The Icelandic Blood Bank has a 25-year track record of successful development of quality care and is the leader in developing a quality system in health care. The blood bank has had a quality system certified in accordance with the management standard ISO 9001 since 2000 or for 20 years. The certification covers all activities of the Blood Bank in accordance with requirements set out in regulations of health authorities as well as international professional standards. The quality system is a keystone in the operation of the Blood Bank and ensures that it is in constant review for its usefulness.

The ISO 9000 series of standards is published by an international standards organisation, with the Icelandic Committee for Standardisation representing Iceland in these projects (https://www.stadlar.is/). ISO 9001 is a requirement standard and it sets out the essential requirements for quality systems. Requirements 9001 are general and can be applied to any organisation, regardless of type or size, or the products and services it offers. The principles of quality management are according to EN ISO 9001:2015:

• Focus on customers

• Leadership

• Activity of people

• Process approach

• Reforms

• Evidence-based decision-making

• Relationship management

The blood bank management and supporting processes are the keystones of production, making a whole, for an image. The figure shows that the requirements of the ISO 9001 standard cover the overall history of blood components, while other requirements cover only parts of it. Correspondingly, the cell and tissues are also applicable.

The operating environment of the Icelandic Blood Bank is complex and very demanding for quality and safety in its services and production. The importance of a quality system is unequivocal, as it makes it more transparent, more coherent and more homogeneous.

The certification of the quality system shall entail an external evaluation to determine whether the quality system meets the requirements of the relevant standard and whether it applies the defined procedures of the quality system. Visits by certification bodies are regular and enable the quality system to be maintained. If certification is accredited, it is ensured that the certification body meets certain conditions.

BSI is an accredited certification body and has carried out audits of the Blood Bank in accordance with the ISO standard. A certified quality system in the time of pandemic, the Blood Bank has been under severe strain in a pandemic year due to a new coronavirus (SARS-CoV2). Risks in the operations have been reviewed regularly as expected by the management system and controls put in place to reduce risk. Thus, the continuous operations of the Blood Bank have been secured.