Workflow Process Documentation Package (PDF)

Complete Mind-map style workflow process matrix documentation package for site implementation and adaptation to ensure immediate compliance to ISO13485 upon implementation of workflow steps including the following:

INCLUDED DOCUMENTS

• Health Technology Management Implementation (New Sites as well as old)
• Acceptance Procedure Workflows (Incl. Procurement workflow procedures
• Preventative Maintenance Process Workflow
• Corrective Maintenance Process Workflow
• Retirement Process Workflow
• Occupational Risk Management Workflow
• Safe Systems of Work Implementation Workflow
• EHS Implementation Workflow
• COSHH Implementation Workflow
• Operations Assimilation with Workflow Process
• Stock Management Workflow Process
• Quality Assurance Workflow Process

Draft Quality Management Documentation Package (PDF & MS Word)

Complete set of ISO13485 compliant policy documentation for HTM managers that can be adapted and personalised to organisation / site specific needs for ease of implementation towards attaining ISO13485 accreditation including the following:

• Draft ISO13485 Quality Manual (Incl. Document Control Policy)
• Draft H&S Policy (Incl. Draft H&S. Statement)
• Draft Decontamination Policy
• Draft HR Manual
• Draft Employment Qualification Policy (Incl. Draft Job Descriptions)
• Draft Complaints Management Policy

Draft Procurement Management Documentation Package (PDF & MS Word)

Complete set of ISO13485 compliant Procurement management documentation for HTM managers and procurement officers that can be adapted and personalised to organisation / site specific needs for ease of implementation towards attaining ISO13485 accreditation including the following:

• Draft “PPQ” Documentation Set (Pre Purchase Equipment & Lifecycle Cost Vetting Questionnaires)
• Draft Supplier / Customer Vetting questionnaire
• Draft Supplier / Customer “Code of Conduct” stipulation

Draft In-House Technical Assessment Documentation Package (PDF, Excel, MS Word)

Complete set of ISO13485 compliant “technical assessment” documents to assist with the establishment of current Health Technology assets and to help establish ownership risk and service / repair / replacement requirements:

• Draft “Sample” Asset Inventory Database List for SQL complaint database field import (Excel).
• Draft asset inspection & validation questionnaire
• Technical Assessment Process Workflow
• Sample Technical Assessment Report including “Risk mitigation data analysis”
• Sample PPM scheduling & Intervention prioritisation algorithm (Excel)

Intervention Specification Documentation Package

Compiled set of ISO13485 compliant “Intervention Specification task lists” based on designations derived from the GMDN database including ownership specification / class & Risk categorisation documents to help classify health technology and related devices towards the same GMDN classification, including the following:

• GMDN based designation assigned health technology asset descriptors list with assigned ECRI and ownership categorised risk and value based class allocation
• Sample Intervention specification task lists for PPM, Acceptance and Corrective actions based on designations as assigned by the GMDN for most categories of health technology devices.

Complete set of ISO13485 compliant policy documentation for HTM managers that can be adapted andComplete set of ISO13485 compliant policy documentation for HTM managers that can be adapted andpersonalised to organisation / site specific needs for ease of implementation towards attaining ISO13485accreditation including the following:

• Draft ISO13485 Quality Manual (Incl. Document Control Policy)
• Draft H&S Policy (Incl. Draft H&S. Statement)
• Draft Decontamination Policy
• Draft HR Manual• Draft Employment Qualification Policy (Incl. Draft Job Descriptions)
• Draft Complaints Management Policy

Complete set of ISO13485 compliant Procurement management documentation for HTM managers andComplete set of ISO13485 compliant Procurement management documentation for HTM managers andprocurement officers that can be adapted and personalised to organisation / site specific needs for ease ofimplementation towards attaining ISO13485 accreditation including the following:

• Draft “PPQ” Documentation Set (Pre Purchase Equipment & Lifecycle Cost Vetting Questionnaires)
• Draft Supplier / Customer Vetting questionnaire
• Draft Supplier / Customer “Code of Conduct” stipulation

Complete set of ISO13485 compliant “technical assessment” documents to assist with the establishment ofComplete set of ISO13485 compliant “technical assessment” documents to assist with the establishment of current Health Technology assets and to help establish ownership risk and service / repair / replacement requirements:

• Draft “Sample” Asset Inventory Database List for SQL complaint database field import (Excel).
• Draft asset inspection & validation questionnaire
• Technical Assessment Process Workflow
• Sample Technical Assessment Report including “Risk mitigation data analysis”
• Sample PPM scheduling & Intervention prioritisation algorithm (Excel)

Compiled set of ISO13485 compliant “Intervention Specification task lists” based on designations derivedCompiled set of ISO13485 compliant “Intervention Specification task lists” based on designations derivedfrom the GMDN database including ownership specification / class & Risk categorisation documents tohelp classify health technology and related devices towards the same GMDN classification, including thefollowing:

• GMDN based designation assigned health technology asset descriptors list with assigned ECRI andownership categorised risk and value based class allocation
• Sample Intervention specification task lists for PPM, Acceptance and Corrective actions based ondesignations as assigned by the GMDN for most categories of health technology devices.