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Preparation for ISO 9001:2015 certification
Answer:
You need to start by obtaining management support and identifying the customer requirements for the QMS, then you will need to define your quality policy, quality objectives, which together define the overall scope and implementation of the Quality Management System. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service.
Here you can find a list of mandatory documentation and commonly used for ISO 9001:2015: https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
This article can help you with the certification process:
- Article - How do you prove to the certification auditor that QMS processes are carry out as plannes: https://advisera .com/9001academy/blog/2016/12/13/how-do-you-prove-to-the-certification-auditor-that-qms-processes-are-carried-out-as-planned/
Certification process should be smooth if the implementation of the standard is successful. Usually certification audits are conducted in 2 stages. The first stage is a review of your documentation by the certification body auditors to verify that, on paper, you have addressed all ISO 9001 requirements. In the second stage the certification body auditors will review the records you have accumulated by operating your QMS processes, including your records of internal audits, management review and corrective actions.
To understand more about the certification steps, see this article:
- Checklist of ISO 9001 implementation and certification steps: https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
There are many benefits regarding the certification, among them - Improvement of your credibility and image; Improvement of customer satisfaction; Better process integration; Improve your evidence for decision making; Create a continual improvement culture; Engagement of employees. Regarding the cons I would say that you will need some effort in the terms of money, personnel involvement, training, etc. in order to implement the standard, either by yourserlf or with the help of a consultant
In this article you can find the benefits of the certification - Six key benefits of ISO 9001 implementation: https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
Also these materials can help you with the implementation and certification process:
- 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/ -
Information security incident by ISO 27001 vs. personal data breach by GDPR
Answer:
If the vulnerability was not exploited to misuse personal data there is no data breach under the EU GDPR. The EU GDPR defines a “personal data breach” in Article 4(12) as: “a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, personal data transmitted, stored or otherwise process ed”
So if the data was not destroyed, lost, altered or transmitted, then it is just a security incident but not a data breach.
To learn more about data breach check out our free “EU GDPR Foundations Course” (https://advisera.com/training/eu-gdpr-foundations-course//). -
Lead auditor certification
Answer:
Usually getting the lead auditor certification is more important if you want to become a lead auditor because in this kind of course you’ll learn everything you need to know about ISO 9001, but also how to become qualified certification auditor of quality management system.
You can attend this course for free here - ISO 9001 Lead Auditor Course: https://advisera.com/training/iso-9001-lead-auditor-course/
If you want to become a consultant I recommend you better the Lead Implementer Course where you can learn everything you need to know about ISO 9001, plus how to become an independent consultant for implementing a Quality Management System
You can at tend this course for free here - ISO 9001 Lead Implementer Course: https://advisera.com/training/iso-9001-lead-implementer-course/ -
Audit Programme
Answer:
The ISO 9001 requirements for the audit program are to plan, establish, implement, and maintain an audit program. The audit program relies on a schedule of all audits, which can be as simple as a spreadsheet or calendar of the audits to be performed.
Therefore, these elements should be included in the program:
- Audit frequency
- Audit methods
- Responsibilities
- Requirements for planning
- Audit reporting
To learn more about the audit programme, you can see these materials:
- Article - https://advisera.com/9001academy/blog/2017/01/24/what-is-the-iso-9001-audit-program-and-how-does-it-work/
- 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/ -
Transition to ISO 9001:2015
Answer:
In order to successfully perform the transition to ISO 9001:2018 you can follow these steps:
1) Define the context of the organization
2) List all interested parties
3) Review the scope of the QMS
4) Demonstrate leadership
5) Align QMS objectives with the company’s strategy
6) Assess risks and opportunities
7) Control documented information
8) Operational control
9) Review the design and development process.
10) Control of external providers
11) Performance evaluation.
12) Measurement and reporting
To learn more about the transition process to ISO 9001:2015, you can see these materials:
- Article - How to make the transition from ISO 9001:2008 revision t the 2015 revision: https://advisera.com/9001academy/blog/2015/10/06/how-to-make-the-transition-from-iso-90012008-revision-to-the-2015-revision/
- 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/ -
Partes interesadas
Respuesta:
Pueden organizar una reunión con la gente relevante de la organización y llevar a cabo una tormenta de ideas para identificar las partes interesadas que pueden tener un impacto en el SGC, es decir, en la capacidad de la organización para proporcionar productos y servicios que cumplan tanto con las necesidades de los clientes como con los requisitos legales.
