ISO 13485:2016 mandates a range of documented procedures to ensure compliance and the consistent production of safe medical devices. While documentation is critical, it’s equally important to keep your Quality Management System (QMS) documentation lean, focusing on key compliance areas without overburdening your system. This approach is particularly valuable for small and mid-sized companies implementing ISO 13485. Here are some strategies to streamline QMS documentation and meet ISO 13485:2016 requirements:
1. Simplifying Documented Procedures
ISO 13485 requires over 20 procedures, but many can be merged. Combining related requirements into fewer documents reduces redundancy and improves clarity.
2. Best Practices for QMS Documentation
- Quality Agreements with Outsourced Partners: Define roles, certification requirements, audit schedules, non-compliance reporting, and resolution protocols.
- Validation of Software Applications: Ensure software is periodically checked for proper configuration and function, especially after updates.
- Quality Manual: Outline the scope of your QMS, responsibilities, exclusions, and process models in a concise manner.
- Quality Policy and Objectives: Establish a clear commitment to quality and set S.M.A.R.T. (Specific, Measurable, Achievable, Realistic, and Time-based) objectives.
3. Document and Record Control
- Maintain up-to-date versions of documents, track changes, and ensure that obsolete versions are removed from circulation. Merge this with record management for better efficiency.
4. Defined Roles and Responsibilities
- Use organizational charts and job descriptions to clearly define QMS roles and ensure responsibilities are well understood.
5. Management Review and Competency Training
- Conduct regular management reviews and implement a robust procedure for employee competency and training.
6. Infrastructure, Maintenance, and Work Environment
- Combine requirements for infrastructure, maintenance activities, and work environment into a single procedure to minimize paperwork.
7. Product and Process Controls
- Develop documented procedures for the control and monitoring of production, including product cleanliness, traceability, and servicing. These can be combined to avoid redundancy.
8. Customer Feedback and Complaints Handling
- Establish a streamlined process for gathering and responding to customer feedback, which can be incorporated into your sales procedures.
9. Internal Audits and Nonconforming Product Control
- Document procedures for internal audits and control of nonconforming products, ensuring they align with corrective and preventive actions.
10. Data Analysis and Continuous Improvement
- Ensure your QMS includes procedures for analyzing performance data and driving continual improvement, focusing on corrective and preventive actions.
By merging procedures where possible and focusing on essential documentation, companies can implement a compliant yet streamlined QMS, saving time and resources. The key to an effective QMS is maintaining simplicity while ensuring all ISO 13485 requirements are met.
Here is the table for mandatory documents required under ISO 13485:2016
| Mandatory Document | Clause of ISO 13485:2016 |
|---|
| Document the role(s) undertaken by the organization | 4.1.1 |
| Written Quality Agreements with outsource partners | 4.1.5 |
| Procedure for the Validation of the Application of Computer Software | 4.1.6, 7.5.6, 7.6 |
| Quality Manual | 4.2.1 |
| Quality Policy | 4.2.1 |
| Quality Objectives | 4.2.1 |
| Procedure for Document Control | 4.2.4 |
| Procedure for Record Control | 4.2.5 |
| Responsibilities and Authorities | 5.5.1 |
| Procedure for Management Review | 5.6.1 |
| Procedure for Competence, Training and Awareness | 6.2 |
| Requirements for the infrastructure | 6.3 |
| Requirements for the maintenance activities | 6.3 |
| Requirements for the work environment | 6.4.1 |
| Requirements for health, cleanliness, and clothing of personnel | 6.4.1 |
| Arrangements for the control of contaminated or potentially contaminated product | 6.4.2 |
| Requirements for control of sterile medical device contamination | 6.4.2 |
| Processes for risk management in product realization | 7.1 |
| Arrangements for communicating with customers | 7.2.3 |
| Procedure for Design and Development | 7.3.1 |
| Procedure for Purchasing and Evaluation of Suppliers | 7.4.1 |
| Procedure and methods for the control of production | 7.5.1 |
| Requirements for cleanliness of product | 7.5.2 |
| Requirements for medical device installation and acceptance criteria for verification of installation | 7.5.3 |
| Procedure for Servicing Activities of Medical Device | 7.5.4 |
| Procedures for Validation of Processes | 7.5.6 |
| Procedure for the Validation of Processes for Sterilization | 7.5.7 |
| Procedure for Product Identification | 7.5.8 |
| Procedure for Traceability | 7.5.9.1 |
| Procedure for Preserving the Conformity of Product | 7.5.11 |
| Procedure for Monitoring and Measuring Equipment | 7.6 |
| Procedure for Customer Feedback Gathering | 8.2.1 |
| Procedure for Complaint Handling | 8.2.2 |
| Procedure for Internal Audit | 8.2.4 |
| Procedure for Control of Nonconforming Product | 8.3.1 |
| Procedure for Issuing Advisory Notices | 8.3.3 |
| Procedure for Rework | 8.3.4 |
| Procedure for Analysis of Data | 8.4 |
| Procedure for Corrective Actions | 8.5.2 |
| Procedure for Preventive Actions | 8.5.3 |
Here is the table for mandatory records required under ISO 13485:2016
| Mandatory Records | Clause of ISO 13485:2016 |
|---|
| Quality Agreement with Outsourced Processes | 4.1.5 |
