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Assessing risks
Answer:
First, what is a risk? A risk is a deviation from the expected due to uncertainty. The expected are desired results, are the outcomes of the QMS.
Second, ISO 9001 mentions risks at three levels (clause 5.1.2b – risks about products and services. Clause 4.4.1f – risks about process outcomes. Clause 6.1.1 – risks about QMS overall results)
For example, yesterday I was working with a company describing the process where materials are ordered, received and prepared for production. We described the process as is. Then the Production Manager said that he would like to make a change in the process to minimize the risk of a supplier delayed a delivery and no one at the warehouse contacts him and Planning does not know that there is a problem of materials missing. This is a typical case about Clause 4.4.1f. For example, during context evaluation an organization can identify a trend for more competition, or more non-technical barriers when exporting beca use of a rise in protectionism. So, the organization can consider that trend as a risk or an opportunity. For example, analyzing all complaints from the previous year an organization can relate reasons for complaints with risks with products and services. After determining risks and opportunities organizations have to decide which need to be addressed and improve the system to eliminate or reduce those risks or take advantage of which opportunities.
The following material will provide you information 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/
- 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 9001 internal audit documentation
Will be very thankful to you. I have download the checklist of the Mandatory documentation requirement for ISO 9001-2015. Is this list is fine or I need more information.
I want information of procedure and documentation of audit. Will be thankful
Answer:
You can see these articles that describe the steps for ISO 9001 Internal Auditing and the requirements of every step:
- Five main steps in ISO 9001 internal audit: https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/
- 13 steps for ISO 9001: internal auditing using ISO 19011: https://advisera.com/9001academy/knowledgebase/13-steps-for-iso-9001-internal-auditing-using-iso-19011/
To learn more about paperwork needed for ISO 9001 auditing you can use these materials:
- Article - ISO 9001 audit checklist: https://advisera.com/9001academy/knowledgebase/iso-9001-audit-checklist/
- You can downl oad a free preview of our audit checklist here: https://advisera.com/9001academy/documentation/internal-audit-checklist/
The list of mandatory documentation shows all mandatory documentation necessary for the implementation of ISO 9001:2015 as well as some common documents used: https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ This list should be enough to demonstrate that you comply with ISO 9001:2015 requirements.
Here you can also download a free preview of our procedure for internal audit - Procedure for intenal audit : https://advisera.com/9001academy/documentation/procedure-internal-audit/ -
Quality Manual requirements
Answer:
Directorates or Sectoral are terminologies not used in ISO 9001:2015. So, I do not know what they stand for, but ISO 9001:2015 no longer considers mandatory to have a quality manual. Because of that, there are no requirements about the content of a Quality Manual, whatever the name chosen by an organization. So, you can have any name with the content that your organization decides useful.
The following materials will provide you details about quality manual in ISO 9001:2015:
- Article - The future of the Quality Manual in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/
- Writing a short Quality Manual - https://advisera.com/9001academy/knowledgebase/writing-a-short-quality-manual/
- [free course] ISO 9001:2015 Foundations Course - https://tra ining.advisera.com/course/iso-90012015-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Legal requirements identification
Answer:
When I start the development of an EMS my first concern is to identify all aspects and impacts that interact with the environment. Then, for each aspect and impact I look for legal requirements in a database of environmental legal requirements for my country. I use a database from a commercial service because I want to be sure that I am doing what can be called due diligence. Then I analyze each legal requirement to check if they apply to the company. Sometimes there are legal requirements that are only applied when an organization use more than a certain amount. For example, in my country there is legislation for heavy consumers of energy. According to ISO 14001:2015, besides legal requirements I also check if relevant interested parties have requirements that the company wants to consid er as compliance obligations. Permits are legal requirements for sure.
The following material will provide you information about legal requirements:
- ISO 14001 – Compliance requirements according to ISO 14001:2015 – What has changed? - https://advisera.com/14001academy/blog/2015/09/14/compliance-requirements-according-to-iso-140012015-what-has-changed/
- 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/ -
Evidences about organizational knowledge
Answer:
Can your organization evidence the determination of what knowledge is necessary for performing a function relevant for achieving process performance and/or products and services conformity?
Can your organization evidence how that knowledge is kept alive and is shared when needed? Can be a database, can be Work Instructions, can be reports, can be sharing information meetings.
Can your organization evidence actions to prevent knowledge loss? For example, today, I visited a company that realized that they had no one prepared to replace a manufacturing sector manager who in the meantime broke a leg at home. Are there other situations that should be identified and prevented?
Can your organization evidence the knowledge transmission when someone starts in a function?
Can your organization evidence routines to be aware of new knowledge? Subscription of technical magazines? Regular meetings with suppliers? Partnerships with customers and/or universities? Regular participation at seminars and conferences?
