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Keeping track of data on context of organization

ISO 14001 does not require context of the organization (internal and external issues) to be documented. However, you can record your internal and external issues on a register, a table, or translate them into a SWOT matrix. This document can be kept separately or can be an appendix to a manual.

Periodically, or when relevant your organization should update and evaluate if some issues became more or less important and if new issues appeared.

Please check this information below with more detailed answers:

• Determining the context of the organization in ISO 14001 https://advisera.com/14001academy/knowledgebase/determining-the-context-of-the-organization-in-iso-14001/
• Enroll for free in the 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/

Integrating business success with ISO 9001

Think about the business management system instead of a quality management system. Integrate your strategic orientation in the business management system. How? Start by determining what is your organization’s competitive advantage and who are your target customers. Develop a quality policy that clearly answers to Who are we? Whom do we serve? What are the few relevant things that we must be excellent at to satisfy target customers? Develop objectives that are relevant for the business and aligned with strategy. Develop action plans that execute the strategy and allow meeting business objectives. Then, working with the process approach and disciplined monitorization will do the rest.

The following material will provide you more information:

• Aligning quality objectives of the QMS with the strategic direction of the company - https://advisera.com/9001academy/blog/2017/03/07/aligning-quality-objectives-of-the-qms-with-the-strategic-direction-of-the-company/
• Free webinar on demand where I develop the challenge of working with relevant indicators - 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/
• Free webinar on demand - 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/
• Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
• I base this book in the process approach - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Keeping track of aspect/impact register

As far as I understand your question, you made your organization’s initial environmental assessment where you determined aspects and impacts and recorded them on a register. After evaluation of significance your organization developed action plans to control, prevent, eliminate or minimize, the most significant impacts. Periodically, your organization, due to changes in legislation, due to new products and services, due to investments in the facilities, due to the impact of previous action plans, may need to update either the aspects and impacts in the register, either their evaluation. For example, a successful action plan may make a previous significant aspect/impact as non-significant now.

Please check this information below with more detailed answers:

• 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
• 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 9001 responsibilities and tasks

With ISO 9001:2015 there is no longer a mandatory requirement for a quality management representative. ISO 9001:2015 makes no mention of a QMS office. So, it is up to each organization to design the set of responsibilities, authorities and tasks of both a QMS office and of a QMR. If your organization decides to keep both functions read your QMS documentation, interview people and list all activities done for each function. Then, separate those where people have latitude for decision (authority) from those where people are just expected to do (responsibility).

For example, an organization may decide that a QMS office has the responsibility to receive and investigate complaints (responsibilities) but have no authority to decide what to communicate to customers (no authority).

The following material will provide you more information:

• How to document roles and responsibilities according to ISO 9001 - https://advisera.com/9001academy/blog/2018/02/26/how-to-document-roles-and-responsibilities-according-to-iso-9001/
• Enroll for free in ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
• Book - Discover ISO 9001 :2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

Sampling (clause 7.3)

From your explanation, if you are testing all the materials used for an installation, then sampling requirements would not apply to your activities. Sampling covers, simply, the taking of a unit or portion of a material, substance or product from the source so that a sample can be tested or calibrated. The intent is that the sampling plan and methodology results in a suitably representative sample for subsequent testing so as to represent the measurement result of the source. As you are doing the testing, look at the risk based on what you are reporting. If the report claims the consignment of aluminium curtain walls, doors and windows used in your installation is fit for purpose, or conforms to a specification; and your laboratory only tested a portion of the consignment, then you do need to comply with Clause 7.3, sampling requirement. The standard you use may state the sampling rate (number of units tested per units in the consignment), in which case you can reference the Standard and provide recorded evidence that the requirement were complied with.

