Search results

Calibrating instruments after due date by fixing the window period

Yes, it is acceptable.

For more information about calibration requirements, please see the following link:

• Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

• Next steps following creation of QMS

  After creating a QMS the next step is to improve it. Because we did not design a perfect system, because clients change, because we learn new things, any QMS that does not continuously improve soon becomes obsolete.

  Time to implement and be certified, with our Toolkit Documentation, can take:

  • Companies of up to 10 employees - up to 3 months
  • Up to 50 employees - 3 to 6 months
  • Up to 200 employees - 6 to 10 months
  • More than 200 employees - 10 to 20 months

  You can find detailed information about how to plan and implement a quality management system in the following links:

  • Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
  • ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
  • Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
  • Free webinar on demand - How to use a Documentation Toolkit for the implementation of ISO 9001 - https://advisera.com/9001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-9001-free-webinar-on-demand/
  • 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/
     

• Organizing legalities and communication plans under ISO 9001:2015

  During an ISO 9001:2015 audit, legal and statutory regulatory requirements are about the product. For example, a car has to comply with a set of specifications and regulations set by standards and country legislation. For example, if your organization builds houses it has to comply with national regulation about houses as a product. For example, organizations manufacturing bricks in Europe have to comply with CE marking regulation, that means that the product, the bricks, have to comply with regulation and standards establishing minimum performance levels.

  About the communication you can check this article - Communication requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2016/11/01/communication-requirements-according-to-iso-9001-2015/ 

  I like to think about communicating the policy, the objectives, the action plans, the monitoring results and conclusions about the system suitability and effectiveness.

  You can find more information below:

  • What does “external documents control” mean in ISO 9001? - https://advisera.com/9001academy/blog/2019/02/04/what-does-external-documents-control-mean-in-iso-9001/
  • How to include statutory and regulatory requirements in your QMS - https://advisera.com/9001academy/blog/2017/02/14/how-to-include-statutory-and-regulatory-requirements-in-your-qms/
  • Free on-line course - 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/
     

   

• Quality Objectives for a manufacturing company

  The best way to start thinking about quality objectives is to start reading your organization’s quality policy. Can you underline any particular commitments, any particular promises made? Of course, every organization want to meet customer satisfaction, but what is needed to get it? Less defects? More innovative products? Lower price? More flexibility with orders? Faster response?

  Your organization want a quality management system (QMS) able to win new customers, satisfy current customers and continue to work with them. What does the QMS need to aim for to get those outcomes as consequences?

  The following material will provide you more information:

  • Article - How to define Key performance indicators for a QMS based ISO 9001: https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
  • Article - How to write good quality objectives: https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
  • Free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 -
    https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
  • Enroll for free course - 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/
     

• Objective targets for mining industries

  Unfortunately, I have no experience of working with mining industries. So, let us follow the standard.

  Your organization has made an environmental assessment where environmental aspects and impacts were determined. Then, your organization evaluated those environmental aspects and impacts and classified some as significant and deserving improvement in their relationship with the environment.

  Let us focus our attention on those environmental aspects and impacts. For example, the quality of the treated wastewater released to nature, or the amount of energy used per amount of ore processed.

  The action plans are about what your organization will do to actually improve the quality of the treated wastewater and to become more energy efficient.

  Please check this information below with more detailed answers:

  • Why mining companies should obtain ISO 14001 certification - https://advisera.com/14001academy/blog/2018/04/17/why-mining-companies-should-obtain-iso-14001-certification/
  • How to Use Good Environmental Objectives - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/how-to-use-good-environmental-objectives/
  • Examples of ISO 14001 objectives based on the different company sizes - https://advisera.com/14001academy/blog/2019/10/22/iso-14001-objectives-examples-for-different-company-sizes/
  • Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
  • Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
     

• Required manuals under ISO 9001

  ISO 9001:2015 has no mandatory requirement for the existence of manual or procedures. It is up to each organization to decide if a manual is useful and what should be its content.

  I recommend organizations to have a quality manual, but it is just a recommendation. Please check this article about mandatory documentation - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

  The following material will provide you information about the quality manual:

  • The future of the Quality Manual in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/
  • Free online training ISO 9001:2015 ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ nal-auditor-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
     

• ISO 20000 implementation benefits

  Usually, implementing anything without control lead, sooner or later, into waste of time and money.

  IT projects (including ITIL/ISO 20000 implementation) usually require interfacing between systems (i.e. technological solution, as a basis for IT services), processes, roles, etc. Without a decent plan and management, implemented solutions will run in isolation without expected benefits. Additionally, maintenance will be complex, data will be duplicated, processes will be chaotic…

  Here are few articles that can give you more information:

  Ready, steady… go – Starting ITIL implementation https://advisera.com/20000academy/blog/2014/06/10/ready-steady-go-starting-itil-implementation/

  ITIL and ISO 20000 – What does Project Management have to do with it? https://advisera.com/20000academy/blog/2015/03/31/itil-and-iso-20000-what-does-project-management-have-to-do-with-it/

  How to use ITIL to avoid 50% of IT project failures https://advisera.com/20000academy/blog/2015/05/12/how-to-use-itil-to-avoid-50-of-it-project-failures/