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 Pharmaceutical and Medical Device industries. During 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. Therefore, we have discussed about the influence of current changes to the whole company and its’ quality management with Egidija Pauriene, MD, Quality Assurance Director.


Egidija Pauriene, MD, Quality Assurance Director

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

E.P. In 2012 Biomapas has been certified by ISO 9001 for the first time. Company was stably growing and we felt the need to keep pace with advancement in quality and technology. Therefore, in 2011, our company started upgrading our Quality Management System (QMS) in order to obtain the ISO certificate. The company has been boosting the business every year, requirements for services were more demanding. Also, regulatory framework requirements were changing at that time, so the implementation of ISO standard helped us to meet client’s expectations and deliver highest quality service. We were certified according to the ISO 9001:2008 in 2012 and re-certified by newest version of ISO 9001:2015 in 2016.

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

E.P. Since we are providing full-scope services for medical devices and we experience a stable growth of projects in this field, obtaining this certificate was an organic, natural consequence. 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 move forward along 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 that supports the strategic direction of the organization. Generally, ISO 13485 includes both ISO 9001 requirements and new medical devices and related services requirements. With implementation of ISO 13485 more broad risk management system was implemented in the first place, staff training programs updated with medical device related regulations, quality plans, auditing programs. 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 changing environment, new regulatory requirements, client and business needs. Our aim is to provide a consistent, compliant and effective service that deliver 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 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 the quality. Preventive actions were replaced by risk-based thinking and integrated in to the section “risk and opportunities”. Important to mention that now purchasing or outsourcing is replaced by external provision. What was missing in the past but was added in the current version, is the new requirement related to the context of organization. Organisation is required to demonstrate understanding of the influence to both internal and external issues that may affect its direction.

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

E.P. Adoption of quality management system is a strategic decision for an organization. On a local or international level operations ISO 13485 certificate helps to improve performance of the services and widen the market opportunities. When certified, organisation can demonstrate compliance with regulatory and legal requirements, as well as meet customer’s expectations more easily. It also helps the organisation’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 company additional credibility with a potential clients.

Thank you for your time and an informative conversation.

Olivija Simkute