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Questions to check gap analysis to 17025:2017

All the requirements so the new revision should be checked as audit criteria. If the laboratory is already accredited to ISO 17025:2005, then the major changes in the 2017 version need to be focussed on. For example Clause 8.5 Addressing Risks and Opportunities. Questions must be asked to seek objective evidence. Two example are “Did the laboratory consider risks and opportunities associated with laboratory activities in order to: Give assurance that the management system can achieve its intended results?” and “Does the laboratory plan and take actions to address these risks and opportunities?”

Your Accreditation Assessment Body would have policies, guidelines and checklists for transition requirements. For example a laboratory would need to ensure that effective implementation of all ISO 17025:2017 requirements have been assessed through the audit programme and gaps closed.

Have a look at the ISO 17025 document template: Internal Audit Checklist, which is an appendix to the main document, Internal Audit Procedure. The checklist has a list of questions required to ensure the management system is implemented and maintained. It includes more than 100 questions to ensure each requirement of the ISO 17025 standard is implemented and maintained within the Laboratory Quality Management System, and includes the ability for you to add additional questions to suit additional needs. It is available at https://advisera.com/17025academy/documentation/internal-audit-checklist/

Queries about ISO 13485

1. What is the basis of this business and the key point?

If your question considers the business of producing medical devices, the key point is to ensure the safety and performance of the medical device. The ISO 13485:2016 specifies requirements for a quality management system for organizations involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g.technical support).

2. How to start easiest and how can we understand 13485

First of all, you need to educate yourself about this standard. You can find some courses about it, find a consultant, and educate yourself with online articles. We recommend that the best start is to read our articles in the ISO 13485 Knowledge database which you can find on the following link: https://advisera.com/13485academy/knowledgebase/ 

Here I can specify the following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

Among all articles on that blog, for starters I can recommend the following articles:

• ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/
• How to define roles and responsibilities within an ISO 13485-based QMS https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/
• Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

3. and how can we apply it completely easiest?

This depends on how much time and resources you have. You can hire a consultant or you can buy a predefined documentation toolkit where all requirements are already described and your job is to and it is your job to adapt them to your processes, products, people, and more.

Here is the link to our ISO 13485 Documentation Toolkit: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

Depending on which package you buy, you can get different levels of expert help.

Here are some more useful articles:

• How to choose a consultant for ISO 13485 implementation https://advisera.com/13485academy/blog/2019/04/04/how-to-choose-a-consultant-for-iso-13485-implementation/
• Implementing ISO 13485:2016 with a consultant vs. DIY approach https://info.advisera.com/13485academy/free-download/implementing-iso-13485-2016-with-a-consultant-vs-diy-approach

• ISO 9001 Presenting Quality System to Top Management

  It seems that the closest thing that we have are these documents: Matrix of Key Performance Indicators; Data Analysis Report and Management Review Minutes. You can find them related with this - Procedure for Management Review - https://advisera.com/9001academy/documentation/procedure-management-review/

  My recommendation is: follow the topics from ISO 9001:2015 clause 9.3.2. Also, put yourself in the shoes of top management: what does top management value more? What is pain for top management? So, show topics about productivity, costs, downtime, complaints, sales, new customers, lost costumers

  You can find more information below:

  • 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/
  • Free webinar – How to perform management review according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-perform-management-review-according-to-iso-9001-2015-free-webinar-on-demand/
  • ISO 9001 document template: Procedure for Management Review - https://advisera.com/9001academy/documentation/procedure-management-review/
  • Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
     

• ISO 9001 Benefits, scope and main requirements

  which ISO should the best we apply for? 

  Answer:

  Does your organization want to use certification as a marketing tool? To whom does your organization want to influence? Consumers? Distribution companies? Other bottlers that may want to outsource their production to your organization? Check which ISO standard is more valued by each interested party: 9001; 14001 or 22000.

  What is the best benefit and scope of ISO 9001?

  Answer:

  About the scope, as you can see in this free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/ - it is a management decision, not a technical decision. The webinar explains some if the nuances behind different scopes. About the benefits, please check in this article - Six Key Benefits of ISO 9001 Implementation -https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/ - which benefits are more valuable for your organization considering its particular situation and context.

  What are the main requirements of ISO 9001?

