Document Structure for ISO 15189 Accreditation Medical Laboratories Certification

ISO 15189 is a globally recognized accreditation that can be used by medical laboratories to measure their own capability. It can also, according to its official document, be used for "confirming or identifying the capability by consumers, regulating authorities and accreditation bodies." In essence, as well as confirming the reliability of own services, it can be used as an indicator for how business is perceived by potential customers on things such as honesty and credibility. Accreditation verifies three key components of a laboratory: integrity, impartiality, and capabilities.

What is the Document Structure for ISO 15189 Accreditation Medical Laboratories Certification?

The ISO 15189 Documentation kit for requirements for the medical laboratory quality management system. A well-designed set of documents help organization to minimize the time and the cost involved in certification. The ISO 15189 documents should contain effectively designed ISO 15189 Manual, procedures, exhibits, SOPs, etc.

• ISO 15189 Quality Manual:

The ISO 15189 manual is a mandatory document for ISO 15189 certification as per medical laboratories. It describes how all requirement of ISO 15189:2012. It covers list of procedures as well as overview of medical laboratories and covers tier 1 of ISO 15189:2012 documents.

• ISO 15189 Procedures:

Mandatory procedures cover all the clause requirements to follow while implementation of medical laboratory quality management system. These procedures help to implement an effective system in the company as per the rules of ISO 15189 requirements.

• ISO 15189 SOPs (Standard operating procedures):

It covers sample copy of standard operating procedures covering all the details of ISO 15189:2012 standard. It takes care of all such issues and used as a training guide as well as to establish control and make system in the organization.

• Formats:

Editable forms and templates for various departments of medical laboratories to fill up records and learn system requirements. It covers sample copy of blank forms required to maintain records as well as establish control and make system in the medical laboratories. The samples given are as a guide and not compulsory to follow and medical laboratories is free to change the same to suit own requirements.

• ISO 15189 Audit Checklist:

It covers sample audit questions based on all the ISO 15189 requirements. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 15189 requirements are fulfilled by the medical laboratories. More than 350 audit questions to verify the implemented quality management system and add effectiveness in the medical laboratory accreditation.

How will ISO 15189 Accreditation Benefit?

ISO 15189 accreditation can assistance business in a variety of different ways, both internally and externally. To name only a few, it can:

• Rise business resilience.
• Improve team morale & staff assurance.
• Help to qualify in the tender application process.
• Accomplish preferred supplier status.
• Attract new clients and business opportunities.
• Deliver with a competitive advantage.
• Improve processes and capability.
• Improve brand reputation.
• Improve quality.
• Create a culture of constant improvements.

Iso 13485:2016 Medical Devices Quality Management System