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Is ISO 17025 designed and intended to be implemented on individual, test-by-test basis?

ISO 17025 implementation applies to the overall activities of the laboratory, including for example personnel training or procurement. The “test-by-test” basis you refer to is applicable to the laboratory’s Scope of Work, for which accreditation is applied for. So you state what is being calibrated (including method and range); or what is being tested (analyte or group of analytes), in what matrix and using what method or instrument. An example is Heavy Metals in Soil by ICP-MS. For each method, yes you need to show technical competence to produce reliable, valid results. If your laboratory may is not involved with sampling, then you state in your documentation that sampling not the responsibility of the laboratory.

For more detail on what is required for ISO 17025, read the whitepaper Clause-by-clause explanation of ISO 17025:2017 available for download from https://advisera.com/17025academy/free-downloads/ and preview the ISO 17025 Academy toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

Addressing management, staff and practical issues within ISO 14001

Each organization is a different case. Each organization has different motivations, different amounts of staff, different starting points in its survey of the initial environmental situation. The implementation phase requires a project manager almost full time, often this does not happen. Some companies may start from a base where they have to make major investments to meet compliance obligations. Some companies may find it difficult to provide time for training in good environmental practices.

Please check this information below about implementation:

• Free webinar on-demand - How to use a Documentation Toolkit for the implementation of ISO 14001 - https://advisera.com/14001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-14001-free-webinar-on-demand/
• List of ISO 14001 implementation steps - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-iso-14001-implementation-steps/
• ISO 14001:2015 Implementation diagram - https://info.advisera.com/14001academy/free-download/iso-14001-2015-implementation-diagram
• 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/

Information Classification Policy - “labeling” of information

ISO 27001 does not prescribe how to define information labeling, so your proposed scheme is acceptable by the standard (i.e., keep “Internal use” information unlabeled, and label public information as public).  

These articles will provide you a further explanation about information classification:

• Information classification according to ISO 27001 https://advisera.com/27001academy/blog/2014/05/12/information-classification-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 regarding information classification:

• ISO 27001 Annex A Controls in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/
• 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/

Asset inventory and risk analysis

I’m assuming you are asking for tools and approaches for asset inventory and risk analysis.

Considering that, it is our policy not making recommendations about tools or technologies.

Regarding the approach for risk analysis, the most common approach used for information security based on ISO 27001 is the asset-threat-vulnerability approach. 

For more information, see:

• ISO 27001/ISO 27005 risk assessment & treatment – 6 basic steps https://advisera.com/27001academy/knowledgebase/iso-27001-risk-assessment-treatment-6-basic-steps/
• ISO 27001 risk assessment: How to match assets, threats, and vulnerabilities https://advisera.com/27001academy/knowledgebase/iso-27001-risk-assessment-how-to-match-assets-threats-and-vulnerabilities/
• How to assess consequences and likelihood in ISO 27001 risk analysis https://advisera.com/27001academy/iso-27001-risk-assessment-treatment-management/#assessment

To see a template of risk assessment compliant with ISO 27001, see this link:

• Risk Assessment Table https://advisera.com/27001academy/documentation/risk-assessment-table/

As for asset inventory, ISO 27001 does not prescribe an approach for asset inventory. Actually, the inventory of assets is not needed, especially when companies are implementing the standard for the first time - it is enough to develop a list of assets for the Risk assessment, and once this is done this list is simply copied to Inventory of assets.

To see a template of inventory of assets compliant with ISO 27001, see this link:

• Inventory of Assets https://advisera.com/27001academy/documentation/inventory-of-assets/

This article will provide you a further explanation about the inventory of assets:

• How to handle Asset register (Asset inventory) according to ISO 27001 https://advisera.com/27001academy/knowledgebase/how-to-handle-asset-register-asset-inventory-according-to-iso-27001/

These materials will also help you with these activities:

