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Organizational knowledge at an university department
Answer:
I would look into the university department and ask:
Do you have a list of relevant functions or roles in this department?
Can you evidence the determination of what knowledge is necessary for performing a function relevant for achieving process performance and/or products and services conformity?
Can you evidence how that knowledge is kept alive and is shared when needed? (Can be a database, can be Work Instructions, can be reports, can be sharing information at meetings)
Can the department evidence actions to prevent knowledge loss? (For example, if someone leaves, if someone is promoted, if someone has an accident.)
Can the department evidence the knowledge transmission when someone starts in a function?
Particularly important at the university environment - Can your department evidence routines to be aware of new knowledge? Subscription of technical magazines? Regular meetings with other organizations? Partners hips with companies, other universities? Regular participation at seminars and conferences? Programs for buying books?
The following materials will provide you details with organizational knowledge:
- ISO 9001 – How to manage knowledge of the organization according to ISO 9001 - https://advisera.com/9001academy/blog/2016/08/30/how-to-manage-knowledge-of-the-organization-according-to-the-iso9001/
- How to ensure competence and awareness in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-ensure-competence-and-awareness-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/ -
Quality Objectives versus Strategic Goals
Answer:
To be honest I can only give you my opinion, because ISO 9000 and ISO 9001:2015 give no instructions about strategic orientation or strategic goals are. ISO 9000:2015 defines strategy (definition 3.5.12) as a “plan to achieve a long-term or overall objective”. In my opinion, strategy comes before the plan, strategy is an intent. Quality is about doing the things right. Strategy is about doing the right things. For example, an organization can establish the “Reduction of the rate of defects” as one of their quality objectives. At the same time, the organization can consider that producing no defects is not a competitive advantage, it is just what customers expect from every supplier. For example, a strategic goal can be: “Increase the rate of new product development”, because the organization wants to be recognize d as very innovative.
An effective quality management system should be aligned with the strategic orientation, that means trying to align quality objectives with the strategic orientation.
The following materials will provide you details about the quality objectives:
- ISO 9001 – Aligning quality objectives of the QMS with the strategic direction of the company - https://advisera.com/9001academy/blog/2017/03/07/aligning-quality-objectives-of-the-qms-with-the-strategic-direction-of-the-company/
- 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/ -
ISO 27001 Lead Auditor course content
Answer:
ISO 27001 is a management standard, so the ISO 27001 Lead Auditor course does not go far on technical aspects of security controls, including IT and cybersecurity topics. It focus on understanding the standard's requirements and how to plan and perform activities to ensure an organization's plans, documents and operations are complaint with those requirements.
However, you can use the knowledge acquired in this course together with ISO 27032 standard, which provides specific information about cybersecurity related controls, to be able to perform audits more detailed in terms of cybersecurity. For more information, see this article: ISO 27001 vs. ISO 27032 cybersecurity standard https://advisera.com/27001academy/blog/2015/08/25/iso-27001-vs-iso-27032-cybersecurity-standard/
It is important to note that the video lectures are completely free to watch, so you can try any lecture to see the level of details that fulfill your needs. -
Cláusula 8.7
Respuesta:
Este requisito se encuentra en la cláusula 8 ya que es necesario implementar un proceso para poder identificar las salidas no conformes, determinar qué hacer y mantener registros de las acciones que hayan sido emprendidas. En la antigua versión de la norma se limitaba a los productos no conformes, pero en la ISO 9001:2015 también incluye procesos y servicios que no cumplen con los requisitos del cliente, normativos o de la propia organización.
Para más información sobre el control de salidas no conformes puede ver este artículo - Five steps for ISO 9001 nonconforming products (disponible en inglés):
https://advisera.com/9001academy/blog/2014/01/13/five-steps-iso-9001-nonconforming-products/
Estos mater iales también pueden ser útiles para saber más sobre el control de salidas no conformes:
- Libro - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Curso gratuito en línea - Fundamentos de ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ -
Issues, interested parties and risks & opportunities
Answer:
Organizations are open systems that interact with its context. For example, an organization can be very efficient, can manufacture quality products and have a top service and nevertheless have economic problems because: the economies of the countries of its major customers are having a bad performance, or demography is acting against the organization, or a technological advance made their product obsolete. These are external issues. Internal issues are about things that can be viewed as strengths or weaknesses. For examples of strengths we can have, an organization can rely on its ability to develop and launch new products, or rely on its brand, or on its manufacturing flexibility. For examples of weaknesses we can have, too many product defects, or too may delivery delays, or too many raw materials with price increases.
