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Audit process according to ISO 9001:2015
Answer:
The audit process haven't changed in the new version of the standard, however the requirements are changed and now the auditor must put some extra effort to conduct the audit.
The manual is gone, that is true but the requirements for documents and records remained although they are differently formulated. When there is a phrase "maintain as a documented information" it means that the document is required, on the other hand, if there is a phrase "retain documented information as an evidence", it means that the record is required. For more information 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/
Regarding the risks in processes, you will need to examine the process and determine what can go wrong and in what stage of the process. Although it is not a requirement, you can use some of the methodologies for risks assessment, for example FMEA (Failure Mode Effect Analysis) or FTA (Fault Tree Analysis) and the can be of great help.
For more information see Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/ or watch the free webinar How to implement risk management in ISO 9001:2015 https://advisera.com/9001academy/binar/how-to-implement-risk-management-in-iso-90012015-free-webinar/ -
Management review and performance evaluation
Currently we review non-conformance's raised for Out of Spec Product etc, however should there be more to this section.
Answer:
In order to review process performances you need to establish KPIs (Key Performance Indicators) for processes, meaning that you need to determine some indicator that can tell you weather your process is working in desired way and if it delivers intended results. For example for warehousing or storage process the number of nonconforming products in storage can be the indicator of storage process performance.
The same is for product conformance, you need to inspect the product against the product requirements and if there are nonconformities, to resolve them with corrective actions. Records of such nonconformities should be reviewed during the management review and the management should make decisions to remove those nonconformities in the future.
Beside nonconformances related to Out of Spec Product you should keep track of all nonconformities in your company in order to have more data to review and make decisions to prevent them from happening in the future. In this way you will truly improve your QMS and your company.
For more information, read these articles:
- How to make Management Review more useful in the QMS https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/
- How to Make Management Review More Practical https://advisera.com/9001academy/blog/2013/12/10/make-management-review-practical/ -
Quality Objectives and Quality Manual
Answer:
The most important thing with the quality objectives is to make them measurable and timed, and in this way it will be much easier to keep track whether they are achieved or not. For example "Increase of customer satisfaction by 10% in 2016"
The biggest challenge when creating a quality manual is to meet requirements of the standard regarding the quality manual (define the scope of the QMS, describe the procedures or make reference to them and describe interactions between the processes and their interactions) and yet make it short, easy to read and useful.
For more information read these articles:
- How to Write Good Quality Objectives https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
- Writing a short Quality Manual https://adviser a.com/9001academy/knowledgebase/writing-a-short-quality-manual/
- The future of the Quality Manual in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/ -
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/