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Soil Testing

ISO 14001:2015 in itself has no mandatory requirement about soil testing. Soil testing is mandatory if national legislation requires it, or if internal procedures require it.

You can find more information below:

• How to create an ISO 14001 list of legal and regulatory requirements - https://advisera.com/14001academy/blog/2019/11/04/iso-14001-legislation-checklist-how-to-create-it/
• 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/

Corrective Action Request

Clause 0.5 is to avoid the situation where you start with a quality audit and finish with a nonconformity about taxes, or you start with an environmental audit and finish with labor relations or social accoutability nonconformity 

Any auditor, internal or external, should stick to the scope and criteria provided before preparing the audit.

Without knowing in detail your documentation I can think that more focus and attention from auditors and audit program manager about objective, scope and criteria can be enough.

Guidelines for complying with ISO 13485 regarding validation and computerized system validation

This basically depends on the type of the medical device that you have and regulations that you need/want to be in compliance with.

In general, in ISO 9001:2015 validation is defined as "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled". As for medical devices, validation involves an "assessment by objective means of whether the specified users are enabled to achieve the specified goals (intended purpose) within the specified context of use".  

Computer System Validation (CSV) is a documented process of assuring that a computerized system does exactly what it is designed to do. Requirements for validation of computer systems can be found in:

• FDA 21 CFR part 820.70
• FDA 21 CFR part 11.10
• FDA 21 CFR part 11
• FDA Guidance Document regarding Software Validation
• ISO 13485, in chapters 4.1.6, 7.5.2.1 and 8.2.3
• Good manufacturing practice directives
• Guidance to achieve compliant computerized systems (GAMP 5), e.g. regarding the "risk-based approach of testing GxP systems"

For more information on validation, please see following articles:

• 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/
• How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/

• Environmental risk analysis

  You can start by determining environmental aspects, determining how an organization interacts with the environment. For example:

  

  Determining risks and opportunities of an organization, according to ISO 14001:2015, is based on its environmental aspects, compliance obligations, and context and interested parties.

  For example, concerning environmental aspects we can have:

  

  Since organizations have to consider the lifecycle of its products and services, do not forget to consider risks and opportunities around your products and services during use or final disposal.

  

  For example, consumers may not follow your instructions about disposal.

  Please check risk definition (3.2.10) on ISO 14001:2015 (effect of uncertainty). With environmental aspects and impacts we are considering normal, expected situations, like startup and closing down operations, but also abnormal and emergency situations. Whenever there is uncertainty there is risk or opportunities, there is a potential deviation from the expected.

  About determining risks based on environmental aspects and compliance obligations I see that different organizations follow different approaches:

  1. There are organizations that determine their environmental aspects and use a risk and opportunities assessment to determine its significant environmental aspects. (Please see the end of the second paragraph of Annex A.6.1.1 of ISO 14001:2015)

  2. There are organizations that determine their environmental aspects evaluate them and determine the significant ones and use a risk and opportunities assessment to determine which ones need an action plan, and which ones need only to be monitored.

  3. There are organizations that only apply the risk-based approach to the context part. In a certain way they are following the same approach as 1 without explicitly mentioning it.

  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/
  • Catalogue of environmental aspects - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/catalogue-of-environmental-aspects/
  • How does product life cycle influence environmental aspects according to ISO 14001:2015? - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
  • Risks and opportunities in ISO 14001:2015 – What they are and why they are important - https://advisera.com/14001academy/blog/2016/03/07/risks-and-opportunities-in-iso-140012015-what-they-are-and-why-they-are-important/
  • 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/
  • 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/

• EU GDPR compliance

  1. will this help me make my websites (cookie bar, privacy policy, terms of service, shop, contact form and newsletter) form fully compliant?

  Yes, our toolkit can help to reach compliance with GDPR requirements because it guides the user in the process.

  You can find more information about our EU GDPR Documentation Toolkit here: https://advisera.com/eugdpracademy/eu-gdpr-documentation-toolkit/

  2. Do I have full support in all the above steps or there is any limitation in terms of the times I can ask?

  Our basic toolkit includes free consultation via Skype, email support (up to 10 questions per month), video tutorial, and document review to help you through the process. We also offer other packages of support that have included more options. You can see the options and what they contain at this link: https://advisera.com/eugdpracademy/eu-gdpr-documentation-toolkit/

  3. And since my websites are visited and used by people from all over the world, do I have to comply with other non-EU countries regulation too? Or is GDPR implementation enough to these countries?I am asking this, because maybe there is need of another package to buy."

