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Environmental aspects and impact procedure requirements

Please check this article - List of mandatory documents required by ISO 14001:2015 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-mandatory-documents-required-by-iso-140012015/ There you can see that a procedure for identification and evaluation of environmental aspects and impacts is not mandatory. What is mandatory is having one or more documents stating:

• Criteria for evaluation of significant environmental aspects;
• Environmental aspects with associated environmental impacts;
• Significant environmental aspects;
• What some organizations do is to create a procedure to standardize the internal practice of determining, assessing and classifying environmental aspects and impacts as significant.

The following material will provide you more information about aspects and impacts:

- Article - 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: Identification 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/
 

Filling templates

Here are the answers:

Document Owner, Document Approver, and Document Reviewer: are they normally the same person?

They could be the same person in a very small company, but in large companies you should try to have different persons for these roles. Even for a very small company you should try to have a different person for a reviewer, in order to create better documents. 

When should the name be noted and when the role/dept. ?

When you describe roles and responsibilities, you should write job titles - this way when a person leaves the company or changes the position you do not need to change the policy. You can use person's name in the Change history of the document to have a record who exactly has made which changes; you can also use person's name when you make a record of who has approved the document. 

Should Owner, Approver, Reviewer… all be on de Document? Or only author and owner?

ISO 27001 does not prescribe such things - best practice is to have author and approver of the document. 

See also: 

• Document management in ISO 27001 https://advisera.com/27001academy/blog/2010/03/30/document-management-within-iso-27001-bs-25999-2/
• Seven steps for implementing policies and procedures https://advisera.com/27001academy/knowledgebase/seven-steps-for-implementing-policies-and-procedures//

These materials will also help you regarding document management:
- 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/

Software validation process and Risk Management procedure

1. 4.1.6 What software needs to follow the software validation process? Would smartsheet or excel have to be validated?

You need to perform validation for any software that is being used in the quality system together with evaluation the risk of each of those applicable pieces of software. This assessment can include databases, Solidworks/CAD files for design activities, issue tracking software, complaint management software or CRM systems, ERP systems, and/or distribution software programs. The evaluation process should be documented, and the results should be tied to actions. You do not need to perform validation of smartsheets and excel. 

For more information, please read the following articles:

How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/

2. We do not only manufacture medical-related products. We produce thermoplastics. Is it ok for us not to use a risk management procedure on non-medical if specifically called out in the procedure?

Yes, it is ok not to use risk management procedure on non-medical devices.

Accepting cookies with banners

 Hi, I would like to know in which cases it is mandatory to use a banner that allows visitors to my site to choose the type of cookies to accept (necessary, marketing and statistical)?

Necessary cookies or technical cookies do not require any kind of consent you just need to make aware the user that you are using such cookies. This can be achieved by using a banner (without the need for the visitor to accept anything). You also need to ensure that your Cookie Policy details the use of the necessary/technical cookies.

In which cases instead of the classic banner where "continue browsing" is sufficiently interpreted as consent to all cookies?

Regarding statistical and marketing cookies these should only be placed on the visitor`s browser based on consent. Consent can be obtained through the cookie banner. You also need to ensure that your Cookie Policy details the use of the statistical/marketing cookie as well as an easy way for the visitor to withdraw its consent.

You can find readily available Cookie Policy in our EU GDPR Mini Toolkit for websites (https://advisera.com/eugdpracademy/eu-gdpr-mini-toolkit-for-websites/).

A.7.3 Human Resource Security

Please note that this control seems incomplete because an Exit Policy would cover at least these controls:
- A.7.3.1 "Termination or change of employment responsibilities"
- 8.1.4 "Return of assets" 
- 9.2.1 "User registration and de-registration"

Considering these controls, and the ISO 27002, a supporting standard which provides guidelines for implementation of ISO 27001 Annex A controls, in terms of information security you should consider:
- remembering the former employee about clauses signed in confidentiality agreements and employment contracts (e.g., not to disclose information, or not work for competitors, for a defined period, etc.)
- communicating with other employees, customers, and contractors about the change in the status of the former employees
- ensuring the return of all physical and electronic assets in possession of the former employee that belongs to the organization or are under the organization's responsibilities 
- disabling or removing user IDs of former employees

Please also note that controls A.7.3.1 also covers when an employee changes his position within the company, so you might address such scenario through a different policy.

