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  • 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.

  • Difference between Quality Policy and Quality Objectives

    Unfortunately, I cannot provide samples here.

    The quality policy consists of a declaration approved by the top management and which establishes a set of guidelines, priorities and commitments related to quality. However useful and well-written a quality policy is, it is only a paper document. The quality objectives translate the statements contained in the policy into a set of specific and measurable challenges. For example, if a quality policy includes a commitment to seek to reduce defects. A quality objective can be: Reduce the defect rate on production line A by 10% in the next 7 months.

    Organizations cannot expect to be excellent at everything they do. The quality policy sets the priorities for excellence.

    The following material will provide you more information:

  • Design and Development in polyclinic


    If the organization strictly applies known technology, protocols, pathways, or procedures then it may exclude element 7.3 of ISO 9001 and must document appropriate justification to assure that the customer/patient/client understands.

    For example: The surgeon goes to learn a new procedure or how to use a new piece of equipment used for surgical procedures. When the surgeon is trained to do this new procedure, it becomes the norm for that surgery. The surgeon is responsible for the care plan, but did not design the actual protocol used in
    the surgery.

    When the organization develops a different way to implement a pathway, protocol, or procedure then the element 7.3 applies.When the design and development element is appropriate, there should be procedures about how design is to be reviewed and approved prior to implementation. Reco rds of design reviews, verification, and validation should be available.

    See here our sample of Procedure for Design and Development https://advisera.com/9001academy/documentation/procedure-design-development/
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