Interested parties are relevant entities that can affect or be affected by an organization activity like customers, suppliers, customers of the customer, regulators, influencers, employees, competitors. For example, some years ago I worked with a construction materials company that had as customers the contractors. Nevertheless, they worked a lot to satisfy architects, although they were not customers, they had a tremendous influence on the contractors (the company’s customers)
About risks and opportunities, I like to see them as topics that can help or hinder the ability of an organization meet its objectives. Imagine that an organization has a sales target, if the economy tanks it will become more difficult to attain the sales volume target (risk). Imagine that an organization expects to launch a new product that it suspects that will be a best seller. In this case the successful launching is an opportunity that will help meet the sales target
The following materials will provide you information about internal and external issues, interested parties and risks and opportunities:
- ISO 9001 – 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/
- How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
- ISO 9001:2015 Case study: Context of the organization as a success factor in manufacturing company - https://advisera.com/9001academy/blog/2016/10/11/iso-90012015-case-study-context-of-the-organization-as-a-success-factor-in-manufacturing-company/
- 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/ -
Managing time on security self-development
Answer:
The main point here is to define what are your priorities. If you think that at this moment studying to SCCP and focusing on other topics are more important to your career then you should focus on them (think on the long term benefits). For other topics you would like to follow you should consider signing newsletters and listen to podcasts recognized by the community to stay upda ted with the most relevant news (the most recognized sources already have this need of their audience in mind and they filter the content for them). -
Writing procedures
Answer: The ultimate responsibility is of the ISO implementer, but in fact this is a four-hands work. The ISO implementer provides knowledge related to standard's requirements that must be fulfilled and the IT staff provides information about current technologies and IT processes. It is important to note that other areas, like HR and facilities, may also be involved in the development of other ISMS documents.
These articles will provide you further explanation about developing documents:
- Seven steps for implementing policies and procedures https://advisera.com/27001academy/knowledgebase/seven-steps-for-implementing-policies-and-procedures//
- 8 criteria to decide which ISO 27001 policies and procedures to write https://advisera.com/27001academy/blog/2014/07/28/8-criteria-to-decide-which-iso-27001-policies-and-procedures-to-write/
- How to write an easy-to-use BYOD policy compliant with ISO 27001 https://advisera.com/27001academy/blog/2015/09/07/how-to-write-an-easy-to-use-byod-policy-compliant-with-iso-27001/ -
AS9100 Application to tanks
Answer:
Producing military tanks would certainly be an example of providing for defense contracts, as would providing components for said tanks. The important thing to remember is to ensure that you understand the customer requirements that are placed on you for a quality management system, if the customer asks for AS9100 certification then this is what you will need to do.
For more information to understand AS9100 Rev D see this white paper: https://info.advisera.com/9100academy/free-download/clause-by-clause-explanation-of-as9100-rev-d -
Hierarchy of documents
Answer:
Documents of external origin (standards, regulations, documents of customers, suppliers and machines) should go at the third level of the Pyramid (of 4 levels) because they define how activities and processes are carried out and by whom.
To learn more about the hierarchy of documents, see this article - How to structure quality management system documentation: https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
These materials can also help you with ISO 9001:2015 documentation:
- Book - Managing ISO documentation: a plain English guide: https://advisera.com/books/managing-iso-documentation-plain-english-guide/
- ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/ -
Codificación de documentos
Respuesta:
Si ya cuenta con una codificación para los contratos indefinidos, también le recomendaría tenerlo para los temporales. No existe la obligación de mantener una codificación específica de los documentos que pertenecen al SGC, aunque sí que es muy recomendable para mantenerlos organizados. Lo único que requiere la norma es que la información documentada para el correcto funcionamiento del SGC se encuentre identificada y sea trazable. Por lo tanto, es la propia organización la que decide cómo hacerlo según sus necesidades.
Para más información sobre la codificación de documentos en ISO 9001:2015, puede ver este artículo - New approach to document and Record Control in ISO 9001:2015 (disponible en inglés): https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
Estos materiales también pueden ayudarle con la identificación y control de documentos en ISO 9001:2015:
- Curso gratuito en línea Fundamentos ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/
- Libro - Gestión de documentación ISO: una guía en un lenguaje sencillo: https://advisera.com/books/gestion-de-documentacion-iso-una-guia-en-un-lenguaje-sencillo/
- Plataforma de cumplimiento en línea: https://advisera.com/conformio/