• Book ISO 27001 Risk Management in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/
• ISO 27001 Annex A Controls in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/
• The basics of risk assessment and treatment according to ISO 27001 [free webinar] https://advisera.com/27001academy/webinar/basics-risk-assessment-treatment-according-iso-27001-free-webinar-demand/
• ISO 27001:2013 Foundations Course https://advisera.com/training/iso-27001-foundations-course/ 

Guidelines for the control of external origin documents

You can find a set of guidelines for controlling external documents in this article - What does “external documents control” mean in ISO 9001? - https://advisera.com/9001academy/blog/2019/02/04/what-does-external-documents-control-mean-in-iso-9001/

You can find more information below:

• How to include statutory and regulatory requirements in your QMS - https://advisera.com/9001academy/blog/2017/02/14/how-to-include-statutory-and-regulatory-requirements-in-your-qms/
• Free on-line course - 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/
   

Nonconformities, OFI's vs Low/Med/High Audit Gaps

First is important to note that major/minor nonconformities are normally used only for certification/surveillance audits of certified ISO management systems. Internal audits in general use the ratings you mentioned.

Considering that, major nonconformities would compare to high rating, while minor nonconformities could be compared to low or medium rating, depending on criteria used by the organization.

As for Opportunities For Improvement (OFIs), they should be rated considering criteria adopted by the organization to evaluate their potential benefits (i.e., they could be rated low, medium, or high).

These materials will also help you regarding NC and OFI ratings:

• Preparing for ISO Certification Audit: A Plain English Guide https://advisera.com/books/preparing-for-iso-certification-audit-plain-english-guide/
• ISO Internal Audit: A Plain English Guide https://advisera.com/books/iso-internal-audit-plain-english-guide/
• Free online training ISO 27001:2013 Internal Auditor Course https://advisera.com/training/iso-27001-internal-auditor-course/

Writing quality assurance policies

Please note that since the year 2000 ISO 9001 is no longer about quality assurance, but about quality management.
An organization with a quality management system should have a quality policy. A quality policy is a set of intentions and directions for an organization as determined by top management.
You will not see this in ISO 9001:2015, this is my practice. When I work with an organization’s top management in developing their quality policy I recommend thinking about some questions:

• Who are our target customers and other very relevant interested parties?
• What are the most important requirements for those target customers and other very relevant interested parties?
• In what activities should our organization be excellent to be able to satisfy target customers and other very relevant interested parties?

After discussing the questions and answers and after arriving at some consensus, I invite the organization to write a text with the following structure:

• For whom do we work (We work for clients that value …) – In your case think about the more relevant interested parties: consumers, local authorities, …
• What are our top priorities? In what things we need to be excellent to satisfy those for whom we work?
• Add the commitments included and required by ISO 9001
• That way you will write a guiding document that will focus your organization in a strategic way and translating that policy into objectives will be easier.

The following material will provide you more information about the quality policy:

• How to Write a Good Quality Policy - https://advisera.com/9001academy/blog/2014/03/25/write-good-quality-policy/
• You can enroll in this free course ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• You can enroll in this free course 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/

Importance of change controls

Change control is very important in ISO 17025, as with any management system. In ISO 17025 it is typically managed at the activity level, for example Data, Information, Document and Record management; or ensuring validity of results. The scope of ISO 17025 is the competence, impartiality, and consistent operation of laboratories. To achieve stability and consistent operation, risks and opportunities must be managed. This means that any changes for management and technical activities must be planned, controlled, and coordinated. For example, changing a supplier of a critical chemical reagent could invalidate a method if the risk is not considered and the impact of the new chemical supply not evaluated.

For more detail on what is required for ISO 17025, read the whitepaper Clause-by-clause explanation of ISO 17025:2017 available for download from https://advisera.com/17025academy/free-downloads/ and preview the toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

ISO 14001 lineamiemtos precisos para establecer en una empresa minera

La implementación de ISO 14001:2015 en una empresa minera es igual que en otro tipo de sectores, teniendo en cuenta que en el caso del sector de la minería se emplean muchos recursos naturales y por lo tanto hay número de aspectos ambientales e impactos significativos para los cuales se tendrán que implantar los consecuentes controles operacionales. 

