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Sub-clause 6.4.2

Clause 6.4.2 states that When the laboratory uses equipment outside its permanent control, it shall ensure that the requirements for equipment of this document are met.

Firstly it is important to note that "Equipment" is considered as any item used to generate a result, so this also applies, for example,  to software, reference materials, chemicals and reagents.

This clause can cover a number of scenarios, for example
1) When equipment is shared within the laboratory facility or another department of the organisation,
2) When items are stored in a storeroom not managed directly by the laboratory,
3) When equipment is calibrated offsite by a service provider or another department and returned for use by the laboratory, and 4) If a service provider performs a service on an item, even if onsite.

In all these cases the activity must comply with ISO 17025 requirements for equipment. This includes facilities and environment, handling, storage, use, verification, performance checks, and appropriate records.

For more information see

• The Article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/
• The ISO 17025 toolkit, specifically Facilities and Equipment procedures and records from  https://advisera.com/17025academy/iso-17025-documentation-toolkit/

ISO 14001 Practises for communicating environmental aspects

I cannot call these as best practices. They are some of the practices I follow.

Employees are not expected to know all significant environmental aspects), or objectives/targets, or monitoring/measuring requirements. What is expected is that they know which are relevant for their job, which ones they can contribute to or influence.

Normally, what I recommend doing is designing a homogeneous audience based on location, and customize a game where people are invited to determine significant environmental aspects from their job and learn about the best practices to handle each one.

Develop the environmental policy day. A day where the environmental policy is presented, with special attention to its commitments, and a link to the environmental objectives and targets.

Again, with a homogeneous audience based on location you can develop a kind of brainstorming about “How can I contribute, in my work, to meet the objectives and targets?”

For each relevant location periodically post the results of monitoring / measurement that people can influence during the performance of their work

Please consider the following information:

• Environmental performance evaluation - https://advisera.com/14001academy/blog/2015/07/06/environmental-performance-evaluation/
• How to perform communication related to the EMS - https://advisera.com/14001academy/blog/2015/08/31/how-to-perform-communication-related-to-the-ems/
• 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/
   

Is IATF 16949 needed for fuel systems manufacturing company?

First of all, the product you produce is mounted on the OEM vehicles such as cars, trucks, buses, etc. so you can apply for IATF 16949 certification. If you are designing products besides production activity, design and manufacturing must be clearly defined in your IATF 16949: 2016 scope. 

If your customer to whom you sell the product requires you to obtain an IATF 16949: 2016 certificate, then you should apply for certification, and your quality management system must be ready for assessment. 

If your customer does not have a request in this regard; you can apply for an IATF 16949:2016 certificate at your own request.

Quality Management Plan

As a laboratory, although a formal risk management program is not required, you need to address risks efficiently and rate them in a way so that actions can be justified and appropriate to the level of risk.

For more information regarding actions to address risks and opportunities, see the ISO 17025 toolkit document template: Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/

and for more information on the five steps to address risks, see the article Five-step laboratory risk management according to ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps/

For a more detailed explanation, you can watch the free webinar How to manage risks in laboratories according to ISO 17025 at https://advisera.com/17025academy/webinar/iso-17025-risk-management-how-to-manage-it-free-webinar-on-demand/

Also have a look at the following for more information - Expert Community Answers

• 8.5 Actions to address risks and opportunities (Option A) (new) at https://community.advisera.com/topic/8-5-actions-to-address-risks-and-opportunities-option-a-new/
• What is the efficient way and tricks to address, handle and treat the risk and opportunity? at https://community.advisera.com/topic/what-is-the-efficient-way-and-tricks-to-address-handle-and-treat-the-risk-and-opportunity/

ISO 9001 KPIs for the documentation department in the pharmaceutical industry

Start by the end!

What is the purpose of a documentation department in the pharmaceutical industry?

That department exists to meet what desirable results?

That department exists to avoid what undesirable results?

For example:

• The documentation department exists to provide approved documents required for introducing new products in the market
• The documentation department exists to ensure that updated documents are used where they are needed

As KPIs you can use for this example:

• Rate of new product introductions delayed because of missing approved documents
• Number of outdated documents found in use during audits 

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/
• 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/

Risk and Opportunity sheet for environmental aspects according to 14001:2015

Consider each environmental aspect that your organization determined.

Can you determine any risk or opportunity associated with those environmental aspects?

