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ISO 9001 The Best Way to Implement QMS

Design and implementing a quality management system (QMS) implies being knowledgeable about ISO 9001:2015. Now the standard is less and less bureaucratic, it is up to each organization the task to design, develop and implement its QMS.

Setup a project sponsor, a project manager and a project team. Determine the scope of the QMS, your organization may decide to include only certain lines of business. Ensure top management support, get training and as a first step perform a Gap analysis, to determine the amount of work to be done - comparing what your organization already has in place versus ISO 9001:2015 requirements. From that GAP Analysis you can develop your Project Plan, listing what needs to be done, by whom, until when.

Then, an important step is to design a model of how your organization work as a set of interrelated processes. For example:

Decide how to describe and monitor those processes.

From there it is implementation in order to close the gaps found. Then, perform an internal audit and the management review. There you can decide if your organization is ready for a certification audit.

This is a very short description of the journey but below you can find more detailed information:

• Free Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
• Should you use a gap analysis in your ISO 9001 implementation? -https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/
• 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 online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
• Enroll for free course - ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

ISO 9001 Implementation in a Start-up Company

A - Let me use new company to represent a new company with an established business model, like a restaurant, like a new shoe manufacturing plant, or a new transport company.

B - Let me use start-up company as a designation for a project of company in search of a business model. Startups, in reality, are not yet companies, they are still projects of companies in search of a successful business model and customer fit. So, a startup is like an experiment being done. The startup can be called a company only after finding the right business model, a customer fit, and when it starts scaling. Only then, the procedures and internal standards are ready to be documented.

So, for situation B it is too early to certify. For situation A, I think it is easier to get ISO certification than with an established company (with same resources and motivation). An established company has to unlearn some practices and that it is not always easy.

You can find more information below:

• Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
• What are the benefits of ISO 9001 for your employees? - https://advisera.com/9001academy/blog/2016/06/14/what-are-the-benefits-of-iso-9001-for-your-employees/
• How to budget an ISO 9001 implementation project - https://info.advisera.com/9001academy/free-download/how-to-budget-an-iso-9001-implementation-project?utm_source=script-for-iso-9001-lead-implementer-course&utm_medium=downloaded-content&utm_content=lang-en&utm_campaign=free-downloads-9001
• 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 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/
   

Disclosing identity of user in a copyright infringement proceeding

I assume that the establishment you are referring to is under extra-EU law and subject to the legislation of its own country. If so, I am afraid it must share personal data in a copyright infringement proceeding. Article 6 paragraph 1 letters c) GDPR allow to disclose personal data to comply with a legal obligation.

Here you can find more information:

• Is consent needed? Six legal bases to process data according to GDPR https://advisera.com/eugdpracademy/knowledgebase/is-consent-needed-six-legal-bases-to-process-data-according-to-gdpr/

You can consider enrolling in our free EU GDPR Foundations Course

• EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

• ISO 14001 Waste Management

  For waste management I find it useful to design a kind of process flow since waste generation, segregation, general collection, disposal, over a plant of the facilities. That way everybody can grasp the whole picture.

  Where are wastes generated, of what kind, in what amounts and by whom? – From here you can think about the need and dimension of different bins to collect segregated wastes, who needs training and awareness about what bins to use. Who will collect? Who is responsible for contacts with waste disposal company? What can be or what makes sense to measure?

  Please check this information below with more detailed answer:

  • 7 steps in handling waste according to ISO 14001 - https://advisera.com/14001academy/blog/2016/11/07/7-steps-in-handling-waste-according-to-iso-14001/
  • Using ISO 14001 to manage and reduce waste in the electronics industry - https://advisera.com/14001academy/blog/2017/02/13/using-iso-14001-to-manage-and-reduce-waste-in-the-electronics-industry/
  • Is a gap analysis desirable for ISO 14001 implementation? - https://advisera.com/14001academy/blog/2016/11/14/is-a-gap-analysis-desirable-for-iso-14001-implementation/
  • 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/

• ISO 9001 Developing Risk Register and an Opportunity Table

  You can certainly see your expertise in the article you write. The world hopes for even more passionate writers like you who aren't afraid to say how they believe. At all times go after your heart.

• ISO 9001 Question

  I start showing that interaction through a picture like this one.

  

  Then, in each process description I list the main relevant clauses.

  The following material will provide you more information about the process approach:

  • 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/ - please check how training can be related with the process approach
  • 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 extensively use the process approach.
     

