john Smith

ISO Documents Consultant

  • Articles Posted: 5
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ISO 45001 Documents – Requirements for Occupational, Health and Safety Management System Certification

  • 02 Nov 2021
  • 0

The latest version of ISO 45001 was published in 2018, and the transition from the previous version is ahead. Records, on the other hand, are controlled by clause 4.5.4, which requires rules for records to be identifiable, properly stored, protected, retrievable, and disposed of at the end of a specified retention period.The purpose of an OH&S management system is to provide a framework for managing OH&S risks and opportunities. The aim and intended outcomes of the OH&S management system are to prevent work-related injury and ill health to workers and to provide safe and healthy workplaces; consequently, it is critically important for the organization to eliminate hazards and minimize

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How ISO 22716 Audit Checklist Useful for an Internal Audit?

  • 23 Oct 2021
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A Cosmetic-Good Manufacturing Practices (GMP) according to the ISO 22716 standard helps organizations to ensure that the micro-level system and a user in fine-tuning the processes and establish a Cosmetic-Good Manufacturing Practices (GMP) that gives better control. ISO 22716 certification can improve a system. If you are planning your ISO 22716 internal audit for your Cosmetic-Good Manufacturing Practices (GMP), you may look for some kind of an ISO 22716 audit checklist.ISO 22716:2007 Cosmetic-Good Manufacturing Practices (GMP) also helps users in preparing and managing ISO 22716 audits by providing detailed ISO 22716 checklists. This ISO22716:2007 audit checklist is designed to be used as a tool to identify compliance with ISO

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ISO 14155 Documents - Requirements for clinical investigation of medical devices.

  • 07 Oct 2021
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The ISO 14155:2020 is an international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. However, it does not apply to in vitro diagnostic medical devices. It is required a specific set of documents for its effective implementation and quick ISO 14155 certification. These ISO 14155 documents should be prepared in such a way so that defines entire implemented system well. A well-designed set of documents help organization to minimize the time and the cost involved in certification as well as better control over the Clinical investigation

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Global Manager Group Launched API Spec Q1 Documentation Kit

  • 11 Sep 2021
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Global Manager Group (GMG) – industry leader in the global market for selling online ISO documentation kits as well as management system awareness and auditor training kits – has recently launched API Spec Q1 Documentation Kit to cater to the documentation needs of manufacturing organizations and management system consultants for the petroleum and natural gas industry.The API Spec Q1 Documentation kit contains a set of total 180 editable document files, which are based on the latest 9th edition of the requirements of API specification Q1 standard for manufacturing organizations in the petroleum and natural gas sector. This newly launched editable documentation package contains a sample API manual for specification

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ISO 13485:2016: Medical device design controls and why they’re important

  • 20 Jul 2021
  • 0

Medical device design controls are a set of policies and practices intended to ensure consistent translation of input requirements into a physical product that meets those requirements. The ISO 13485 Certification is based on the quality management system, which helps to implement the medical device preventive system. Good design controls are important to:·        Reduce product risks·        Demonstrate your product is fit for purpose·        Align your organisation Prepare procedures for design and development:Document Manager enables you to prepare ISO 13485 procedures for design and development. So a Procedure is a high-level SOP and a work instruction is more for deep dive, and controlled documents. Under the requirements of ISO 13485, there are certain procedures that must

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