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Clause 6.4.3

ISO 17025 does not specify particular tests. The responsibility is with the laboratory to consider and address the risks related to all equipment that could impact the validity of results.

See the previous response at https://community.advisera.com/topic/glassware-cleaning-within-microbiology-labs/

The following may be of interest.

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/
and the ISO 17025 document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

ISO 13485:2016 laboratory equipment

1. In what way is the laboratory equipment involve in the ISO 13485?

2. If laboratory equipment is used within a project for a medical device then does this need to be included in the QMS ?

Laboratory equipment is involved in ISO 13485 in the following situations:

• if it is used for quality control of the raw material, semi-products and finished medical device
• if it is used for the design of the medical device
• if it is used to calibrate any equipment in the production process

3. Is the ISO based on a medical device the company is trying to sell or is this for all instruments used for the development of devices?

In section 1 Scope of the ISO 13485:2016 is stated that this standard specifies requirements for a quality management system where the organizations need to demonstrate its ability to provide a medical device and related services that meet customer requirements and applicable regulatory requirements. It furthermore states that these organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation or servicing, and any other technical support activities. 

For more information on ISO 13485, please see the following link:

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

• Glassware cleaning within microbiology labs

  You asked

  Question - When washing and reusing glassware that can impact the recovery of organisms, does the laboratory require a procedure to test for residual detergents ? Is this mandatory or purely a best practice ?

  Yes, indeed a procedure is required for any equipment where in your case, contamination, interferences or inhibitors may impact the validity of results. This should be part of your validation. You should suitable verification tests initially and thereafter as often as necessary to ensure the process is in control. Typically this may be every 6 or 12 months or before you change the detergent or procedure (e.g. hand washing versus dishwasher)/

  Depending on the method, you could also consider routinely including two process QC blanks per batch – one where the glassware had additional rinsing and one following normal washing practice.

  You also asked

  Should a test such as this be written in to the SOP ?"

  To ensure that the procedure is standardised and enforced, yes it is advisable to include in a SOP or quality control manual.

  The following article may be of interest:

  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/
  and the ISO 17025 document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

• ISO 14001 going global

  To go global, you have two main priorities:

  • Demonstrate competence;
  • Be known by potential clients.
     

  To demonstrate competence, you must invest in recognized training and personal certifications.

  To demonstrate competence, show expertise and be known by potential clients you must also develop your own brand by evidencing your knowledge. You evidence your knowledge when you write. You should write. Share what you know, share your experience and results, share testimonies of your customers about the outcomes of working with you. Use blogs, professional networks, trade magazines, use your LinkedIn profile, make presentations at conferences. And don’t forget to develop a network of contacts.

  After developing some track record of projects, you can also apply to work for international organizations both as employee or as freelancer.

  Please check some of our courses, perhaps they may be useful for your future:

  • How to choose the most appropriate training - https://advisera.com/training/compare/
  • Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
  • Enroll for free in ISO 14001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/
  • Enroll for free in this course - ISO 14001:2015 Lead Implementer Course - https://advisera.com/training/iso-14001-lead-implementer-course/
  • Enroll for free in this course - Enroll for free in this course – ISO 14001:2015 Lead Auditor Course - https://advisera.com/training/iso-14001-lead-auditor-course/
     

• Is it necessary to generate document change report against newly added document in activity chart?

  That will ultimately depend on your organization’s own procedures. Theoretically, when you add a new document what do you need? You need that users of that new document are made aware of it and start using it. How do you plan to do this in your system? Is it to be done by a document change report? Can it be done by a simpler way?

  You can find more information 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/

• Difference between CIP and RBT in ISO implementation

  Continual improvement process (CIP) is based both on when you are reacting to a problem that has already happened (corrective action), and while developing a preventive action applied to a problem that is found before something bad happens. RBT (Risk-Based Thinking) is another way of developing preventive actions. So, one can say that RBT is part of CIP.

  You can find more information below:

  • Seven Steps for Corrective and Preventive Actions to support Continual Improvement - https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/
  • Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
  • How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
  • 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/

• Getting people interested in ISO

  If by people you mean the general public, society at large, you must remember that ISO 9001 was developed and is more popular for B2B relationships. In B2C interactions people are more interested in a brand or in price. However, general campaigns could associate ISO 9001 certification with higher product reliability.

  If by people you mean the employees of an organization, you can develop a communication plan based of the topics included in these articles - Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/ and What are the benefits of ISO 9001 for your employees? - https://advisera.com/9001academy/blog/2016/06/14/what-are-the-benefits-of-iso-9001-for-your-employees/

  You can find more information below:

  • How to budget an ISO 9001 implementation project - https://info.advisera.com/9001academy/free-download/how-to-budget-an-iso-9001-implementation-project?utm_source=script-for-iso-9001-lead-implementer-course&utm_medium=downloaded-content&utm_content=lang-en&utm_campaign=free-downloads-9001
  • Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-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/

• Certifying body exercising

  almost all establishement, manufacturing companies were ISO 14001 certified,beside auditing and recertification what else does the certifying body exercising that the program were fully monitored and implemented

• CFO exclusion from ISMS Scope

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• ISO 14001 in an educational institution

  Who can be interested in the environmental performance of an educational institution?

  • Neighborhood
  • Students
  • Employees
  • Local authorities
  • Suppliers

  Internal context - what actions or products and services may affect the educational institution environmental performance? For example, internal rules about energy use or about reusing resources.

  External context - what legal, economic, social, or political issues may affect the educational institution environmental performance? For example, environmental legislation trends, social trends like students and families growing concern with the environment.

  Environmental context - all other environmental aspects that may be susceptible to damage by your organization’s environmental performance

  The following material will provide you more information:

  • Determining the context of the organization in ISO 14001 -https://advisera.com/14001academy/knowledgebase/determining-the-context-of-the-organization-in-iso-14001/
  • How to determine interested parties according to ISO 14001:2015 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/how-to-determine-interested-parties-according-to-iso-140012015/
  • White paper - Case study for ISO 14001:2015 transition in a construction company - https://info.advisera.com/14001academy/free-download/case-study-for-iso-14001-2015-transition-in-a-construction-company
  • 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/