• ISO 9001 Remote Audit Procedure

  Unfortunately, we still have not develop that procedure, but perhaps this free webinar on demand can help you - - How to perform an internal audit remotely - https://advisera.com/9001academy/webinar/remote-internal-audit-free-webinar-on-demand/ a detailed explanation about how to remotely audit operations using a tablet, a smartphone, CCTV or a drone.

  You can find more information below:

  • What are the benefits and barriers when performing remote audits? - https://advisera.com/articles/what-are-benefits-and-barriers-when-performing-remote-audits/
  • ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
  • Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

• ISO 9001 Creating Risk and Opportunities Assessment

  

  The risk-based thinking (RBT) should be an ongoing process, it can’t be done once a year and considered as effective. The best way to apply is through the PDCA cycle.

  First you should define the scope of RBT. According to clauses 4.4.1 f), 5.1.2 b) and 6.1 of ISO 9001:2015 I recommend determining risks around processes, around products and services and around processes.

  About the methodology to treat risks and opportunities there are a lot of available methodologies and there is no single methodology that will fit all organizations. My advice is to do a little research and select the methodology according to criteria that you find appropriate.

  Determine the risks and opportunities. Although not mandatory, I recommend using a register to record risks and opportunities.

  Next step is, of course, to conduct the risk evaluation. The best way is to include relevant people from your organization and get the most relevant information and data needed for the evaluation. I use and recommend using a simple approach like the one embodied in the following matrix:

  

  For opportunities think advantage instead of severity.

  Once you identify unacceptable risk, you need to create the plan for mitigation of those risks. This can be done in same way you performed the preventive actions.

  And, at the end, you need to do a follow up to determine whether the actions for risk mitigation were effective and if the risk assessment methodology or scope should be altered. If there is need for further action, you need to initiate corrective actions.

  Consider the non-conformities, complaints, devolutions, lost customers as signs, as warnings about the quality to update of the risk assessment or of the risk evaluation. Are they signaling that changes must be made?

   

  You can find more information below.

  • How to address risks and opportunities in ISO 9001: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
  • Does ISO 9001 require a procedure for addressing risks and opportunities?: https://advisera.com/9001academy/blog/2017/10/10/does-iso-9001-require-a-procedure-for-addressing-risks-and-opportunities/
  • 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/
     

• ISO 9001 Pregunta

  Lo primero q debe contar es con el apoyo de la dirección para que pueda facilitar todos los recursos necesarios, tanto económicos como de personal, para llevar a cabo un proyecto de tal complejidad.

  Posteriormente puede hacer un análisis GAP o de brecha para saber con qué requisitos ya cuenta y con cuáles debe aún cumplir. En este enlace puede realizar este análisis de forma gratuita - Herramienta de análisis de brecha ISO 9001: https://advisera.com/9001academy/es/herramienta-analisis-de-brecha-iso-9001/

  Así mismo, le recomiendo establecer un Plan de Proyecto, en el que determine cada uno de los hitos del proyecto, responsabilidades y metas. Aquí puede descargar un Plan de Proyecto gratuito para ISO 9001:2015 - Project Plan for ISo 9001 implementation: https://info.advisera.com/9001academy/free-download/project-plan-for-iso-9001-implementation-ms-word

  Más tarde ya puede comenzar a determinar la política de calidad, los objetivos del SGC, el contexto de la organización y así hasta llegar a la auditoría interna y la revisión por la dirección. 

  En el caso de un laboratorio de materiales debe de poner especial atención a la cláusula 7.1.5 de Recursos de seguimiento y medición.  

  Estos materiales pueden serle de utilidad para la implantación de la norma en un laboratorio de materiales

  - Monitoring and measurement equipment control: https://advisera.com/9001academy/blog/2014/05/06/monitoring-measurement-equipment-control/

  - ISO 9001 audit checklist for laboratory: https://advisera.com/9001academy/blog/2018/09/04/iso-9001-audit-checklist-for-laboratory/

  - ISO 9001 implementation diagram: https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram

  - Curso de Fundamentos de la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

  - Discover ISO 9001:2015 through practicale examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

• ISO 9001 introduction to the staff

  As part of the induction for all staff I recommend following clause 7.3 of ISO 9001:2015. Each function may have its specific requirements for competence and awareness, but for all people it is a must to know the quality policy. Not verbatim, but the sense, the meaning, the purpose behind it. All people must know the quality objectives, or at least those that they can contribute to or influence. All people must know how they can contribute to an effective quality management system and what may be the consequences of non-conformities.

  You can find more information below

  • How to ensure competence and awareness in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-ensure-competence-and-awareness-in-iso-90012015/
    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/