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ISO 14001 Categorizing entities

Based on ISO 14004 guidance we can categorize interested parties this way:

Your organization exists to serve some interested parties. That service is constrained, helped or hindered by other interested parties. Considering the life cycle approach to your organization’s environmental aspects interested parties are of paramount importance.

You can find more information about interested parties below:

• Understanding the needs & expectations of interested parties in ISO 14001 - https://advisera.com/14001academy/blog/2017/04/03/understanding-the-needs-expectations-of-interested-parties-in-iso-14001/
• 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 Quality management in hospitals

Unfortunately, I have no personal experience of working with hospitals. According to what I read many hospitals decide to start by certifying just a service. For example, blood services, and then, year after year they enlarge the scope of the system including further services like imaging services or outpatient consultation.

The following material will provide you information:

• Would hospitals benefit from ISO 9001? https://advisera.com/9001academy/blog/2015/07/21/would-hospitals-benefit-from-iso-9001/
• Free online training ISO 9001:2015 ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

Why would a non-medical dev manufacturer want to implement QMS using 13485?

If you are looking for guidance for Quality Policy and Quality Manual, but you are not a manufacturer of medical devices, then you should look for the ISO 9001. ISO 9001:2015 is a standard that is applicable to all businesses.

Following articles can help you to understand the ISO 9001:2015:

• Quality Management System: What is it? - https://advisera.com/9001academy/knowledgebase/quality-management-system-what-is-it/
• ISO 9001 Requirements and Structure - https://advisera.com/9001academy/knowledgebase/iso-9001-requirements-and-structure/
• Where does quality management / ISO 9001 fit into your organization? - https://advisera.com/9001academy/blog/2017/06/06/where-does-quality-management-iso-9001-fit-into-your-organization/
• Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
• How to write a short, concise Quality Manual - https://advisera.com/9001academy/knowledgebase/writing-a-short-quality-manual/
• How to Write a Good Quality Policy - https://advisera.com/9001academy/blog/2014/03/25/write-good-quality-policy/

You can even look at our Quality manual template and Quality Policy template from our ISO 9001:2015 Documentation toolkit:

• ISO 9001 Quality manual https://advisera.com/9001academy/documentation/quality-manual/
• ISO 9001 Quality Policy https://advisera.com/9001academy/documentation/quality-policy/

• Quality Manual for ISO 13485 and ISO 9001

  ISO 9001:2015 does not require a Quality Manual. So, you can design your Quality Manual as best fits your organization’s purpose. For example, you can include the internal and external issues as a topic to be reviewed during management review or while updating quality objectives. Internal and external issues will affect the ability of an organization to perform.

  You can find more information below:

  • How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
  • Free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-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/
     

• Quality Manual

  No, ISO 9001:2015 does not require a quality manual as a mandatory document. However, I recommend organizations to develop their own quality manual as a document presenting the quality system.

   

  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/

• Approval of records

  First, please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ where you can find a list of mandatory records required by the standard.

  Second, please check clause 7.5.2 a) of ISO 9001:2015 about identification and control of documents. Title, date, author or reference number are just examples. Your organization does not need to use all of them at the same time.

  You can find more information about records below:

  • How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
  • New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
  • Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
  • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

• External issue

  Organizations are not closed systems. External issues are relevant topics that can influence the future of an organization. For example, governments can issue legislation that will affect the activity of an organization. Socials trends can influence consumers or clients’ priorities. You can use the PESTLE analysis to determine external issues (PESTLE stands for Political, Economic, Social, Technology, Legislation and Environment).

  You can find more examples of external issues in this free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/

  You can find more information below:

  • How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
  • 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/
     

• Formalization and numeration

  If you have a quality management system (QMS) in place you can formalize both the procedures and reporting formats by introducing them into the QMS. Someone with authority should approve the documentation. Then, include that documentation in a register of controlled documents where you identify designation, version, distribution and approval authority. Please check this procedure - Procedure for Document and Record Control - https://advisera.com/9001academy/documentation/procedure-document-record-control/ and the free preview.

  About the 'ISO document numbering system' there is no particular prescription from ISO 9001:2015. The only requirement is that your organization have method that allows for a unique identification of each document. Different organizations use different methods. Use a method to identify the document and the version, by a number or a date.

  You can find more information about records below:

  • How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
  • New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
  • Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
  • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/
     

• Production, Maintenance and Manufacturing engineering

  Considering ISO 9001:2015:

  • About Production use clauses 8.5, 8.6 and 8.7.
  • About Maintenance use clause 7.1.3. In some organizations clauses 7.1.4 and 7.1.5 are also auditable in that department.
  • About Manufacturing engineering use clause 8.3 

  You can find more information in the following links:

  • What is the ISO 9001 audit program, and how does it work? - https://advisera.com/9001academy/blog/2017/01/24/what-is-the-iso-9001-audit-program-and-how-does-it-work/
  • 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/
  • Enroll for free in online training 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/

• Importance of documentation aspect

  I’m sorry, I cannot agree with you. Please check this article - List of mandatory documents required by ISO 14001:2015 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-mandatory-documents-required-by-iso-140012015/ where you can see that the list of mandatory documents is very short. There are more mandatory records than documents, they are needed to evidence compliance.

  ISO 14001:2015 is much more or can be much more action prone than ISO 9001:2015 because Section 8 is based on the priorities of section 6 where organizations set what they need to improve. All the environmental management systems that I develop as consultant are based in a set of action plans. Action plans point what kind of procedures, practices, measurements and monitorizations are needed. Not because I want but because it is what is required to improve environmental performance.

  Please check this information below with more detailed answer:

  • Plan-Do-Check-Act in the ISO 14001 standard - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/plan-do-check-act-in-the-iso-14001-standard/
  • 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/