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Garment manufacturing and 8.5.1
Answer
Yes, your company need to comply with ISO 9001:2015 clause 8.5.1, independently of who designs the product.
Your company:
a) need product specifications that describe features and performance targets
b) need the necessary monitoring and measuring resources to confirm product quality according to specifications and performance targets
c) need a process control plan that defines for each manufacturing step what is relevant to control with what frequency and within which limits in the process. (For example, a temperature or pressure control). Need a process control plan that defines for each manufacturing step what kind of quality control should be done for raw-materials and work-in-progress materials with what frequency and within which limits
d) need suitable equipment (to avoid any abnormal rate of breakdowns or lost production time). Need a suitable environment (If relevant to protect product quality – moisture control, pest control, …)
e) need enough people in your production process and they need to be competent according to criteria
g) need to determine risks of human error, evaluate potential consequences and implement actions to prevent it.
The following material will provide you more information about production control:
ISO 9001 – Understanding Product & Service Provision in ISO 9001 – https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/
- 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/ -
Using scratch paper
Answer
Yes, there is no problem as long as the forms are legible and can be stored for the planned period without loss of information. On a personal note, I remember starting to work in a multinational company in 1990 where they had the practice of re-using paper sheets for invoices and other documents.
The following material will provide you more information about record control:
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/
- 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 27001 and ISO 9001
Answer:
All ISO management systems published after 2012 have the same general structure, and this makes integrating them a lot easier. In the integration process you should consider two phases:
1 – Integration of the common parts of ISO management systems, e.g., control of documents, internal audit, etc. These have basically all the same requirements, requiring only minor adjustments to refer to all systems covered
2 – Integration of the specific parts of each system (basically sections 6 and 8 of each standard). Regarding ISO 27001, this means including in the organizational process the activities related to information security risk assessment and treatment processes, while for ISO 9001 this means product planning and development.
These article will provide you further explanation about integrating ISO management systems:
- How to implement integrated management systems https://advisera.com/articles/how-to-implement-integrated-management-systems/
- Using ISO 9001 for impl ementing ISO 27001 https://advisera.com/27001academy/blog/2010/03/08/using-iso-9001-for-implementing-iso-27001/
This material can also help you:
- ISO 27001 implementation: How to make it easier using ISO 9001 [free webinar on demand] https://advisera.com/27001academy/webinar/iso-27001-implementation-make-easier-using-iso-9001-free-webinar-demand/ -
Compliance with the ISO/IEC 17025:2017 requirement for Impartiality
Answer:
The ISO/IEC 17025:2017 impartiality requirement is to ensure that conflicts of interest do not affect the laboratory activities unfavorably or negatively. The extent to which risks to impartiality need to be addressed will depend on your Food testing laboratory’s purpose. For example, if your laboratory provides testing for an internal manufacturing division as well as third party customers, addressing impartiality could be more complex than the scenario where your laboratory is an independent commercial facility.
The following are ways to demonstrate compliance:
1. Commitment to impartiality. Address this through organisational structure, policies and awareness discussions with personnel. Include commitment to impartiality within your quality policy and engage in discussions during meetings, including management review. The policy document and minutes of meetings are suitable ev idence.
2. Management of risks to impartiality. On an ongoing basis, identify possible threats to impartiality from laboratory relationships, or from personnel relationships. Assess organisational ownership, governance and structure; marketing; contracts and finances and shared resources between departments. Eliminate or minimize identified risks through appropriate treatment; for example, by separating conflicting activities through changing a process or changing personnel reporting lines and authorizations. Review customer and employment contracts to address specific treatment of financial, commercial, or other pressures that may compromise impartiality.
Records of risk assessment and treatment are suitable evidence.
For further insight into the purpose of the impartiality clause, refer to ISO/IEC Clause 8.5 “Actions to address risks and opportunities”. -
Advantage of preparing an environmental balance for a company
Answer:
An environmental balance helps organizations take an objective picture of their current environmental situation. That picture is useful for communicating performance and priorities, setting goals and managing change more effectively.
The following material will provide you more information about an environmental balance:
How to measure the effectiveness of your EMS according to ISO 14001:2015 - https://advisera.com/14001academy/blog/2016/09/05/how-to-measure-the-effectiveness-of-your-ems-according-to-iso140012015/
4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
Environmental aspect identification and classification - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/environmental-aspect-identification-and-classification/
Free webinar - Free webinar - ISO 14001: Ide ntification and evaluation of environmental aspects - https://advisera.com/14001academy/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/
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/ -
Determining and monitoring external documents
Answer
Do your organization’s products or services have to comply with legislation or technical standards? These are typical examples of what can be considered external documents. An organization has to monitor if those documents are updated or new documents are issued because issuers of those documents don’t contact your organization to warn of changes.
