ISO 13485:2016 QMS Assessment

Evaluate compliance with ISO 13485:2016 Quality Management System requirements for medical device design, development, production, and servicing

BiotechHealthcare22 minutes22 questions

1. Context & Leadership (Clauses 4-5)

Is the scope of your quality management system clearly defined and documented?*

Clause 4.3: QMS scope including device types and exclusions

Does top management demonstrate commitment to the QMS with a quality policy?*

Clause 5.3: Quality policy appropriate to purpose of organization

Are quality objectives established and measured at relevant functions and levels?*

Clause 5.4.1: Measurable objectives consistent with quality policy

Has a management representative been appointed with defined QMS responsibilities?*

Clause 5.5.2: Management representative reports on QMS performance

2. Planning & Risk Management (Clause 6)

Do you have a documented risk management process per ISO 14971?*

Clause 7.1: Risk management throughout product lifecycle

Are changes to the QMS planned, implemented, and verified for effectiveness?*

Clause 6.3: Changes controlled and impact on QMS assessed

3. Support & Resources (Clause 7)

Are infrastructure and work environment maintained to achieve conformity?*

Clauses 6.3-6.4: Facilities, equipment, IT, environmental controls

Do personnel have appropriate education, training, skills, and experience?*

Clause 6.2: Competency requirements with documented training

Are quality management system documents controlled with version management?*

Clause 4.2.4: Document control procedures for approval and changes

Are quality records retained and protected with defined retention times?*

Clause 4.2.5: Records provide evidence of conformity

4. Design & Development (Clause 7.3)

Are design and development processes planned with documented procedures?*

Clause 7.3.2: Design planning defines stages, reviews, verification, validation

Do design inputs include functional, performance, usability, and regulatory requirements?*

Clause 7.3.3: Complete, unambiguous input requirements

Are design outputs verified against inputs and approved before implementation?*

Clause 7.3.4-7.3.5: Outputs meet inputs, verification documented

Is design validation performed under actual or simulated use conditions?*

Clause 7.3.6: Validation confirms product meets user needs

5. Production & Service Provision (Clause 7.5)

Are production processes validated before implementation and revalidated periodically?*

Clause 7.5.6: Process validation demonstrates consistent results

Do you maintain traceability from raw materials through production to distribution?*

Clause 7.5.8: Traceability for implantable devices and as required

Are monitoring and measuring equipment calibrated and maintained?*

Clause 7.6: Calibration traceable to international/national standards

Is product cleanliness and contamination control addressed where required?*

Clause 7.5.5: Sterility, particulate, and microbial control

6. Improvement & CAPA (Clauses 8-10)

Are internal audits conducted at planned intervals to verify QMS effectiveness?*

Clause 9.2: Internal audit program covering all processes

Does top management review the QMS at planned intervals for continuing suitability?*

Clause 9.3: Management review evaluates opportunities for improvement

Do you have a documented CAPA system that addresses root causes?*

Clause 8.5.2-8.5.3: Corrective and preventive action procedures

Are customer complaints investigated and regulatory reporting requirements met?*

Clause 8.2.2: Complaint handling with timeline and reporting

Please answer all required questions to see your results