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Implementing risk-based thinking
Answer:
ISO 9001:2015 does not require neither procedures nor records about implementation of risk-based thinking. When I work with companies implementing a quality management system according to ISO 9001:2015 I recommend having a risk register and having a small instruction or procedure to assure a consistent procedure year after year. Attention, remember that my approach is not mandatory. So, your approach is acceptable, although I would like to work with recrds of the full risk assessment.
The following material will provide you information about risk -based thinking:
- 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 webinar – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
- - ISO 9001:2015 Risk Management Toolkit https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Implementing a QMS
Answer:
This question has a huge scope, not easy to answer in some lines. Pick a project manager, a small team and a project sponsor with influence over the top management. Study ISO 9001, develop a process map of how your organization works and develop a project plan. Then is simple project management.
The following material will provide you information about internal audits:
- ISO 9001 – Case study for ISO 9001:2015 transition in a construction company https://info.advisera.com/hubfs/9001Academy/9001Academy_FreeDownloads/Case_study_for_ISO_9001_2015_transition_in_construction_company_EN.pdf - 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/ -
Hard copies not a must
Answer:
False. Check clause 7.5.2 b)
The following material will provide you information about documented information
- ISO 14001 – A new approach to documented information in ISO 14001:2015 https://advisera.com/14001academy/blog/2015/08/24/a-new-approach-to-documented-information-in-iso-140012015/
- free online training ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
- book - THE ISO 14001:2015 COMPANION – A A Straightforward Guide to Implementing an EMS in a Small Business - https://advisera.com/books/the-iso-14001-2015-companion/ -
Policy in business card
Answer:
In this case Quality policy is nothing else but a marketing material, so you don´t need to have a revision listed for this.
If you want to learn more about document and record control, see - 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/
These materials can also help you to understand more ISO 9001:2015:
- Book "Discover ISO 9001:2015 through practical examples": https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/
- Conformio - Compliance tool: https://advisera.com/conformio/ -
ISO 22301 manual
If it's required,kindly oblige me ways to go about it.
Answer: ISO 22301 does not require the elaboration of a manual, and we do not recommend organizations to adopt one, because:
- merging required documents in a single document makes them no easier to read;
- the longer the documents are, the smaller the chance someone will read them because not every BCMS document is intended for everyone in an organization;
- since individual BCMS documents change rather often, it would be a nightmare to update such handbook so frequently.
This article will provide you further explanation about ISO 22301 required documents:
- Mandatory documents required by ISO 22301 https://advisera.com/27001academy/knowledgebase/mandatory-documents-required-by-iso-22301/
This dilemma for ISO 22301 Manual is the same as for ISO 27001 Manual, and you can find more information here:
- Is the ISO 27001 Manual really necessary? https://advisera.com/27001academy/blog/2014/02/03/is-the-iso-27001-manual-really-necessary/ -
Interested parties
Answer: Examples of internal interested parties are pretty much the same regardless the industry: employees, top management, and shareholders.
As for examples of external interested parties we can mention: regulatory agencies, clients, local community, and suppliers.
This article will provide you further explanation about interested parties:
- How to identify interested parties according to ISO 27001 and ISO 22301 https://advisera.com/27001academy/knowledgebase/how-to-identify-interested-parties-according-to-iso-27001-and-iso-22301// -
Nonconformity occurrence and risks
Answer:
I have not seen the nonconformance. Looking into clause 10.2 I can guess what the intention of the auditor was. Please, check the first part of clause 10.2 – “When a nonconformity occurs” it is about the occurrence of a nonconformity, not about corrective action. When a nonconformity occurs, your organization should update risks and opportunities determined during planning, if necessary. A nonconformity is the manifestation of a risk that actually happened. Was that risk initially determined? Was that risk correctly classified and evaluated? The nonconformity can be about something that you overlooked during the initial risk determination. Waiting for an annual revision exercise can be too late to act.
The following material will provide you information about risks and opportunities:
- ISO 9001 – 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/
- 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/
- - ISO 9001:2015 Risk Management Toolkit – https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Changes in the scope
Answer:
If some changes happen in your company, like reorganization, then you will need to redetermine the scope of your organization and you will have to analyse how this will affect your entire QMS, including the context of your organization, risks and opportunities, etc.
You don´t need to put in the ISO since it is just a PDF document published by ISO.
To learn more about changes in the scope you can see these articles:
- How to define the scope of the QMS according to ISO 9001:2015: https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- QMS change management in 7 steps: https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/
Also these materials can help you with the implementation of IS O 9001:2015:
- Book "Discover ISO 9001:2015 through practical examples": https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/
- Conformio - Compliance tool: https://advisera.com/conformio/ -
Staff commitment
In order to increase the commitment of the employees you can organize an awareness session with them presenting the myths and benefits of ISO 9001:2015 as well as the importance of their role in the implementation. For that purpose you can use this presentation - Why ISO 9001:2015 - Awareness Presentation: https://info.advisera.com/9001academy/free-download/why-iso-9001-2015-awareness-presentation
You can also read this white paper which explains how implementing ISO 9001 can help your business grow and perform better - How can ISO 9001 help your business grow: https://info.advisera.com/9001academy/free-download/how-can-iso-9001-help-your-business-grow
To learn more about the importance of the personnel commitment in the i mplementation, you can use this materials:
- 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/ -
FSSC vs FSMS
Answer:
FSMS stands for Food Safety Management System. FSSC stands for Food Safety System Certification. ISO 22000 is not recognized by GFSI (Global Food Safety Initiative), however a certification scheme that uses ISO 22000 as part of its requirements is. This certification is FSSC 22000, and it is recognized by GFSI.