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Templates, forms and records
Answer:
The ISO 9000 - Quality management systems Fundamentals and vocabulary, doesn't describe the terms "template" and "form". The difference is that the template is only a model of document or record, but when it becomes approved and adopted by the organization it becomes a form. When the form is filled in, it becomes a record, evidence that activity is performed as prescribed in corresponding procedure.
The ISO 9001 does not explicitly requires that the records have unique form number or ID, but it requires them to be easily identifiable so you may say that ID number of the form should be displayed on it.
For more information read this article:
- Some Tips to make Control of Records more useful for your QMS https://advisera.com/9001academy/blog/2014/01/28/tips-make-control-records-useful-qms/
- 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/ -
Implementation of ISO 9001 in small business
Answer:
Yes, you can definitely implement the standard without consultant's help, the best way to do it is to approach the implementation as a project and prevent missing anything out. It would be good to have a copy of the standard, but there is a lot of free material on our website that can help you do it without actual copy of the standard.
For more information see this materials:
- ISO 9001 Documentation Toolkit https://advisera.com/9001academy/iso-9001-documentation-toolkit/
- Free ISO 9001 Gap Analysis Tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
- Clause by clause explanation of ISO 9001 https://advisera.com/9001academy/free-downloads// -
ISO 9001 certification for organic food industry
In order to get the ISO 9001 certificate, you need first to implement the ISO 9001 standard. This means that you need to create all necessary documentation and make your processes compliant with the requirements of the standard.
For more information read this article:
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/ -
Starting ISO 9001 in public department
Our documentation templates are applicable to any kind of organization including the public department. Since they are 80% filled in, you only need to write in some small adjustments to make them fit to your organization.
Together with documentation toolkit you get one hour online meeting with an expert and you can ask unlimited number of questions via email. You can also send us some of your documents for a review to make sure that your documentation is compliant with the standard.
Here is the link to our documentation toolkit: https://advisera.com/9001academy/iso-9001-documentation-toolkit/ -
Getting ISO 9001 certificate
Before you apply for registration you must implement the standard, which means you need to create necessary documentation and start following new procedures.
Once you implemented the standard (this includes performing internal audit and management review) you can call the certification body to conduct certification audit.
For more information read these articles:
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- Four things you need to start your ISO 9001 project https://advisera.com/9001academy/blog/2015/02/10/four-things-need-start-iso-9001-project/
- How should you pick an ISO 9001 certification body? https://advisera.com/blog/2021/01/11/how-to-choose-an-iso-certification-body/ -
ECR & ECO
An engineering change request (ECR) form is used to describe a suggested enhancement or problem with a product. A change request originates from customer complaints, field failures, non-conforming materials, audits, product enhancement ideas and other various sources.
An engineering change order (ECO) is a documentation packet that outlines the proposed change, lists the product or part(s) that would be affected and requests review and approval from the individuals who would be impacted or charged with implementing the change.
The simplified translation to QMS language would be that ECR is non-conformance record and ECO is corrective action record related to design and development process.
The bot h can be considered as a part of the process of continual improvement and they can be included in quality objectives. The objectives you stated "reduce minimum cycle time for ECO by 3 days and reduce ECR percentage by 1" are very good objectives to start with.
For more information read this articles:
- How to Write Good Quality Objectives https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
- The ISO 9001 Design Process Explained https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
- Seven Steps for Corrective and Preventive Actions to support Continual Improvement https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/ -
What questions to expect during certification audit
The certification body will try to determine whether your organization is compliant with the standard or not. They will ask you questions about every requirement of the standard.
For more information see these materials:
- Free ISO 9001 Gap Analysis Tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/ -
When to start with corrective action
It is best to start corrective action immediately. Conducting corrective action includes determining the root cause of nonconformity and taking action to prevent non-conformance from recurring.
The whole corrective action process can take some time, an you need to determine the time frame for investigating and removing non-conformance, but you should initiate the corrective action as soon as possible.
For more information read this article:
- Seven Steps for Corrective and Preventive Actions to support Continual Improvement https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/ -
Implementation of ISO 9001 over ISO 27001
Since you have implemented the ISO 27001, I suggest you to conduct the GAP analysis first since there are a lot of common requirements of both standards. Once you determine what ISO 9001 requirements you already met, you can create your project plan and met the remaining requirements.
For more information see these materials:
- Free ISO 9001 Gap Analysis Tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
- ISO 9001 vs. ISO 27001 matrix (PDF) https://info.advisera.com/9001academy/free-download/iso-9001-2015-vs-iso-27001-2013-matrix/
- ISO 9001 Implementation Diagram (PDF) https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram/ -
How much to wait until certification
It is best to ask your certification body, some certification bodies allow certification audit to be performed immediately and some require 3 or more months to pass before certification audit. But it is important that you complete the whole QMS cycle which means you need to perform internal audit and management review in order to be able to pass the certification.
For more information read this article:
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/