Algunas partes interesadas pueden ser: clientes (en su caso pudieran ser los ciudadanos a los cuales prestan un servicio), proveedores, organizaciones gubernamentales, ONGs, empleados, etc.
Estos materiales pueden ser de ayuda para comprender las necesidades y expectativas de las partes interesadas:
- How to determine interested parties: https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015//015 /
- Understanding needs and expectations of interested parties in ISO 9001:2015: https://advisera.com/9001academy/: academy/blog/2017/10/24/understanding-needs-expectations-of-interested -parties-in-iso-90012015/
- Libro - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Curso Fundamentos ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ -
ISO 9001 in a construction company
Answer:
Evidence of Valid ISO 9001:2015 Accredited Quality Management System (QMS) – means that your client wants that your company implements a Quality Management System (QMS) according to ISO 9001:2015 and then certifies that system by a certification body accredited according to ISO 17021
“We are a family company in the construction business for long time but now I want my company to improve the quality skills and paperwork so if you can send me some sample construction QC plans and HSE plans for a war zone design and build contractor that would be great. I couldn’t download from your webpage somehow.”
The following material will provide you information about implementing an ISO 9001 management system in a construction company:
- 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?t=1493297551317
- Would construction companies benefit from ISO 9001? - https://advisera.com/9001academy/blog/2016/06/07/would-construction-companies-benefit-from-iso-9001/
- free online training ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Answer to audit findings
Answer:
If your certification body raised negative audit findings (nonconformities) you have first to correct those nonconformities, remove what is wrong. Then, you have to search the root cause behind each nonconformity. After identifying each root cause, you can implement corrective actions, actions to remove the root causes. Normally, certification bodies specify the time frame for answering to them with a description of the correction and of the corrective action.
The following material will provide you information about answering to audit findings:
- ISO 9001 – How to deal with nonconformities in an ISO 9001 certification audit - https://advisera.com/9001academy/blog/2015/06/09/how-to-deal-with-nonconformities-in-an-iso-9001-certification-audit/
- ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ 5-internal-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
What to expect during a surveillance audit
Answer:
The surveillance audit, like the certification audit, is an on-site audit done by the certification body. The difference is the number of hours devoted to processes in the audit.
For the certification audit, the certification body auditors will look at the implementation of every process within your management system to check for conformance to the applicable standards, as well as your organization documentation, process effectiveness, and continual improvement.
However, the surveillance audit will spend less time on only some portions of your management system. Surveillance audits will take less time to perform than the original certification audit. I cannot tell you what auditors will ask but I can assure you that they will start each time by looking at your key activities (such as management review, internal audit, corrective actions and co mplains treatment), and will then only look at some of the remaining parts within your management system.
The following material will provide you information about surveillance audits:
- ISO 9001 – What is an ISO 9001 surveillance audit? - https://advisera.com/9001academy/blog/2016/10/18/what-is-an-iso-9001-surveillance-audit/
- Surveillance visits vs. certification audits - https://advisera.com/27001academy/knowledgebase/surveillance-visits-vs-certification-audits/
- ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Quality objectives considering customer satisfaction
Answer:
I would like to know first what the strategic orientation of your company is, and who is the target-customer of your organization. Some target-customers want the lowest price others prefer service and customization or flexibility, others still prefer innovation or the best product or service.
This is important because what satisfies a target-customer group is different from what satisfies other target-customers. Normally, successful companies try to be the best for one particular type of target-customer.
I have no experience on “Metal Fabrication” but if my company is working with customers they want the lowest price, for example, I would choose objectives around QCD: Quality, Cost and Delivery. (% of defects, Productivity; Production Breakdowns, delivery delays, for example)
The following material will provide you information about quality objectives:
- ISO 9001 – How to Write Good Quality Objectives - https://advis era.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
- What has changed with quality objectives in ISO 9001:2015? - https://advisera.com/9001academy/blog/2018/05/08/what-has-changed-with-quality-objectives-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/