Interview Jordi Ortiz – Quality Manager and Senior Consultant at GENESIS Biomed

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Interview Jordi Ortiz - Quality Manager and Senior Consultant at GENESIS Biomed

Jordi Ortiz: “We have designed the implementation of annual quality plans that will allow us to reach the standards required by ISO9001”.

Jordi Ortiz holds a degree in Chemistry (specialising in Biochemistry) from the UB and an advanced course in quality management from the UOC (Universitat Oberta de Catalunya). For 25 years he held different positions in both management and project management in the pharmaceutical industry, always in the R&D area (Sanofi, Ferrer and Spherium Biomed). He has extensive experience in biopharmaceutical development as well as in the field of autoimmune diseases, muscle recovery, ALS, oncological mucositis and acute kidney injury among others. Since 2019 he joins GENESIS Biomed where he currently holds the position of Quality Manager.

What part of your professional profile do you think you can contribute most to the position of Quality Manager?

Before answering the question, it is necessary to consider what the functions and characteristics of a quality manager are. A corporate quality manager, in my opinion, is a person with experience within quality management and operational experience in the company environment. He or she should have specific accredited training and personal skills. Apart from being responsible for ensuring that all the processes carried out in the company meet the standards set by top management, one of his main objectives would be to raise awareness at all levels of the company of the importance of implementing quality programmes. He is, therefore, an initiative-taking and experienced person in this field.

And to come back to the question, I am not sure that it is only one part of my professional profile that will bring the most to this new position. I prefer to see myself as a whole and with experience in most of the areas in which we move in the company. I would say that a quality manager is not the one who manages the quality of the company, but the one who enables the company to be managed globally with quality, with the participation of all its members.

Are there limits to the implementation of a quality system in a company? What are the limits?

There are never limits to quality management, there are always aspects that require improvement. The International Organisation for Standardisation (ISO) itself has modified the package of what we know as ISO 9000 standards on several occasions. The revision in 2000 was a major breakthrough as its focus shifted from quality assurance to quality management in the organisation. A clear focus on customer satisfaction and process management was introduced with a focus on continuous improvement. But once ISO 9001 is certified, a company should aspire to management excellence, which in Europe is promoted by the European Foundation for Quality Management (EFQM). EFQM defines the EFQM Quality and Excellence model as a way for self-assessment and determination of continuous improvement processes in private and public business environments. ISO 9004 would be the tool for promoting excellence in quality management.

Is it enough for a company to have a Quality Plan or is it advisable to be certified with an ISO9001?

One must always set oneself limits. However, I believe that in the long term it is always a good idea to show that what you boast about is recognised by specialists. With this in mind, we have designed the implementation of annual quality plans which, in our case, will enable us to reach the standards required by ISO9001.

GENESIS Biomed gives support in the creation of numerous start-ups, do you think there is also a need in this type of companies to receive support in the creation of a quality plan?

There is no doubt about it. According to the ISO 9000 standard of 2015 (“Fundamentals and vocabulary”), a quality plan is a specification of the procedures and associated resources to be applied, when they are to be applied and who has to apply them. A quality plan is documented information that specifies which work procedures and resources are associated and have to be applied in the process, who are the people who have to apply them and when they have to be applied to a specific project, product, process or contract. I believe that all companies should have these requirements clear in their day-to-day operations, no matter how recently they were founded.

What particularities of quality management apply to this type of companies mainly dedicated to R&D&I? Is the UNE 166002 Certification of R&D&I management systems necessary?

Research, Development and Innovation are still company processes. I also believe that they are extremely important or relevant processes in the company and that they are going to generate the company’s main assets. It would be very dangerous for the company not to manage R&D&I efficiently. There are companies that certify their activities with ISO 9001 and UNE 166002. Thus, for example, the scope of ISO 9001 certification would cover production, marketing and distribution. UNE 166002 certification would cover research, development and innovation in the production, marketing and distribution of the company’s products. However, it must be considered that most of our clients operate in the field of medical devices, where ISO 13485 must be complied with. Their R&D&I would be within the environment managed by this standard.