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Surveillance audit

The surveillance audit will be used to verify that the quality management system is still working, and procedures are being used. Particular attention will be paid to verifying the actions taken to close any non-conformities raised during the certification audit. The records associated with the system review, internal audits, complaints, treatment of non-conformities and development of corrective actions will be audited. some processes will be audited at random to prove that the system continues to be followed.

You can find more information below:

• What is an ISO 9001 surveillance audit? - https://advisera.com/9001academy/blog/2016/10/18/what-is-an-iso-9001-surveillance-audit/
• Surveillance visits vs. certification audits - https://advisera.com/27001academy/knowledgebase/surveillance-visits-vs-certification-audits/
• ISO 9001:2015 Lead Auditor Training Course - https://advisera.com/training/iso-9001-lead-auditor-course/
• Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

ISO 9001 for companies vs individuals

Yes, ISO 9001:2015 is for organizations, not for individuals. If you want to be qualified in relation to ISO 9001:2015 you can look for courses where you can get a certificate.

You can find more information below:

• Quality Certification - https://advisera.com/9001academy/knowledgebase/quality-certification/
• ISO 9001 online training - https://advisera.com/training/iso-9001-courses/

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.