Readymade ISO 15189 Documentation Toolkit Has Introduced Online by Documentationconsultancy.Com


Posted March 24, 2023 by documentconsultant

DocumentationConsultancy.com has very excited to introduce the editable ISO 15189:2022 documentation kit with manuals, procedures, exhibits, SOPs, etc.
 
A new version of the ISO 15189:2022 Documentation Toolkit has been released by Documentationconsultancy.com to define the documentation requirements for complete medical laboratory accreditation. An entire set of required and additional ISO 15189 documentation is available for purchase online from Documentationconsultancy.com. According to the requirements of ISO 15189:2022 standard, the documentation kit contains documents such as manuals, mandatory procedures, exhibits, SOPs, formats, audit checklists, etc.

The ISO 15189 standard's fourth edition was published in December 2022. The ISO 15189:2022 standard edition has been fully revised and is now in compliance with the ISO/IEC 17025 standard. The current standard contains the requirements for point of care testing (POCT), which were previously established in the ISO 22870 standard, among other notable modifications such as the increased emphasis on risk throughout the standard. More than 120 editable files for requirements for the medical laboratory quality management system are included in the editable ISO 15189 Documentation kit.

The overall purpose of the documentation kit for medical laboratories is to increase confidence in the ISO 15189 consultant, regulating authorities, Individuals, and accreditation bodies that are connected to the medical laboratory as well as laboratory customers (patients, corporate customers, hospitals, etc.). The user adaptability of the ISO 15189 certification documentation kit is its main benefit. It is a widely used documentation tool with simple editing features and compatibility with clause-by-clause standards, allowing users to modify pre-made templates by their working system and build their unique documents for rapid accreditation.

Additionally, the format and procedure documents included in the documentation kit may be used to improve management system control and fine-tune the processes. ISO 15189:2022 documents reduce the amount of time and money required for preparing documents. Customers receive value for their money from it. With more than 500 internal audit questions provided in the kit, an audit checklist for ISO 15189 accreditation can be used to prepare all staff for an accreditation audit. The following is a list of the documents that are included in the ISO 15189 documentation kit:

• ISO 15189:2022 Manual (01 editable file)
• ISO 15189 Procedures (34 procedures)
• Sample Exhibits (08 exhibits)
• Standard Operating Procedures (07 SOPs)
• Blank Formats /Templates (62 forms)
• Job description
• ISO 15189 Audit Checklist (more than 500 questions)
• Sample Risk Assessment and Opportunity Sheet (01 editable file)
• ISO 15189:2022 document compliance matrix (01 editable file)

To know more about ready-to-use ISO 15189:2022 documents, visit here: https://www.documentationconsultancy.com/iso-15189-documents.html

About DocumentationConsultancy.com
DocumentationConsutlancy.com is offering 4-Steps online ISO documentation consultancy for all ISO certifications and other international system and product certifications. The company has a team of expert consultants having rich experience in implementing systems and/or documentation for ISO certification for more than 2400 clients. From all over the world, any ISO certification-seeking organization can contact and saves costs and time in the certification process as a company offering online documentation and certification consultancy services. All the communication under this E-documentation consultancy program will be done via phone calls, emails, and online conferences.
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Last Updated March 24, 2023