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Significant Aspect

No, it is not in the standard that any aspect/impact that has a legal requirement is automatically significant.

Please check this picture:

If an environmental aspect has compliance obligations and they do not comply the aspect is significant, but if they are satisfied then it is up to your evaluation criteria to determine if they are or not significant.
 
Please check this information below with more detailed answers:

• 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/
• ISO 14001 document template: Procedure for Identification and Evaluation of Environmental Aspects and Risks - https://advisera.com/14001academy/documentation/procedure-for-identification-and-evaluation-of-environmental-aspects/
• Enroll for free in this course – ISO 14001:2015 Lead Auditor Course - https://advisera.com/training/iso-14001-lead-auditor-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
   

11.2.8 and 11.2.9

Please note that while control A.11.2.8 aims at equipment (e.g., computers and mobile devices), control A.11.2.9 has a wider coverage, including papers, removable storage media, and other equipment normally found on workstations (e.g., photocopiers).

In a sense, you can think that control A.11.2.8 can be used to implement a part of control A.11.2.9.

This article will provide you a further explanation about clear desk policy and clear screen policy:

• Clear desk and clear screen policy – What does ISO 27001 require? https://advisera.com/27001academy/blog/2016/03/14/clear-desk-and-clear-screen-policy-what-does-iso-27001-require/

This material will also help you regarding clear desk policy and clear screen policy:

• ISO 27001 Annex A Controls in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/

Mandatory procedures

No mundo ISO, os requisitos / documentos obrigatórios estão relacionados às palavras “deve” ou “deverá”, enquanto os requisitos / documentos não obrigatórios estão relacionados às palavras “pode” ou “deveria”. Os documentos e registros obrigatórios para cumprir as cláusulas das seções principais da norma (seções 4 a 10) são:

• Escopo do SGSI (cláusula 4.3)
• Política e objetivos de segurança da informação (cláusulas 5.2 e 6.2)
• Avaliação de risco e metodologia de tratamento de risco (cláusula 6.1.2)
• Declaração de aplicabilidade (cláusula 6.1.3 d)
• Plano de tratamento de risco (cláusulas 6.1.3 e e 6.2)
• Relatório de avaliação de risco (cláusula 8.2)
• Registros de treinamento, habilidades, experiência e qualificações (cláusula 7.2)
• Resultados de monitoramento e medição (cláusula 9.1)
• Programa de auditoria interna (cláusula 9.2)
• Resultados das auditorias internas (cláusula 9.2)
• Resultados da análise crítica da gestão (cláusula 9.3)
• Resultados das ações corretivas (cláusula 10.1)

Outra situação é que alguns documentos são necessários para cumprir controles que são obrigatórios se pelo menos uma dessas situações acontecer:

• Existem riscos inaceitáveis que justificam a aplicação do controle
• Existem requisitos legais (por exemplo, leis ou cláusulas contratuais) aos quais a organização deve cumprir que demandam a aplicação do controle
• Existe uma decisão da alta administração para implementar o controle, considerando-o como uma boa prática.

Se nenhuma das condições acima acontecer, não há necessidade de implementar um documento relacionado a esse controle.

Além dos documentos para cumprimento das cláusulas das seções principais, sem uma avaliação detalhada de uma organização, não é possível definir quantos documentos uma organização teria e quais seriam um exagero.

Estes artigos fornecerão mais explicações sobre os documentos ISO 27001 e seleção de controles:

• Lista de documentos obrigatórios requeridos pela ISO 27001 (revisão de 2013) https://advisera.com/27001academy/pt-br/knowledgebase/lista-de-documentos-obrigatorios-requeridos-pela-iso-27001-revisao-de-2013/
• A lógica básica da ISO 27001: Como a segurança da informação funciona? https://advisera.com/27001academy/pt-br/knowledgebase/a-logica-basica-da-iso-27001-como-a-seguranca-da-informacao-funciona/
• 8 critérios para decidir quais políticas e procedimentos da ISO 27001 escrever https://advisera.com/27001academy/pt-br/blog/2014/07/31/8-criterios-para-decidir-quais-politicas-e-procedimentos-da-iso-27001-escrever/

ISO 14001 and engaging an external consultant

No, it is not a requirement to engage an external consultant to help develop and implement a management system.
That is precisely one of the reasons for the existence of Advisera, to help organizations to work without the need of a consultant. Please check this article - Do you really need a consultant for implementation of ISO 14001? -  https://advisera.com/14001academy/blog/2019/02/28/do-you-really-need-a-consultant-for-implementation-of-iso-14001/

Please consider our courses to help practitioners, you can enroll for free:

• Enroll for free in this course - ISO 14001:2015 Lead Implementer Course - https://advisera.com/training/iso-14001-lead-implementer-course/
• 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/

ISO 14001 number of electronic copies

It is up to your organization to decide how many copies are needed. If your organization decides that way you do not even need a Master in paper as original or paper copies. You may have all the documentation only in digital support.

