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8.5 production and service provison

Clause 8.5.3 may not be applicable to every organization.

Simple case – a customer bought a product and that product is returned for planned maintenance, or for correcting some defect, or for upgrading some part (last week I updated my computer battery, for example).

Business to business case – consider a brand that outsources the manufacturing of its jackets to a manufacturer. The manufacturer buys and applies all materials, but the brand supplies the high-profile brand labels. Those labels must be protected from theft or any kind of loss. For all purposes, those labels are like money.

Intellectual property – a customer send you, the manufacturer, the blueprints of its later high-tech gadget. Customers expect that the blueprints are protected from theft or leaking into the media.

Molds – A customer has a mold and asks your organization to manufacture injection molding parts with it. The customer expects that you don’t start injection parts with that mold for your own use.

External providers – It is becoming more common that organizations don’t possess equipment, they rent it to an external provider. For example, in a construction company, the scaffolding structure used may belong to an external provider.

You can find more information below:

• How does ISO 9001 property clause 8.5.3 reflect on software? - https://advisera.com/9001academy/blog/2018/03/23/how-does-iso-9001-property-clause-8-5-3-reflect-on-software/
• 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/
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/

ISO 17025 Quality Manual Option B

Firstly a comment. As laboratories that are already ISO 17025:2017 accredited do not typically seek ISO 9001 certification, I assume you are referring to the larger organisation going for ISO 9001 certification for support departments like HR and Finance ? A laboratory that is accredited to ISO 17025 conforms to the requirements of ISO 17025 clause 8, Management requirements for laboratory activities. As these are the clauses covered in ISO 9001 management, It is considered that the laboratory fulfils the intent of ISO 9001.

You can refer to a similar question and reply, Are there any things in ISO 9001 not covered by ISO 17025? at https://community.advisera.com/topic/are-there-any-things-in-iso-9001-not-covered-by-iso-17025/

You asked

Is it better to integrate or have two separate manuals. The chances of having an integrated or combine audit is zero, since it is two separate bodies. There is a strong suggestion to integrate the manuals”

This is a organisational preference. If top management is the same for the ISO 17025 and ISO 9001 activities, then rather have one manual.  This is simpler, and duplication will be avoided. The argument for two separate manuals can be made if there are different people involved, for different departments, such as HR. I suggest you look at the risks of combining them, versus having them separate in terms of responsibilities for processes such as dealing with complaints and noncomformances, auditing, management review and couemntation.

For more information, see ISO 17025 – Main guidelines at https://advisera.com/17025academy/what-is-iso-17025/  and the article ISO 17025 vs. ISO 9001 – Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/ for some more insight.

Test validity for the regulatory bodies

You asked if your laboratory's use of a internal Standard test method will be valid for the regulatory bodies, even if you are not accredited.

I am not in the position to comment on specific regulations (e.g. FDA GMP) and can only comment from an ISO 17025 implementation and accreditation point of view.  Performing a test is only a part of the overall management system requirements of ISO17025. The competency required to provide a consistently valid result is demonstrated through a number activities to meet the requirements of ISO 17025. Hence the importance of accreditation – the process of independent assessment and attestation to this competency.

I do not know what regulatory bodies you are referring to, nor the purpose of the test, i.e. type of product and application. Bear in mind the requirements may be different; for example if the test results were being used for quality control for a manufacturer, compared to studies for research or a product registration.  As the laboratory, your responsibility is to understand, define and document the requirements for the work you do.  Out of interest, I can mention that if the testing relates to alcohol-based hand sanitizer products during the COVID-19 pandemic; the FDA has issued a Temporary Policy for the preparation of certain products. See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during

I suggest you enquire as to the specific requirements of your customers (the use / purpose of the test result) and the requirements of their applicable regulatory bodies. ISO 17025:2017 clause 7.1 Review of requests, tenders and contracts and clause 7.2 Selection Verification and validation of methods are particularly relevant to your question. These are covered under section 09_Customer_Service and 10_Test_and_Calibration_Method in the ISO 17025 toolkit. https://advisera.com/17025academy/iso-17025-documentation-toolkit/

Sandblasting under ISO 14001

ISO 14001:2015 does not forbid any specific practice. ISO 14001:2015 require that organizations commit to comply with legislation or regulation applicable. So, if in your country there are no compliance obligations forbidding sand blasting you can use it. If during your initial environmental assessment, you conclude that sand blasting has significant environmental impacts, your organization should take actions to minimize or control those impacts.

Please consider these sources of information:

• Article - Identifying environmental aspects in the engineering business according to ISO 14001 - https://advisera.com/14001academy/blog/2017/03/20/identifying-environmental-aspects-in-the-engineering-business-according-to-iso-14001/
• Article - 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/
• Article - Catalogue of environmental aspects - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/catalogue-of-environmental-aspects/
• 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/

Environmental Management System in transport company

Unfortunately, we don’t have a vase study about an Environmental Management system in a transport company.

However, we have this article about the steps needed to implement an Environmental Management system in general - List of ISO 14001 implementation steps - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/list-of-iso-14001-implementation-steps/

As you can see in step 3, one of the cornerstones of an Environmental Management system is to determine its environmental aspects. In this article - How the transportation business can benefit from identifying environmental aspects according to ISO 14001 - https://advisera.com/14001academy/blog/2016/05/09/how-the-transportation-business-can-benefit-from-identifying-environmental-aspects-according-to-iso-14001/ you can get some ideas about how to do it.

