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Scope of the QMS - our document
Answer:
The chapter 3.1 refers to the processes inside your company that are included in the scope of the quality management system, if we take your example it can be something like this:
"The processes of our company that are included in scope of the QMS are:
Purchasing
Sales
Production of nuts and bolts
Warehousing
Transportation"
In the section 3.2 you need to write the products and services your organization provide that are included in the scope of your QMS:
"Our Quality Management System covers production and delivery of nuts and bolts."
In the section 3.3 you need to describe what units and functions are included in the scope and how they are separated from the ones that are not included in the scope. To expand your example, let's say that the company produces not only nuts and bolts but also screwdrivers and production of screwdrivers is excluded form the QMS scope. In that case, you need to write something like this:
"Scope of our quality management system covers purchasing and sales department, department for production of nuts and bolts and transportation department. Department for screwdrivers production is not inside the scope of the QMS and it is divided in the separate facility on another location"
The chapter 3.4 requires you to define all locations of your company that are included in your QMS scope, for example:
"Administrative building, 123 boulevard, New York
Production facility, 456 street, Boston"
The chapter 3.5 requires you to list organizational elements (units, departments, processes, etc.) that are excluded from the scope. In our example it would be:
"Accounting
Production of screwdrivers"
For more information read this article:
- 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/ -
Processes vs. Departments
Answer:
Every department has processes that are their responsibility. For example the HR department is responsible for recruitment and for providing necessary training for employees. So, they may decide to create Procedure for Human Resources that will explain how they execute their processes but that is not mandatory by the ISO 9001.
For more information, see:
- Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/ -
Documentation for the context and risks and opportunities
Answer:
Actually, the ISO 9001:2015 doesn't explicitly requires you to create any documents regarding context of the organization and risks and opportunities, it will depend mostly on the size and type of the organization and complexity of your processes.
My recommendation for addressing requirements regarding context of the organization and risk and opportunities is to create some documents because it is much easier when it's done for the first time and, frankly, it will be much easier to demonstrate your conformance to the requirements to certification auditor.
For more information, see:
How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/05/26/how-to-identify-the-context-of-the-organization-in-iso-90012015/
The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/
List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015// -
ISO 9001 in outsourcing company
Answer:
Yes, ISO 9001 is definitely suitable for your type of business since it helps you demonstrate your ability to deliver quality products and services and also that you care about your customer satisfaction.
For more information see:
- Six Key Benefits of ISO 9001 Implementation https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/ -
One department in scope of ISO 9001:2015
Answer:
Yes, you can have only one department of our organization within the scope of your quality management system, you only need to state that clearly in your document about QMS scope. Once you decide to go for ISO 9001 certification you will receive the certificate that refers only to that department.
For more information, see: 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/ -
Internal and external issues and risks and opportunities prioritization
Answer:
Internal and external issues differ from organization to organization but there are some that are common for all organization. Internal issues can be the organizational structure, the culture of the organization, issues related to your employees (current competence vs needed competence, their needs and expectations, etc), issues related to technology and equipment your organization use, etc.
External issues are related to the external environment in which the company operates, this can be economical and political situation in your country, legislation, but also needs and expectations of external interested parties such as your supplier, subcontractors, customers, etc.
Determining internal and external issues is closely related to the identification of needs and expectations of interested parties and that can be e asier and can provide you with inputs on what to consider when addressing internal and external issues. There is no formal requirement to document context of the organization but it can be very useful to do so when you are doing it for the first time.
For more information, see:
- How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/05/26/how-to-identify-the-context-of-the-organization-in-iso-90012015/
- 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/
The crucial step in identifying risks and opportunities is to properly determine context of the organization. Once you have this information you can start thinking about the risks and opportunities regarding your QMS. There is no single way to prioritize risks and opportunities but you should start with risks and opportunities that are directly affecting quality of your products and services and customer satisfaction, or start with ones that require least resources and time and can be resolved easily. Important thing is to make plan to address risks and opportunities, meaning to define resources, responsibilities and actions to address each risk and opportunity.
For more information, see:
- Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
- The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/ -
Where to start with ISO 9001:2015 implementation
educational institution (University), so I want advice I started with
reading the mandatory documents & records but does it right to start with
that? and if not where should I start.
Answer:
The first step is to do a GAP analysis, meaning to compare your current state with requirements of the standard. Identifying mandatory documents is only a part of this step but a very good one. So beside determining mandatory documents, I suggest you to do a GAP analysis and find out what other requirements you need to meet. Than you can make a project plan to fill in the gaps and make your department compliant with the standard.
For more information see:
- List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/ -
After certification
Answer:
After the initial certification you will have surveillance audits in the next year, in the year after that you will have recertification audit. Surveillance and recertification audits are not so different from the certification audit and they usually cost almost the same.
For more information, see:
- 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 Certification https://advisera.com/9001academy/iso-9001-certification/
- How should you pick an ISO 9001 certification body? https://advisera.com/blog/2021/01/11/how-to-choose-an-iso-certification-body/ -
Risks in ISO 9001:2015
ISO 9001:2015 sólo te obliga a analizar riesgos en tu Sistema de Gestión de Calidad, no te obliga a gestionar riesgos de manera activa, y hay muchas maneras de analizar riesgos en tu negocio. Este artículo te resultará interesante Methodology for ISO 9001 Risk Analysis : https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
Por cierto, ISO 31000 es un código de buenas prácticas que puedes usar para desarrollar tu propia metodología (este estándar es para cualquier tipo de riesgo). Tu puedes comprar y descargar la ISO 31000 desde el sitio oficial de iso.org: https://www.iso.org/standard/43170.html -
Integrating ISO 9001 and ISO 14001
Answer:
Integration of ISO 9001 and ISO 14001 become much easier with new revisions of both standards, similarities spread throughout most of the clauses and the clause numbers are the same for common requirements.
Here are the similarities and how they should be met:
clause 4 Context of the organization - Both standards require context of the organization to be identified, along with internal and external issues relevant to ISO 9001 and ISO 14001. The requirements of both standards can be met in a single document (e.g. Procedure for Determining the Context of the Organization and corresponding records).
clause 5 Leadership - Each standard requires appropriate policy to be established, but the requirements for Quality Policy and Environmental Policy are different so it would be better to have separate documents, but it is not a mistake to create one policy for int egrated management system.
clause 7 Support - This clause has the same requirements in both standards so, only one procedure for competence training and awareness will cover the requirements of both standards, as well as the Procedure for Document and Record Control. The only thing to be mentioned here is, when creating the procedure make sure that you stated that the scope of the procedure is integrated management system and in reference documents section list both standards.
clause 9 Performance evaluation - Requirements that can be merged from this clause are internal audit and management review. Since the process of internal audit and management review are the same for both standards, the same procedure can apply for both standards. Only thing that is different are the requirements to be audited during the internal audit so different checklist should be kept but the Procedure for Internal Audit and the rest of the records can be used for both standards, and also for management review the same procedure can be used only the input and output elements are different so Management Review Minutes can be kept separately or merged in one record.
clause 10 Improvements - Nonconformities regarding different standards can be resolved by the same corrective action process, therefore the same Procedure for Managing Nonconformities and Corrective Actions can be used for both standards.
For more information, see:
- Integrating ISO 9001 and ISO 14001 https://advisera.com/9001academy/blog/2013/11/19/integrating-iso-9001-iso-14001/