The Critical Process
(Pre-Audit) Assessment

What MedMMAP Will Do

Conduct free a Critical Process Assessment (“pre-audit”) to the MedAccred audit criteria.
Work with the supplier to develop a gap closure plan.
Train and mentor the supplier team in gap closure and accreditation audit preparation.

Audit all non-conformances following gap closure, prior to the PRI MedAccred audit.
Assist the supplier in closing any PRI MedAccred audit findings.

The Critical Process Assessment (Pre-Assessment Audit) is conducted to the MedAccred audit criteria used in an accreditation audit.

The time for the Critical Process Assessment is the same as the accreditation audit.

A MedMMAP Critical Process Assessment is based on MedAccred’s industry-approved criteria and includes a review of the procedures, work instructions, training records and other documentation that evidences the competency of the company to meet customer requirements.

A Critical Process Assessment also involves observing the critical processing through job audits to ensure that documented requirements are properly flowed down to and implemented on the shop floor.

A job audit is a step-by-step review of the critical process for producing an item and evaluating how the customer requirements are met by using the MedAccred audit criteria.

What makes a MedAccred Audit different from a QMS audit?

MedAccred Subscribers are leading medical device industry OEMs who drive a common audit criteria

Medtronic

Baxter

Philips

Johnson & Johnson

Stryker

Bausch Health

Boston Scientific

Roche Diagnostics

Edwards Lifesciences

Subscribers manage program, determine all audit criteria, interview and select the auditors,
have full access to audit findings and determine who is granted MedAccred Accreditation.

Critical Process Accreditations

Plastics

Plastics – Extrusion

Tubing / Profile
Sheet / Film
Blown Film
Over-Jacketing
Co-Extrusion
Ram Extrusion

Plastics – Injection Molding

Compression Molding
Injection Blow Molding
Insert Molding
Overmolding
Transfer Molding

Plastics – Mechanical Assembly

Adhesives / Bonding
Mechanical Fasteners
Plastics Welding
Heat Staking

Electronics

Printed Circuit Board Assemblies (PCBA)

Printed Boards (Bare Boards)

Flexible*
Rigid*

Cable & Wire Harness

STERILIZATION / PACKAGING / LABELING

Sterilization

Ethylene oxide
Radiation (Gamma & E-Beam)

Sterile Device Packaging

Assembly of Packaging Systems
Sealing
Forming Sterile Barrier Systems*

Labeling / Printing / UDI*

METALS

Heat Treating

Metal Systems
Heat Treating Processes
Heat Treating Equipment
Brazing (Vacuum Brazing / Atmosphere Brazing)
Sintering*

Welding

Electron Beam
Laser
Resistance Welding*
Fusion
- GTAW (TIG)
- GMAW (MIG)
- Plasma

*audit criteria under development

A Critical Process Assessment (like the MedAccred audit) is not a Quality Systems (QS) Audit, but a detailed technical audit focused on the specific commodity requirements.

Results from the Critical Process Assessment are used by MedMMAP and the company to develop and execute a plan to close all non-conformances and root cause corrective actions.

The MedMMAP Critical Process Assessment meets the MedAccred requirement that a supplier perform an internal pre-audit prior to the accreditation audit.

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The Critical Process (Pre-Audit) Assessment