GAB Consultancy
ISO Certification Made Simpler

The regulatory landscape for medical device manufacturers is fast changing. With the overall healthcare industry becoming more patient-centric, the governing bodies like ISO are issuing a multitude of operational and functional standards to protect the best interest of medical device end-users, i.e., physicians and patients. In this regard, some of the most prominent standards issued today by ISO include healthcare industryspecific quality standards ISO 13485, environmental safety standard ISO 14001, and occupational health and safety standard OHSAS 18001, on top of the baseline ISO 9001 quality management certification. Only when medical device manufacturers and OEMs comply with this ever-growing volume of standards will they be able to bring true value-based innovation to care delivery.

However, despite every medical device company understanding the importance of these additional certifications in upholding patient and physician safety, the progress seen in going through with the certification process is meager. Why, one may ask?

There are two major roadblocks that complicate a medical device company’s ISO certification process. First and foremost, many businesses lack the knowledge and understanding of the new ISO standards and their different audit processes. “Traditionally, they only had to comply with ISO 9001 certification, and it used to be a one and done audit process. So medical device manufacturers and OEMs naturally did not have a dedicated team with substantial knowledge for ongoing ISO certification processes,” opines Wesley E. Brower, vice president of GAB Consultancy and a renowned ISO/aerospace (AS) consultant. Such businesses now find it overwhelming to comply with all the new ISO certifications while maintaining their other daily operations. The second roadblock arises when these businesses try to streamline the ISO certification process by opting for an off-the-shelf audit management software. “Even though the software solutions look simple to implement for achieving ISO compliant processes, the reality is different,” Brower adds. One would still require the knowledge and understanding of different ISO audit processes to collate and prepare their operational documents according to these regulations. Moreover, since no two medical device manufacturers and OEMs follow the exact same operational processes, each organization’s documentation needs to be tweaked, adding extra steps, which again need niche domain knowledge.

Fortunately, this is where Brower’s company, GAB Consultancy, has been able to make all the difference. As a renowned ISO consulting firm that has worked with different businesses across the aerospace, medical devices, and production sectors, GAB Consultancy is helping its clients’ optimize the current ISO certification workflow in such a way that it fills in the knowledge gaps and hastens the entire process without the clients’ needing to change existing ISO audit management tools or overcomplicating the endeavor. And how do these capabilities ultimately benefit GAB Consultancy’s clients? “Contrary to the misconception that it can take more than a year to achieve ISO compliance, with our streamlined implementation approach, businesses can complete the entire certification process in as little as a few weeks,” claims Brower.

GAB Consultancy’s Approach to ISO Implementation

Typically, GAB Consultancy starts its partner engagement with a gap analysis and a preliminary internal audit to assess the client’s specific roadblocks in attaining different ISO certifications. “This allows us to both learn about their organization in general and find out where they may need to optimize their existing tools or processes,” shares Brower.

GAB Consultancy then develops the initial quality management system documentation by incorporating all the policies, processes, and procedures following alignment with ISO requirements, and in line with their existing workflows. At this time, GAB Consultancy additionally generates the organization’s quality manual, which serves as a top-level document outlining the ISO compliant quality management system. GAB Consultancy then performs a final audit and presents its findings to the client with a checklist of steps and actions they need to take for optimizing their ISO certification processes even further, which, once completed, will ensure a smooth certification for the client. It is also important to note that since GAB Consultancy follows universal best practices prescribed for ISO audits, the company can enable its clients to take the same documentation and tweak it to meet the audit criteria of multiple certification processes at once. “So if an organization chooses to opt for multiple ISO certifications, we can easily incorporate the additional requirements associated with the new standards and allow them to transition seamlessly,” states Brower.

What’s more? In addition to such end-to-end ISO certification and implementation support, GAB Consultancy also provides a few ala carte services, including annual internal audits, general documentation review or generation, and audit liaison. GAB Consultancy acts as a mediator and answers questions for its clients when the audit committee brings up any concerns. “We want every single company that uses our services to ultimately achieve ISO certification. We’re going to be there at every step of the way until they eventually reach that goal,” says Brower.

Going a step forward, GAB Consultancy also offers its clients training modules developed by Brower’s father and founder of GAB Consultancy, Greg Brower, on different aspects of ISO certification as well as quality management, in general. “Greg has personally been trained by some of the leading names in the ISO arena, namely Edward Demings and Philip Crosby, which has influenced the internal development of training modules on topics such as root cause analysis, corrective actions, the ‘Five S (5S)’ methodologies of quality control, and more,” states Brower. Combined, these training modules and consulting services minimize GAB Consultancy’s clients’ overall time and expense in procuring ISO certification and help them compete locally, nationally, and internationally. But these rich offerings of GAB consultancy are not just limited to the medical devices sector alone. The company offers its bestin- class ISO consultancy services to businesses from other verticals as well.

One such example is a GAB Consultancy client who operates in the power converting industry. This particular client contacted GAB Consultancy at an early stage of their journey to become ISO 9001 certified. With the help of GAB Consultancy, the client implemented their basic quality management system. Since the operational best practices and the baseline standard prescribed by GAB Consultancy were suited for other certification processes as well, the client could continue to grow its businesses by complying with all the newer ISO standards.

Moving ahead, with many similar success stories under its hood, GAB Consultancy wants to continue focusing on its existing business processes and approaches. Nevertheless, as Brower shares, his company is also planning to implement a more streamlined and universal software-based solution that will be customizable for its clients’ specific operational flows. GAB Consultancy will provide this software to its existing clientele as a complementary offering. “With the release of this software, we are envisioning a significant leap from the current ISO compliant management software applications. The solution will not only enable us to turn our backs on outdated tools and move on to a more organized and future-oriented platform but also allow us to usher in a higher level of digitalization into ISO certification audits,” concludes Brower.