This article will provide you a further explanation about employment contracts and termination or change of employment:
- What to consider in security terms and conditions for employees according to ISO 27001 https://advisera.com/27001academy/blog/2018/05/23/what-to-consider-in-security-terms-and-conditions-for-employees-according-to-iso-27001/
- What to consider in case of termination or change of employment according to ISO 27001 https://advisera.com/27001academy/blog/2018/09/03/what-to-consider-in-case-of-termination-or-change-of-employment-according-to-iso-27001/

Asset Inventory

ISO 27001 does not define the structure of Asset inventory - controls A.8.1.1 and A.8.1.2 require you to list only name of the asset, and the asset owner. 

So if you have an Asset inventory with those two columns it will be enough for the certification. Each company needs to assess whether some additional information is needed or not - in any case, you should not add information that is not necessary because it will create an overkill for you. 

This article will also help you: 5 ways to avoid overhead with ISO 27001 (and keep the costs down) https://advisera.com/27001academy/blog/2012/06/19/5-ways-to-avoid-overhead-with-iso-27001-and-keep-the-costs-down/ 

Desing-responsible

I read your question and I remember ISO 9001:2015 clause 8.3.2 d). 

Let us look into design and development as a process:

Who is going to collect the design and development (D&D) inputs?
Who is going to perform each activity in the D&D project? For example, who is going to develop a new specification for the landing page? Who is going to test it? 
Who is going to have authority to make decisions during D&D revisions?
Who is going to have authority to make decisions during D&D verification?
Who is going to have authority to make decisions during D&D validation?
 
A quality management system has to plan authorities and responsibilities for those important activities.
 
The following material will provide you more information about design and development:
 
-      The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
-      Procedure for Design and Development - https://advisera.com/9001academy/documentation/procedure-design-development/
-      Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
-      Book – (where I use the process approach this way) - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Requirements for becoming an external consultant

Your question has two different topics.

“I want to setup my own business of consulting.”

Normally, countries have no legal requirements to start a career in consultancy. So, if you feel motivated you can start right away. For the technical side you already have credentials that can signal your competence. Now, potential customers need to know you. For the commercial side I recommend starting a blog about your reflections about ISO 9001, and keeping an active participation in Linkedin for networking and developing your “personal brand”. Below you can find some information that can be useful for you about this topic.

“I want to setup an organization A which can issue an ISO compliance certificate to my client company B.”

Consulting and certification are two different businesses, and due to reputational issues, they should not be treated by the same organization. You can start your career as consultant and have your own business, and at the same time apply to work as lead auditor for one or more certification bodies.

The following material will provide you information about starting a consultant business:

- How to become an ISO 9001 consultant - https://advisera.com/9001academy/blog/2016/11/15/how-to-become-an-iso-9001-consultant/
- How to sell your ISO 9001 consulting services - https://advisera.com/9001academy/blog/2017/06/20/how-to-sell-your-iso-9001-consulting-services/
- How to get new clients for your ISO 9001 consultancy - https://advisera.com/9001academy/blog/2019/03/05/how-to-get-new-clients-for-your-iso-9001-consultancy/
- Free webinar on demand – How to sell ISO consulting services - https://advisera.com/9001academy/webinar/how-to-sell-iso-consulting-services-free-webinar-on-demand/
- ISO 9001 Tools for Consultants - https://advisera.com/9001academy/consultants/
 

Internal Audit program requirements

To clarify the requirement, in clause 5.4 d 8) in consultation and participation of workers, ISO 45001 does mention the consultation of non-managerial workers in the planning, establishment, implementing and maintaining of an audit programme per clause 9.2.2; however, there is no mandated process for doing this with only a requirement to provide a mechanism for consultation and participation (clause 5.4 a).

So, this means how you involve workers in deciding the internal audit program is up to you (you need to provide the mechanisms), and this consultation will differ form company to company depending on many factors such as number of employees. You can gather the non-managerial workers opinions through any method you desire, including a simple survey, asking strategic employees (such as a joint health & safety committee if one exists), asking work representatives (if they exist), etc,

No matter how you gather these opinions, some of the elements of an internal audit programme that you might want worker opinion on could include: importance of processes to determine frequency of audits, how audit results will be reported to workers, or by finding out what other factors the workers see as important.

You can find out more on consultation and participation in the article: How to meet participation and consultation requirements in ISO 45001, https://advisera.com/45001academy/blog/2016/03/16/how-to-meet-participation-and-consultation-requirements-in-iso-45001/