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@punyamisoconsu
Joined Feb 11, 2022
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punyamisoconsultant
@punyamisoconsu
How to Conduct and Plan an ISO 14155 Compliant Clinical Investigation
As we know ISO 14155 provides the general specifications and requirements for clinical investigations of medical devices. Also, the newest version of the ISO 14155 standard was published in 2020 and is intended to serve as a guide for clinical research professionals during the...
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Aug 27, 2022
punyamisoconsultant
@punyamisoconsu
What Benefits Does the ISO 22301 System Offer to the Company?
Business continuity management is defined by ISO 22301 as a component of comprehensive risk management in the enterprise, with some overlap with information security management and IT management. Implementation and certification can help an organization demonstrate compliance...
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Aug 17, 2022
punyamisoconsultant
@punyamisoconsu
How Does ISO 13485 Apply to Manufacturing Companies?
An international quality management standard called ISO 13485:2016 is used by companies that make medical devices. It describes the specifications for a quality system that the manufacturer must meet to prove its capacity to produce secure medical devices. Establishing a syste...
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Aug 10, 2022
punyamisoconsultant
@punyamisoconsu
The ISO 20121 Standard and Steps for Implementation
ISO 20121 is a global standard that defines the requirements for organizations and individuals to help them improve the sustainability of their event-related activities. It offers an efficient tool for event-related activities, products, and services to contribute to the three...
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Aug 1, 2022
punyamisoconsultant
@punyamisoconsu
6 Steps of Getting an ISO/IEC 17025 Accreditation and its Benefits
ISO/IEC 17025 is a global standard that specifies the general requirements for laboratories to perform competently, impartially, and consistently. The International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC) collaborated on...
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Jul 20, 2022
punyamisoconsultant
@punyamisoconsu
Recognize the Types of Products that Require CE Marking
The main goal of the CE marking is to promote free trade of products inside the EU and lessen the impact of the actual boundaries between member states. Making the regulatory requirements for safety, health, and the environment consistent across the EEA is another goal of CE m...
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Jul 9, 2022
punyamisoconsultant
@punyamisoconsu
Recognize the Benefits of Implementing the ISO 17025 For Testing and Calibration Laboratories
The ISO 17025 is a global standard for laboratories that can be implemented by all laboratories that perform testing, calibration, or sampling. If the laboratory has decided that they want to offer competent, professional testing services, accreditation is a strong assurance t...
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Jul 5, 2022
punyamisoconsultant
@punyamisoconsu
11 Key Principles and Benefits of ISO 21001 Based Educational Organizations Management System
ISO 21001 standard object is to provide a common management tool for businesses that deliver educational products and services capable of meeting the needs and requirements of learners and other beneficiaries. It is important to comply with the standard will require a variety...
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Jul 1, 2022
punyamisoconsultant
@punyamisoconsu
How to Obtain FSSC 22000 Certification in 12 Easy Steps
FSSC 22000 is a Food Safety Management Certification Scheme, managed by Foundation FSSC 22000 and governed by an independent Board of Stakeholders which consists of representatives from several sectors in the food industry. Risks related to food safety are managed using FSSC 2...
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Jun 27, 2022
punyamisoconsultant
@punyamisoconsu
Understand ISO 10002 Customer Satisfaction and Complaints Handling and its Benefits
ISO 10002 delivers guidance on the procedure of complaints handling associated to products within an organization, with planning, design, operation, maintenance, and enhancement. The complaints-handling process defined is appropriate for use as one of the procedures of an over...
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Jun 23, 2022
punyamisoconsultant
@punyamisoconsu
Learn Fundamental Requirements of the BRC Food Safety Standard
BRC is a global standard for food safety management systems. It includes a list of guidelines that food processors must adhere to create a successful food safety management system. The standard is available in various editions for producers, distributors, agents, and brokers o...
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Jun 22, 2022
punyamisoconsultant
@punyamisoconsu
9 Important Guidelines for Implementing GMP according to ISO 22716 Standard
GMP-related processes are essential to quality assurance and the guidelines help organizations manufacture practices that are constantly high in quality from every batch. Also, implementing industry-standard GMP according to ISO 22716 that requires considering the following GM...
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Jun 14, 2022
punyamisoconsultant
@punyamisoconsu
Understand BS 10012 Personal Information Management System
Personal information security has never been more significant. Any organization that handles personally identifiable information (PII) has a responsibility to confirm the security of privacy data. Organizations essential show that they take privacy management seriously, especi...
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Jun 13, 2022
punyamisoconsultant
@punyamisoconsu
Understand the steps of ISO 14155 Consultancy to implement Clinical Investigation of Medical Devices
The International Organization for Standardization released ISO 14155:2020, Clinical investigation of medical devices for human subjects - Good clinical practice, ISO 14155 standard established to guide clinical research professionals through the design, conduct, recording, an...
