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Requirements of iso 15189 documents


ISO 15189 certification required documents like Manual, Procedures, Work Instruction, etc. for Medical Laboratory Management System. This presentation describes in brief about documents – PowerPoint PPT presentation

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Title: Requirements of iso 15189 documents

Requirements of Documents for Medical Laboratory
Management System ISO 15189 Certification
What is Requirement of ISO 15189 Documents?
The ISO 15189 documents basic requirements for an
organization to establish, document, implement,
and maintain a medical laboratory quality
management system and continually improve its
effectiveness in accordance with the requirements
of this International Standard
Structure of Medical Laboratory Management System
The manual is a series of policy statement for
each of the elements of the ISO standard
Procedures define the policy in teams of who,
what and where. Responsibilities and action are
Work Instruction define specific steps to
accomplish task.
To show USE of the system
What to Includes ISO 151892012 Documentation Kit?
  • ISO 151892012 standard published by the
    International Organization for Standardization,
    has certain Medical Laboratory Management Systems
    documentation requirements. The international
    standard specifies four levels of documents for
    ISO 15189 Certification that an organization must
    observe to document its quality management
  • Quality Manual
  • Quality Procedures
  • Quality Policy
  • Word Instruction
  • Record
ISO 15189 Manual
The Medical Laboratory Quality Management
System documentation standard prescribes the
minimum requirements for the content of a ISO
15189 manual. The standard recognizes that the
structure and format of the ISO 15189 Manual will
depend on the size, culture and complexity of the
Mandatory Procedures for ISO 15189 Certification
The quality procedures are the essence of the ISO
15189 documentation. The ISO 15189 procedures
explicitly describe how certain key processes
within the company must be performed, and who is
responsible for them. Ideally, the quality
procedures and the quality manual are combined in
a single user-friendly document.
Quality Policy Work Instruction
The ISO 15189 quality policy is the company's
policy defining its stance towards quality and
customer satisfaction. As such, the ISO 15189
quality policy is the overall guiding
principle.  A Work Instruction describes how to
undertake a specific part of a function, or
activity. It is similar to a procedure but is
characterized by increased focus and further
detail on a particular task. A work instruction
is mandatory, and must be subordinate to a
Forms Templates for Registration
Forms and templates are a way of documenting that
the policies, procedures, and work instructions
have been followed. Records may be forms that are
filled out, a stamp of approval on a product, or
a signature and date on some type of document,
such as routing sheet. Records are used to
provide traceability of actions taken on a
specific product or batch of products. They
provide data for corrective actions and a way of
recalling products, if necessary.
Advantages of Using ISO 15189 Documents
  • By using these documents, you can save a lot of
    your precious time while preparing the system
  • Take care for all the section and sub sections
    of standard and helps you in establishing better
  • Document kit enables you to change the contents
    and print as many copies as you need. The user
    can modify the documents as per their industry
    and create own ISO 15189 documents for their
  • Readymade templates and sample documents are
    available which can reduce your time in document
  • Save much time and cost in document preparation.
  • The audit questions helps in making perfect
    audit checklist.
  • You will get better control in your system due
    to our proven formats
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