If applicable, have a look at the ISO 17025 document template previews: Sampling Procedure available at https://advisera.com/17025academy/documentation/sampling-procedure/ as well as the 2 related appendices Sampling Plan at https://advisera.com/17025academy/documentation/sampling-plan/ and Sampling Report at https://advisera.com/17025academy/documentation/sampling-report/

UDI procedure that covers the EU MDR requerment

Unfortunately, the UDI procedure is not part of our ISO 13485:2016 and MDR Documentation toolkit. According to the MDR Article 27 – Unique Device Identification system and MDR Annex 6 – Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29; and the UDI system, there is no need to have documented procedure for UDI. The requirement is for the List of UDI which you have in your toolkit.  

For more information, please read the following:

• EU MDR Article 27 – Unique Device Identification system https://advisera.com/13485academy/mdr/unique-device-identification-system/
• EU MDR Annex 6 – Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29; and the UDI system  https://advisera.com/13485academy/mdr/information-to-be-submitted-upon-the-registration-of-devices-and-economic-operators-in-accordance-with-articles-294-and-31-core-data-elements-to-be-provided-to-the-udi-database-together-with-the-ud/ 

For more information on the mandatory documents in the MDR, please see the following material:

• EU MDR Checklist of Mandatory Documents https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents

• Environmental areas tracking and economic impact

  Some years ago, I wrote about the "Tuning environment and strategy for the business". The idea was based on the fact that organizations want economic results and that is why they develop business strategies. Environmentally conscious organizations should try to obtain business results while complying with environmental legislation and improving its relationship with the environment.

  Simplifying reality, an organization can compete based on:

  • The lowest cost;
  • The best service;
  • The most innovative product/service.

  While developing an environmental management system an organization must determine its aspects and impacts. To evaluate aspects and impacts significance an organization must develop some criteria to give a classification based, for example, on frequency, severity for the environment, and importance for the business.
  If competition is based on the lowest cost your organization can consider as important those aspects that can increase costs. For example, hazardous waste disposal.

  If competition is based on service, your organization can consider ways of improving relationships with the environment jointly with the customers. For example, once I worked with a company that worked together with a customer to start using reusable packaging for its supplies instead of single-use only.
  If competition is based on innovative products/services, your organization can consider developing new products/services that reduce the environmental footprint of products and services throughout the life cycle as important. Allowing your organization’s brand to have a connotation of environmentally friendly.

  Please check this information below with more detailed answers:

  • 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
  • What makes an environmental aspect significant in ISO 14001? - https://advisera.com/14001academy/blog/2015/03/09/what-makes-environmental-aspect-significant-in-iso-14001/
  • 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/

• AS9100 internal audit report

  As per AS9100 Clause 9.2 your internal audit needs to confirm that you have met the requirements of the standard, as well as meeting your own internal requirements. So, in a certification audit you will need to demonstrate that your intern audits have done this. While it is not a mandate to record this as you have stated, quoting the clauses of the standard in your audit report is one common way to demonstrate this. You may also keep track of this in a different format, as long as you can demonstrate it.

  You can learn more about how certification audit works in the whitepaper: What to expect at the ISO certification audit: What the auditor can and cannot do, https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit

• ISO 9001 benefits and safety

  Perhaps presenting the story behind the appearance of ISO 9001 and how it is related to globalization and the increase of international trade.
  The more an organization needs to trust in a supplier, the more an organization wants to develop partnerships with suppliers, the more important ISO 9001 standard is as a way for ensuring that a common language can be used and understood for interfacing processes, in a world where supplier and client can be a continent away.

  The following material will provide you more information:

  • The history and future of the ISO 9000 series of standards - https://advisera.com/9001academy/blog/2019/04/15/history-of-the-iso-9000-series-of-standards-and-what-to-expect-next/
  • Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
  • Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

• Involving employees in ISO 9001

  As a first approach ask your top management to give the example. If top management with their agenda do not show the importance of the quality management system, it will be difficult for employees to be involved.

  As another approach translate ISO 9001:2015 requirements into benefits for employees and the organization

  • Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
  • What are the benefits of ISO 9001 for your employees? - https://advisera.com/9001academy/blog/2016/06/14/what-are-the-benefits-of-iso-9001-for-your-employees/
  • Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
  • Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/