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Validation, Qualification, and Verification procedure

My first instinct was to recommend you check ISO 9000:2015 definitions, but then I realized that ISO 9000:2015 uses qualification and verification interchangeably. Verification is commonly used in design activities to name a set of activities done to confirm that specifications were met. Meeting specifications is not a guarantee that requirements for intended use are met, that is the topic of validation: confirmation that requirements for intended use are met. Now, about qualification I have doubts about what you want to mean with it. Perhaps, qualification is the state after a verification well succeeded.

You can find more information below:

• The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
• About conducting design and development reviews consider - ISO9001 Design Verification vs Design Validation - https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
• 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/
   

Statutory and regulatory requirements

There is no universal answer, a specific answer for your own organization will depend on its organization chart and job descriptions. I see many maintenance departments being held responsible for fleet inspection management.

You can find more information on Statutory and regulatory requirements below:

• 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/
• 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/
• Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Auditing internal audit processes

I start by checking if they have an annual audit program. If the program is approved and is being followed. I pick two internal audits and ask to see the audit reports. After checking the name of the auditors, I ask to see evidence that they comply with the organization’s requirements for competence. If there were non-conformities raised I ask to see if they were treated and properly closed.
If there is an internal audit procedure I can check if the right forms were used and if records are correctly kept.

You can find more information below:

• How to deal with nonconformities in an ISO 9001 certification audit - https://advisera.com/9001academy/blog/2015/06/09/how-to-deal-with-nonconformities-in-an-iso-9001-certification-audit/
• How to write a good ISO 9001 audit nonconformity? - https://advisera.com/9001academy/blog/2018/04/24/how-to-write-a-good-iso-9001-audit-nonconformity/
• Free webinar on-demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/
• ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ ernal-auditor-course/
• ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/

ISO 14001 compliance in local municipality

I listed below a set of links that can help you start your draft proposal. What can be the benefits for the municipality and its interested parties? What environmental aspects and impacts? What risks and opportunities? From there a project plan to meet environmental objectives and improve the relationship with the environment.

• ISO 14001 Knowledge Base - https://advisera.com/14001academy/knowledgebase/
• Is a gap analysis desirable for ISO 14001 implementation? - https://advisera.com/14001academy/blog/2016/11/14/is-a-gap-analysis-desirable-for-iso-14001-implementation/
• Project checklist for ISO 14001 implementation - https://info.advisera.com/14001academy/free-download/project-checklist-for-iso-14001-implementation
• 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-foundations-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
   

ISO 9001 requirements for new equipment

First, considering the topic generally, I think about clauses 5.5.1 b) and f).

Welding equipment is a typical case of what can be included in entry f).

If the welding equipment operates automatically it must be previously validated.

If the welding equipment operates under human supervision, the human competence must be validated. The point is, whenever a critical operation is performed and cannot be tested with quality control, the process must be validated.

The following material will provide you more information:

• How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/

Emergency situation vs Incident

Neither ISO 14001:2015 nor ISO 9000:2015 define what is an emergency situation or what is an incident. So, each organization can develop its own scale to classify environmental events based, for example, on dimension and severity of the event. If your organization wants to use both words meaning different things it is best to define and clarify what is what.

Note – In the book below the word incident is used as having the same meaning as event. For example, an “emergency incident” has occurred.

You can find more information below:

• ISO 14001 emergency preparedness and response - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/iso-14001-emergency-preparedness-and-response/
• 5 steps to set up an emergency plan according to ISO 14001 - https://advisera.com/14001academy/blog/2014/07/23/5-steps-set-emergency-plan-according-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/

Is ISO 13485 for medical devices only?

As is stated in the section 1 Scope of the ISO 13485:2016, this standard is applicable for medical devices or related services. In section 3 Terms and definitions, in 3.11 is stated what is considered as medical device. According to that, hand sanitisers and chemicals used on masks are not medical devices. 

Approaching quality objectives

As far as I understand your question, quality objectives must derive from the quality policy and each quality objective must be built upon the SMART framework. Naturally, quality objectives should be translated into action plans.

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/
• How t write good quality objectives: https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
• 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/
   

Which clause in ISO 17025:2017 does talk about any exclusion?

ISO 17025:2017 does not have a clause on exclusion. The clause of relevance on this topic will be Clause 5.3, where the laboratory is required to define the scope and range of laboratory activities that conform to ISO 17025:2017. For example, for many laboratories, sampling does not apply. The scope and range of activities will typically be stated in the Quality Manual.

For further information, Have a look at the article What is ISO 17025 at https://advisera.com/17025academy/what-is-iso-17025/ and the preview of the ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

You can download the free Diagram of ISO 17025:2017 Implementation Process, the Project Plan as well as relevant white papers at https://advisera.com/17025academy/free-downloads/

If you are familiar with ISO 9001, the following may also be of interest - 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//