Search results for "iso17025 vs gmp"

Technical requirements for a physico-chemical lab

... from the ISO17025 Academy at https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation,

Creating a new manual when implementing ISO 17025

... from the ISO17025 Academy at  https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation to assist you; as well as preview the ISO 17025 Quality Manual at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

For more information on Option B, see the article Maintaining and improving quality management in laboratories according to ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/08/30/iso-17025-maintenance-and-improvement-in-laboratories/For more information on the relationship between ISO 9001 and ISO 17025, see the article ISO 17025 vs. ISO 9001 – Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/

ISO 17025 accreditation cost

I assume from your question, that your company has a testing laboratory which plans to implement a management system according to ISO17025:2017. The pathway to accreditation basically consists of 2 stages. Stage 1 is Implementation and maintenance. Stage 2 is application, assessment and awarding of accreditation by your national accreditation body. The costs depend on the current resources you have and the fees of your accreditation body. A big component can be the cost related to method development and procuring calibration services to assure metrological traceability. 

Stage 1 starts with purchasing the standard, having personnel available to establish the processes and documented information (procedures and records), personnel to evaluate performance of activities (such as test method performance, handling complaints), perform internal audits and management to review the entire system. Here you can determine your costs through a project pan. Have a look at what Advisera can offer, and if using templates will be beneficial for your company. 
For more  support, Download a free Project plan (MS Word) for ISO/IEC 17025 implementation at https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation; 

Download the free Diagram of ISO 17025 Implementation Process at https://info.advisera.com/17025academy/free-download/diagram-of-iso-17025-implementation-process; and 
Preview the ISO/IEC 17025:2017 Documentation Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

Stage 2  involves applying for accreditation. I recommend you contact your national accreditation body, the Philippine Accreditation Bureau, who is listed, along with their contact and website detail, in the ILAC MRA Signatory search page at https://ilac.org/signatory-search/. You can request a quote from them. 

For more information on Accreditation, view the Advisera 17025 Academy Free webinar – What are the steps in the ISO 17025 accreditation process? This is available at https://advisera.com/17025academy/webinar/what-are-the-steps-in-the-iso-17025-accreditation-process-free-webinar-on-demand/

What is the efficient way and tricks to address, handle and treat the risk and opportunity?

... rong>Free ISO17025 Academy webinar – How to manage risks in laboratories according to ISO 17025. You can register at https://advisera.com/17025academy/webinar/iso-17025-risk-management-how-to-manage-it-free-webinar-on-demand/ to attend on the 1 July 2020.

For more information regarding  actions to address risks and opportunities, see the ISO 17025 toolkit document template: Addressing Risks and Opportunities Procedure - 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 - https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps/

Hand sanitizers under ISO 13485

... ractices (GMP) — Guidelines on Good Manufacturing Practices.

For more information read the following article: 

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/

In case you decide to implement ISO 13485:2016, following link can help to see which documentation is necessary: 

• ISO 13485:2016 Documentation Toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/  

ISO 17025 implementation

... Practice (GMP) accreditation will be required for the production activities. 

In any case, the confidence in the quality of the results is achieved through implementing a management system based on ISO 17025 for calibration activities. The traceability of the measurement must be ensured through a formal unbroken chain of calibrations using references traceable to international measurement standards. 

The following may be of interest:

• Calibration of measurement equipment https://community.advisera.com/topic/calibration-of-measurement-equipment/
• Project Plan for ISO/IEC 17025 implementation - https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation
• Checklist of ISO 17025 implementation steps - https://advisera.com/17025academy/blog/2019/08/28/checklist-of-iso-17025-implementation-steps/

Good Documentation Practice - GDocP

... ... ments are created and maintained. GDocP has a lot of similar requirements as ISO 9001 but they have a lot of additional requirements and ISO 9001 would not be enough to cover GDocP.

GDocP is published by FDA (U.S. Food and Drug Administration) and WHO (World Health Organization) and it is not related to ISO, so other independent bodies are conducting the audit and they are called GMP regulators.

Identifying gaps between ISO 13485 and ISO 9001

We do not have as part of our documentation toolkit any GAP analysis template. But you can look at this article for details:

• Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

Also, you can check the Annexes in ISO 13485:2016, where you have a cross-reference table between ISO 9001:2015 and ISO 13485:2016.

Regulatory Compliance QMS Program

... You can download the complete list of documents on the following link: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

More details regarding the differences and similarities between the US and EU markets are discussed in this article:

• FDA vs. EU MDR Technical Documentation Matrix https://info.advisera.com/13485academy/free-download/fda-vs-eu-mdr-technical-documentation-matrix

How to write a separate strategic risk assessment?

... assign rankings based on the specific criteria for each category. Strategic risks may receive rankings based on their potential impact on long-term goals, while operational risks are ranked according to their daily impact and likelihood.
 
You can find more information in:

• ISO 14001 risks and opportunities vs. environmental aspects
• The role of risk management in the ISO 14001:2015 standard