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Difference between ISO 13485 and EN 14683:2019

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes - is a standard that is applicable for all manufacturers of medical devices, it is considering the quality management system of the manufacturing the medical device.

EN 14683:2019 Medical face masks. Requirements and test methods – is a standard that covers requirements under which medical masks must be produced and which tests must be performed to prove that medical masks are in compliance with this standard.

So, those two standards complement each other, which means that medical masks must be designed and made according to the EN 14683:2019, but the manufacturer must have implemented a quality management system in accordance with ISO 13485:2016.

For more information about ISO 13485:2016 please see the following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• Quality Management System: What is it? - https://advisera.com/9001academy/knowledgebase/quality-management-system-what-is-it/

• ISO 9001 scope of the quality management system in a cemetery

  Start by thinking about who the cemetery’s customers are. What kind of services does the cemetery offer to its customers? From all the services provided, will all of them be part of the quality management system (QMS)?

  For example, without the proper vocabulary of the area, I can imagine something like: we provide services of burials, cremations, exhumations, and transfers.

  The scope defines and communicates the borders of the QMS. Consider the purpose of the scope, it should clearly describe the type of Products and Services covered by the system and provide sufficient information, preventing the transmission of erroneous or misleading information about what the organization covers in the QMS and what it is able to provide to its customers.

  The following material will provide you more information:

  • How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
  • You can see this free webinar on-demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope -
  • Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
  • Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

• industrialization KPI's

  You can set a project implementation budget target and look at the realization rate of this budget. The project implementation budget target should be set on an individual project basis. The project budget should be determined on a project basis. When you define the project budget,   you should take into consideration of; 

  - Number of the tool to be made, 

   -the new machine to be taken cost, 

  - the number of samples to be made, 

  - investment cost, 

  - Product validation, test cost 

  - New test machine investment 

  - travel cost to customer or supplier site, 

  - supplier investments,  

  - etc.

   

   

• ISO 9001 Mandatory processes

  No, it is not mandatory to put in place such processes while implementing a QMS based on ISO 9001:2015. Please check the content of the antepenultimate paragraph of clause 0.4 of ISO 9001:2015.

  Please check this free webinar on-demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ - where I explain how to develop process mapping, drawing a model of how an organization works, based on the process approach, and how to draw a flowchart describing each process.

  The following material will provide you information about processes:

  • Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ (where I apply the process approach as the basis for developing a quality management system)
     

• How far is the ISO 27001/GDPR package away from being ISO 27701 compliant?

  Please note that ISO 27701 was developed as an extension of ISO 27001 and ISO 27002. Considering that, ISO27001/GDPR toolkit is approximately 80% compliant with ISO 27701. The remaining 20% refers to small adjustments to include the protection of privacy in the context of the documents (e.g., where a document states “information security”, it now should state “information security and privacy”, and applicable controls should consider complementary privacy protection measures), and the inclusion of applicable controls specifically developed for ISO 27701 (in a total of 49 controls).

  For further information, read:

  • Relationship between ISO 27701, ISO 27001, and ISO 27002 https://advisera.com/27001academy/blog/2019/12/10/relationship-between-iso-27701-iso-27001-and-iso-27002/

  These articles will provide you a further explanation about ISO 27001:

  • What is ISO 27001 https://advisera.com/27001academy/what-is-iso-27001/
  • Where to start from with ISO 27001 https://advisera.com/27001academy/knowledgebase/iso-27001-where-to-start-most-important-materials/

  These materials will also help you regarding ISO 27001:

  • Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
  • ISO 27001 Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

• Incident Management Procedure

  Records are specific types of documents used to evidence that activities were performed and/or results were achieved, and to be compliant with ISO 27001 standards you need to keep some records about incident handling, such as the incident log, for a period of time-related to some need defined by the organization, or by a legal requirement that must be fulfilled (e.g., a law, regulation or contract). Once the retention period is over you can dispose of the record, simply by deleting them, or through specific procedures to prevent them to be accessed once disposed of.

  Additionally, once a record is created, it cannot be amended, so access to such records need to be controlled.

  This article will provide you a further explanation about managing records:

  • Records management in ISO 27001 and ISO 22301 https://advisera.com/27001academy/blog/2014/11/24/records-management-in-iso-27001-and-iso-22301/

  These materials will also help you regarding records management:

  • Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/
  • ISO 27001 Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

• Implementing ISO 9001:2015

  Let me clarify how I interpret your question:

  Your organization is implementing a quality management system. A quality management system requires that an organization performs internal audits by a competent person, an auditor. Normally, organizations decide that internal auditors should have a good knowledge of the standard and of good auditing practices. It is up to each organization to decide the extent of knowledge needed and the way to evidence it.

  If your organization determines that internal auditors have to go through an internal auditor course and that the evidence is the certification test, then you must have the certification test to evidence competence. If you fail to pass, you must retry. By the way, with our - Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/ - you have a second attempt without paying and you only repeat the part of the exam where you failed.

  You can find more information below:

  • Article - ISO 9001 internal auditor training: Is it for me? - https://advisera.com/9001academy/blog/2015/06/02/iso-9001-internal-auditor-training-is-it-for-me/
  • Webinar - Free webinar on-demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/
  • Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/
     

• Timeline and cost associated with getting ISO 13485 certified

  Excellent way of telling, and pleasant piece of writing to take information about my presentation focus, which i am going to present in school. save refuges

• ISO 17025 requirements for Pharmaceutical organization

  ISO 17025 requirements apply to all laboratories for all testing, calibration and sampling. The Pharmaceutical sector, as for any other sector or accreditation program such as, e.g. Veterinary or Pesticide analysis for product registration; have national and perhaps international regulatory requirements. The requirements depend on what the “Pharmaceutical organization” activities are. A production QC laboratory might. for example, be ISO 17025 accredited as per “general” requirements for Chemical Testing. Typically an accreditation body would have a program for Pharmaceutical Laboratories or include Pharmaceutical biological, microbiological and biochemical testing and measurement under the Biological Programme. The requirements would depend on the scope which could be, for example,  Drug testing, Chemical Analysis or Pharmaceutical Testing.

  I recommend you look at your accreditation body website or call them to obtain specific requirements.

  For a list of accreditation bodies have a look at https://ilac.org/signatory-search/

  For more information on ISO 17025 see

  • The whitepaper Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
  • The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

• Creating a template for an equipment PM plan

  You want that particular equipment at a particular moment in time to have preventive maintenance. So, you can think about something like:

  

  It is like having a calendar scheduling preventive maintenance at each equipment.

  Normally, what to do at each preventive maintenance intervention is not included in the PM plan but at each equipment documentation.

  You can find more information below:

  • ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/