Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

Compliance with high-quality standards is a non-negotiable performance parameter in the Pharmaceutical and Medical Device industries. In 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485 implementation into BIOMAPAS Quality Management System was initiated. We discussed the influence of current changes on the whole company and its quality management with Egidija Pauriene, MD, Quality Assurance Director.

When Biomapas obtained ISO 9001 standard certification for the first time? What was the main reason for implementing it?

E.P. In 2012 Biomapas was certified by ISO 9001 for the first time. The company was experiencing stable growth and we felt the need to keep pace with advances in quality and technology. Therefore, in 2011, our company started upgrading our Quality Management System (QMS) in order to obtain the ISO certificate. With year-on-year growth, the business requirements for services were more demanding. Also, regulatory framework requirements were changing at that time, so the implementation of the ISO standards helped us to meet clients’ expectations and deliver high-quality services. We were certified according to the ISO 9001:2008 in 2012 and re-certified to the latest version of ISO 9001:2015 in 2016.

Why was it decided to implement an additional ISO 13485 standard, specifically for medical devices?

E.P. Since we are providing full-scope services for medical devices and are experiencing an increasing number of projects in this field, obtaining this certificate was an organic, natural consequence. The medical device industry is one of the biggest industries in healthcare, driven by innovation and new technology. The medical device market is still growing tremendously, so to keep pace with growing quality requirements, it was decided to obtain the ISO 13485 certification.

How long did it take to prepare for the certification of the new integrated ISO 9001:2015 and ISO 13485:2015 standards? What are the main changes in the whole Quality Management System of the company?

E.P. The company started to prepare at the end of 2016. The ISO 9001:2015 requirements provide a strong basis of management system for business and support the strategic direction of the organization. Generally, ISO 13485 includes both ISO 9001 requirements and new medical devices and related services requirements. With the implementation of ISO 13485 a broader risk management system was implemented, staff training were programmes were updated with medical device-related regulations, quality plans and auditing programmes. Policies and procedures were reviewed and amended. We have also implemented process and service validation, performance, and conformance measures. However, it is an ongoing process. Over time, services and their monitoring can change due to a changing environment, new regulatory requirements, client and business needs. Our aim is to provide a consistent, compliant, and effective service that delivers business value.

Apart from obtaining the ISO 13485 certification, the previous standard version was updated from ISO 9001:2008 to ISO 9001:2015. What are the main changes in the updated standard?

E.P. There are numerous enhancements and changes in the new version of the ISO 9001 standard. Firstly, products are being replaced by products and services in the newest version of the standard. Also, senior management is obliged to take a greater active involvement in managing quality. Preventive actions were replaced by risk-based thinking and integrated into the section “risk and opportunities”. It’s important to mention that now purchasing or outsourcing is being replaced by external providers. What was missing in the past but was added in the current version, is the new requirement related to the context of the organization. The organization is required to demonstrate understanding of the influence on both internal and external issues that may affect its direction.

In what way is this integrated standard important for the company? How does it influence Quality Management? Does it give some added value to clients?

E.P. Adoption of a quality management system is a strategic decision for an organization. On a local or international level, the ISO 13485 certificate helps to improve the performance of services and widen market opportunities. When certified, organizations can demonstrate compliance with regulatory and legal requirements, as well as meet customer’s expectations more easily. It also helps the organization’s capability to address product safety and effectiveness. And of course, it allows the organization to obtain external recognition of conformity of the quality management system to accepted requirements. Therefore, it takes effort and time to prepare and to attain the certificate, however it most definitely gives the company additional credibility with potential clients.

Thank you for your time and an informative conversation.

Olivija Simkute

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