Our Team
Harpa Arnardóttir, owner & co-founder
For 20 years, Harpa has implemented and operated quality management systems in biotechnology, IT and medical devices internationally. Harpa has installed quality management systems at companies in Iceland, America and Canada, from small companies (10 people) to large companies (600 people). Fulfilling requirements like:
ISO 13485, Medical Device Single Audit Program(MDSAP), Australian TGA, Canada Medical Device Regulation, Japan's Pharmaceuticals and Medical Devices Act and MHLW Ordinance No. 169, FDA 21 CFT part 820, 2017/45 EU Medical Device Regulation, Swiss Medical Devices Ordinance (MedDO), UK MDR, General Data Protection Regulation (GDPR), Personal Data Protection and Processing Act (Act No. 90/2018), Medical Devices Act (Act No. 132/2020), ISO 9001, Act No. 46/1980 on Environment, Health and Safety at Work
Harpa has competed in team sports from a young age and has used those values when implementing a quality culture in companies, as well as when developing employees. She believes with all her heart that quality management is a team sport where everyone's strengths must be appreciated if the company is to flourish. That the projects are adapted to this strength of the staff with knowledge and training to achieve the best in a fun and tactical way for the benefit of the company.
Harpa's top 5 talents according to Gallup strengthsfinder
Achiever
Responsibility
Relator
Learner
Developer
Jenný Dögg Björgvinsdóttir, owner & co-founder
For more than 25 years, Jenný has worked to support companies and individuals in becoming the best version of themselves. She does it in a soft but determined way where simplicity is the guiding principle.
Jenný understands that each company and individual is special and meets their needs in a customized way.
She has always taught alongside implementation, consulting and audits of management systems, but teaching is one of the most enjoyable things she does.
Jenny loves to see her clients grow. She therefore finds solutions with them that enable them instead of freezing in the face of challenges and doing nothing, or doing too much and complicating things, which is all too common.
She emphasizes that work should be fun, so she does her best to make it a reality in her work.
Jenný has experience in audits, training, consulting, implementation and maintenance of quality management systems and quality systems according to standards such as ISO 9001, ISO 14001, FSSC 22000, ÍST 85, ISO 45001, ISO 17025, ISO 17021, ISO 19011, ISO 22716, ISO 13485 and MDSAP.
She has worked for most types of companies in most sectors.
Jenný is a fisheries expert to the core, but has added knowledge as needed over time, but most recently she became an ICF certified coach.
She is a scout and will always be a scout in her heart, as Jenný worked closely with the scout movement for more than 30 years.
Jenny's top 5 talents according to Gallup strengthsfinder
Individualization
Learner
Connectedness
Empathy
Developer