The following material will provide you more information about external documents:
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/
ISO 9001 document template: List of External Documents - https://advisera.com/9001academy/documentation/list-external-documents/
- Enroll for a free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book – Discov er ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
ISO 45001: Dealing with risk
Answer:
Clause 6.1.2.1, hazard identification, talks about the hazards to workers as it affects illness and ill health. Likewise, clause 6.1.2.2, assessment of OH&S risks and other risks to the OH&S management system deals with risks to workers and other risks that affect the OHSMS. All of these risks need to be assessed and decisions made on what is to be done (if anything) and plans made.
That being said, the ISO 45001 standard does not state that the risk assessment process used for the OHSMS needs to be separate from all other risk assessment processes. So, I agree with you that if you have a risk assessment process that works for you, and includes assessing the risks for the OH&S management system (such as personnel risk), then this is ac ceptable as per the standard. It could be helpful, for both you and the auditor, if your presentation of the risks from your process included an easy indicator of which risks were applicable to the OHSMS, and which were other risks, if you choose to do so. If there is another requirement that is imposed on you that the auditor is referring to, they should be able to clearly identify and quote it. If not, the ISO 45001 standard does not make this statement.
For more on understanding certification auditors, see the whitepaper: What to expect at the ISO certification audit: What the auditor can and cannot do, https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit -
Importancia de implantar ISO 9001
Respuesta:
La implantación de ISO 9001:2015 independientemente del sector del que se trate, incluido un laboratorio, conlleva numerosos beneficios, de ahí su importancia. Entre ellos podemos encontrar los siguientes:
- Gestión eficiente de los procesos .
- Alta satisfacción del cliente y conservación de los mismos
- Calidad y servicio mejorados.
- Mayor potencial para conseguir nuevos clientes y también contratos.
- Información y resultados confiables y valiosos sobre el negocio
- Mejor reputación comercial
- Procesos consistentes
- Incremento en el volumen de negocios
Para más información sobre la importancia de implantar ISO 9001 puede ver este artículo - Benefits if ISO 9001 implementation for small businesses:
https://advisera.com/9001academy/blog/2018/09/17/benefits-of-iso-9001-implementation-for-small-businesses/
Estos materiales también pueden ayudarle con conocer la importancia de ISO 9001 en su organización:
- 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/ -
GDPR and sensitive data
1. “Data concerning health” or "health information" is defined by the GDPR as “personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status.”
Processing means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction
2. The GDPR primarily applies to businesses established in the EU. It will also apply to businesses based outside the EU that offer goods and services to, or monitor, individuals in the EU.
You can gain more insight into the EU GDPR by checking out our free EU GDPR Foundations Course https://advisera.com/training/eu-gdpr-foundations-course// -
Identificación y evaluación de aspectos ambientales
Respuesta:
Primeramente debe de identificar los aspectos ambientales que derivan de los procesos de su organización, no sólo aquellos que controla sino también sobre los que tiene influencia su organización. Para identificar esos aspectos ambientales puede elaborar un mapa de procesos de su organización (si el alcance es toda la organización y sino del alcance correspondiente del SGA) y posteriormente definir los aspectos ambientales de cada uno de los procesos identificados. Además en esta nueva versión de la norma es necesario identificar los aspectos ambientales asociados al ciclo de vida de su organización, producto o servicio, es decir desde la adquisición de las materias primas hasta la eliminación del producto o servicio.
En este artículo puede encontrar un catálogo de los aspectos ambientales más comunes - Catalogue os environmental aspects:
https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/catalogue-of-environmental-aspects/
U na vez ha identificado los aspectos ambientales debe de evaluar su significancia mediante una serie de criterios, por ejemplo, la probabilidad y frecuencia de los aspectos ambientales. Esto quiere decir que debe evaluar qué aspectos tienen un mayor o menor impacto en el medio ambiente. Por ejemplo, aquellos aspectos ambientales que están legalmente regulados pasan a ser significativos y debe de tomar las acciones necesarias para poder controlarlos.
En este artículo puede leer más sobre la identificación de aspectos ambientales y su clasificación - Environmental aspect identification and classification: https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/environmental-aspect-identification-and-classification/
Estos materiales pueden ayudarle también a entender la identificación y evaluación de aspectos ambientales:
- Libro - The ISO 14001:2015 companion: https://advisera.com/books/the-iso-14001-2015-companion/
- Curso gratuito en línea - Fundamentos de ISO 14001:2015: https://advisera.com/training/es/course/curso-fundamentos-iso-14001/