The increased complexity of PMD may potentially heighten the tendency for errors, as is in fact the case in all disciplines [6]. However, making mistakes in forensic diagnostics is essentially unacceptable and can have serious consequences. There are several ways to prevent and reduce PMD errors [7]. Quality Assurance (QA), which involves monitoring and evaluating various aspects of the diagnostic process to ensure that standards of quality are being met, emerges as a potential key factor. Moreover, some contend that QA programs in forensic pathology are no longer optional [7, 8].

Unfortunately, there is no specific “PMD-QA program” that addresses the three phases (pre-inspection, inspection, and post-inspection) of PMD. However, organizations such as the College of American Pathologists (CAP) and the National Association of Medical Examiners (NAME) have developed practical guidelines for a QA program in response to compelling research into how and why laboratory errors occur [7, 9].

Accreditation represents an external QA process wherein an organization or facility undergoes evaluation by an independent body, typically referred to as an accreditation body or agency. Within the European Economic Area, according to EU regulations, there is only one national accreditation body per country [10]. The accreditation process assesses the technical competence and integrity of these organizations and is conducted using competency-based standards. Accreditation ensures that the facility meets specific standards [11]. Standards establish specifications and procedures designed to ensure the safety, reliability, and consistent performance of products, services and systems. The International Organization for Standardization (ISO) is the largest international standards body, with 171 member countries [12, 13].

Thus far, there is no specific ISO standard for conducting either medical or forensic autopsies or PMD in general. The ISO standard for forensic science (ISO/DIS 21043) will not be applicable to (forensic) autopsies [14]. The international standards that are currently used in PMD by the accreditation bodies include ISO/IEC 17020:2012 and ISO 15189:2022, which largely adhere to the same principles [15].

In September 2022, the technical board of the European Association of National Accreditation Bodies (EA), tasked with harmonizing accreditation standards across Europe, decided that there is no need to define a preferred accreditation standard for forensic autopsies and other forensic activities. In their one voice report, they stated that EN ISO/IEC 17020 and EN ISO/IEC 17025 can be applied for the accreditation of laboratories performing forensic autopsies [15]. They further specified that the preferred standard for accrediting clinical pathology, including fetal and medical autopsies, is ISO 15189.

ISO/IEC 17020:2012 was last updated in 2017 [16]. In 2022, ISO voted to revise this standard, and concurrently, a working draft study was initiated [17]. Since the ISO/IEC 17020 standard, titled in full ‘Conformity assessment – Requirements for the operation of various types of bodies performing inspection’, is not written specifically for conducting autopsies, there are no designated inspection schemes. In practice, inspections are primarily based on the ‘Harmonization of medico-legal autopsy rules’ and ‘ECLM accreditation of forensic pathology services in Europe’ in Europe [18, 19], the ‘NAME inspection and accreditation checklist’ in the USA [20] or the area-specific Code of practice and performance standards for Forensic Pathology in the UK [21].

Exact figures on how many institutes have already been accredited according to ISO/IEC 17020 for autopsies are not easily available. However, this information can be derived indirectly by consulting national accreditation bodies and, for the USA, the website of NAME [22, 23].