Quality Manager QMS Iso13485

What This Skill Does

This skill assists Quality Managers in implementing, maintaining, and supporting certification for ISO 13485:2016 compliant Quality Management Systems (QMS). It provides workflows and references for medical device organizations seeking to establish or improve their QMS. It helps ensure compliance with ISO 13485 standards.

When to Use

• Implementing a QMS from gap analysis to certification.
• Managing document control.
• Conducting internal audits.
• Validating processes.
• Qualifying suppliers.
• Referencing QMS processes.

Key Features

• Provides a QMS implementation workflow.
• Offers guidance on document control.
• Includes an internal audit workflow.
• Details a process validation workflow.
• Presents a supplier qualification workflow.
• References QMS processes.

Manual Installation

Table of Contents

QMS Implementation Workflow

• Document Control Workflow.
• Internal Audit Workflow.
• Process Validation Workflow.
• Supplier Qualification Workflow.
• QMS Process Reference.

Decision Frameworks Tools and References

QMS Implementation Workflow

Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.

Workflow: Initial QMS Implementation

• Conduct gap analysis against ISO 13485:2016 requirements
• Document current state vs. required state for each clause.

Prioritize gaps by:

• Regulatory criticality

• Risk to product safety

• Resource requirements Develop implementation roadmap with milestones Establish Quality Manual per Clause 4.2.2:

• QMS scope with justified exclusions

• Process interactions

• Procedure references

• Create required documented procedures — see Mandatory Documented Procedures for the full list.

• Deploy processes with training.

• Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained

Use the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions.

QMS Structure

Document Control Workflow

Establish and maintain document control per ISO 13485 Clause 4.2.3.

Workflow: Document Creation and Approval

Identify need for new document or revision Assign document number per numbering convention:

• Format: [TYPE]-[AREA]-[SEQUENCE]-[REV]

• Example: SOP-02-001-01

• Draft document using approved template.

• Route for review to subject matter experts.

• Collect and address review comments.

• Obtain required approvals based on document type.

• Update Document Master List.

• Validation: Document numbered correctly; all reviewers signed; Master List updated

Document Numbering Convention

Area Codes

Document Change Control

Document Review Schedule

Internal Audit Workflow

Plan and execute internal audits per ISO 13485 Clause 8.2.4.

Workflow: Annual Audit Program

Identify processes and areas requiring audit coverage Assess risk factors for audit frequency:

• Previous audit findings

• Regulatory changes

• Process changes

• Complaint trends

• Assign qualified auditors (independent of area audited)

• Develop annual audit schedule.

• Obtain management approval.

• Communicate schedule to process owners.

• Track completion and reschedule as needed.

• Validation: All processes covered; auditors qualified and independent; schedule approved

Use the Audit Program Template in qms-process-templates.md to schedule audits by clause and quarter across processes such as Document Control (4.2.3/4.2.4), Management Review (5.6), Design Control (7.3), Production (7.5), and CAPA (8.5.2/8.5.3).

Workflow: Individual Audit Execution

• Prepare audit plan with scope, criteria, and schedule.
• Notify auditee minimum 1 week prior.
• Review procedures and previous audit results.
• Prepare audit checklist.
• Conduct opening meeting.

Collect evidence through:

• Document review

• Record sampling

• Process observation

• Personnel interviews Classify findings:

• Major NC: Absence or breakdown of system

• Minor NC: Single lapse or deviation

• Observation: Risk of future NC

• Conduct closing meeting.

• Issue audit report within 5 business days.

• Validation: All checklist items addressed; findings supported by evidence; report distributed

Auditor Qualification Requirements

Finding Classification Guide

Process Validation Workflow

Validate special processes per ISO 13485 Clause 7.5.6.

Workflow: Process Validation Protocol

Identify processes requiring validation:

• Output cannot be verified by inspection

• Deficiencies appear only in use

• Sterilization, welding, sealing, software Form validation team with subject matter experts Write validation protocol including:

• Process description and parameters

• Equipment and materials

• Acceptance criteria

• Statistical approach

• Execute IQ: verify equipment installed correctly and document specifications

• Execute OQ: test parameter ranges and verify process control

• Execute PQ: run production conditions and verify output meets requirements

• Write validation report with conclusions.

• Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved

Validation Documentation Requirements

Revalidation Triggers