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Top management and QMS implementation
My question is, Is there any requirement in ISO 9001:2015 standard that QMS manager reporting should be to the top management neither to any specific department head?”
Answer:
There is no requirement in ISO 9001:2015 about responsibilities and roles in the implementation phase. ISO 9001:2015 requires that management system leadership is a top management responsibility. If top management is not involved in the implementation phase it may be difficult, not impossible, to evidence knowing and leading the management system.
The following material will provide you information about top management responsibility:
- ISO 9001 – How to comply with new leadership requirements in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-comply-with-new-leadership-requirements-in-iso-90012015/
- free online training ISO 9001:2015 Foundations Co urse – 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/ -
Cláusula 4.4
Respuesta:
No hay plantillas relacionadas con la cláusula 4.4 porque la norma no requiere ninguna documentación obligatoria para esta cláusula.
La cláusula 4.4 incluye requisitos generales para el SGC que están relacionados con cada parte del SGC. Esto significa que en realidad está cumpliendo de forma indirecta con esta cláusula 4.4 con todos los procedimientos, políticas y registros documentados necesarios para cada parte del SGC.
Para obtener más información sobre los documentos y registros obligatorios en ISO 9001: 2015, puede ver este artículo - Lista de documentos obligatorios requeridos por 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/
Estos materiales también pueden ayudarle con la información documentada en ISO 9001: 2015:
- Libro "Descubra ISO 9001: 2015 a través de ejemplos prácticos": https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ ver-iso-9001-2015-through-practical-examples/
- Curso de Fundamentos ISO 9001: 2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/
- Conformio - Herramienta de cumplimiento en línea: https://advisera.com/conformio/ -
Environmental Performance Indicators
Answer:
The MPIs and OPIs are 2 types of Environmental Performance indicators.
- MPIs include policies, people/employees, activities, practices, procedures, decisions and actions in the organization. Examples of MPIs are: Hazardous waste generated per unit of product (kg/unit); Wastewater discharged per unit of product (1000 L/unit).
- OPIs include the inputs, the supply of those inputs, i nstallations, faclities and equipment operation, design, outputs and delivery of those outputs. Examples of OPIs are: Percetage of environmental targets achieved; Environmental budget (%/year).
To learn more about key performance indicators in ISO 14001, see these articles:
- How to define EMS key performance indicator (KPIs) according to ISO 14001: https://advisera.com/14001academy/blog/2016/05/30/how-to-define-ems-key-performance-indicators-kpis-according-to-iso-14001/
- 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/ -
Implementing ISO 9001 (the big picture)
Answer:
When I start implementing an ISO 9001 project I start with the team: Who is the Project Sponsor, someone that can influence top management, who is the Project Manager, who is included in the Project Team.
Then, training about ISO 9001 and what is a management system.
After that we can design a Project Plan (what will be done, by whom, until when with what resources). Normally, I divide the Project in two parallel work fronts: one strategic (about strategic orientation, policy, context, interested parties, strategic risks and and oppotunities, objectives with action plans) and another much operational (mapping processes and designing its risk management with procedures, instructions, control plans). My book, linked bellow, descrives this approach.
Then, implementing is following the Project Plan and making verifications, performing audits and having management meeting to make decisions and improving.
The following material will provide you information about ISO 9001 implementation:
- I SO 9001 – Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- 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/ -
GDPR processor compliance
Answer:
Things are not so simple as you would imagine, among the responsibilities for processors under the EU GDPR the most important are:
To appoint a representative if based outside of the Union;
- ensure certain minimum provisions in contracts with controllers (see Mandatory obligations for data processor contracts);
- Not appoint sub-processors without specific or general authorisation of the controller and to ensure there is a contract with the sub-processor containing certain minimum provisions;
- process personal data on the instructions of the controller unless required to process for other purposes by Union or Member State law ;
- keep a record of processing carried out on behalf of a controller );
- co-operate with the supervisory authorities;
- implement appropriate security measures;
- notify the controller o f any personal data breach without undue delay;
- appoint a data protection officer in certain cases;
- comply with the rules on transfers of personal data outside of the Union (see Transfers outside the Union).
To learn more about the EU GDPR check out our free “EU GDPR Foundations Course“ https://advisera.com/training/eu-gdpr-foundations-course// -
Documents for ISMS implementation
Answer: In this article you will see not only mandatory documents, but also the most commonly used documents for ISO 27001 implementation:
- List of mandatory documents required by ISO 27001 (2013 revision) https://advisera.com/27001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-27001-2013-revision/
These articles will provide you further explanation about ISMS implementation:
- What is ISO 27001 https://advisera.com/27001academy/what-is-iso-27001/
- ISO 27001 implementation checklist https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/
These materials will also help you regarding ISMS implementation:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/ -
New revision of ISO 14001 and its changes
2. The main changes to the standard and the implications for corporates that are ISO14001:2004 certified
Answer:
1. All ISO standards are reviewed every five years in order to keep it current and relevant for the marketplace. ISO 14001:2015 was designed to respond to latest trends and ensure it is compatible with other management system standards.
2. These are the main changes to the standard:
Increased prominence of environmental management within the organization's strategic planning processes
Greater focus on leadership
Addition of proactive initiatives to protect the environment from harm and degradation, such as sustainable resource use and climate change mitigation
Improving environmental performance added
Lifecycle thinking when considering environmental aspects
Addition of a communications strategy
In this infographic you can find more information about the main changes in ISO 14001:2015: https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/infographic-iso-140012015-vs-2004-revision-what-has-changed/
These materials can help you with the new version of the standard:
- Book - The ISO 14001:2015 companion: https://advisera.com/books/the-iso-14001-2015-companion/
- ISO 14001:2015 Foundations Course: https://advisera.com/training/iso-14001-internal-auditor-course/ -
Objetivos estratégicos vs. Objetivos de calidad
Respuesta:
Los objetivos de calidad están orientados a establecer las pautas y acciones para gestionar la organización en relación con la calidad, mientras que los objetivos estratégicos están orientados a gestionar la organización en general.
Aunque la calidad y los objetivos estratégicos no son los mismos, deben estar alineados. Puede decidir en su empresa que la calidad es un factor estratégico, por lo tanto, los objetivos de calidad serán parte de su plan estratégico.
Un ejemplo de un objetivo de calidad puede ser aumentar la satisfacción del cliente al 5%, y un ejemplo de un objetivo estratégico puede ser aumentar el 3% de las ventas.
Para obtener más información sobre los objetivos de calidad, consulte estos artículos:
- Cómo escribir buenos objetivos de calidad: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/como-escribir-buenos-objetivos-de-calidad/
- Lo que ha cambiado con los objetivos de calidad en ISO 9001: 2015: https://advisera.com/9001academy/blog/2018/05/08/what-has-changed-with-quality-objectives-in-iso-90012015/ -
Sending marketing emails
Answer:
If you send the newsletters to existing of former customers, you provide a means for the user to unsubscribe and the content of the newsletter refers to similar services of products they purchased from you the answer would be yes. -
Cross Border Data Transfers
Answer:
If the data of your employees are being processed outside the EEA then you need to have specific safeguards in place such as Standard Contractual Clauses. Ideally you would have one singed with all suppliers processing your personal data outside the EEA. However, when dealing with SaaS suppliers they usually tend to have documents that would cover all range of customers. For starters, you could ask them to inform you about the safeguards that they are using when sending data outside the EEA.
If you want to find out more about cross border data transfers check out our webinar “How to make personal data transfers to other countries compliant with GDPR” (https://advisera.com/webinars/how-to-make-personal-data-transfers-compliant-with-gdpr-free-webinar-on-demand/).