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SOP-014-PostMarketSurveillance.md

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SOP-014-PostMarketSurveillance.md

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sop_id SOP-014
title Post-Market Surveillance
revision R07
revision_date 2026-05-04
status Published
owner_role qa_lead
approver_role qa_lead
related_issue #10

1. Purpose

Define systematic post-market surveillance (PMS) to monitor product safety/performance, detect trends, and drive timely corrective/preventive actions.

2. Scope

Applies to all released products and product versions in active use.

3. Inputs

  • Feedback and complaint data
  • Incident reports
  • Usage and operational quality indicators
  • Scientific/regulatory updates relevant to product risks

4. Outputs

  • PMS periodic analysis report
  • Risk/control reassessment actions
  • CAPA/change recommendations

5. Roles and Responsibilities

Role Responsibilities
QA Lead Owns PMS plan execution, trend analysis, and PMS output/escalation review.
Engineering Lead Implements product actions from PMS findings.

6. Procedure

6.1 PMS Planning

  1. Maintain product-level PMS plan defining data sources, collection methods, analysis methods, responsibilities, review frequency, and signal detection thresholds.
  2. Align PMS metrics with product risk controls and intended use.

6.2 Data Collection and Consolidation

  1. Collect periodic data from complaints, incidents, support, and reliability signals.
  2. Validate data completeness and remove duplicates/noise with documented rationale.

6.3 Signal Detection and Analysis

  1. Perform trend analysis periodically for active products.
  2. Assess signal significance by severity, frequency, and detectability.
  3. Determine if action is required (risk update, CAPA, incident reporting, design change).

6.4 Reporting and Escalation

  1. Issue PMS summary with conclusions and required actions.
  2. A PMS report shall be maintained for each product and updated at defined intervals.
  3. Escalate critical trends immediately to management and incident workflow.
  4. Include PMS outputs in management review package.

6.5 Effectiveness Tracking

  1. Track outcomes of PMS-driven actions.
  2. Confirm trend stabilization or continue escalation if unresolved.

7. Required Records

  • Product PMS plan
  • PMS analysis reports
  • Escalation and action tracking evidence

8. Traceability

Standard Clause Control in this SOP
ISO 13485:2016 8.2.1 Defines ongoing feedback collection as PMS input.
ISO 13485:2016 8.2.6 Defines monitoring and measurement of product/process outputs post-release.
ISO 13485:2016 8.4 Defines analysis of quality data and trend-based decision controls.

9. Related Controlled Documents

  • SOP-012 Feedback and Complaint Handling
  • SOP-013 Regulatory Incident Reporting
  • SOP-016 Quality Metrics and Data Analysis

10. Revision History

Revision Revision Date Change Summary
R00 2026-03-02 Initial full release.
R01 2026-03-07 Renamed the PMS business owner role to the controlled product/regulatory owner role used in small-team deployments.
R02 2026-03-07 Simplified the PMS role names to regulatory_lead and engineering_lead.
R03 2026-03-18 Removed top-table standards clause metadata; normative references remain in the Traceability section.
R04 2026-03-25 Expanded PMS-plan minimum content, generalized active-product trend frequency wording, and required maintained per-product PMS reports.
R05 2026-03-27 Consolidated the standalone regulatory-lead PMS-owner role into the QA-lead baseline and aligned the role table plus ownership metadata.
R06 2026-04-27 Renamed YAML metadata field effective_date to revision_date to align controlled-document metadata with the tag-based publication model. The effective date is derived from the published QMS release tag rather than from the document front matter.
R07 2026-05-04 Standardize standards citations to specific versions.