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Form of writing procedures
The standard does not prescribe the way of writing procedures or some mandatory elements of procedure. In case of smaller company you can even insert the procedures into the Quality Manual.
There are some elements that are very common and logical, such as purpose, scope, users and reference documents. Take a look at free preview of our Procedure for Document and Record Control https://advisera.com/9001academy/documentation/procedure-document-record-control/
Here are some very informative articles that you can find interesting:
How to structure quality management system documentation https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
Some Tips to make Document Control more useful for your QMS https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/ -
Configuration Management vs Record Control
Configuration management (CM) is a systems engineering process for establishing and maintaining consistency of a product's performance, functional and physical attributes with its requirements, design and operational information throughout its life and it is just a part of Quality Management System since it refers only to product not the whole management system.
Control of records (and documents) covers not only the record requirements of Configuration Management but also the management system requirements for records. The principles are the same but the scope is different.
Here is one informative article regarding the subject:
- 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/ -
Changes in ISO 9001:2015
Regards
Yes, there will be significant changes in the new version of ISO 9001. Official news can be found on ISO website (https://www.iso.org/iso-9001-quality-management.html) and for additional information take a look at this article 5 Main Changes Expected in ISO 9001:2015 from the 2014 Draft International Standard (DIS) https://advisera.com/9001academy/knowledgebase/5-main-changes-expected-in-iso-90012015-from-the-2014-draft-international-standard-dis/ -
Nonconformities of outsource partners
Can we manage them ( solve/eliminate the problem ) with the Process "Control of non conforming product/service" and carry on with the Process"Corrective / Preventive Actions" ?
Or we must determine a different process for controlling and problem solving of these two outsourced processes?
These two mentioned above mandatory processes, are only for our internal system services and control ?
Thank you for your time,
Answer:
There is no need you to manage nonconformities in outsource organization. If you find any irregularities in operation they perform in your behalf, you should file a complaint and request evidences that the nonconformity is removed.
There is no need to establish another process.
Yes, the control of nonconforming product and corrective and preventive ac tions are only for internal processes.
Here are some informative articles regarding the subject:
Understanding dispositions for ISO 9001 nonconforming product https://advisera.com/9001academy/blog/2014/11/18/understanding-dispositions-iso-9001-nonconforming-product/
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/ -
Work instructions for outsource partners
1) Should I do a documented procedure over this outsource process? (we do not perform this process, we just control and check them all the time and receive the job results that we demand)
2) We need to give Work Instructions. How should be done this? Within a process or not?
Answer:
We need to give Work Instructions to our outsource process.
There is no need you to write working instructions for your outsource partners, you only need to precisely define your requirements regarding the service they provide to you through contract.
1) Should I do a documented procedure over this outsource process? (we do not perform this process, we just control and check them all the time and receive the job results that we demand)
You can write procedure for managing outsourced processes, but it would be your internal procedure, not a procedure for your outsource partner. Here you can write methods and frequency of control of outsourced process.
2) We need to give Work Instructio ns. How should be done this? Within a process or not?
Again, you don't need to give work instructions. You need to ensure that your outsource partner is capable and competent to provide the service you requested. It can be done in several ways, you can inspect and approve the qualification of employees, activities, processes and equipment of your outsource partner or to request evidences of their capability to deliver the service.
All above mentioned details in cooperation with outsource partners should be documented in purchasing procedure. Take a look at our Procedure for Purchasing and Evaluation of Suppliers https://advisera.com/9001academy/documentation/procedure-purchasing-evaluation-suppliers/
Here is one very informative article regarding the subject: Purchasing in QMS The Process & the Information Needed to Make it Work https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/ -
Developing Quality Manual
The Quality Manual is a document that describes your Quality Management System and should contain a scope of your QMS, including the exclusions from the scope, reference to procedures and description of process interaction in your QMS.
Here is one very informative article regarding the subject: Writing a short Quality Manual https://advisera.com/9001academy/knowledgebase/writing-a-short-quality-manual/
You can also take a look at our free preview of Quality Manual template https://advisera.com/9001academy/documentation/quality-manual/ -
Preparation for recertification
In the event of Re-Certification for ISO 9001:2008,
What are the basic things/areas that a consultant has to look into for a client company?
What are those things the client company should do to get ready for the Re-Certification Audit
If the client company is undergoing transition in all areas of operation, how does it affect the Re-certification process.
Answer:
1. The first thing you should look is whether the internal audit and management review have been performed correctly, including the status of nonconformities, corrective and preventive actions. Also you should review the recommendations and nonconformities from the previous certification audit to make sure that they are resolved.
2. The certification audit is mainly focused on compliance with the standard and documented procedures, the recertification audit is more focused on application, maintenance and improvement of the system; this me ans the focus of recertification audit will be reviewing of quality objectives, application of the procedures and results of internal audit and management review.
3. If there are changes in operation you should adapt the procedures and/or make a new ones to describe the new processes in organization in order to maintain the integrity of clients Quality Management System. Also you should consider change of recertification scope if there was changes in business activities and processes.
Here are some very informative articles regarding the subject:
Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
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/
How to make Management Review more useful in the QMS https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/ -
SOP and Quality Manual
You can create the SOP that will describe all processes but then it would be better just to integrate all procedures in Quality Manual and create one single document that will cover whole QMS (clause 4.2.2 b)). This approach is used only in small organizations (one to five employees) where one person performs several processes, otherwise it's not recommendable.
In case of bigger organization with more complicated processes it would be unpractical to keep all information in one place.
Here is one very informative article regarding the subject. Writing a short Quality Manual https://advisera.com/9001academy/knowledgebase/writing-a-short-quality-manual/ -
Internal records vs QMS
check sheets don't affect the product, Where do they go? Are they included as reference or just separate from the quality documents?
Answer:
Besides the mandatory documents and records, the ISO 9001 standard also requires the documents and records that the organization identified as necessary.
I assume that that logs and check sheets are used for processes and activities monitoring so they should be incorporated in procedures describing those processes. They may not affect the product quality directly, but they can be important for monitoring and measuring process, also they can be referenced in procedure for management review as a input element.
If the logs and check sheets are used for monitoring processes and activities they should definitely be a part of quality documents.
Here are very informative articles regarding the subject:
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/
Monitoring and Measurement: The basis for evidence-based decisions https://advisera.com/9001academy/blog/2020/09/21/how-to-perform-monitoring-and-measurement-according-to-iso-9001/ -
Auditing odd shifts according to IAF MD 5 Section 3.5
Answer:
The standard IAF MD:2013 clearly says that extent of auditing depends on processes performed in each shift and level of applied control. Since the performed processes are identical, under identical conditions and identical SOPs it is enough to audit one shift and provide evidences of same process controls and workers competence in unaudited shifts. In this way you apply the Evidence-based approach, principle from ISO 19011:2011 standard, clause 4 f).
By using established methods of identification and traceability, you can provide evidences that product requirements are met in every shift.
All mentioned above can be used as justification for not auditing odd shifts.