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Periodicidad de las calibraciones
Respuesta:
Para establecer la periodicidad de calibración su organización debe tomar en cuenta por un lado las recomendaciones del fabricante así como otras consideraciones en función de las características del equipo. Estas consideraciones tienen que ver con los resultados que se van obteniendo en el tiempo y de la información de que la empresa dispone sobre el equipo.
No obstante, si su organización de trata de un laboratorio es muy común que haya una legislación o normativa específica que indique la periodicidad con la que se tienen que calibrar los equipos
Para más información puede ver estos materiales:
- Artículo https://advisera.com/9001academy/blog/2014/05/06/monitoring-measurement-equipment-control/
- 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 la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ -
Reviewing documentation
Answer:
Since ISO 9001:2015 does not mention “mission statement” I believe you are really mentioning the quality policy. There is no requirement for a quality policy updating frequency. Your organization should evaluate, for example, at management review if the current policy is still useful or should be updated.
“2. The same question for ISO 9001 2015 needs and expectation of the interested parties, how often it has to be updated?”
Answer:
There is no requirement for an updating frequency about needs and expectations of the interested parties. Your organization should monitor and evaluate the need to update or not who are those interested parties and what are their needs and expectations.
“3. Are there any other ISO 9001 2015 documentation that does have lifespan limitations?”
Answer:
There are no lifespan limitations in what concerns ISO 9001:2015 documentation. There maybe lifespan limitations in the result of re gulation or legislation, not because of ISO 9001:2015.
Be aware that the word “review” in ISO 9001:2015 does not necessarily mean updating a document or something. Review means “critical analysis”. For example, your organization should make a critical analysis of its quality policy and evaluate if it still is actual or needs some change.
The following material will provide you more information:
- ISO 9001 – How to set up document approval/withdrawal within your QMS based on ISO 9001:2015 - https://advisera.com/9001academy/blog/2016/04/12/how-to-set-up-document-approvalwithdrawal-within-your-qms-based-on-iso-90012015/
- You can enroll for free at ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/ -
Evidencing version control
Answer: No, a version number does not have to remain on the actual document.
2. Does a version number have to be on the documents at all as long as you have version history showing under the Standard Documents under your QMS?
Answer: No, please check ISO 9001:2015 clause 7.5.3.2 c) about version control. You need to figure out how you will identify documents so that the people who need to use them know there is a change, as well as ensure that if a user has two versions of a document, they know which is the latest version to use. So, how does your QMS guarantee that users are aware that they are using the latest version? Some organizations instead of a version number use a date, others use a name, others only control digital versions and whenever a document is printed it has a warning to users saying that they don’t control documentation on paper.
The followin g material will provide you more information:
ISO 9001 – 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/
You can enroll for free at ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Design Control Documents
Answer:
For the design control document, we do have one available on hand: https://advisera.com/13485academy/documentation/procedure-for-design-and-development-iso-13485-2016/ .
Concerning the user requirements, you should think about the roles of each function in the company with respect to design and development. Some examples of inputs could be intended application, usability requirements, risk control and etc. For outputs, you should factor in raw materials, manufacturing processes and quality assurance.
For more information, please refer to:
-How to manage design and development o f medical devices according to ISO 13485:2016: https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/ -
Defining the vision of a company
Answer:
A vision statement is future-based, and its purpose is to inspire and give direction to employees. Your company is on a journey to become what? If everything goes well what kind of company do you want as a whole to become? When I help organizations define their vision, I invite people to think about what would make them proud of working for that organization or owning that organization. Don’t think about what needs to be done, that is strategy stuff, do a time travel to the future and describe what you see in that future. What kind of work does it do, for what kind of clients does it work, how is it known, why is it praised, why does it make a difference? Keep it short, simple and focused to be of help and motivation.
The following material will provide you more information:
- 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/
- To what extent should top management be involved in your QMS? - https://advisera.com/9001academy/blog/2016/11/22/to-what-extent-should-top-management-be-involved-in-your-qms/
- you can enroll for free at ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Changes in the Organization Chart
Answer:
Yes, you can. Later, when the certification body schedules with your organization the next surveillance audit, your organization can send them a new version of the organization chart.
The following material will provide you more information:
ISO 9001 – What is an ISO 9001 surveillance audit? - https://advisera.com/9001academy/blog/2016/10/18/what-is-an-iso-9001-surveillance-audit/
Surveillance visits vs. certification audits - https://advisera.com/27001academy/knowledgebase/surveillance-visits-vs-certification-audits/
You can enroll for free at ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Becoming technical writer
Answer:
For BC and DR documentation elaboration jobs I suggest you to consult this list from DRJ (Disaster Recovery Journal): https://www.drj.com/business-continuity-consultants/all.html
Additionally, if you want to participate as contributor to 27001 and 22301 standards you have to contact the standardization body of your country to verify if it has working groups related to these standards and submit your resume. -
Lead Auditor certification renew
Answer:
To renew your certification you have two options:
1 - You should consult your certification issuer, or other accredited training provider, to verify if they provide an update course related to your lead auditor certification. Normally these courses are available after a new version of a standard is released. Such courses presents to auditors what has changed in the release of a new version of a standard, and can be used to renew a certificate.
2 - You can take a full course and retake the exam. Here you can have access to the accredited Lead Auditor course provided by Advisera: https://advisera.com/training/iso-27001-lead-auditor-course/
It is important to no te that for purposes to become an auditor for a certification body you have to renew your certificate before the three years period validity of the lead auditor certificate expires. -
Application of AS9110
Answer:
While AS9100 Rev D applies to any manufacturers in the aerospace industry (specifically Aircraft, Space and Defense organizations). AS9110 is specifically for aviation maintenance organizations, precisely for organizations that do repair and overhaul for the aircraft industry. This standard is for companies that take parts from aircraft, such as motors, and repairs or overhauls them to make them work again. It is not for standardized repairs of a company’s own products as part of a customer return scenario.
So, you are correct, unless a customer or legal entity specifically requires that a company is AS9110 certified, this may not apply to you. If you do overhaul functions for aircraft electronics you may wish to investigate this standard for these operations, but not if you are strictly fix ing customer returns, and certainly if you are not in the aircraft portion of the aerospace industry.
For more on the differences, see the article: How does AS9110 & AS9120 relate to AS9100 Rev D?, https://advisera.com/9100academy/blog/2017/10/30/how-does-as9110-as9120-relate-to-as9100-rev-d/