Search results

Non-applicable clauses for supplier of component for medical device

I do not have enough information here, but the following requirements can be marked as non-applicable :

• 6.4.2 Contamination control – if it is no necessary to have special control of the work environment during production
• 7.5.2 Cleanliness of the product - if it is no necessary to monitor cleanliness of the product, if it is not sterile
• 7.5.3 Installation activities - if your component does not need installation
• 7.5.4 Service activities – if your comnponent does not need service
• 7.5.5 Particular requirements for sterile medical devices – if your component does not need to be sterile
• 7.5.7 Particular requirements for validation of processes for sterilization and sterile barier systems - if your component does not need to be sterile

Maybe there are some more requirements that can be marked as non-applicable, but for defining that I need more information regarding the product.

For more information regarding the ISO 13485:2016, please see following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

For any other question regarding the ISO 13485:2016, please do not hesitate to ask us.

Managing records kept on the basis of documents

Although ISO 27001 requires the storage of specific documents and records (clause 7.5.3 d), and that changes on them are controlled (clause 7.5.3 e), it does not prescribe how to store them or control changes on them, so organizations are free to define the methods that best suit their needs.

Considering that, storing documents in Excel or Word form is acceptable by the standard. However, the version history feature in Office365 may not be sufficient, because it can help detect an unauthorized change, but cannot prevent it. One way to make your solution more robust, you can limit the users that can edit a document to a small group of users.

These articles will provide you a further explanation about documentation management:

• Document management in ISO 27001 & BS 25999-2 https://advisera.com/27001academy/blog/2010/03/30/document-management-within-iso-27001-bs-25999-2/
• Records management in ISO 27001 and ISO 22301 https://advisera.com/27001academy/blog/2014/11/24/records-management-in-iso-27001-and-iso-22301/

These materials will also help you regarding documentation management:

• Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/
• ISO 27001 Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

Network controls

By “system” you should understand software or set of software. For example, operational systems, Office 365, and SaaS applications are examples of systems.

When control A.13.1.1 (Network controls) requires a system to be authenticated, it means that the system must show proof that it is the system it claims to be (much like a human user must prove his identity when accessing a system or physical area), by means of presenting a password or one-time code provided by a token along with its identification. By adopting this control, you can ensure that only systems you know and have authorized can access your network. For example, when you access your organization’s network you need to provide your identification and authentication information, right? It is the same thing, only applied to systems (each system should have its own identification and authentication information).

When we talk about the restriction of system connection, we mean that a system should access only what is necessary for its activities. For example, a payment application should have access to the organization’s finance systems and customer databases, but most probably should not have access to HR systems or R&D applications.

These articles will provide you a further explanation about network controls:

• How to manage network security according to ISO 27001 A.13.1 https://advisera.com/27001academy/blog/2016/06/27/how-to-manage-network-security-according-to-iso-27001-a-13-1/
• Using Intrusion Detection Systems and Honeypots to comply with ISO 27001 A.13.1.1 network controls https://advisera.com/27001academy/blog/2016/07/04/using-intrusion-detection-systems-and-honeypots-to-comply-with-iso-27001-a-13-1-1-network-controls/

These materials will also help you regarding network controls:

• ISO 27001 Annex A Controls in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/
• ISO 27001:2013 Foundations Course https://advisera.com/training/iso-27001-foundations-course/ 

ISMS Manual contents

The information about the Information Security organizational structure can be described in the Information Security Policy. You can see a demo template of this document at this link: https://advisera.com/27001academy/documentation/information-security-policy/

The documental framework of the ISMS can be defined in a Procedure for Document and Record Control. You can see a demo template of this document at this link: https://advisera.com/27001academy/documentation/procedure-for-document-and-record-control/

These articles will provide you a further explanation:

• Is the ISO 27001 Manual really necessary? https://advisera.com/27001academy/blog/2014/02/03/is-the-iso-27001-manual-really-necessary/
• What should you write in your Information Security Policy according to ISO 27001? https://advisera.com/27001academy/blog/2016/05/30/what-should-you-write-in-your-information-security-policy-according-to-iso-27001/
• Document management in ISO 27001 & BS 25999-2 https://advisera.com/27001academy/blog/2010/03/30/document-management-within-iso-27001-bs-25999-2/

These materials will also help you:

• Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/
• ISO 27001 Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

Changing career to Lead Auditing from LIMS company

To start your journey to become an information security auditor you should attend an ISO 27001 Lead Auditor Course, so you can understand the concepts of the ISO 27001 management system and the processes and techniques involved in an audit.

After attending the course and be approved in the exam, if you want to work as a certification auditor, you need to accumulate audit hours working for a certification body, first as an observer, and after that as an audit team member, so you can gain understanding and experience in practical audits. After sufficient auditing hours for a certification body, and good evaluations from your team leader, you can achieve the status of certification auditor and after that certification for lead auditor.