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Jun 10, 2022
punyamisoconsultant
@punyamisoconsu
Understand the ISO 29001 Standard and Its Benefits
ISO 29001 standard describes the quality management system requirements for the plan, development, manufacture, connection, and service of products for the petroleum, petrochemical, and natural gas industries. To support users of the documents, the requirements of ISO 29001 ar...
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Jun 8, 2022
punyamisoconsultant
@punyamisoconsu
5 Steps of The ISO 13485 Certification Process That Must Be Followed
ISO 13485 is an individual QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing envi...
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Jun 4, 2022
punyamisoconsultant
@punyamisoconsu
The ISO 22301 Requirements and a List of Mandatory Documentation
ISO 22301 is a globally recognized management system for business continuity. ISO 22301 Business Continuity certification purposes to help organizations to plan, launch, implement, operate, monitor, preserve, and examine the organizations to minimize the unexpected incidence,...
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May 24, 2022
punyamisoconsultant
@punyamisoconsu
5 Things That Must Know About the ISO 22716 Certification
ISO 22716 is an international standard of good manufacturing practices for the cosmetics manufacturing industry and defines the principles of applying GMP in a facility that produces complete cosmetic products. The ISO 22716 standard procedures suggest organized and practical...
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May 18, 2022
punyamisoconsultant
@punyamisoconsu
Steps of AS9100 Certification and Documents Requirements
AS9100 is an international standard contain requirements for creating and maintaining a quality management system for the aerospace industry. Its official name is AS9100 Quality Management Systems – Requirements for Aviation, Space and Defense Organizations and it is intended...
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May 13, 2022
punyamisoconsultant
@punyamisoconsu
Understand the Requirements of SA 8000 Certification
As an internationally active business, it is responsibility to maintain human working conditions. The SA8000 standard delivers documentary evidence of company's dedication to social and occupational norms around the world. It describes minimum standard that are useful for orie...
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May 9, 2022
punyamisoconsultant
@punyamisoconsu
What are the Steps of ISO 15378 Consultant Service?
ISO 15378: 2017 - Providers of ingredients for use as packaging have been developed to deliver a quality management system (QMS) by stakeholders in the pharmaceutical sector to primary pharmaceutical packaging drugs materials. This international standard classifies the princip...
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May 6, 2022
punyamisoconsultant
@punyamisoconsu
What are the important System Requirements needed to implement ISO 44001 certification?
The ISO 44001 is an International Standard for the collaborative business relationship management system. ISO 44001 is a roadmap for establishing and managing collaborative relationships with suppliers, customers, partners, and inter-department or functions to generate benefit...
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May 3, 2022
punyamisoconsultant
@punyamisoconsu
Key Points of ISO 18788 Structures for Security Operations Management System
ISO 18788 provides a framework for establishing, implementing, maintaining, and improving the management of security operations. It can be applied to Private Security Companies (PSCs), and their clients worldwide. What is the ISO 18788 system? ISO 18788 specifies the necessiti...
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Apr 26, 2022
punyamisoconsultant
@punyamisoconsu
What are the 15 Steps to Implementing ISO 22301 System in the Organization?
The ISO 22301 standard was formed by the International Organization for Standardization (ISO) business continuity management. The first edition of ISO 22301 was published in 2012 and the latest version was launched in 2019, so the standard is formally known as ISO 22301:2019....
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Apr 19, 2022
punyamisoconsultant
@punyamisoconsu
Mandatory Steps for Effective ISO 13485 Certification
ISO 13485:2016 specifies for a quality management system where an organization wants to prove its capability to deliver medical devices and associated services that constantly meet client and applicable regulatory requirements. Such organizations can be involved in one or more...
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Mar 28, 2022
punyamisoconsultant
@punyamisoconsu
What are the key benefits of ISO 20000 Implementation?
ISO 20000 is the international standard for IT Service Management (ITSM), published by ISO, and ICE. To become an international standard, ISO 20000 had to be approved upon by a majority of member countries, which means it is recognized by a majority of countries worldwide. The...
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Mar 10, 2022
punyamisoconsultant
@punyamisoconsu
Benefits of ISO 15378 Primary Packaging Materials for Medicinal Products
The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the medicinal sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products. Published in 2006, the...
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Mar 1, 2022
punyamisoconsultant
@punyamisoconsu
Importance of ISO 55001 Asset management system in Organization
What is ISO 55001? ISO 55001 is an asset management system standard, the main objective of which is to help organizations accomplish the lifecycle of assets more efficiently. By executing ISO 55001 organizations will have better control over daily activities, achieve higher re...
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Feb 11, 2022
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