iso 13485 standard (8)
Date Rating Views Comments Length

How to Perform an ISO 13485 Management Review Within the Organization?

The ISO 13485 standard addresses the management review procedure in requirement 5.6. It entails assessing the applicability and efficacy of the quality management system, finding areas for development...
08 December 2023 ·
0
· 8 · john
How to Perform an ISO 13485 Management Review Within the Organization?

Know the Common Nonconformities and How to Manage Those While Implementing the ISO 13485 Standard

Unless otherwise specified, ISO 13485 applies to companies of all sizes and types. ISO 13485 standard includes requirements for any business working at any level of the medical device and pharmac...
29 November 2023 ·
0
· 3 · Punyam Academy
Know the Common Nonconformities and How to Manage Those While Implementing the ISO 13485 Standard

Know the Necessity of Having an ISO 13485 Quality Policy

ISO 13485 Certification is the universal standard for the establishment and maintenance of an archived quality management system in the medical device industry. If a manufacturer has followed the ISO...
28 October 2023 ·
0
· 1 · sarahfrancoise
Know the Necessity of Having an ISO 13485 Quality Policy

How to Maintain the Quality Manual for the ISO 13485 Standard

The new ISO 13485 preserved the requirement for a Quality Manual in part because it is based on ISO 9001:2015, in contrast to the most recent edition of ISO 9001, which omitted the Quality Manual from...
17 October 2023 ·
0
· 3 · sarahfrancoise
How to Maintain the Quality Manual for the ISO 13485 Standard

What is the Most Efficient Way to Comply with ISO 13485's Requirements for Medical Device Infrastructure?

Any company cannot operate its operations without an infrastructure, which is required for the production, design, or supply of any good or service. Buildings, offices, utilities, machinery, tools, co...
16 September 2023 ·
0
· 1 · john
What is the Most Efficient Way to Comply with ISO 13485's Requirements for Medical Device Infrastructure?

Understand the 12-Step Implementation Checklist of ISO 13485 Quality Management System of Medical Devices Standard

The chosen medical device standard in the medical sector, ISO 13485 guarantees that all medical devices adhere to consumer and regulatory requirements. ISO 13485 certification is a vital certificate t...
06 September 2023 ·
0
· 1 · Punyam Academy
Understand the 12-Step Implementation Checklist of ISO 13485 Quality Management System of Medical Devices Standard

Consider the Fundamental Steps Before Selecting an ISO 13485 Consultant

The most effective medical device standard accessible is ISO 13485, which guarantees that all medical devices adhere to legal requirements for regulatory compliance and patient demands. An important c...
26 July 2023 ·
0
· 1 · Punyam_consultant
Consider the Fundamental Steps Before Selecting an ISO 13485 Consultant

How to Handle Process Validation Using the ISO 13485 Standard in the Medical Device Manufacturing Sector?

ISO 13485 allows organizations, specifically medical device manufacturers, to connect their quality management system (QMS) with medical device industry requirements. ISO 13485 offers significant bene...
25 May 2023 ·
0
· 1 · Punyam Academy
How to Handle Process Validation Using the ISO 13485 Standard in the Medical Device Manufacturing Sector?