Here is the ISO 27001 Lead Auditor course from Advisera: https://advisera.com/training/iso-27001-lead-auditor-course/

This article will provide you further explanation about becoming lead auditor:
- How to become ISO 27001 Lead Auditor https://advisera.com/27001academy/knowledgebase/how-to-become-iso-27001-lead-auditor/

ISO 27001 corporate vs business functions

I’m assuming that by business functions you mean activities related to the organization’s core business, while for corporate functions you mean supporting activities.

Considering that, please note that ISO 27001 aims to protect any kind of information, and depending on the defined scope, the information can be either related to Business functions as well as to Corporate functions. So, you need to clarify first with your assessment team which information, processes, and/or locations will be part of your ISMS to verify which functions need to be assessed.

These articles will provide you a further explanation about ISMS scope:

- How to define the ISMS scope https://advisera.com/27001academy/knowledgebase/how-to-define-the-isms-scope/
- Problems with defining the scope in ISO 27001 https://advisera.com/27001academy/blog/2010/06/29/problems-with-defining-the-scope-in-iso-27001/

These materials will also help you regarding ISMS scope:
- How to set the ISMS scope according to ISO 27001 [free webinar on demand] https://advisera.com/27001academy/webinar/how-to-set-the-isms-scope-according-to-iso-27001-free-webinar-on-demand/
- 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/
- ISO 27001 Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

ISO 17025 accreditation

Note that the correct term is accreditation, not certification; as it involves formal recognition of technical competence.

The period of implementation will depend on the size of the labororatory, the number of tests to be added to the Scope of work; as well as naturally, the available reources. Typically from start of project to application for accredition could be anything from 12 months onwards. Once you have applied, it may be up to 3 months before the accredition body perfom the assessment. You then would usually have 3 months to implement any corrective actions before being awarded accreditation.  This means that for a small laborory, it may be a short as 12 months, but typically longer. 

The costs will depend on the accreditation body. I suggest you contact them and request a quotation. In awarding accreditation, the accreditation body attests to your laboratory’s competence to provide consistently valid results through meet the requirements of 17025. An accreditation certificate, which details your scope of accreditation is then issued.

Have a look at how the ISO/IEC 17025:2017 Documentation Toolkit may assist you, available at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ and download some free tools to help with project planning, at https://advisera.com/17025academy/free-downloads/

• Project Plan for ISO/IEC 17025 implementation
• Diagram of ISO 17025 Implementation Process

For some more information here are some useful resources, Download the complimentary white papers:

• Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
• Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025

and watch the Free webinar – https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025 at https://advisera.com/17025academy/webinar/what-are-the-steps-in-the-iso-17025-accreditation-process-free-webinar-on-demand/

Environmental criteria/groups that hydroelectric power projects can face

Unfortunately, that is a very specific question and I do not have particular information on that area. What I can list is a set of topics that may be considered risk factors:

• Earthquake can deteriorate construction
• Excess rain may determine the need to discharge water from the dam and promote floods downstream
• Lack of rain may determine failure to supply water downstream at ecological levels
• High temperature and stagnant waters may develop hazardous bacteria or promote eutrophication
• Blocking the flow of water when it is contaminated, for example, by discharges from a chemical company, preventing contamination downstream (opportunity)
• Destroying or badly affecting traditional river fishing activities due to high variations in water level downstream within a 12 hour period

Do you get the pattern?

Events that may happen, but you cannot say when will it happen

Perhaps the last one is not a risk, there is no uncertainty, it is forecastable and the probability is far from zero.

Please check this information below with more detailed answers:

• ISO 14001 risks and opportunities vs. environmental aspects - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
• 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/

Differences between medical device certifications and ISO 13485

Medical device certification is a process where you will get the CE mark and you can sell your product on the EU market. This means that you need to prepare technical documentation that is requested in the Medical device directive 93/42/EEC (unitl May 2021) or in Medical device regulation 2017/745 – Annex 2 (from May 2021). 

ISO 13485:2016 is a standard for quality management systems. It means that you need to prepare your processes and documentation to prove that it is under control and fulfill all applicable requirements from the standard. On the EU market, all medical devices must be in compliance with harmonized standards. In MDR, in Article 10 General obligations of manufacturers, it is stated that the manufacturer must have implemented a quality management system. The list of harmonized standards is published by the Official Jurnal of the European Union. On this list, ISO 13485:2016 is the only standard covering quality management system, therefore it is expected for manufacturers to have implemented ISO 13485:2016. 

For more data, please see the following links:

• EU MDR Article 8 – Use of harmonized standards https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
• EU MDR Annex 2 - https://advisera.com/13485academy/mdr/technical-documentation/
• What are EU harmonized standards? - https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/
• Link to the harmonized standards published by EU https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC
• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
• How to determine regulatory requirements according to ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-determine-regulatory-requirements-according-to-iso-13485/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

• How to prepare an audit?

  Thanks for answering the question. I really appreciate...