También es importante destacar la necesidad de estar al día en cuanto a los requisitos de cumplimiento, especialmente regulatorios, que son bastante numerosos en el sector de la minería, pero también aquellos relacionados con los requisitos contractuales

En primer lugar es muy importante contar con el apoyo lo de la alta dirección, que va a facilitar los recursos tanto de personal como económicos para poder llevar a cabo el proyecto de implementación.

Más adelante puede llevar a cabo un análisis de brecha (o GAP, por sus siglas en inglés) que le ayudará a identificar aquellos requisitos con los que la organización aún no cumple. Esto le va a facilitar la implementación ya que reducirá significativamente el tiempo de implementación. Aquí puede llevar a cabo el análisis de forma gratuita - Herramienta de análisis de brecha en ISO 14001: https://advisera.com/14001academy/es/herramienta-gap-analysis-iso-140012015/

También le recomiendo que defina un plan de proyecto, donde determine las responsabilidades, hitos durante la implementación, plazos, etc. Aquí puede descargar de forma gratuita un plan de proyecto - Project Plan for ISO 14001:2015 implementation: https://info.advisera.com/14001academy/free-download/project-plan-for-iso-140012015-implementation-ms-powerpoint

Más tarde ya podrían empezar con lo que es la implementación en sí de la norma, definiendo el alcance del Sistema de Gestión Ambiental, para lo cual le recomiendo que primeramente de las cuestiones internas y externas del contexto de la organización, ya que le puede ser de gran ayuda a la hora de saber cuáles van a ser los límites de su SGA. A continuación, puede determinar tanto la política de su SGA así como los objetivos del SGA. Aquí puede obtener más información de cómo definir el alcance de su SGA - How to determine the scope of the EMS according to ISO 14001:2015: https://advisera.com/14001academy/blog/2016/02/01/how-to-determine-the-scope-of-the-ems-according-to-iso-140012015/

Más adentante, deberá de establecer todos los procesos relacionados con el sistema e implentarlos para finalmente realizar la auditoría interna y finalmente llevar a cabo la revisión por la dirección.

Estos materiales  pueden ayudarle a saber cuáles son los pasos en la implementación de ISO 14001:2015:

- Why mining companies should obtain ISO 14001 certification: https://advisera.com/14001academy/blog/2018/04/17/why-mining-companies-should-obtain-iso-14001-certification/

- Artículo: Lista de pasos para la implementación de la ISO 14001: https://advisera.com/14001academy/es/knowledgebase/lista-de-pasos-para-la-implementacion-de-la-iso-14001/

- Curso gratuito - Fundamentos de ISO 14001:2015:  https://advisera.com/training/es/course/curso-fundamentos-iso-14001/

- Libro - The ISO 14001:2015 companion: https://advisera.com/books/the-iso-14001-2015-companion/

Documents needed in term of testing methods

You asked 

....what all documents would we need in term of testing for the said methods? for example, do I need to validate/ verify these methods?

Yes, you do need to validate all test methods that are going to be on your scope of accreditation. You need to meet requirements of ISO 17025 clauses 7.2 and 7.6 for this activity

You would need to include at least all mandatory procedures and records.
See the Whitepaper Checklist of mandatory documents required by ISO 17025:2017
For more detail on what is requires, read the whitepaper Clause-by-clause explanation of ISO 17025:2017
Both are available for download from https://advisera.com/17025academy/free-downloads/

You asked How?

The ISO 17025 toolkit includes the procedure for validation and verification of methods, named Test and Calibration Method Procedure, along with two supporting documents Test Method Development, Verification and Validation Register and Test Method Development, Verification and Validation Record. The procedure is also available separately at https://advisera.com/17025academy/documentation/test-and-calibration-method-procedure/

The overall techniques for method validation are listed as well as the required records. It is the responsibility of the laboratory to choose the suitable technique and performance parameters, plan experiments and use suitable calculations. This is not in the scope of the toolkit. It is important to reference sector specific guidelines and meet specific regulatory and accreditation body requirements.