting ourselves in their shoes and finding the best way of getting them through the process, using the experience built up. Other than that, I would say ensure you are delivering value at every level and every customer touch point possible.”

Looking Ahead—2024 and Beyond

For IMSM, it is always about a forward-looking perspective. In addition to growth within its existing markets, the company is always looking ahead at additional standards, industries, and needs.

Right now, the IMSM team is looking at the range of challenges that their client base face and continue to look at how they can support them through the use of ISO Standards—everything from climate change, energy, and supply chain disruptions to data security and the future of work.

ISO and Medical Laboratories

We offer knowledgeable ISO guidance and standard implementation that can be especially suited to your organization’s requirements. For instance, ISO 13485:2016 is focused on the tools and equipment used in medical labs. You are ensuring quality in the production, safety, and delivery of medical devices all over the world by implementing ISO 13485:2016. More specific ISO standards for medical laboratories that we provide include:

  • ISO/IEC 17025 – Laboratory Competence
  • ISO 22716 – Cosmetic GMP
  • ISO 15189 – Medical Laboratories

Different ISO standards can be combined and put into practice alongside one another while operating harmoniously. You can implement an ISO management system tailored to your industry’s needs, making it easier and more efficient to become ISO certified.

Organizations in the medical and laboratory fields know how vital it is to adhere to the evolving laws and regulations demanded of them in their sector. As science and medicine advance and discoveries that alter the way we do things are produced, the standards of these laboratories and medical labs will only rise.

Businesses can improve their quality and adherence to legal regulations by seeking consultation for ISO with IMSM, where we make the ISO implementation process easy to follow for organizations.



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