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  1. Programs
  2. Introduction/Overview Review of Requirements - ISO 13485

Introduction/Overview Review of Requirements - ISO 13485

Alabama Training Network

Course

Become a contributor for free to openly demonstrate student outcomes, industry alignment & eligibility criteria.

The overview offers a detailed examination of the ISO 13485 standard, including the structure, management requirements, and registration and auditing processes.

Duration

8 Hours

Format

Hybrid

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Program Pathways

Credentials this program stacks toward

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Program Details

Detailed information about this program

The overview offers a detailed examination of the ISO 13485 standard, including the structure, management requirements, and registration and auditing processes. Participants will learn the requirements of ISO 13485 and have the opportunity to discuss application and implementation of the standard in their facility using real-world examples.

Requirements

What you need to earn this credential

No requirements listed.

Financial Aid

Eligible funding programs

No funding information available.

Scholarships

No scholarships listed.

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Locations

Where this program is offered

  • Alabama

    Alabama

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Related Programs

Programs related to this one

No related programs.

Skills & Competencies

Skills developed through this program

  • Knowledge Of ISO13485Standard Requirements
  • Plan Implementation Of ISO13485In Facility
  • Apply Management System Principles In Medical Device
Career Pathways

Occupations this program prepares you for

  • Chemists19-2031.00
  • Compliance Officers13-1041.00
  • Industrial Engineers17-2112.00
What You'll Learn

Key competencies developed through this program

Auto-populated·from NSX Competency Framework

Mastery: emerging (Level 1)(based on Course)

  • Standard analytical techniques (HPLC, GC, FTIR, UV-Vis) — operate per SOP under a senior chemist's review.
  • Reagent prep and titration — perform to method on a QC lab bench.
  • Lab safety (PPE, hood etiquette, MSDS) — apply consistently in a multi-chemist environment.
  • Sample receiving and chain of custody — maintain accurately for routine commercial work.
  • Calibration runs and check standards — schedule and document on assigned instruments.
  • Glassware cleaning and instrument maintenance — execute per the lab's recurring schedule.
  • Lab notebooks and electronic batch records — maintain auditably for assigned methods.
  • Routine statistical comparisons and outlier rules — apply to standard datasets.
  • Solvent waste and chemical disposal — segregate and label per RCRA-compliant procedure.
  • Method-of-analysis documentation — read, follow, and flag deviations to a supervisor.

Some details on this page are auto-populated from public workforce data sources: O*NET (opens in new tab), BLS (opens in new tab), College Scorecard (opens in new tab), DOL Training Provider Results (opens in new tab), NSX (opens in new tab). Provided in partnership with LER.me Career Intelligence.

Student Outcomes

Performance metrics for this program

Completion Rate
Not reported
Placement Rate
Not reported