You may find more information below:

• How to structure ISO 14001 documentation - https://advisera.com/14001academy/blog/2016/11/28/how-to-structure-iso-14001-documentation/
• Free online training ISO 14001:2015 Foundations Course -https://advisera.com/training/iso-14001-internal-auditor-course/
• Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/
   

ISO 9001 Clause 8.4 implementation

About 8.4.1
What processes (subcontracting), what products and services are relevant to the operation of your organization? Relevant in the sense: They help to make a difference; or avoid flaws that the customer recognizes and negatively values In other words, you do not need to apply the requirements of the standard to everything you buy.

And:

About 8.4.2, this clause better specifies the part of the control mentioned above.

8.4.3 is about the information that goes on orders or contracts: The description of the product, service or process (1) Methods, processes or equipment to be used or to be followed in the provision of services (2) Relevant quality control criteria (3) In cases where there is a requirement of competence, mention it (c) It can sometimes make sense to describe means of contact, contact persons, authorities (d) It may make sense to define quality control rules during the provision of the service (e). It is to clarify that the company can go to the supplier's premises to carry out an audit or quality control (f)

The following material will provide you more information:

• Purchasing in QMS – The Process & the Information Needed to Make it Work - https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/
• 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/ where I use the risk-based thinking in several examples.

Data sharing

It depends on the policy of the company. If your colleague has the right to access data to fulfill his/her tasks you can share data, even via the company email. A data breach is an unauthorized access or disclosure, but if your colleague is authorized to access data, GDPR is not a problem. 

There may be a problem if your email is not protected with encryption or safe transfers protocols (to be sure you may ask your IT department) Usually business email account are safe enough, it would be different if the email address is a personal one (like Gmail or Yahoo or Hotmail with individual plans because these emails have different safeguards.

Here an article on how increasing cybersecurity can help with GDPR compliance

• How cybersecurity solutions can help with GDPR compliance https://advisera.com/eugdpracademy/blog/2017/11/27/how-cybersecurity-solutions-can-help-with-gdpr-compliance/

To have a deeper idea of the list of requirements of GDPR you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

Working as an assessor for ISO/IEC 17025

To become an assessor for an accreditation body would involve firstly having the appropriate knowledge of ISO 17025 and secondly the experience and skills to audit ISO 170025 aboratories.  As a lead assessor you would focus on the management requirements, however as a technical assessor you would audit in your area of technical expertise. I suggest you contact your accreditation body as they will have a recruitment and training requirement.  

For more general information regarding ISO 17025 auditing see the article ISO 17025 technical internal audit: The basics at https://advisera.com/17025academy/blog/2020/11/10/iso-17025-technical-internal-audit-the-basics/ and the white paper How to perform an internal audit using ISO 19011 at https://info.advisera.com/free-download/how-to-perform-an-internal-audit-using-iso-19011
Also see some further information at the expert questions, which may be of value,
·        

• ISO 17025 Lead Auditor Certification at https://community.advisera.com/topic/iso-17025-lead-auditor-certification/
• ISO 17025 Auditing at https://community.advisera.com/topic/iso-17025-auditing/ that mentions our ISO 9001 Internal Auditor Course (https://advisera.com/training/iso-9001-internal-auditor-course/ modules 5 to 8 that provide the details, also applicable to ISO 17025.

FDA

From your question, I assume that you are outside of the US and that your customer wants to register the product on the US market. FDA registration is the basic requirement for all domestic and foreign establishments that manufacture medical devices in the USA. 

All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement and without US FDA Agent; the registration cannot be completed.

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

ISO 14001 Clause 6.1.4.2b

Your organization has a list of compliance obligations. If you mention clause 6.1.4 it is because previously there was some problem(s) with compliance obligations and your organization developed a project with a set of actions to be done.

Was that set of actions effective?

If they were effective there is no problem(s) with compliance obligations today. Something like:

What is important is that the problem(s) disappeared!

Now, if you want to follow the standard by the book you need to introduce clause 9.1.2 – Compliance evaluation.

In this case, the conclusions of 9.1.2 (compliance evaluation) are used to evaluate effectiveness as in 6.1.4 b)2 (check there the note to see clause 9.1)

Please consider the following information:

• Environmental performance evaluation - https://advisera.com/14001academy/blog/2015/07/06/environmental-performance-evaluation/
• How to perform communication related to the EMS - https://advisera.com/14001academy/blog/2015/08/31/how-to-perform-communication-related-to-the-ems/
• 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/