The following material will provide you more information:

• 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/
• 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/

Prioridades en la implementación

Lo más importante al comienzo es contar con el apoyo de la dirección que es quien proporcionará los recursos necesarios para llevar a cabo un proyecto de tal complejidad, tanto recursos financieros como recursos de personal durante la implementación de la norma. 

Una vez cuente con el apoyo de la dorección puede empezar a analizar con qué requerimientos de ISO 9001:2015 aún tiene que cumplir. Para ello puede emplear la herramienta de cumplimiento de Análisis de Brecha o GAP. En este enlace puede encontrar la herramienta de forma gratuita - ISO 9001 GAP analysis tool: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

Luego debe conocer cada una de las cláusulas con las que tiene que cumplir para poder llevar a cabo el proyecto de implementación de ISO 9001. En este white paper puede encontrar información resumida sobre cada una de ellas - Clause by clause explanation of ISO 9001: https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015

Posteriormente puede escribir un plan de proyecto en el que de signa responsabilidades, define la documentación que va a escribirse, los plazos etc. En este enlace puede descargarse una plantilla - Plan de Proyecto para la implementación de ISO 9001:https://info.advisera.com/9001academy/es/descarga-gratuita/plan-de-proyecto-para-la-implementacion-de-iso-9001-ms-word

Luego ya podría empezar con la implementación de la norma: la definición de la política de calidad, los objetivos de calidad y planes para llevarlos a cabo, el contexto de la organización y sus partes interesadas, el alcance del SGC, etc...hasta llegar a la auditoría interna y la revisión por la dirección, que sería el paso previo para certificarse. En este enlace puede descargarse un checklist para la implementación de la norma - Porject checklist for ISO 9001:2015: https://info.advisera.com/9001academy/free-download/project-checklist-for-iso-9001-2015-implementation

Para más información sobre las prioridades durante la implementación puede ver los siguientes materiales: 

- To what extent should top management be involved in your QMS: https://advisera.com/9001academy/blog/2016/11/22/to-what-extent-should-top-management-be-involved-in-your-qms/

- Libro – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Formación gratuita en línea – Fundamentos de ISO 9001:2015 : https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

Para más información sobre las prioridades durante la implementación puede ver los siguientes materiales: 

https://advisera.com/9001academy/blog/2016/11/22/to-what-extent-should-top-management-be-involved-in-your-qms/

Adaptation for small medico-social establishments

ISO 27001 was designed to be implemented on organizations of any size and industry, so the general steps are the same.

Broadly speaking, after getting support for your project (through approval of the ISMS project plan) and approval of the Procedure for Document and Record Control, you should consider these steps:

• defining ISMS basic framework (e.g., scope, objectives, organizational structure), by understanding the organizational context and requirements of interested parties;
• development of risk assessment and treatment methodology;
• perform a risk assessment and define the risk treatment plan;
• controls implementation (e.g., policies and procedures documentation, acquisitions, etc.);
• people training and awareness;
• controls operation;
• performance monitoring and measurement;
• perform an internal audit;
• perform management critical review; and
• address nonconformities, corrective actions, and opportunities for improvement.

To see how documents compliant with ISO 27001 look like, I suggest you take a look at the free demo of our ISO 27001 Documentation Toolkit at this link: https://advisera.com/27001academy/iso-27001-documentation-toolkit/

This article will provide you a further explanation about ISMS implementation:

• ISO 27001 implementation checklist https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/

These materials will also help you regarding ISO 27001 implementation:

• Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
• ISO 27001 Foundations Course at this link: https://advisera.com/training/iso-27001-foundations-course/ 

Oximeter and Heart Rate Measurement

Medical devices can not be ISO certified. Medical devices are certified according to product standard Medical device directive (MDD) or Medical device regulation (MDR). 

Nor in the ISO 13485:2016 standard nor in the MDD or MDR, there is no direct value for the accuracy. This data is usually in the technical standards. If you can tell me more about your medical device, what it is, I can guide to tehcnicals tnadrds that is applicable for it. 

Tackling clause 8.5.1

Clause 8.5.1 f) is not applicable to many organizations. Consider your organization’s soap specifications to customers or according to regulations. Can your organization control product specifications prior to delivery? If yes, clause 8.5.1 f) is not applicable. For example, heat treatment processes, welding processes, sterilization processes, are examples of where clause 8.5.1 f) is applicable.

You can find more information below:

• ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance - https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
• Free online training 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/