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Emergency categories

ISO 14001:2015 does not provide either in the text of the standard (Clause 8.2) or in its annex (A.8.2) any requirement for the classification of emergency situations in categories. ISO 14001:2015, clause 8.2 c) provides some guidance for the need to classify each emergency situation. Each organization should define what is the best technique for doing that. Once I worked at a chemical industry manufacturing plant with high environmental impacts associated to emergency situations. We used categories because they were very useful to communicate standardized response actions to everybody in the plant, easily and without going into details. 

The following material will provide you more information about emergency situations:

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/
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/
Environmental aspect identification and classification - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/environmental-aspect-identification-and-classification/
Free webinar - Free webinar - ISO 14001: Identification and evaluation of environmental aspects - https://advisera.com/14001academy/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/
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/
 

Quantifying perceived quality

Please check the use of a Likert scale. You define a scale and you characterize what should be included at each level, for example with a description to minimize subjectivity. You can also use a Likert scale when you ask an opinion to customers something like:

🔆 - Awful

🔆🔆 - Bad

🔆🔆🔆 - Average

🔆🔆🔆🔆 - Good

🔆🔆🔆🔆🔆 - Awesome

Please check also the SERVQUAL research instrument and SERVPERF specifically for perceptions/expectations.

The following material will provide you information about customer satisfaction: 

- ISO 9001 – Main elements of handling customer satisfaction in ISO 9001 - https://advisera.com/9001academy/blog/2014/07/01/main-elements-handling-customer-satisfaction-iso-9001/

- 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/

Security assurance and Security assessment

Do you respond to Security assurance questions? 

Not sure if I understood your question correctly, but if you purchase our documentation toolkits https://advisera.com/27001academy/product-tour/ then we will answer any of your questions regarding security implementation. 

Can you provide an exec summary of Security assessment and remedial action?

If your question is about the risk management process according to ISO 27001, here are the materials that can help you:

• white paper Step-by-step explanation of ISO 27001 risk management https://info.advisera.com/27001academy/free-download/step-by-step-explanation-of-iso-27001-risk-management 
• webinar The basics of risk assessment and treatment according to ISO 27001 https://advisera.com/27001academy/webinar/basics-risk-assessment-treatment-according-iso-27001-free-webinar-demand/

These materials will also help you regarding risk assessment and treatment:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your
Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free online training ISO 27001 Foundations Course
https://advisera.com/training/iso-27001-foundations-course/

Applicability of A 14.2.2 Change Management for staff augmentation companies

The exclusion of controls in ISO 27001 can be made only if there are no related risks, and if there are no legal or contractual requirements.

So you have to perform risk assessment and review all the requirements, and then you can conclude whether you can exclude this control. 

These materials will also help you regarding exclusion of controls, managing risks and listing requirements:

• Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own
  https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
• Free online training ISO 27001 Foundations Course
  https://advisera.com/training/iso-27001-foundations-course/

Work Instruction

ISO 27001 does not prescribe how to format the documents, in other words you're free to use the headings and the structure in your working instructions as you see fit. 

Of course, it might be easier for the users of your documents to see the same style in all documents, but again you have to estimate if this makes sense. 

Interested parties requirements

You can schedule a meeting with the relevant people of your organization (those that are familiarized with the different processes of your company, such as heads of department or top management) in order to conduct a SWOT analysis (strengths, weaknesses, opportunities and threats).  This analysis is going to help you to understand the internal and external issues of your organization as well as the relevant interested parties and their needs and expectations plus risks associated. Some interested parties may include: shareholders. customers, employees, government, etc. You can write a procedure to state this process, although it is not necesary, it can help you to conduct it in a systematically way. 

For more information about how to identify the interested parties of your organization and addressing risks and opportunities, see the following materials: 

- Article - 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//

- Article . 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/

- 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/

ISO 27001 helping in implementing ISO/IEC 17024

The official title of ISO/IEC 17024 is "Conformity assessment — General requirements for bodies operating certification of persons" - so this standard is about how training organizations need to be organized in order to issue certificates to its students. 

Therefore, ISO 27001 Lead Auditor or ISO 27001 Lead Implementer courses cannot really help you implement ISO 17024.

FDA / GMP guidelines

If I understand the question correctly, you are looking for an answer to whether the FDA / GMP guidelines say when to produce in a clean room. It is not up to the guidelines to tell you whether or not to produce your medical device in a clean room. That is the decision of the Top Management. The guidelines are there to show you how clean rooms need to be installed, how to maintain them, what to measure, how to validate them, and the like. Most often, medical devices that must be sterile are produced in clean rooms.

ISO 14001 implementation procedures and steps

First, ISO 14001 internal auditor must be a qualified auditor, but it is your organization that establishes the qualification criteria.

ISO 14001:2015 does not mandates an EMS manual.

When I start implementing an ISO 14001 EMS I start with a Gap Analysis and with an initial determination of environmental aspects and impacts. ISO 14001:2015 has little mandatory documents. One should only consider writing procedures for those situations classified as critical. For example, you want to know legal requirements and to check if the organization complies.

The following material will provide you more information about ISO 14001 implementation:

- ISO 14001:2015 Gap Analysis Tool - https://advisera.com/14001academy/iso-14001-gap-analysis-tool/
- List of mandatory documents required by ISO 14001:2015 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-mandatory-documents-required-by-iso-140012015/
- Article - 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
- Environmental aspect identification and classification - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/environmental-aspect-identification-and-classification/
- Free webinar - Free webinar - ISO 14001: Identification and evaluation of environmental aspects - https://advisera.com/14001academy/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/
- 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/
 

Clause 8.3 - Design and development interpretation and implementation

Imagine design & development as a project.

You receive inputs explicitly mentioned by the client, you gather other inputs either regulated or implicit. You plan a D&D project with several activities. Between some of those activities you have D&D revisions to check if things go according to inputs. At the end you compare the output with the project inputs with a verification activity. If everything is OK you send a sample or the product to the customer to be tested in use, to validate D&D. 

The following material will provide you more information about design and development:

- The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
- Procedure for Design and Development - https://advisera.com/9001academy/documentation/procedure-design-development/
- Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book – (where I use the process approach this way) - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/