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Root Cause analysis
Answer:
Root cause analysis is part of Problem Management activities.
There are several techniques:
Chronological analysis
Pain value analysis
Kepner and Tregoe
Brainstorming
5-Whys
Fault isolation
etc.
More on Problem Management in the article:
ITIL and ISO 20000 Problem Management – Organizing for problem resolution https://advisera.com/20000academy/blog/2014/07/29/itil-iso-20000-problem-management-organizing-problem-resolution/
ITIL Problem Management: getting rid of problems https://advisera.com/20000academy/blog/2013/08/05/itil-problem-management-getting-rid-problems/
2) Does the organization must have a designated incident management team?
Answer:
I think you should have designated Incident Management team. There are many advantages, but here are more details:
ITIL Incident Management benefits – Simple explanation for your top management https://advisera.com/20000academy/blog/2015/11/24/itil-incident-management-benefits-simple-explanation-for-your-top-management/
ITIL Incident Management https://advisera.com/20000academy/knowledgebase/itil/-incident-management/
as well as our free webinar
ITIL Incident Management Process Demystified https://advisera.com/20000academy/webinar/itil-incident-management-process-demystified-free-webinar-on-demand/ -
Cómo empezar con la documentación ISO 9001:2015
Respuesta:
Con respecto a la documentación que tiene que existir en una organización conforme a la norma ISO 9001:2015, puede divirse en dos tipos: los registros y los documentos (políticas, procedimientos). Los registros son referidos en la norma como información documentada que debe retenerse, mientras que los documentos son referidos en la norma como documentación que debe mantenerse. Por otro lado, existe un tipo de documentación que es obligatoria por la norma y otra, como los procedimientos, que la organización puede decidir si desarrollarla o no. Aquí puede ver un artículo sobre la documentación obligatoria y la más comúnmente usada - Lista de documentos obligatorios requeridos por la ISO 9001:2015: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/lista-de-documentos-obligatorios-requeridos-por-la-iso-90012015/
Ambos tipos, registros y documentos deben ser controlados por la organización según establecer los requisitos de ISO 9001. Aquí pue de ver más información sobre el control de documentos y registros: https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
Es importante que sepa que no existe ningún formato obligatorio a seguir por la organización en cuanto a la documentación, sino que es la propia compañía la que decide cómo lo hace siempre y cuanto .
Estos materiales pueden ayudarle con la documentación de ISO 9001:2015:
- Libro - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/
- Curso gratuito en línea - Fundamentos de ISO 9001:2015: -
SWOT analysis and context
Answer:
An organization determines internal and external issues (clause 4.1).
When those external and internal issues are analyzed from the perspective of strategic direction, they can gain a positive or a negative connotation. That way those issues can be classified as:
Positive internal issues are strengths;
Negative internal issues are weaknesses;
Positive external issues are opportunities;
Negative external issues are threats.
Now you can organize that information with a SWOT matrix.
The following material will provide you information about SWOT analysis:
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 – 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/ -
Clauses and situations
Answer:
Are they relevant for the product or service delivered by your organization? If they are not relevant don’t include them on your QMS. If they are relevant that will depend on their influence. For example: 7.1.3; 7.1.4 or 8.5.1.
2. A quality assurance SOP dealing with the inspection of incoming material and resulting products would come under the heading of which clause according to standard (9001:2015)?
Answer:
I would consider clause 8.4.2
3.An SOP on the maintenance of equipment would come under the heading of which clause according to standard (9001:2015)?
Answer:
I would consider clause 7.1.3
The following material will provide you information about ISO 9001:2015:
How to evaluate supplier performance according to ISO 9001:2015 -h ttps://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-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/ -
Requested documented information
hello, i want to tell you, i'm very satisfy to your intervention. Thanks! -
Documented information of external origin during the certification audit
what other ISO standards should be available in my office while the certification body is auditing'
Answer:
You should have at list a paper or electronic copy of ISO 9001:2015. You should also have paper or electronic copies of standards that are relevant for the quality of your product or service. Those determined under clause 7.5.3.2 as documented information of external origin.
The following material will provide you more information about documented information of external origin:
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/
Enroll for free in this 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/ -
Context and risks
Answer:
You can elaborate a report where you list the internal and external issues determined by your organization. See the example below in the white paper.
From issues do we refer to RISKS or the current PROBLEMS the organization is experiencing?
Answer:
Issues are not risks. Issues are elements that can affect and organization’s approach to developing and achieving its objectives. For example, a competitor may enter your market with a superior product due to new technology. Another example, your potential market may grow or shrink due to demographic changes.
And how does the context of the organization relate to risk assessment?
Answer:
Internal and external issues can help or hinder in meeting expected results. For example, your organization expects to grow market share among the wealthiest segment (an objective). That can be hindered by the move of a competitor that presented a superior product due to new technology. For example, your organization sells its best seller to parents with young kids. Your organization’s growth perspectives may be hindered by the demographic evolution of your main markets. Whatever helps your organization in meeting objectives is an opportunity. Whatever hinders your organization in meeting objectives is a risk.
And another question is that under the heading of which clause would a security cameras SOP come under?
Answer:
Perhaps under ISO 9001:2015 clause 7.1.4 Environment for the operation of processes
The following material will provide you more information about context and risk:
White Paper - Case study for ISO 9001:2015 transition in a construction company - https://info.advisera.com/hubfs/9001Academy/9001Academy_FreeDownloads/Case_study_for_ISO_9001_2015_transition_in_construction_company_EN.pdf 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/
How to identify risk significance in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
Free webinar – 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/
Enroll for free in this 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/ -
Certification costs
Answer:
That will depend on several factors like number of employees, economic sector, particular environmental situation and from country to country.
If you want to implement and certify an environmental management system in your organization, please consider the cost of training and implementation, and the cost of certification.
The following material will provide you more information about implementation and certification costs:
Article - How much does ISO 14001 implementation cost? - https://advisera.com/14001academy/blog/2017/01/23/how-much-does-iso-14001-implementation-cost/
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/ -
SOC 2 and ISO 27001
Answer:
There are many common points between SOC II and ISO 27001:2013: risk management, internal audit, business continuity, access control, etc. If you want to know details about the similarities about both standards, and what resources can be shared, you can see the document “Trust Services Map to ISO 27001” in the official site of American Institute of CPAs. You can find it at this link: https://www.aicpa.org/content/dam/aicpa/interestareas/frc/assuranceadvisoryservices/downloadabledocuments/othermapping/trust-services-map-to-iso-27001.xlsx -
ITIl and ISO 20000
Answer:
ITIL and ISO 20000 overlap quite a lot. Usage of ITIL processes for ISO 20000 implementation depends also on the detail of the implementation. Ownership of the processes depends on how many employees your ITSM organization have. Ideally, every process would have different owner. But, process owners can be combined.
Here are more details:
ITIL and ISO 20000: A Comparison https://advisera.com/20000academy/knowledgebase/itil-iso-20000-comparison/
Defining roles and responsibilities for ISO 20000-based IT Service Management https://advisera.com/20000academy/blog/2017/10/18/defining-roles-and-responsibilities-for-iso-20000-based-it-service-management/
What ITIL roles can be combined in one person? https://advisera.com/20000academy/knowledgebase/itil-roles-can-combined-one-person/