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

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Structure of Medical Laboratory Management System Documentation The manual is a series of policy statement for each of the elements of the ISO standard

Manual

Procedures Work Instruction define specific steps to accomplish task.

Procedures define the policy in teams of who, what and where.

Responsibilities and action are outline

Word Instruction Record and Documents www.certificationconsultancy.com

To show “USE� of the system

What to Includes ISO 15189:2012 Documentation Kit? ISO 15189:2012 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 system.

Quality Manual Quality Procedures Quality Policy Word Instruction Record www.certificationconsultancy.com

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 organization.

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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 userfriendly document.

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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 procedure. www.certificationconsultancy.com

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. www.certificationconsultancy.com

Advantages of Using ISO 15189 Documents  By using these documents, you can save a lot of your precious time while preparing the system documents.  Take care for all the section and sub sections of standard and helps you in establishing better system.  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 organization.  Readymade templates and sample documents are available which can reduce your time in document preparation.  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 www.certificationconsultancy.com

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