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Document control - do we need that?

First is important to note that Document control and confidentiality levels (i.e., information classification) are different things.

Control of documents and records is a requirement of the standard (one that does not require to be documented), while information classification is one of the information security controls from ISO 27001 Annex A.

Considering that, the use of the information classification control to identify confidentiality levels is needed only if your organization has relevant risks, or legal requirements (e.g., laws, regulations, or contracts) demanding the implementation of this control. If no such situations occur, you do not need to implement information classification.

This article 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/

Configuration management

Configuration management in AS9100 (clause 8.1.2) is all about ensuring that the end product meets the requirements fully as per the design, with any design changes noted. For a company that is creating designs as their deliverable, the most important thing is traceability for the design to the design requirements to show they are met. This is very much like a design verification activity.

As for FOD, which is an example given in clause 8.5.4 on preservation, this would not really be applicable to a company delivering a design. You will not that the list in this clause is listed as “when applicable”

You can learn more on configuration management in AS9100 in the article: Understanding configuration management in AS9100 Rev D, https://advisera.com/9100academy/blog/2017/05/08/understanding-configuration-management-in-as9100-rev-d/ 

Organizational risk management

Operational risk management in AS9100 (clause 8.1.1) is all about identifying and tracking the risks that are in place during the creation and delivery of the product or service. In an organization that delivers designs you still have risks for completing and delivering the design (e.g. incomplete requirements, tight timeline for delivery, etc.). These risks need to be identified for the project, assessed and communicated, and mitigation actions assigned when necessary, with the understanding that some risks will have no action other than tracking until they are gone (e.g. time-critical delivery from a supplier)

You can learn more on operational risk management in AS9100 in the article: 5 key elements of risk management in AS9100 Rev D, https://advisera.com/9100academy/blog/2017/05/15/5-key-elements-of-risk-management-in-as9100-rev-d/

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/