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Using a designated hold location for defective product
Answer
Please check ISO 9001:2015 clause 8.7 b). Segregation is one of the possible ways of dealing with a defective product. Sometimes physical segregation to a designated hold area is not possible, for example, the defective product is very big or there is not enough space for a hold location. So, segregation in a designated hold location is not mandatory. What is mandatory is to avoid the unintended use of defective products. For example, sometimes a red label is the way used to warn about product status.
The following material will provide you more information about dealing with defective product:
Five Steps for ISO 9001 Nonconforming Products - https://advisera.com/9001academy/blog/2014/01/13/five-steps-iso-9001-nonconforming-products/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://training.a dvisera.com/course/iso-90012015-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Primeros pasos en la implementación
Respuesta:
Lo primero que debe de hacer es contar con el apoyo de la dirección de la organización, que será clave durante la implementación de ISO 9001:2015, también para proporcionar los recursos necesarios.
Después lo que puede hacer es un análisis GAP o de brecha, que le va a ayudar a identificar aquellos requisitos que ya cumple y los que le debe aún cumplir. Aquí puede llevar a cabo el análisis de forma gratuita: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
Luego debe conocer cada una de las cláusulas con las que tiene que cumplir para poder llevar a cabo el proyecto de implementación de ISO 9001. En este white paper puede encontrar información resumida sobre cada una de ellas - Clause by clause explanation of ISO 9001: https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015
Posteriormente puede escribir un plan de proyecto en el que de signa responsabilidades, define la documentación que va a escribirse, los plazos etc. En este enlace puede descargarse una plantilla - Plan de Proyecto para la implementación de ISO 9001:https://info.advisera.com/9001academy/es/descarga-gratuita/plan-de-proyecto-para-la-implementacion-de-iso-9001-ms-word
Luego ya podría empezar con la implementación de la norma: la definición de la política de calidad, los objetivos de calidad y planes para llevarlos a cabo, el contexto de la organización y sus partes interesadas, el alcance del SGC, etc...hasta llegar a la auditoría interna y la revisión por la dirección, que sería el paso previo para certificarse. En este enlace puede descargarse un checklist para la implementación de la norma - Porject checklist for ISO 9001:2015: https://info.advisera.com/9001academy/free-download/project-checklist-for-iso-9001-2015-implementation
Estos materiales pueden ayudarle con la implementación de ISO 9001:2015:
- Libro – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Formación gratuita en línea – Fundamentos de ISO 9001:2015 : https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ -
Controlling policies in a handbook
I would keep that revision table at the end of the document but would add some kind of revision number, or date, or color to warn users that something in the page was changed. In a QMS we want to avoid the unintended use of obsolete documents. Perhaps these documents could bring more information to the topic "Common mistakes with ISO 13485:2016 documentation control and how to avoid them" https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/ -
Quality assurance vs quality control
Answer
Quality control is about checking if product or service specifications are being met. You can have a Quality Control Plan that states what to control, when and where, how, by whom, with what specifications and methods. Quality assurance is about the set of processes in place to provide confidence that quality requirements will be met.
The following material will provide you more information about a quality management system:
Quality Management System: What is it? - https://advisera.com/9001academy/knowledgebase/quality-management-system-what-is-it/
- 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 standard for publishing industry
Answer:
This type of ISO standard is out of our field of expertise, but what we can tell you is that ISO standards related to content identification and description are under responsibility of ISO working group ISO TC 46 SC 9 and the current available standards can be found at this link: https://www.iso.org/committee/48836/x/catalogue/p/1/u/0/w/0/d/0
We hope that one or some of these standards can fulfill your needs. -
GDPR and inventory of processing activities
1. Does the GDPR standard apply to EU employees or global employees? I’m wondering if we can inventory our processing activities for employees only.
