Best Practices for ISO 27001-Compliant Remote Access Policy

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest Managing and securing your data has become critical in the data-driven IT era. This guide will walk you through best practices for an ISO 27001-compliant remote access policy and effective implementation of information […]

Medical Device Recalls: Managing and Implementing Effective Measures

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest A recall, along with necessary advisory notices, is a reactive but crucial approach used by medical device manufacturers to remove a device from the market due to regulatory violations, serious risk of injury, […]

Free Access to ISO 13485 for COVID-19 Support

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest To support efforts against COVID-19, the International Organization for Standardization (ISO) has made certain standards accessible for free. These standards are crucial for the biological evaluation of medical devices and protective clothing used […]

Unraveling the Mystery of Annex A.17 in ISO 27001

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest One of the most puzzling aspects of implementing ISO 27001 is tackling Annex A.17, which addresses business continuity management. How does business continuity relate to information security, and why is it a part […]

Making the Most of Your ISO 27001 Certification Audit Report

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest For those already running a management system like an ISMS based on ISO 27001, the certification audit process is familiar. The auditor arrives, performs the audit, evaluates processes and records, states the result, […]

ICT or Remote Auditing for Management System Standards

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest Since companies have to maintain their certification and the provision for ICT auditing or remote auditing is already there is the auditing standards, but was never practiced extensively by certification bodies. Now due […]

What is ISO 13485?

Table of Contents What is ISO 13485? A Step-by-Step Guide to Medical Devices Quality Management ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), ISO 13485 provides a comprehensive framework for a Quality Management System (QMS) in the medical device industry. […]

ISO 13485: Documentation Requirements

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest The new ISO 13485 is based on ISO 9001:2008, meaning its documentation requirements build on the previous version of ISO 9001, with additions specific to the medical device industry. Below is a list […]

Crafting an Effective ISO 13485 Quality Policy

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest When implementing a Quality Management System (QMS) for your medical device manufacturing organization, one of the first steps is to create your Quality Policy as per ISO 13485:2016 (requirement 5.3). But what exactly […]

Mandatory ISO 27001:2022 Documentation

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest If you’ve ever wondered which documents are mandatory in the 2022 revision of ISO/IEC 27001, here’s the list you need. Below are both the mandatory documents for ISO 27001:2022 implementation and the most […]