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Document hierarchy
Answer:
The purpose of the document hierarchy is to demonstrate the importance of different types of documents and to show the relationships between them. The document hierarchy reflects also the responsibilities within the company regarding the documents, e.g. the top management is responsible for defining the policies, while the workers are responsible for filling in the records.
You cannot have or don't have the documentation hierarchy, it is defined as you define responsibilities for documents and define their type and purpose. The policy will always be above the procedures, work instructions and records. The benefits of having document hierarchy is that the organization and employees are always aware of the importance and relationships between the documents in organization's documentation system.
For more information, see:
- How to structure quality management system documentation https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/ -
External audit 2nd year
Answer:
Unlike the objective of the first external audit that is mainly focused on compliance to the requirements of the standard, the second audit is more focused on maintenance of your system. Meaning that the auditors will be more interested on how you conduct your internal audit, management review and how did you resolve nonconformities if there were any.
Another important thing is how did you handle results from your previous audit, meaning have you resolved all nonconformities and addressed recommendations.
For more information see:
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- How to deal with nonconformities in an ISO 9001 certification audit http:/ /advisera.com/9001academy/blog/2015/06/09/how-to-deal-with-nonconformities-in-an-iso-9001-certification-audit/ -
Risks and opportunities
Answer:
Identifying risks and opportunities can be done by using several different methodologies and it depends on the size of the company and complexity of its processes. However, the standard does not requires organization to document the methodology. For initial stage and introduction of risk-based thinking in an organization it is better to apply some more simple tools such as SWOT analysis or you can simply gather all relevant people in your organization and arrange brainstorming session regarding risks and opportunities in your organization, and the minutes from that meeting can be the evidence that the risks and opportunities are identified.
Risks and opportunities to be identified are the ones emerging from the context of the organization and you need to consider all internal and external issues related to your quality management system.
Plans for addressing risks and opportunities can also come in different forms, it can be q uality objective, some new or updated procedure or work instruction or introduction of some new processes and technologies.
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/
- Risk-based thinking replacing preventive action in ISO 9001:2015 The benefits https://advisera.com/9001academy/blog/2015/09/08/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
- 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/ -
Context of the organization
Answer:
Context of the organization includes all internal and external issues related to the QMS.
An organizations internal context is the environment in which it aims to achieve its objectives. Internal context can include its approach to governance, its contractual relationships with customers, and its interested parties. Things that need to be considered are related to the culture, beliefs, values, or principles inside the organization, as well as complexity of processes and organizational structure.
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/ -
Control of business processes according to ISO 9001
Answer:
Implementation of ISO 9001 includes establishing criteria for processes in order to ensure that the processes will deliver intended results. When defining necessary controls for processes it is important to identify activities in the process where something might go wrong and establish control to prevent it from happening.
The best way to establish controls is through procedure where you will define what should be controlled, by whom and who is responsible to monitor execution of controls.
For more information, see these articles:
- Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/
- Watch Your Language! Dont confuse processes with procedures https://advisera.com/9001academy/blog/2014/11/04/watch-language-dont-confuse-processes-procedures/
- How links between processes can increase level of quality https://advisera.com/9001academy/blog/2015/04/07/how-links-between-processes-can-increase-level-of-quality/ -
Auditing production process
Answer:
There are some steps in conducting internal audit that are applicable to any process and they will prevent you from missing something out.
First thing you should do is to review the documentation related to the production process, meaning all procedures, SOPs, records, etc. This will help you perform a second step and that is to develop the audit plan where you will define the processes you want to audit, the people and functions you want to interview and precise timing for all this. Then, you should conduct the audit according to the plan. Since it is your first time to perform the audit it is recommendable to create internal audit checklist for the production process and list all requirements that you need to audit.
Once you finish the internal audit, you need to create an internal audit report and to deliver it to relevant authority in your organization.
If you noticed some problems or nonconformities during the audit you will also need to perform a follow-up to ensure that the problems are resolved, but this step will be taken in agreements with the top management.
For more information, read this articles:
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/
Five Main Steps in ISO 9001 Internal Audit https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/
Writing an Audit Checklist for ISO 9001 Processes https://advisera.com/9001academy/blog/2014/11/25/writing-audit-checklist-iso-9001-processes/ -
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/