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ISO 15189 Internal Auditor Training

Course summary
Length: 2 days
Price: 745 - 795 GBP excl. VAT
Language: English
Provider: Bywater plus
Course type: Open / Scheduled
Next available date: 05/12/2017 - Greenwich
Course Dates
05/12/2017   (English)
795 GBP
06/02/2018   (English)
745 GBP

ISO 15189 Internal Auditor Training

ISO 15189 Internal Auditor Training

ISO 15189 Internal Auditor Training - Medical Laboratories

This training course is designed to provide delegates with the skills necessary to conduct internal audits against the requirements of ISO 15189.

ISO 15189 is the internationally recognised standard relating to the competence of medical laboratories. It specifies criteria for the development and assessment of management systems and laboratory technical controls that provide confidence in the results obtained. The standard covers the medical laboratory services including examination requests, patient preparation, sample collection, transport and storage, processing, examination of clinical samples, interpretation and advice in addition to consideration of safety and ethics relating to clinical work. Our course will equip delegates with effective auditing techniques and increase their understanding of audit methodologies to assess against ISO 15189 in order to ensure continued compliance, determine improvements, professionally report findings and implement corrective action programmes.

Delegates should have a reasonable working knowledge of ISO 15189 or equivalent (e.g. Clinical Pathology Accreditation requirements) prior to attending this course. Bywater offers an Introduction to ISO 15189 course which covers the standard in detail.

Suitability - Who should attend?

Bywater's ISO 15189 Internal Auditor course is suitable for;

  • Quality Managers
  • Companies seeking ISO 15189 accreditation
  • Certification / Registrar / Accreditation body auditors
  • Existing internal auditors who are looking to expand their skills in the area of laboratory practices
  • Supplier Quality Auditors who need to evaluate clinical laboratory services


Outcome / Qualification etc.

Using a combination of interactive tutorials, discussions, practical workshops and case studies, our course will enable the delegates to:

  • Interpret the requirements of ISO 15189 as it relates to clinical laboratory operations
  • Apply auditing principles and objectively assess the compliance of a laboratory and identify areas to improve competency and management systems
  • Develop continuous improvement that provides on-going future benefits to the organisation

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Training Course Content

Key topics

  • The role of accreditation
  • Introduction and review of ISO 15189 requirements
  • Quality and quality management principles
  • Coordination of a management system audit using ISO 15189 (including the roles of the Quality Manager and Internal Auditors)Audit planning, horizontal, vertical and witness
  • Checklist preparation
  • The concept of ‘risk-based’ auditing
  • Effective auditing techniques and communication skills
  • Witness/Technical audits
  • Reporting and grading of audit findings
  • Preparation of summary reports
  • Developing and verification of effectiveness of corrective action


The price includes course materials, lunch, refreshments and certificate.

Bywater also offer the option to be a residential delegate, enabling you to stay at the training venue and reduce your travel time. If you are interested in this please contact Bywater on 0333 123 9001.

This course can also be run in-house and tailored to your organisation's requirements.

In-House Training - Making an Informed Decision

Training that is delivered in-house at your organisation can be a more cost-effective training solution and reduces travel costs. Bywater can tailor the training to match your own processes or requirements according to the knowledge level of your staff.

If you would like to discuss In-house training or if you would like a quote please contact 0333 123 9001.

Provider: Bywater

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Providing Approved Auditor & Management Systems Training & Consultancy

Bywater is one of the largest independent providers of CQI and IRCA / IEMA approved Auditor and Management Systems training in Europe.  Bywater specialise in the improvement of business performance, supported by appropriate management systems, through provision of auditor training, consultancy and business...

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Reviews by course attendees

Premaitha   |   06/02/2017
Tutor managed difficult questions well. Provided lots of information, very good presentation 5 out of 5 for course materials.I liked the workshop elements throughout, makes people practically apply the knowledge. Professional presentation of materials.
Private Booking   |   16/01/2017
5 out of 5 for the Tutor. The most useful elements of the course were the use of each change within a QMS.
Addenbrookes   |   04/07/2016
Good detail and discussion. Tutor made a dry subject interesting, facilitated good discussion.