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Query regarding the career with ISO 27001 Certificate

As a telecom security engineer, I’m assuming your main tasks will be of technical nature.

Considering that, ISO 27001 can help you understand the main concepts of information security and information security controls that can be applied to telecom, however, it will not provide you technical details on how to implement controls. For such knowledge, you should look for other certifications, like CISSP and CompTIA.

Regarding ISO 27001 certifications, if you want to consider an ISO 27001 career you can follow:

• ISO 27001 Lead Implementer – this certification recognizes people who have competency in the ISO 27001 implementation process.
• ISO 27001 Lead Auditor – this certification recognizes people who have competency in auditing an ISMS against ISO 27001 requirements and want to become certification auditors (and with this provides more confidence to an organization for being certified).

These articles will provide you a further explanation about ISO 27001 personnel certifications:

• What does ISO 27001 Lead Implementer training look like? https://advisera.com/27001academy/blog/2016/11/28/what-does-iso-27001-lead-implementer-training-look-like/
• What does ISO 27001 Lead Auditor training look like? https://advisera.com/27001academy/blog/2016/08/29/what-does-iso-27001-lead-auditor-training-look-like/
• Lead Auditor Course vs. Lead Implementer Course – Which one to go for? https://advisera.com/27001academy/blog/2014/06/16/lead-auditor-course-vs-lead-implementer-course-which-one-to-go-for/

For courses related to these certifications, please see:

• ISO 27001:2013 Lead auditor course https://advisera.com/training/iso-27001-lead-auditor-course/
• ISO 27001:2013 Lead implementer course https://advisera.com/training/iso-27001-lead-implementer-course/

ISO 27001 Foundations Course comment

Please note that the question refers to the Statement of Applicability document (“The Statement of Applicability document should include:”)

Considering that, ISO 27001 clauses 6.1.3 d), and 6.1.3.c requires that all 114 controls from Annex A are included in the SoA, not only those deemed applicable, as well as additional controls from other sources. For those controls from Annex A deemed not applicable, you need to provide justification for their exclusion.

This article will provide you a further explanation about the Statement of Applicability:

• The importance of Statement of Applicability for ISO 27001 https://advisera.com/27001academy/knowledgebase/the-importance-of-statement-of-applicability-for-iso-27001/

ISO 9001 Audit objectives

Let us consider two cases:

Case A

If the audit Program only includes one audit (the scope is the whole quality management system) we may say that both audit program and audit plan have the same purpose, have the same objective.

Case B

If the audit program includes a set of audits, then we have different objectives. For example, the audit program objective is about the whole set of audits, but each audit will have a different objective and a different audit plan because they may have different scopes and different audit objectives.

For each audit, whatever the case, the audit process objective is the same: being able to arrive at sound conclusions based on the audit plan objectives and on the findings based on solid evidence.

You can find more information below:

• Article - ISO 9001 internal auditor training: Is it for me? - https://advisera.com/9001academy/blog/2015/06/02/iso-9001-internal-auditor-training-is-it-for-me/
• Webinar - Free webinar on-demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/
• Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

Do I need ISO 17025 certification in order to audit laboratories?

You asked

as a lab expert, do I also need ISO17025 certification in order to audit laboratories? Or is 9001 is sufficient?

 
There are very few options to obtain ISO 17025 auditing certification. As ISO 9001 is incorporated into the ISO 17025:2017 Management requirements and ISO 17025 Lead Auditor certification courses may not be as readily available, the ISO 9001:2015 Lead Auditor Training Course is a good option. (see https://advisera.com/training/iso-9001-lead-auditor-course/)
There are two components to auditing to consider:

• Auditing skills - Training should include exposure /introduction to ISO 19011: Guidelines for Auditing Management Systems as it is provides guidelines for auditing all management systems.
• Knowledge of the standard against which you are auditing. 

Auditing basics, roles and the principles of auditing covered in the ISO 9001 auditing course will be applicable to auditing ISO 17025 as well. In ISO 17025 auditing the lead auditor should have appropriate auditing skills to assess the management clauses, meaning all those that do not have a technical component. The technical auditor also needs to also have appropriate auditing skills but must also have the ability to audit the technical aspects, including method validation and measurement uncertainty, quality control. In other words the depth of knowledge and skill to delve deep enough into the risks and assess technical validity and competency. This experience comes from hands on working in a laboratory and attending additional training on technical matters. Based on your comments, this is experience you have.

If you choose to obtain ISO 17025:2017 Lead Auditor certification; select a suitable course offered by an approved Training Partners of an international certification body such as Exemplar Global (formally RABQSA) or IRCA (The International Register of Certificated Auditors). 

