Process, application, requirements

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Accreditation Canada Diagnostics

Assessment Programs

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Process

AC Diagnostics accreditation is a four year cycle with an assessment every two years and a certificate that is valid for four years.

New AC Diagnostics applicants must submit a self-assessment within a year of application. An initial assessment visit can occur in as little as four months after completion of the self-assessment. It will take about five months after the initial assessment to correct any non-conformances identified and for AC Diagnostics to issue an accreditation certificate. A surveillance visit will occur two years after the initial visit. Full reassessment will occur in another two years. Thereafter, assessment visits and surveillance visits will alternate every two years. Additional focused surveillance visits for cause may be required during the four-year accreditation cycle.

Requirements

The principle international standard on which our programs are based is ISO 15189 Medical laboratories - Requirements for quality and competence.

For each program, AC Diagnostics has defined the applicable requirements necessary to issue an accreditation certificate and has provided extensive guidance for each requirement. The AC Diagnostics Accreditation Requirements include not only the applicable clauses of ISO 15189, but also:

Additional ISO standards
Provincial Statutes and Regulations
Health Canada Guidelines
Standards and guidelines achieved through consensus by international, North American, Canadian and provincial associations, federations, organizations and regulatory bodies.

Because of the extra rigour of our requirements, our programs are brand named ISO 15189 Plus™.

Each accreditation requirement has an accompanying reference source. Accompanying each requirement is “What To Look For” guidance information that explains the intent of the requirement and provides insight into its application. Usually, this guidance information is phrased as a question, and may include an indication of documents and records required to meet the requirements.

AC Diagnostics Accreditation Requirements are available for purchase. Once an application for accreditation is submitted, that facility will receive additional enhanced access to the requirements and guidance information through QView™, our password-protected client portal. This will include automatic updates of new versions of the requirements.