Answer:
The GDPR applies to data of individuals in the Union (EU). This means that it would apply to all processing activities where the personal data of the employees in the EU is involved with regard to which you are acting as a controller. The same applies to the data of the clients' employees for which you perform the reimbursement services as a processor.
2. Data is transferred from the EU to the US and back. This could include a contact name for a customer as well as a business email and phone number. Would inventory of processing activ ities be applicable in this case?
Answer:
Yes, you would need to be compliant with the provisions of art. 30 and to document the processing activities.
3. Is a business email address considered personal data?
Answer:
Usually, business emails are name.surname@companyname.com so it would be considered personal data except for generic email addresses such as office@companyname.com. -
Decommissioning Apps/Software
Answer:
Some resources I suggest you to check are:
- Office of Systems Integration of Government of California: https://www.bestpractices.ca.gov/system_development/system_decommission.shtml
- The State Archives and Records Authority of New South Wales from Australia’s Government: https://www.records.nsw.gov.au/recordkeeping/advice/decommissioning-systems
- Information Systems & PIT Systems Decommissioning Guide from DoD: https://www.dau.mil/search/Pages/results.aspx?k=Information%20Systems%20and%20PIT%20Systems%20Decommissioning%20Guide -
AS9100 Rev D: Material test reports
"When a customer or organization has identified raw material as a significant operational risk (e. g., critical items), the organization shall implement a process to validate the accuracy of test reports."
Does this mean that although we have material supplied to us through our supply chain, (that are certified to AS9100/9001, monitored, audited and measured) is supplied with full traceability and C of C of raw material. Do I need to send this material away for testing to verify that these results are valid?
Answer:
While sending material away for test is one way to validate the accuracy of test reports, the standard only requires that you have a process to validate accuracy. Your process could be through the choice of legitimate suppliers for this material to ensure that you get valid material and not counterfeit material that does not meet the necessary requirements. Review of the traceability and C of C may be included into the process for this validation.
That being said, if you have a customer requirement to perform this validation testing then the contract overrides the standard and you must meet the customer contractual requirement.
To help make sure you don’t miss any required documentation for AS9100 in your transition, see the whitepaper: AS9100 Rev D List of Mandatory Documents, https://info.advisera.com/9100academy/free-download/as9100-rev-d-list-of-mandatory-documents -
Action taken to address risks an opportunities
Answer:
FMEA is a great methodology to address the risk, what I can guess that is missing from your question is actions to address risks. After you calculate RPN, if it is too high you have to take actions to address those risks. The same goes for corporate risk assessment.
For more about FMEA, please read the article:
What is FMEA and how to apply it in IATF
https://advisera.com/16949academy/blog/2017/09/06/what-is-fmea-and-how-to-apply-it-in-iatf-16949/
Also, about Control plan (that can be used as actions to address risks), please read the article:
How to develop a Control plan according to IATF 16949
https://advisera.com/16949academy/blog/2017/09/27/how-to-develop-a-control-plan-according-to-iatf-16949/
What is also missing if you are usin g FMEA and corporate risk, is assessment and actions to address opportunities. You can use benefit-effort matrix or similar so you can assess opportunities your business has. -
Updating roles and responsibilities
I have generic statements that would apply all staff and some that would be specific to certain staff only. For instance, an Information Security Officer, this is not a dedicated role within our organization, however, these responsibilities may sit in other role descriptions such as senior networks engineer and CTO perhaps.
Any guidance would greatly be appreciated.
Answer
ISO 9001:2015 promotes the process approach. Each process can be described by a flowchart and swim lanes for roles, responsibilities and authorities.
Now, for every process flowchart you can list for each role or function their authorities and responsibilities and at the end you will have a clear picture. This way it is much easier t o plan relevant training to attain competence at each role.
The following material will provide you more information about roles and responsibilities:
How to document roles and responsibilities according to ISO 9001 - https://advisera.com/9001academy/blog/2018/02/26/how-to-document-roles-and-responsibilities-according-to-iso-9001/
- 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/
- 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/