ISO 15189 Certification

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Quality Systems Enhancement
ISO 15189 Medical Laboratories Requirements for
Quality and Competence
Those having medical laboratory applications
should take into consideration implementation of
special Disaster Recovery processes in the event
of any possible emergency situation such as the
recent Covid 19 virus. It is essential to follow
cGMP requirements without any violation. To be
ahead of standard requirements, the Disaster
Recovery Plan should include social distancing,
increased sanitation, and use of Personal
Protective Equipment (PPE). This Disaster
Recovery Plan must cover the initial handling of
incoming raw materials and all processes up to
and including dispatch. ISO 15189 certification
https//enhancequality.com/standards/iso-15189-me
dical-laboratories-requirements-for-quality-and-co
mpetence/
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Other standards to consider for integration
include ISO 153782017 for addressing those with
packaging processes ISO 17025, Quality
Management Systems for Laboratories to address
emergency situations and ISO 151892017, Medical
Laboratories requirements for quality and
competence support of ISO 15189
https//enhancequality.com/standards/iso-15189-m
edical-laboratories-requirements-for-quality-and-c
ompetence/
3
The following Bullets reference information for
the 2012 revision and will be updated soon.

• ISO Consulting services are required to assist
  organizations in building a comprehensive quality
  management system to meet all requirements of ISO
  15189
• ISO Consulting services can build a QMS that can
  prepare organizations with a robust system to
  produce quality products and services
• ISO Consultants assist in meeting Annex SL, a
  section of the ISO/IEC Directives part 1 that
  prescribes how ISO Management System Standard
  (MSS) standards should be written. which in turn
  meets ISO 15189 requirements
• A good ISO consulting firm provides training to
  top management in promoting Risk-Based Thinking,
  Process Approach, and Continual Improvement
• ISO Consultants assist in developing a
  comprehensive, simplified QMS to meet all
  requirements of ISO 15189 and 3rd Party
  Certification Body stage 1 audit requirements.
  The stage 1 audit from Certification Bodies vary
  depending on the selected Certification Bodies
  which verifies the documented system meeting all
  the requirements of ISO 15189 certification
• https//enhancequality.com/standards/iso-15189-me
  dical-laboratories-requirements-for-quality-and-co
  mpetence/

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Quality Management System Consulting is the
practice of assisting small, medium and large
organizations in developing, training,
implementing, and maintaining a documented
quality management system for achieving ISO 15189
certification. Quality Management Consultants
can prepare your facilities to have a Quality
Management System (QMS) and associated
documents/records to show as evidence of having
implemented the system. Quality Management System
Consultants assist facilities to prepare
documentation to show as evidence of having a
streamlined process that ensure quality product
or service every time without fail.
https//enhancequality.com/standards/iso-15189-med
ical-laboratories-requirements-for-quality-and-com
petence/
5

• Quality Management System Consultants assist to
  build a robust system which compels task
  performers to have defined roles,
  responsibilities and controls to ensure quality.
• Quality Management System Consultants assist
  organizations to identify all manufacturing and
  nonmanufacturing processes and facilitate in
  establishing process performance metrics or
  process performance indicators (Key Process
  Indicators KPIs) to effectively monitor and
  measure organizations intended Goals and
  Objectives.
• Quality management consultants provide
  clarifications on which standard is to be
  followed for medical laboratories and avoid
  confusion between ISO 13485 and ISO 15189
• Audits are unbiased, structured and documented
  evaluation of any given international standards
  such as ISO 15189, ISO 10993-1, ISO 14001, ISO
  15189, ISO 45001, ISO 50001, ISO 55001, ISO
  22000, ISO 27001, IATF 16949, AS 9100, AS 9110,
  AS 9120, BRC, FSSC 22000, SQF, TL 9000, and
  recording the results.
• 1st Party Audit Audits performed by a team
  within the facility is called 1st Party Audit
• 2nd Party Audit Audits performed by
  organizations on their suppliers is called
  2nd Party Audit
• 3rd Party Audit Audits performed by
  Certification Bodies is known as a 3rd party
  audit
• 3rd Party audit Certification Bodies (Accredited
  by International Accreditation Forum IAF)
  perform the audits on the organizations to grant
  ISO 15189 Certifications with demonstrated
  evidence of conformity to all the requirements of
  ISO 151892012 https//enhancequality.com/standard
  s/iso-15189-medical-laboratories-requirements-for-
  quality-and-competence/