Search results

QMS Objectives

Timeframe is one thing, monitoring frequency is another:

If the monitoring frequency is made equal to the timeframe there will not exist any monitoring during the journey to the desired future. You will have only one verification at the end, and if you fail to meet the objective it is too late to act. For example, in the picture above, before the end of the time frame there are three interim moments of monitoring allowing action if needed.

What is the best timeframe for an objective? It will depend on the dimension of the change needed and on the availability of resources.

The following material will provide you more information:

• How to define Key performance indicators for a QMS based ISO 9001: https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
• How to write good quality objectives: https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
• 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/
   

ISO 13485 workflow explanation

Following article explains how to create an ISO 9001 process flowchart, and provides an example of a process flowchart that can be used as a guideline for creating a flowchart for your own company. You will also learn:

• What the process approach is
• Why it is important
• An overview of commonly used terminology

For more information, please see:

• How to create an ISO 9001 process flowchart https://info.advisera.com/9001academy/free-download/how-to-create-an-iso-9001-process-flowchart

Also, this webinar may provide additional information:

• The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/

• GDPR consent and scope identification

  ABC Company is the controller of his own staff's personal data. In the job contract or in the staff privacy notice, the staff gave consent to ABC company to process personal data to carry the task of the job, which means also transfer data to processors or the third parties if related to the job.

  The application, therefore, will be a processor that processes ABC’s staff personal data on the behalf of the organization for the scope to fulfill the software license agreement (use the application). Therefore, there will be a data processing agreement between ABC Company and Application Company which regulates how ABC’s data will be processed accordingly Article 28 GDPR requirements.

  GDPR applies to the whole organization and all its data processing activities whether they are computer-based or not.

  Here you can find more information:

  • Article 28 GDPR: https://advisera.com/eugdpracademy/gdpr/processor/
  • Is consent needed? Six legal bases to process data according to GDPR: https://advisera.com/eugdpracademy/knowledgebase/is-consent-needed-six-legal-bases-to-process-data-according-to-gdpr/
  • 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//

• ISO 14001 Internal Audit

  Internal auditors receive a kind of order for their audits. That order specifies three critical topics:

  • The scope of the audit (it can be the overall management system or just a part)
  • The objective, the purpose, the reason for the audit (for example checking conformance, or checking effectiveness)
  • The criteria (the part of the standard and the internal documents applicable to the scope)
     

  You can look for more information below:

  • Using internal audits to drive real improvement in ISO 14001:2015 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/using-internal-audits-to-drive-real-improvement-in-iso-140012015/
  • Enroll for free in ISO 14001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/
  • Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

• ISO 14001 Examples of Life Cycle Persepctive Analysis

  Imagine a wooden furniture manufacturing company. Life cycle analysis can begin with a concern for the origin of the wood, the guarantee that the wood came from a legitimate origin with proper exploitation practices. Then, the wood is worked in a way to be used well. And it can reach the point where the company proposes to customers to collect the furniture at the end of its useful life.

  Another example may be that of a toy manufacturer that includes information for customers to properly dispose of toy batteries at the end of their useful life.

  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/
  • 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 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/

• ISO 14001 Question

  ISO 14001 is about an environmental management system (EMS). So, risk assessment in ISO 14001 is related with desired or undesired results about the EMS.

  In a laboratory you can start by determining environmental aspects and impacts generated by laboratory operation. Then, you can determine if there are any risks and opportunities around those environmental aspects and impacts. For example, I worked in a laboratory that generated hazardous wastes. Risks could be about giving the right treatment for those wastes, working with the authorized waste operators, using practices to minimize waste generation, minimizing wastes mixture.

  You can find more information below:

  • 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/
  • 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/
     

• ISO 14001 Question

  ISO 14001 gives a great framework for doing that. Determine environmental aspects and impacts, evaluate them, and develop a set of objectives and action plans in order to improve performance around the most critical, the most significant impacts.

  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/
  • 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/

• ISO 14001 Processes that need to be covered

  No, it is not mandatory to use the process approach with ISO 14001, but you can follow the process approach in the way you manage environmental aspects and impacts. For example, I like to draw the process of managing wastes from generation until leaving the organization, or the process of managing water from sourcing to disposal.

  If you develop a register of environmental aspects and impacts it may be useful to have a column to identify the source of the aspect, and the source may be a product, a service or within the scope of a quality system process. This way it is easier to see where to act, to improve environmental performance.

  You can find more information below:

  • Application of the process approach in ISO 14001 implementation - https://advisera.com/14001academy/blog/2017/01/30/application-of-the-process-approach-in-iso-14001-implementation/
  • 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 Measuring Effectiveness with KPIs

  What is the purpose of iso 14001? ISO 14001 sets out the requirements for an environmental management system (EMS). It helps organizations improve their environmental performance.

  After updating your environmental assessment, you have a list of the most significant environmental impacts of your organization. So, it seems logical that a great EMS is a system that improves performance according to those significant environmental impacts. For example, if your organization is an intensive user of energy, or generates a lot of hazardous wastes, good KPI’s are the ones that measure performance on those two areas.

  Please check below more information:

  • How to define EMS key performance indicators (KPIs) according to ISO 14001 - https://advisera.com/14001academy/blog/2016/05/30/how-to-define-ems-key-performance-indicators-kpis-according-to-iso-14001/
  • Case study: Using ISO 14001 KPIs to reduce waste in manufacturing - https://advisera.com/14001academy/blog/2016/05/16/5135/
  • 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/
     

• Change management

  First is important to note that change management exists in ISO 27001 as one control from its Annex A (control A.12.1.2 Change management), but it can be excluded under certain conditions.

  Provided that your organization does not have relevant risks or legal requirements (e.g., laws, regulations, or contracts) that require the implementation of change management, it is possible to be certified against ISO 27001 without implementing this control.

  To see how a change management document compliant with ISO 27001 looks like, please see the demo on this link: https://advisera.com/27001academy/documentation/change-management-policy/

  These articles will provide you a further explanation about the definition of controls and change management:

  • The basic logic of ISO 27001: How does information security work? https://advisera.com/27001academy/knowledgebase/the-basic-logic-of-iso-27001-how-does-information-security-work/
  • How to manage changes in an ISMS according to ISO 27001 A.12.1.2 https://advisera.com/27001academy/blog/2015/09/14/how-to-manage-changes-in-an-isms-according-to-iso-27001-a-12-1-2/