Guides by Role & Industry
Practical guides for one quality role in one industry: medical devices, pharma, automotive, aerospace and financial services.
18 articles
- QMSR Gap Analysis: A Guide for Medical Device Quality Managers A practical QMSR gap analysis for medical device quality managers: what changed on Feb 2, 2026, how FDA inspects, a step-by-step method and a checklist.
- QMSR and ISO 13485 Documentation: What Quality Systems Managers Must Update What medical device quality systems managers must update after QMSR: procedures, terminology, records FDA can now request, and a document-by-document plan.
- Supplier Controls Under QMSR: A Guide for Medical Device Supplier Quality Engineers How medical device SQEs should evaluate, monitor and audit suppliers under QMSR and ISO 13485 7.4, now that FDA can read supplier audit reports.
- Management Review Under QMSR: What Medical Device Quality Directors Need to Know Under QMSR, FDA can read management review records. What medical device quality directors should change in oversight, decisions and evidence.
- UN R155 and R156 for Automotive Quality Managers: CSMS and SUMS Compliance What automotive quality managers need to know about UN R155 (CSMS) and R156 (SUMS): dates, audits, the evidence auditors expect and quality's role.
- Supplier Cybersecurity Under UN R155: A Guide for Automotive Supplier Quality Engineers How automotive SQEs can assess supplier cybersecurity for UN R155: what OEMs must show, ISO/SAE 21434 Clause 7, and the evidence to collect.
- UN R156 Software Update Evidence: A Guide for Automotive Quality Engineers What automotive quality engineers need to know about UN R156 software updates: RXSWIN, configuration records, compatibility checks and audit evidence.
- FDA GMP Inspection Readiness: A Playbook for Pharmaceutical QA Managers A GMP inspection readiness playbook for pharma QA managers, built on FDA's most-cited FY2025 observations: quality unit, investigations, procedures, labs.
- GMP Lab Inspection Readiness for QC Managers and QC Supervisors How pharma QC managers and supervisors prepare a lab for FDA inspection: 211.160 controls, 211.194 records, OOS investigations and a daily review routine.
- GMP SOP Review: A Guide for Pharmaceutical Plant Quality Managers How pharma plant quality managers review SOPs for GMP inspection readiness: what Part 211 requires, a review method, and closing procedure-practice gaps.
- IATF 16949 Supplier Evaluation: A Guide for Supplier Quality Engineers How automotive SQEs evaluate suppliers under IATF 16949 section 8.4: selection, QMS development, monitoring, second-party audits and development.
- Running an IATF 16949 Supplier Management Program: A Guide for Supplier Quality Managers How automotive supplier quality managers design an IATF 16949 supplier program: risk tiers, audit criteria, CSR cascade and the 2026–27 revision.
- IATF 16949 Audit Readiness for Plant Quality Managers and Quality Supervisors How automotive plant quality managers and supervisors prepare for IATF 16949 audits under Rules 6th Edition: deadlines, audit days, shop-floor readiness.
- DORA ICT Third-Party Risk: A Guide for Supplier Quality Managers Moving into Financial Services How supplier quality skills transfer to DORA ICT third-party risk: pre-contract due diligence, the register of information, contracts and monitoring.
- DORA ICT Contract Review: A Guide for Quality Assurance Managers in Financial Services A quality-assurance approach to DORA Article 30: the terms every ICT contract needs, extra terms for critical functions, and reviewing contracts at scale.
- AS9100 Design and Document Cross-Checks: A Guide for Aerospace Quality Engineers How aerospace quality engineers cross-check drawings, specifications, certifications and FAI records under AS9100, and what IA9100 may add.
- AS9102 First Article Inspection: A Guide for Aerospace Quality Inspectors A practical AS9102 Rev C guide for aerospace quality inspectors: the three FAI forms, ballooning, full vs partial FAI, and why FAIRs get rejected.
- AS9100 Audit Readiness: A Guide for Aerospace Quality Managers How aerospace quality managers keep AS9100 audits clean and prepare for the IA9100 revision: timing, expected themes and an evidence-first readiness plan.
Subjects covered
- QMSR gap analysis
- QMSR supplier controls
- QMSR management review
- UN R155
- UN R156
- IATF 16949 supplier evaluation
- IATF 16949 audit readiness
- GMP inspection readiness
- GMP lab inspection
- GMP SOP review
- DORA ICT third-party risk
- DORA Article 30