  Our toolkit helps to comply with GDPR requirements which are considered as a standard through privacy laws all around the world. However, you need to be aware that some requirements may differ from legislation to legislation and while the compliance with GDPR can cover most requirements, you may need some adjustments.

  Here you can find more information:

  • EU GDPR Documentation Toolkit https://advisera.com/eugdpracademy/eu-gdpr-documentation-toolkit/
  • What is the EU GDPR and why is it applicable to the whole world? https://advisera.com/eugdpracademy/knowledgebase/what-is-the-eu-gdpr-and-why-is-it-applicable-to-the-whole-world/
  • First steps to take to reach GDPR compliance: https://advisera.com/eugdpracademy/blog/2018/10/08/first-steps-to-take-to-reach-gdpr-compliance/

  If you want to know more about GDPR compliance you can consider enrolling in this EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

• Elements for QMS improvement

  Continual improvement of a QMS can include actions to reduce variability of processes, products and services. So, a good starting point is about considering the results from analysis and evaluation (ISO 9001:2015 clause 9.1.3) and from management review (ISO 9001:2015 clause 9.3) in order to determine if continual improvement actions are needed.

  

  The cycle of the left is the control cycle or the daily cycle. When you perform 9.1.3 or 9.3 you are checking performance (C) and deciding what to do (A).

  If the decision is: we like this performance level we can keep the process without changes, you keep your internal standard (S) (procedures, rules, instructions).
  If the decision is: we must improve performance, you must jump into the improvement cycle, and perform the PDCA. You have to determine the root cause(s) and design a solution to remove them. That solution will be part of an action plan that must be implemented to change one or more processes of your QMS. Any relevant result of a QMS (desirable or undesirable) will always be the outcome of one or more processes. Removing the root cause(s) means changing, improving one or more processes. Like in this example:

  

  The following material will provide you with information about root cause analysis and improvement:

  • ISO 9001 – How to use root cause analysis to support corrective actions in your QMS - https://advisera.com/9001academy/blog/2016/03/01/how-to-use-root-cause-analysis-to-support-corrective-actions-in-your-qms/
  • Free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 -
    https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
  • 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/
     

• Planning a remote audit

  I think that this free webinar on demand about that topic can be useful for you right now - How to perform an internal audit remotely - https://advisera.com/9001academy/webinar/remote-internal-audit-free-webinar-on-demand/ a detailed explanation about how to remotely audit operations using a tablet, a smartphone, a CCTV or a drone.

  You can find more information below:

  • What are the benefits and barriers when performing remote audits? - https://advisera.com/articles/what-are-benefits-and-barriers-when-performing-remote-audits/
  • 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/

• ISO 17025 accreditation Of laboartory

  You asked

  “what are the basic requirements to meet standards of 17025.from documentation till testing."

  ISO 17025 provides general guidelines for the competence of testing and calibration laboratories. A laboratory working in accordance with, and seeking accreditation to ISO 17025 must implement policies, establish processes, set objectives and structure the management system to meet the requirements and adhere to the quality principles of ISO 17025. For example applying risk based thinking. There are certain mandatory requirements to establish processes, for documentation and records. Both Management and Technical competency must be demonstrated before accreditation. Your accredition body should make the criteria and checklists they will use, available to you; ahead of the audit so you can assess the gaps that may exist. 

  The ISO/IEC 17025:2017 Documentation Toolkit provides template to document how the requirements are met. Previews are available at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

  The following will provide further information:

  • Complimentary white paper Clause-by-clause explanation of ISO 17025:2017 available at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
  • The article List of mandatory documents required by ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/08/30/list-of-mandatory-documents-required-by-iso-170252017/
  • The article Checklist of ISO 17025 implementation steps at https://advisera.com/17025academy/blog/2019/08/28/checklist-of-iso-17025-implementation-steps/
  • Diagram of ISO 17025 Implementation Process at https://info.advisera.com/17025academy/free-download/diagram-of-iso-17025-implementation-process
  • The Webinar What are the steps in the ISO 17025 accreditation process? Available at https://advisera.com/17025academy/webinar/what-are-the-steps-in-the-iso-17025-accreditation-process-free-webinar-on-demand/