Accreditation

MedAccred AUDIT & ACCREDITATION PROCESS

The MedAccred audit and accreditation process has been designed to benefit from industry input at critical points, while minimizing customer workload where possible. Ultimately, industry representatives make all the key decisions regarding which processes require audits and which Suppliers receive MedAccred critical process accreditation.

ABOUT THE MedAccred AUDIT & ACCREDITATION PROCESS

MedAccred Accreditation process

SUBSCRIBER ROLE

  • Recommend MedAccred critical process accreditation to suppliers
  • Review the audit package (audit report, non-conformances and root cause corrective actions)
  • Make final decision on accreditation

SUPPLIER ROLE

  • Liaise with PRI to schedule the MedAccred audit
  • Provide MedAccred auditor with pre-audit information (quality manual, procedures etc)
  • Liaise with PRI to close out any non-conformances

PRI  ROLE

  • Schedule audit with qualified auditor on convenient dates for all parties
  • Perform audit and submit report (Auditor)
  • Review report and liaise with Supplier to close out any non-conformances
  • Issue certificate to Supplier after approval from Task Group

SCOPE OF ACCREDITATION

Auditable activities are grouped as follows. Click on the critical process to view the scopes that can be included in an audit.

In order to smoothly facilitate your upcoming MedAccred initial or re-accreditation audit, each Task Group would like you to be aware that eAuditNet contains numerous self-help documents to guide you through the process. The path provided below will lead you to the relevant area where you will find links to numerous self-help documents pertinent to every stage of the MedAccred audit process. You are encouraged to take advantage of these valuable self-diagnostic references prior to your MedAccred audit. They may help you to avoid many of the most common findings and maximize your benefit throughout the audit while minimizing overall costs to your business.

Cable and Wire Harness

MedAccred is actively seeking worldwide auditors click here for more information

The Cable and Wire Harness Task Group (CH) conducts audits to demonstrate compliance to the following audit criteria:

AC8121 – Cable and Wire Harness

Ready to begin the accreditation process? Then log on to eAuditNet

For more information on Cable and Wire Harness, please contact:

electronics@p-r-i.org

Heat Treating

MedAccred is actively seeking worldwide auditors click here for more information

The Heat Treating Task Group (HT) has developed the audit checklist AC8102, which includes the following:

Metal Systems (Carbon & Alloy Steel / Tool Steel / Stainless Steel / pH Steel/ Cast Iron / Aluminum Alloys / Titanium Alloys/ Heat Resisting Alloys / Other Nonferrous Metals)

Heat Treating Processes (Normalizing / Annealing  / Hardening & Tempering / Solution & Aging / Carburizing / Nitriding  / Stress Relieving)

Heat Treating Equipment (Furnace / Pyrometry / Instrumentation / Atmospheric Control/Quench Systems/Refrigeration)

Brazing (Vacuum Brazing / Atmosphere Brazing)

Ready to begin the accreditation process? Then log on to eAuditNet

For more information on Heat Treating, please contact:

heattreating@p-r-i.org

Plastics

MedAccred is actively seeking worldwide auditors click here for more information

The Plastics Task Group conducts audits to demonstrate compliance to the following audit criteria:

AC8160 – Injection Molding (Insert Molding, Overmolding, Injection Blow Molding, Transfer Molding, Compression Molding)

Ready to begin the accreditation process? Then log on to eAuditNet

For more information on Plastics, please contact:

plastics@p-r-i.org

Printed Circuit Board Assembly

MedAccred is actively seeking worldwide auditors click here for more information

The Printed Circuit Board Assembly Task Group (PCBA) conducts audits to demonstrate compliance to the following audit criteria:

AC8120 – Printed Circuit Board Assemblies

Ready to begin the accreditation process? Then log on to eAuditNet

For more information on Printed Circuit Board Assembly, please contact:

electronics@p-r-i.org

Sterilization

MedAccred is actively seeking worldwide auditors click here for more information

The Sterilization Task Group (STN) conducts audits based on the AC8113 series of checklists, which includes the following:

Radiation (Gamma & E-Beam)

Ethyleneoxide

Ready to begin the accreditation process? Then log on to eAuditNet

For more information on Sterilization, please contact:

sterilization@p-r-i.org

Welding

MedAccred is actively seeking worldwide auditors click here for more information

The Welding Task Group (WLD) has developed process specific requirements based on the AC8110 series of checklists, which includes the following:

Electron Beam Welding

Fusion Welding (i.e. GTAW, PAW etc)

Laser Welding

Ready to begin the accreditation process? Then log on to eAuditNet

For more information on Welding, please contact:

welding@p-r-i.org