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 Certification Documentation

D135 : Documentation Kit for ISO 15189:2012 Accreditation

450.00 USD Demo

The standard ISO 15189:2012 is developed to use by medical laboratories in developing their quality management systems and assessing their own competence. ISO 15189 can be also used for confirming or recognizing the competence of medical laboratories by laboratory customers (patients / corporate customers / hospitals etc.), regulating authorities and accreditation bodies.

The standard ISO 15189:2012 Documentation; quality manual, procedures, SOPs, forms, audit checklists etc., are primary requirement which conforming to the competence of medical laboratories. The documentation kit is designed by Global Manager Group contains ready to use sample documents like ISO 15189 manual, procedures, standard operating procedures, formats, forms & templates as well as more than 350 questions in audit checklist etc., which covers all documented information required for ISO 15189:2012 accreditation. The overall aim of this documentation kit for medical laboratories is to give confidence to the laboratory customers (patients / corporate customers / hospitals etc.), regulating authorities and accreditation bodies that are associated with the medical laboratory. The key advantage of ISO 15189 documentation kit is its user compatibility; it is globally used documentation tool available with easy editing features and compatible with clause-wise requirements. All the documents covered in 170 MS Word files are editable and written in simple English. The user can update sample document templates as per organization working system and create own documents for their company in just couple of man days.

 

Content of ISO 15189 Medical Laboratory QMS Documentation Kit

The ISO 15189 Documentation - total 170 editable files for requirements for medical laboratories quality management system, includes following ready-to-use templates, which can accelerate documentation process for ISO 15189 accreditation.

  1. Sample ISO 15189 Manual - 01 editable file to define how ISO 15189:2012 system is implemented.
  2. Mandatory Procedures - total 30 Procedures in word format for various departments.
  3. Standard Operating Procedures - total 40 SOPs for collection, operation and testing process and used as reference documents.
  4. Exhibits - 06 editable exhibits in word format to follow while implementing effective system.
  5. Readymade Formats - 94 editable forms and templates for various department of medical laboratories to fill up records and learn system requirements.
  6. ISO 15189 Audit Checklist - more than 350 audit questions to verify implemented quality management system and add effectiveness in the medical laboratory accreditation.
  Features
  • Written in simple English.
  • Written in MS Word 7 and compatible with window 1997 and higher version.
  • Documents are user compatible, easy to learn and easy to use.
  • Anyone can visit sample DEMO with list of documents that helps to take decision to purchase this documentation kit.
  • Contains manual, quality procedures, SOPs, exhibits and formats which are complete set of documentation.
  • Defines the baseline system that satisfies requirements for medical laboratory as well as covers ISO 15189:2012 principles.
  • Minimize excessive paperwork.
  • Most compatible for QMS implementation in medical laboratories in USA, UK, Europe and Asia.
  • User-friendly and easy to learn as well as modify to make own documents.
  • Designed under guidance of experienced consultants.
 

How ISO 15189 Manual, Templates and Checklists are Useful?

  • The user can modify readymade templates as per their working system and they can create own documents for quick accreditation.
  • Procedures and formats provided in document kit can help in fine-tuning the processes and establish better control over management system.
  • Saves much time and cost in document preparation. It gives value for money to customer and payback is very low.
  • Ready to use templates in .doc format will reduce your time in documentation process as well as useful in giving training to staff.
  • Takes care for all the section and sub sections to get better confidence as well as improve the system.
  • Audit checklist is given with more than 350 internal audit questions, which easy to train all the employees for accreditation audit.
  Other Details

Method of Delivery for Documentation Kit

The ISO 15189 documents for requirements for medical laboratory quality management system can be purchase through secure online transaction. Soft-copy of Total Documentation Kit shall be delivered online after 12 hours of confirmation of payment. After purchase of our any product online via secure payment get-way, we are giving username and password with download link to the buyer, for easy download the purchased product from our server.

Note: All the documents are editable and all rights of using at one site will be given to buyer for changing company name, logo etc as per company system requirements.

This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.

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D135 : Documentation Kit for ISO 15189:2012 Accreditation 450.00 USD Demo