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  • 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/

  • Measurements and Metrics in Software Development Projects


    The purpose of measurements and metrics in ISO 9001 is to provide evidence that the product or service meets initial requirements for product or service quality.

    The measures can be direct (cost, effort, lines of code (LOC), speed, memory) or indirect (functionality, quality, complexity, efficiency, reliability, maintainability), the metrics can beSize of the software produced, Lines Of Code (LOC), 1000 Lines Of Code KLOC, Effort measured in person months, Errors/KLOC, Defects/KLOC, Cost/LOC, Documentation Pages/KLOC, LOC is programmer & language dependent, etc.

    The ISO 9001 standard doesn't prescribe the types of measurement and metrics or force you to perform measuring. You need to perform only the measurements that provide the evidence of product quality, if such measurements don't exist you can exclude the clause 7.6 of the standard.

    Here is one very informative article regarding the subject: 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/

  • SRS in Software Product Deleopment


    The SRS (Software Requirements Specification) is necessary for software product development since the SRS is a description of a software system to be developed, laying out functional and non-functional requirements.

    The detailed SRS with information on what the software product is to do as well as what it is not expected to do will reduce the need for future redesign of the software product.

    The SRS is just a product requirements established by customer to a supplier. Here you can find one very informative article regarding the subject: How Product Requirements work in ISO 9001 https://advisera.com/9001academy/blog/2014/04/08/product-requirements-work-iso-9001/

  • Exclusion of clause 7.3 Design and Development


    Design and development can be excluded when organization doesn't perform design of new products or development of existing products. This clause can also be excluded when the design and development are outsourced.

    Here is one article explaining design and development process: ISO9001 Design Verification vs Design Validation https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
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