Have a look at Advisera’s Certification FAQs at https://advisera.com/training/eu-gdpr-courses/ for further information regarding certification

Checklist for pre-/post site inspections

We do not have a checklist, but here are some questions that you can ask:

• How they maintain the refrigerators/cold rooms
• How do they monitor the temperature of the refrigerators / cold rooms
• Are equipment for monitoring temperature calibrated – ask for the certificate of the calibration
• What is the principle of the storage – First in first out (FIFO) or First expire first-out (FEFO)?
• Is there other special conditions for the refrigerators/cold rooms that need to be monitored (for example: is humidity important to be monitored; if refrigerators are used, is it necessary to ensure the conditions of the room in which the refrigerators are located in order to prevent overheating)

For more information regarding storage, please see the following articles:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/
• Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

• Can one person be lab director and quality manager at the same time?

  Glad you found the webinar interesting.

  In terms of ISO 17025, the Quality Manager needs to be impartial, but need not, if the risk is accepted, be independent. There may however, for certain sectors be regulatory requirements or other standards; that require independence of the QM. What is important is the functional role in ISO 17025, for example the appointed laboratory manager my function as the QM as well, as long as risk is managed, and impartiality is evident.

   

  There are some activities, where you should appoint an independent person; even a person reporting to you, or a colleague; to review for example, documents you author. Furthermore internal auditing requires independence so you will need to contract an independent third party consultant or an independent competent person from another department or sister company to assist with audits.

• ISO 9001 MRM & MOM

  I think that MRM stands for Management Review Meeting:

  • Please consider this free webinar on-demand - How to perform management review according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-perform-management-review-according-to-iso-9001-2015-free-webinar-on-demand/

  Consider also the following information:

  • How to make Management Review more useful in the QMS - https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/
  • How to Make Management Review More Practical - https://advisera.com/9001academy/blog/2013/12/10/make-management-review-practical/
  • ISO 9001 document template: Procedure for Management Review - https://advisera.com/9001academy/documentation/procedure-management-review/
     

  I think MOM for Manufacturing Operations Management:

  Consider the following information:

  • Understanding Product & Service Provision in ISO 9001 - https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/
  • Enroll for the 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/

• Procedure sign-off under ISO 9001

  Please check ISO 9001:2015 clause 7.5.2 c). Each organization has the authority to determine what is to be considered the appropriate review and approval for suitability and adequacy. Many smaller or centralized organizations decide that all procedures are approved by the owner or General Manager. Bigger and or more decentralized organizations determine that different documents can be approved by different functions and one or more functions. As a consultant, I ask organizations to write a document register where the authority to sign off each procedure is written, and that document is approved by top management. Showing clearly who has the authority to approve each document.

  You can find more information about the documentation below:

  • Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
  • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

• Where to begin implementing ISO 9001 for a Port Authority

  If your organization wants to implement a quality management system (QMS) according to ISO 9001:2015 requirements you can start by reading this article - How to get ISO 9001 certified - https://advisera.com/9001academy/iso-9001-certification/

  A possible approach to implement a QMS can be:

  • Setup a project sponsor, a project manager, and a project team. Ensure top management support, get training about the standard. Designing and implementing a quality management system implies being knowledgeable about ISO 9001:2015.
  • As a first step perform a Gap analysis, to determine the amount of work to be done - comparing what your organization already has in place versus ISO 9001:2015 requirements. From that GAP Analysis, you can develop your Project Plan, listing what needs to be done, by whom, until when.

  Then, an important step is to design a model of how your organization works as a set of interrelated processes. For example:

  

  Decide how to describe and monitor those processes.

  From there it is implementation in order to close the gaps found. Then, perform an internal audit and the management review. There you can decide if your organization is ready for a certification audit.

  If you need to speed-up your implementation process you can consider our Documentation Toolkit for the implementation of ISO 9001:2015 here - https://advisera.com/9001academy/iso-9001-documentation-toolkit/ and check the free previews. You can also watch this free webinar on-demand - How to use a Documentation Toolkit for the implementation of ISO 9001 - https://advisera.com/9001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-9001-free-webinar-on-demand/

  This is a very short description of the journey but below you can find more detailed information:

  You can find more information below:

  • Free Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
  • Should you use a gap analysis in your ISO 9001 implementation? -https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/
  • Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
  • ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
  • How to budget an ISO 9001 implementation project - https://info.advisera.com/9001academy/free-download/how-to-budget-an-iso-9001-implementation-project?utm_source=script-for-iso-9001-lead-implementer-course&utm_medium=downloaded-content&utm_content=lang-en&utm_campaign=free-downloads-9001
  • Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
  • 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/

• Fines issued in UK for non-compliance to GDRP

  You can find all enforcement decision issued by the Information Commissioner's Office on its website: https://ico.org.uk/action-weve-taken/enforcement/

  There is also this Enforcement tracker where you can filter by country: https://www.enforcementtracker.com/

  If you need more information about GDPR enforcement and how the Supervisory Authorities work, you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//