ISO 13485

What Is ISO 13485 QMS

ISO 13485 Is A Management Systems Standard Specifically Developed For The Manufacture Of Medical Devices.

ISO 13485 Contains Requirements That Are Essential For Any Organization Operating At Any Tier In The Medical Device And Pharmaceutical Supply Chain. It Is Especially Relevant To Manufacturers That Wish To Demonstrate Applicable Regulatory Requirements, And By Organizations Whose Services Support Medical Device Manufacturers. 

ISO Can Be Applied By Any Size Of Medical Service Provider Throughout The Life- Cycle Of Device. It Is Entitled In Every Stage Of Device Life, From Planning, Production, Supply, Distribution, Storage, Installation, Controlling, Monitoring, Maintain And Even For Post Production. It Is Not Obligatory But Still A Necessity For Medical Service Providers To Be Trusted By Consumers, Stakeholders And All The Parties Concerning To Them.

ISO 13485 Can Be Adopted By Any Organization Manufacturing Medical Devices Irrespective Of Its Shape, Size, Age, And Geographical Location. It Is Currently Implemented By The Organization In 21 Countries.

ISO Have Adopted Process Approach Which Follows PDCA Act (Plan – Do – Check – Act) Cycle Which Brings In A Drive For Continued Perfection In The Process Of Organization.

Its Primary Objective Is To Facilitate Harmonized Medical Device Regulatory Requirements.

The Standard Contains Specific Requirements For Manufacture, Installation And Servicing And Calls For:

  • Implementation Of A Quality Management System With Several Enhancements
  • Risk Management Approach To Product Development And Product Realisation
  • Validation Of Processes
  • Compliance With Statutory And Regulatory Requirements
  • Effective Product Traceability And Recall Systems
  • Benefits Of Iso 13485
  • Customer Satisfaction - Through Delivery Of Products That Consistently Meet Customer Requirements As Well As Quality, Safety And Legal Requirements
  • Reduced Operating Costs - Through Continual Improvement Of Processes And Resulting Operational Efficiencies
  • Improved Stakeholder Relationships - Including Staff, Customers And Suppliers
  • Legal Compliance - By Understanding How Statutory And Regulatory Requirements Impact The Organization And Its Customers
  • Improved Risk Management - Through Greater Consistency And Traceability Of Products And Use Of Risk Management Techniques
  • Proven Business Credentials - Through Independent Verification Against Recognized Standards
  • Ability To Win More Business - Particularly Where Procurement Specifications Require Certification As A Condition To Supply In A Highly Regulated Sector

How To Achieve ISO 13485 Certification - ISO 13485 Implementation / Compliance / Certification Steps

Times Business Services Offers A Well Defined And Globally Proven Implementation Methodology For ISO 13485 Certification.

  • Gap Analysis
  • Awareness Training
  • Process Identification And Definition
  • Documentation Design And Finalization
  • Implementation
  • Internal Auditor Training And Conduct Of Internal Audit
  • Management Review Meeting
  • Review Of Implementation
  • Pre-Assessment
  • Stage 1 – Certification Audit
  • Stage 2 – Certification Audit
  • Award Of ISO 13485 Certification
  • Continual Improvement Of The System Through Value Added Consulting And Training Services

What Are The Requirements Of ISO 13485 Standard ?

As Mentioned, The ISO-13485 Has Special Requirements That Are Not Covered By ISO-9001:2008. These Special Requirements Include Both Documentation And System/Process Requirements That Cater To The Medical Device Industry. 

Aside From Regulation-Required Documents, Additional Documentations Required By ISO-13485 Include Those Pertaining To: 1) Responsibilities And Authorities; 2) Training Procedures; 3) Health, Cleanliness, And Clothing; 6) Environmental Conditions; 7) Control Of Contaminated Products; 8) Risk Management; 9) Customer Requirements; 10) Design And Development; 11) Purchasing Control, Including Purchase Traceability And Verification; 12) Reference Materials; 13) Labeling And Packaging; 14) Installation And Verification; 15) Sterilization Process Validation; 16) Preservation Of Product (Including Shelf Life); And 17) Measurement And Monitoring. 

Special System/Process Requirements Of The ISO-13485 Include: 1) Risk Management Systems; 2) Clinical Evaluations And Trials; 3) Product Cleanliness And Contamination Controls; 4) Requirements For Implantable Devices; 5) Proper Communication Of Advisory Notices; And 6) Additional Research And Development Requirements

Integrate ISO 13485 With Other Management System Standards

ISO 13485 Is Designed To Be Compatible With Other Management Systems Standards And Specifications, Such As ISO 9001, OHSAS 18001, ISO 22000, ISO 17025, ISO 27001, ISO 14001 Environment And Other ISO Standards. They Can Be Integrated Seamlessly Through Integrated Management System Approach. They Share Many Principles So Choosing An Integrated Management System Can Offer Excellent Value For Money And An Easier Approach To Implement, Manage And Improve Multiple Standards Simultaneously.

What We Offer In The Field Of ISO 13485 Standard And Certification

As One Of The Largest ISO Management System Certification Consulting Companies Across The World With Clients In More Than 40 Countries, Our Knowledge And Experience Of The Standards Is Unsurpassed. We Understand How To Fully Exploit The Benefits Of Your Quality Management System To Ensure You Unlock The True Potential In Your Organization. 

We Provide Unmatched Expertise And Technical Competence To Ensure That Your ISO 13485 Quality Management System Certification Project Adds Value To Your Organization. 

We Provide Consulting, Training, Internal Audits, Pre Assessment Audits And Facilitation During ISO 13485 Certification Audit.

We Offer Our Global Knowledge Moulded Locally To Bring In The Best Results For Our Clients And Partner Their Journey Of Standardization, Compliance, Growth, Success And Continual Improvements.

Contact Us Now, To Get Your Organization ISO 13484 Certified In The Most Effective And Efficient Manner While Realizing The True Benefits Of The Certification Using Our Specialized ISO Implementation Methodology That Is Less Time Consuming, Fast, Easy To Understand And Implement, Result Oriented, Time Bound And Cost Effective. Get ISO 13485 Certified Now With Us….


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