The following materials will provide you details with organizational knowledge:
- Article - How to manage knowledge of the organization according to ISO 9001
- https://advisera.com/9001academy/blog/2016/08/30/how-to-manage-knowledge-of-the-organization-according-to-the-iso9001/
- Article - How to ensure competence and awareness in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-ensure-competence-and-awareness-in-iso-90012015/
- [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/ -
Business Continuity Plan Concept
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The purpose of the Business Continuity Plan is to define precisely how the organization will manage incidents in the case of a disaster or other disruption of business, and how it will recover its critical activities within set deadlines.
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NO, a plan details WHAT a company will do to manage incidents. A Procedure details the steps on HOW this will be accomplished.
Answer: The term "Business Continuity Plan" is used well before the release of any ISO standard related to business continuity, meaning the actions to be performed in case of disaster, and when related ISO standards were elaborated it was decided to keep this term to avoid confusion.
The ISO 22300:2018 (Security and resilience — Vocabulary), defines business continuity plan as documented procedures that guide an organization to respond, recov er, resume and restore itself to a pre-defined level of operation following a disruption, making the link with the concept of procedures used in ISO standards.
This article will provide you further explanation about business continuity plan:
- Business continuity plan: How to structure it according to ISO 22301 https://advisera.com/27001academy/knowledgebase/business-continuity-plan-how-to-structure-it-according-to-iso-22301/
These materials will also help you regarding business continuity plan:
- Book Becoming Resilient: The Definitive Guide to ISO 22301 Implementation https://advisera.com/books/becoming-resilient-the-definitive-guide-to-iso-22301-implementation/
- https://advisera.com/27001academy/knowledgebase/business-continuity-plan-how-to-structure-it-according-to-iso-22301/ https://advisera.com/27001academy/webinar/writing-a-business-continuity-plan-according-to-iso-22301-free-webinar-on-demand/ -
Organizational knowledge
for example:
Company maintains its quality standard of creating and managing training solutions for the last 25 years of excellent provision of human resource development, leadership training programmes given the recognition of different international accreditation and awarding bodies and of the Ministry.
Is this correct or we need to change our Manual? by the way we are using this manual for 10 years now and we just had our surveillance audit and certificate for ISO 9001-2015.
Answer:
You are correct. Organizational knowledge is referred to specific knowledge to the company, generally gained by experience, which is used and shared to achieve the objectives of the organization. This can come internally, such as intellectual property, lessons learned from failure and successes, or the results of improvements; or it can come externally from conferences, customer knowledge, or supplier knowledge.
To learn more about organizational knowledge, see this articles - How to manage knowledge of the organization according to the ISO 9001: https://advisera.com/9001academy/blog/2016/08/30/how-to-manage-knowledge-of-the-organization-according-to-the-iso9001/
For more information about organizational knowledge you can see these materials:
- 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/ -
Plan de auditoria de un SGC
Consiste en definir qué va a ser auditado, quién llevará a cabo la auditoria y quién será auditado. En el plan de auditoria también se decide cómo se va a dividir la auditoria en caso de que exista más de un auditor, y cuánto tiempo se dedicará a cada proceso durante la misma.
Para saber más sobre la auditoria interna en ISO 9001:2015, puede ver estos materiales:
- Artículo - 13 pasos para la auditoria interna de ISO 9001 utilizando ISO 19011: https://advisera.com/9001academy/knowledgebase/13-steps-for-iso-9001-internal-auditing-using-iso-19011/
- Curso de auditor interno ISO 9001:2015: https://advisera.com/es/formacion/curso-auditor-interno-iso-9001/
- Preparación para la auditoria de certificación ISO: Una guía en un lenguaje sencillo: https://advisera.com/books/preparacion-para-la-auditoria-de-certificacion-iso-una-guia-en-un-lenguaje-sencillo/ -
Starting a career as consultant
Answer:
Although there are no legal requirements to start a career in consultancy, for the technical side I recommend getting certified training about ISO 9001 and about internal audits. For the commercial side I recommend starting a blog about your reflections about ISO 9001, and keeping an active participation in Linkedin for networking and developing your “personal brand”. About the financial side I can only tell you my own experience: I worked for some years as quality manager I saved money for starting my own business as consultant, then winned the first projects as trainer, auditor and consultant and then the business became sustainable.
The following material will provide you information about the advice:
- How to sell ISO consulting services [free webinar] - https://advisera.com/9001academy/webinar/how-to-sell-iso-consulting-services-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/ -
QMS Scope and Quality Manual
Answer:
The Scope of the QMS normally does not change. So, include it in section 4.3 of the Quality Manual is a good option. The other option is also possible, keep it as an external document referred in Section 4.3. Scope and Process Map are two different things. For example, you can have a very similar Process Map for two companies in the same economic sector, but since they have different strategic orientations they have different scopes.
The following material will provide you information about QMS scope:
- ISO 9001 – 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/
- 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/