| Records of Software Validation Activities | 4.1.6, 7.6 |
| Medical Device File | 4.2.3 |
| Records of Management Review | 5.6.1 |
| Records of Education, Training, Skills and Experience | 6.2 |
| Records of the Maintenance Activities | 6.3 |
| Records of Risk Management Activities | 7.1 |
| Outputs of Product Realization Planning | 7.1 |
| Records of the Results and Actions Arising from Review of Requirements Related to Product | 7.2.2 |
| Records of Product Requirements Changes | 7.2.2 |
| Design and Development Planning Documents | 7.3.2 |
| Design and Development Inputs | 7.3.3 |
| Design and Development Outputs | 7.3.4 |
| Records of Design and Development Review | 7.3.5 |
| Records of the Results and Conclusions of the Design and Development Verification | 7.3.6 |
| Design and Development Validation Plans | 7.3.7 |
| Records of the Results and Conclusion of Design and Development Validation | 7.3.7 |
| Results and Conclusions of the Design and Development Transfer | 7.3.8 |
| Records of Design and Development Changes | 7.3.9 |
| Design and Development File | 7.3.10 |
| Records of the Results of Evaluation, Selection, Monitoring and Re-evaluation of Supplier | 7.4.1 |
| Records of the Purchased Product Verification | 7.4.3 |
| Record for Each Medical Device or Batch of Medical Devices | 7.5.1 |
| Records of Medical Device Installation and Verification of Installation | 7.5.3 |
| Records of Servicing Activities | 7.5.4 |
| Records of Traceability | 7.5.9.2 |
| Internal Audit Report | 8.2.4 |
| Evidence of Conformity of Products with the Acceptance Criteria | 8.2.6 |
| Records of Actions relating to the Issuance of Advisory Notices | 8.3.3 |
| Records of Rework | 8.3.4 |
| Records of the Results of Data Analyses | 8.4 |
| Records of Corrective Actions | 8.5.2 |
| Records of Preventive Actions | 8.5.3 |
Here is the table for the additional documents required under ISO 13485:2016:
| Document Title | Clause of ISO 13485:2016 |
|---|
| Procedure for Measuring Customer Satisfaction | 5.2 |
| Procedure for Identification of Regulatory and Customer Requirements | 5.2 |
| Procedure for Internal Communication | 5.5.3 |
| Procedure for Planning Product Realization | 7.1 |
| Quality Plan | 7.1 |
| Sales Procedure | 7.2 |
Here is a list of additional mandatory documents as per Indian Medical Device Rules, 2017 under the Quality Management System (QMS), which are not covered by the ISO 13485:2016 clauses you have already listed:
| Document Title | Relevant Clause |
|---|
| Medical Device Registration Documents | MD Legal Forms |
| Device Master File (DMF) | Fourth Schedule |
| Site Master File (SMF) | Fourth Schedule |
| Post-Market Surveillance (PMS) Plan | Fourth Schedule |
| Adverse Event Reporting Procedure | Fourth Schedule |
| Procedure for Handling Recalls | Rule 38, 26 & Rule 89 |
| Procedure for Regulatory Reporting of Field Safety Corrective Actions | Rule 38, 26, Fourth Schedule |
| Procedure for Labelling and Packaging Requirements | Chapter VI |
| Procedure for Import/Export Control | Chapter V |
| Clinical Investigation Plan | Chapter VII |
| Procedure for Compliance with Essential Principles of Safety and Performance | Rule 6, 7 |
| Shelf Life Studies & Stability Data procedure | Fourth Schedule |
| Procedure for Batch Release and Record Keeping | Rule 26 |
| Distribution Record Keeping | Chapter XI, Rule 87 |
Documents Required under EN ISO 13485:2016 (in addition to what we listed earlier)
| Mandatory Document | Relevant Clause |
|---|
| Procedure for Design and Development Changes | 7.3.9 |
| Design and Development Transfer Records | 7.3.8 |
| Procedure for Control of Monitoring and Measuring Equipment | 7.6 |
| Work Environment Control Procedure | 6.4 |
| Procedure for Control of Nonconforming Product | 8.3 |
| Procedure for Traceability of Product | 7.5.9 |
| Records of Design and Development Review | 7.3.5 |
| Records of Design and Development Validation | 7.3.7 |
| Verification of Purchased Product | 7.4.3 |
| Procedure for Post-Market Surveillance (PMS) | 8.2.1 |
Documents Required under EU MDR (EU 2017/745)
| Mandatory Document | Relevant MDR Article/Annex |
|---|
| Technical Documentation (Device Dossier) | Article 10, Annex II |
| Post-Market Surveillance Plan | Article 84, Annex III |
| Clinical Evaluation Plan and Reports | Article 61, Annex XIV |
| Procedure for Market Surveillance | Article 83 |
| Unique Device Identification (UDI) Procedure | Article 27, Annex VI |
| Procedure for Risk Management | Article 10, Annex I |
| Procedure for Incident Reporting and Field Safety Corrective Actions (FSCA) | Article 87, 88, Annex II |
| Procedure for Vigilance and Adverse Event Reporting | Article 87 |
| Procedure for Periodic Safety Update Reports (PSUR) | Article 86 |
| Post-Market Clinical Follow-up Plan and Reports | Article 61, Annex XIV |
Documents Required under EU IVDR (EU 2017/746)
| Mandatory Document | Relevant IVDR Article/Annex |
|---|
| Performance Evaluation Plan and Reports | Article 56, Annex XIII |
| Post-Market Performance Follow-up Plan | Article 10, Annex XIII |
| Technical Documentation (IVD Device Dossier) | Article 10, Annex II |
| Procedure for Labelling and Instructions for Use (IFU) | Article 11, Annex I |
| Procedure for Analytical and Clinical Performance Studies | Article 56, Annex XIII |
| Procedure for Handling and Reporting Serious Incidents | Article 82, Annex III |
| UDI Procedure | Article 24, Annex VI |
| Procedure for Conformity Assessment | Article 48, Annex IX |
All the SOPs, Documents and records are for indicative and may be legally binding based upon the jurisdiction pertaining to the scope of the organisation.
