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Does ISO 13485 apply to clinical CRO?

Yes, according to the ISO 13485:2016, in the section 1 Scope is stated that this standard is applicable for all organizations involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing, design, and development or provision of associated activities.

For more information about that, please see the following articles:

• EU MDR Annex 15 – Clinical investigation https://advisera.com/13485academy/mdr/clinical-investigations/

For more information what is ISO 13485 and what will you get with it, please see following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

Should you have any other question about this standard, do not hesitate to contact us.

Setting up an internal audit

About setting up an internal audit I invite you to watch this free webinar on-demand - How to perform an ISO 14001:2015 internal audit - https://advisera.com/14001academy/webinar/how-to-perform-an-iso-14001-2015-internal-audit-free-webinar-on-demand/
You can also attend this free course – ISO 14001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/

About being competent, each organization has the authority to determine its competency requirements for its internal auditors. Normally, organizations consider that internal auditors should have knowledge of the audit criteria (ISO 14001:2015 in this case) and should have training in internal audits. You can even decide that an auditor has to study a book on audits or attend an online course and do an in-house exam. Internal auditor competence requirements can be established in a job description, for example.
I would recommend training about ISO 14001:2015 and an internal audit course. As a plus I would recommend that you participate as an auditor, making part of an audit team, in 2 or 3 internal audits.

You can find practical information in the links below:

• Internal Audits in the EMS: Five Main Steps - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/internal-audits-in-the-ems-five-main-steps/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

Ensuring ISO implementation in the workplace

Based on my experience as consultant:

• Start with the why, start with the purpose
• Invite people, future users of instructions, procedures, forms and future actors of operating the system in the daily routines, to participate with ideas and suggestions about how to meet the why
• Use plenty of visual management routines and cues
• Train people, better than in a classroom, train people on the job with games, examples and challenges
• Follow-up implementation closely to fine tune and help solve and clarify the things that only appear “when the rubber hits the road” 

You can find more information below:

• 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 Lead Implementer Course - https://advisera.com/training/iso-14001-lead-implementer-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

Environmental objectives

Your organization determined the significant environmental aspects and impacts.

Your organization determined priorities from improving some of those significant environmental aspects.

You can traceback all the sources that contribute to each of those significant environmental aspects to be improved. Chose the most important sources and link them to one or more processes.

So, you want to improve a significant environmental aspect, you translate that want into an environmental objective. Now, you can relate that environmental objective to one or more relevant processes.

For example, yesterday I audited an organization that wanted to improve the unitary consumption of energy. As an opportunity for improvement I wrote in the report that they can identify the great sources of energy consumption and act on those locations, on those processes.

You can find more information below:

• How to Use Good Environmental Objectives - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/how-to-use-good-environmental-objectives/
• Examples of ISO 14001 objectives based on the different company sizes - https://advisera.com/14001academy/blog/2019/10/22/iso-14001-objectives-examples-for-different-company-sizes/
• 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/
   

ISO 45001 Clause 6

ISO 45001, clause 6 wants you to identify top level risks and opportunities for the OHSMS, such as the risk of a supplier going out of business that supplies the least hazardous cleaning chemical, or the opportunity of a supplier developing a safer cleaning chemical that you can use. It goes beyond the risks associated with the hazards of your processes. The clause requires you to keep information on what the risks and opportunities are, as well as the processes you have identified to determine the risks and opportunities, as well as the actions you need to address the risks and opportunities (where you have chosen to do so). The idea of this documentation is so that you can later compare your results to know if the plans you had were carried out, both in how you determined the risks and opportunities and how you dealt with them.

You can learn more about the standard requirements in the article: What are the new requirements for risks and opportunities according to ISO 45001?, https://advisera.com/45001academy/blog/2018/04/25/what-are-the-new-requirements-for-risks-and-opportunities-according-to-iso-45001/

ISO 9001 audit in manufacturing

In a manufacturing setting you can ask questions related with clauses:

• 7.1.3; 7.1.4; 7.1.5
• 8.5; 8.6; 8.7

You can check if preventive maintenance is done, if critical environmental conditions are satisfied, if monitoring and measuring resources are calibrated or verified.

Look into clause 8.5.1 that details several relevant topics.

• Products and Services to be produced defined and characterized with results to be obtained
• Availability of adequate monitoring and measurement resources
• Process and Products and Services control defined and implemented
• Adequate and available infrastructure and environment
• Competent and available people
• Special processes periodically validated and revalidated
• Prevention of human error
• Release, delivery and post-delivery activities 

You can check if traceability is a requirement and if that is so if it works.

You can check if the control state is clear

You can check if process control activities are done and recorded if required.

You can check if quality control activities are done and recorded

You can check if nonconformities are treated

You can check if mandatory records are kept. You can check if documents and records, decided by the organization as relevant, according to clause 4.4.2 are kept or maintained.

You can find more information below:

• List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
• ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance - https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
• Record of Traceability [ISO 9001:2015] - https://advisera.com/9001academy/documentation/record-traceability/
• 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/
   

ISO 9001 certification process and cost

Based on your answer I believe you are in the correct way

Internal and external environmental issues

I like to use the SWOT matrix approach.

Internal issues are specific to your organization and they may be Strengths (like strong environmental image among local authorities) or Weaknesses (like equipment performance - it may be old and very pollutant - like employees - it may be difficult to find new workers).

Now imagine that the opposition party wins the next local elections and will increase environmental compliance obligations, that is a risk.

Now imagine that a major equipment may breakdown and contaminate soil and water surfaces, that is a risk.

The prospect of exploring a new, richer ore lode will increase the efficiency of the facility, that is an opportunity

The possibility of restoring the landscape of an abandoned area can improve the company's image among environmental NGOs, that’s an opportunity.

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/
• ISO 14001 risks and opportunities vs. environmental aspects - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
• Risks and opportunities in ISO 14001:2015 – What they are and why they are important - https://advisera.com/14001academy/blog/2016/03/07/risks-and-opportunities-in-iso-140012015-what-they-are-and-why-they-are-important/
• 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/

Where requirement comes from to monitor and or record temperature and humidity during calibrations?

No, there is no direct requirement to measure and record temperature and humidity while calibrating inspection in the ISO 13485:2016 in section 7.6 Control of monitoring and measuring equipment. There is only a requirement that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. This statement indicates that it should be assessed separately for each measuring instrument according to the rules of the profession what is the manner that is needed to calibrate monitoring and measuring equipment. 

For more information about calibration, please see following article: 

• Calibration requirements in ISO 13485 - https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

• Listing traceability

  If traceability is a requirement and if machine identification is relevant for traceability requirement, then it should be recorded.

  You can find more information below:

  • ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance - https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
  • Record of Traceability [ISO 9001:2015] - https://advisera.com/9001academy/documentation/record-traceability/
  • 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/