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Applicability of 17025 to GMP analytical laboratory

Yes, ISO 17025 is definitely applicable for your laboratory. Both the laboratory and customers will benefit from the assurance of technical competency. The context for your laboratory it seems from your question, is that there are other interested parties and certifications involved. They could in fact require your testing laboratory to be ISO 17025 accredited.

The following articles may be of interest:

• Six key benefits of ISO 17025 implementation at https://advisera.com/17025academy/blog/2019/10/18/six-key-benefits-of-iso-17025-implementation/
• What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/

Also have a look at the 17025 Expert Advice Community topic ISO 17025 for internal quality control laboratory at https://community.advisera.com/topic/iso-17025-for-internal-quality-control-laboratory/
and the free demo of the ISO 17025 Documentation Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

Structuring a table of interested parties

Normally, I recommend organizations to include a column with what the organization expects or requires from the interested party. I find it particularly useful to segment interested parties. For example, there are many potential customers that are not well suited for an organization.

With some organizations I already used three more columns: one for determine the power they have in the relationship, another to determine their interest for the organization and results column. These three columns allow to segregate interested parties this way:

You can find more information below:

• How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
• Free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/
• Free online training 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/

Design office ISO objectives

Organizations, considering its strategic direction, establish a quality policy that sets orientation for the definition of quality objectives. Strategic direction defines who are the relevant interested parties. Who are the main interested parties of the design office? What do they need or expect from the design office? For example, who are the target clients? What do they value? For example, for the owners of the design office, what results do they expect?

Some years ago, I developed this crazy metaphor of seeing an organization with all its processes as an athlete. If you compare the body of someone competing on athletics with the body of someone that competes on weightlifting, they are very, very different. The body of a soccer player is very different from the body of a basketball player. Different strategic orientations require different process content. Two different organizations with two different strategic orientations may have very different relevant quality objectives.

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/

Writing IQA non-conformance report

How to write IQA non-conformance report?

I understand you want to say "Internal Quality Audit" from the abbreviation "IQA". First of all, these are the questions of internal auditor training. It is not easy to answer questions in such an environment without providing this training, because we are doing case studies for these questions. Therefore, if you have not received internal auditor training, I recommend you attend this training.

Let me briefly try to explain. Non-conformance in internal and external audits are written against the ‘’shall’’ articles of the standard. This is the ISO 19011 standard rule and applies to all standards. While writing nonconformity, objective evidence should be clearly presented and referred to the article of the relevant standard.

How to close?

The relevant process owners are responsible for closing the non-conformance.

First of all, root cause analysis should be done, they should take and apply permanent and systematic actions. After all the actions to be taken, the internal auditor should check the effectiveness and, if the finding is effective, close the non-conformance. Of course, all these studies should be documented in the corrective action form.

For more information, see:

• Using Corrective Actions to Drive Continual Improvement in IATF 16949  https://advisera.com/16949academy/knowledgebase/using-corrective-actions-to-drive-continual-improvement-in-iatf-16949/
• Five Main Steps in an IATF 16949:2016 Internal Audit  https://advisera.com/16949academy/knowledgebase/five-main-steps-in-an-iatf-169492016-internal-audit/
• Requirements for the competence of IATF 16949 internal auditors https://advisera.com/16949academy/blog/2017/10/19/requirements-for-competence-of-iatf-16949-internal-auditors/
• How to make an Internal Audit checklist for IATF 16949:2016 https://advisera.com/16949academy/knowledgebase/how-to-make-an-internal-audit-checklist-for-iatf-16949/

ISO 14001 Noise management plan

Unfortunately, I’m not an expert on noise limitation.

In the past, in certain projects with environmental noise challenges, I recommended that organizations found the main sources of that noise and then contact equipment manufacturers to minimize noise generation or noise propagation through building noise-proof cases.

Please check this information below with more detailed answer:

• 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
• 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/

ITIL & ISO 20000 Implementation

Here are important elements before you start the implementation:

- Considerations before ITIL implementation https://advisera.com/20000academy/blog/2014/05/21/considerations-itil-implementation/

As well as how to start the implementation:

- Ready, steady… go – Starting ITIL implementation https://advisera.com/20000academy/blog/2014/06/10/ready-steady-go-starting-itil-implementation/

Since you'd like to start your own consultancy business, you can find a few ideas in this article - How to find clients for your ITIL/ISO 20000 consultancy https://advisera.com/20000academy/blog/2017/04/05/how-to-find-clients-for-your-itil-iso-20000-consultancy/

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Cookies and pixels under EU GDPR

Are pixels and cookie IDs regarded as personal data? 

I am assuming you are referring to Facebook pixels ID which is considered as an analytic cookie. If so, yes, analytic cookies are considered personal data, and they are ruled by the e-privacy directive (a new e-privacy regulation is under approval procedure between the EU Commission and the EU Parliament). 

How can we cope with a deletion request if we cannot correlate a cookie ID with a specific person?

Usually, cookies deletion is managed by users’ browser and it is the user who can manage cookie deletion by its own browser.

Do we have to delete the cookie IDs after a specific period of time? 

Yes, you should establish the data retention period in your data policy. Some cookies last one session, others 24 hours, and some last one year. On the market, there is plenty of tools that can help you to determine the period. 

Do we require consent to place cookies?

It depends on the cookies. The e-privacy directive states that you need consent, except for strictly necessary cookies which are essential to browse the website and use its features, such as accessing secure areas of the site. You should, however, explain their existence and use, in the privacy notice.

Here you can find more information:

• EU GDPR vs. European data protection directive: https://advisera.com/eugdpracademy/blog/2017/10/30/eu-gdpr-vs-european-data-protection-directive/
• Is consent needed? Six legal bases to process data according to GDPR: https://advisera.com/eugdpracademy/knowledgebase/is-consent-needed-six-legal-bases-to-process-data-according-to-gdpr/
• Everything you need to know about the GDPR Privacy Notice: https://advisera.com/articles/gdpr-privacy-notice-6-key-elements-to-include/

You can consider enrolling in our free EU GDPR Foundations Course
EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

ISO 9001 - 10 Must have documents

Please check this article about mandatory documentation - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ these are the documents and records that all organizations must have. Each organization will have a particular organizational structure where these mandatory documents will fit. For example, design and development will be done by different departments in different organizations.

You can find more information about documents and records below:

• How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
• New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
• Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
• Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/
   

ISO 9001 - Is quality manual mandatory?

ISO 9001:2015 does not mention the existence of a quality manual. So, it is not mandatory to have a quality manual, neither is forbidden to have one. I recommend organizations to have a quality manual, but it is just a recommendation. Please check this article about mandatory documentation - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

The following material will provide you information about the quality manual:

• The future of the Quality Manual in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/
• Free online training ISO 9001:2015 ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ nal-auditor-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/