Check also this other article that may be relevant to your challenge - Importance of ISO 14001 for shipping companies - https://advisera.com/14001academy/blog/2019/05/07/iso-14001-for-shipping-companies-why-is-it-important/

Please consider these sources of information:

• Article - 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/
• Article - Catalogue of environmental aspects - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/catalogue-of-environmental-aspects/
• 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/

Has e-Privacy come into effect?

In "Module 13: Sustaining and improving compliance", in the "Keep Looking Forward" video, the lecturer says that the e-Privacy regulation is in the drafting stage and will soon set rules for privacy and security in the context of electronic communications. My question is, has the e-Privacy already come into effect?

I assume that you are referring to Advisera's EU GDPR DPO Course, Module 13. E-Privacy regulation is still a proposal to be approved by the European Parliament. The approval procedure is not concluded.

And where can I find out more information about it?

You can find all information about e-Privacy regulation discussion on the Official European Union websites.

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the respect for private life and the protection of personal data in electronic communications and repealing Directive 2002/58/EC (Regulation on Privacy and Electronic Communications): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52017PC0010

Here you can find the ongoing approval procedure: https://eur-lex.europa.eu/legal-content/EN/HIS/?uri=celex:52017PC0010

On the website of European Data Protection Board (EDPB) you can find the EDPB’s statements on this proposal: https://edpb.europa.eu/our-work-tools/our-documents/statements/statement-32019-eprivacy-regulation_en

If you want to have more information about e.Privacy regulation and GDPR you can check this article:
GDPR vs e-Privacy regulation https://advisera.com/eugdpracademy/blog/2018/02/21/gdpr-vs-e-privacy-regulation/

ISO 14001 controllers

So, you want to perform an environmental initial assessment in your lab in order to implement control.

Let us start with an example:

You need to determine all aspects and impacts under normal, abnormal and periodical situations. Then you need to evaluate those impacts and determine what kind of control or improvement you need in place, to improve your relationship with the environment.

You can start by getting a plant of your lab. Make several copies and use each copy for a specific environmental aspect. Please check this article to get a starting point about the main environmental aspects - Catalogue of environmental aspects - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/catalogue-of-environmental-aspects/

Let us consider, as an example, that you are with your lab plant for “hazardous chemical waste” (both in chemical form and materials contaminated with chemicals such as filters from a vent hood): Gather a team from the lab and go to each location and write, draw, comment in your lab plant all situations, all activities, where hazardous chemical wastes can be generated. You can repeat this procedure for every environmental aspects.

Then, you can organize all that information into a table and write the environmental impacts. Define an evaluation scheme to determine which aspects/impacts are critical or not. Please check these articles - 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/ and - What makes an environmental aspect significant in ISO 14001? - https://advisera.com/14001academy/blog/2015/03/09/what-makes-environmental-aspect-significant-in-iso-14001/ to help design that evaluation scheme.

For each critical environmental aspect/impact you can design one or more actions. For example:

• Invest in buying a pallet spill to minimize leaking impacts;
• Invest in training, procedures and/or simulations to improve practices or minimize wrong practices
• Decide to eliminate an activity, for example some organizations decide to no longer paint and subcontract that activity
• Decide to establish control procedures – frequently checking appearance or making measurements

Please consider these sources of information:

• Article - 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 - 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/

ISO 9001 vs ISO 17025

That will depend on the extra benefits that your organization can get from being ISO 9001 certified. Do your company’s target customers value ISO 9001 certification besides ISO 17025 accreditation? It that is so, perhaps getting ISO 9001 certification could be useful.

Just implementing ISO 9001 on top of ISO 17025 accreditation can be useful if used by top management to introduce the business flavor. ISO 17025 is about technical competence. ISO 9001 has several business-related topics not included in ISO 17025 like:

• Context of organization and interested parties
• Quality policy and strategic direction
• Quality objectives
• Monitoring and measurement that can be very useful together with the use of the process approach.

You can perform an initial Gap Analysis to check was is missing from ISO 9001:2015 in your organization - Free ISO 9001:2015 Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

You can find more information below:

• Should you use a gap analysis in your ISO 9001 implementation? - https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/
• Six key benefits of ISO 17025 implementation - https://advisera.com/17025academy/blog/2019/10/18/six-key-benefits-of-iso-17025-implementation/
• Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
• ISO 17025 vs. ISO 9001 – Main differences and similarities for some more information, available at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities//
• 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/
• 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/

ISO 9001 program vs process

Let us use an example of what can be a flowchart for an internal audit process:

A process consists of a set of main steps. In one of these steps, an Audit Program must be established and approved. This Audit Program must be approved by someone who has been given the authority to do so.

However, the internal audit process includes more steps. The person responsible for the process as a whole is responsible for the fulfillment of the process purpose and for its effectiveness and compliance with the procedures. If your organization has a procedure describing the internal audit process it must have an item answering to the question: who is responsible for this process as a whole.

You can find more information below:

• What is the ISO 9001 audit program, and how does it work? - https://advisera.com/9001academy/blog/2017/01/24/what-is-the-iso-9001-audit-program-and-how-does-it-work/
• 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/ (includes the slide above)
• ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/