  Please check this article - ISO 9001 Requirements and Structure - https://advisera.com/9001academy/knowledgebase/iso-9001-requirements-and-structure/

  You can find more information below:

  • What are the benefits of ISO 9001 for your employees? - https://advisera.com/9001academy/blog/2016/06/14/what-are-the-benefits-of-iso-9001-for-your-employees/
  • How to budget an ISO 9001 implementation project - https://info.advisera.com/9001academy/free-download/how-to-budget-an-iso-9001-implementation-project?utm_source=script-for-iso-9001-lead-implementer-course&utm_medium=downloaded-content&utm_content=lang-en&utm_campaign=free-downloads-9001
  • Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
  • Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
     

• Equipment calibration certificate/test report

  You asked

  according to iso 17025:2017, who in the laboratory is responsible for: 1- reviewing equipment calibration certificates?

  I assume you are referring to a testing not calibration laboratory, meaning that “reviewing equipment calibration certificates” refers to review of calibration certificates supplied to you by an accredited calibration laboratory.

  The person responsible for the performance of test methods influenced by the calibrated apparatus is responsible, or alternatively the technical or laboratory manager. All personnel using the calibrated apparatus should however understand the certificate and know how the result outcome (performance) could impact on the validity of the performed test methods. The review of the certificate should ensure a) the supplier is / was competent,  b) the required metrological traceability is evident (traceable to International standards),  c) the necessary uncertainty and performance parameters are reported suitably to make an objective decision on the performance and risks and d) the specification and measured performance is acceptable to use the apparatus for the purpose intended.

  You also asked

  according to iso 17025:2017, who in the laboratory is responsible for: 2- signing of test report?"

  Typically an appointed and competent “signatory” is assessed by the laboratory’s accreditation body and they take responsibility for the technical validity of results. Often the laboratory manager will co-sign a test report, taking overall responsibility for the approval of a report to go to a customer. The laboratory’ s quality assurance process should specify this, meaning what objective checks and responsibility does a “signature” indicate. A laboratory should also document responsibility for confirming the validity of the results after evaluating control parameters such as internal and external quality control monitoring and data transcription (integrity). Who this is, will depend on the organisational structure.

  The following Academy ISO 17025 document template: Testing Report Procedure may be of interest, available at https://advisera.com/17025academy/documentation/testing-report-procedure/ It outlines the requirements for writing test reports, to meet the requirements of ISO/IEC 17025:2017 for reporting test results.

• Internal and External issues

  There is no mandatory requirement to retain records of internal and external issues determination. So, organizations are free to decide how to do it. For example, you may create a register for internal and external issues. In my case, I like to translate internal issues as positive or negative (strengths or weaknesses) and the external issues also as positive or negative (opportunities or threats). This way I record internal and external issues with a SWOT matrix. Please check how I do it in this free webinar on demand - - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/

  You can find more information below

  • How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
  • Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
  • Book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
     

• Certification requirements for SME's - Automotive

  As I mentioned before, there is no clear link with the small business regarding the implementation of IATF or the supply of parts to the OEM customer.However, in order for new businesses to obtain an IATF certificate, there is a right called ‘’letter of conformance.’’  I share the details of this below from IATF Rules 5.

  5.14 Letter of conformance The purpose of the letter of conformance is to confirm that processes exist that satisfy the requirements of IATF 16949 and these "Rules" and where the client is not able to achieve IATF 16949 certification because of:

  a) a new site without twelve ( 12) months of internal or external performance data for the automotive production and/or service parts in the scope of certification

  b) an existing site that can demonstrate it is 

  5.14.4 Eligible for certificationOnce the client has twelve ( 12) months performance data for the new site or if the client on an active bid list receives a contract from the customer requiring IATF 16949 certification, the certification process shall proceed by the same certification body with an initial audit (stage 1 readiness review and stage 2) with a maximum reduction of 50% possible in audit days for the stage 2 audit (see section 5.2 and 5.4 g).The 50% reduction applies only to the initial audit and only if the initial audit starts before the expiration date of the letter of conformance. The reduction shall not be applied to the subsequent surveillance audit cycle.A member of the audit team that performed the initial audit for the letter of conformance should be assigned to participate in the initial audit and each surveillance audit of the three (3) year audit cycle.The stage 2 audit shall start before the expiration date of the letter of conformance. lf the timing is exceeded, the client shall start over with an initial certification audit (stage 1 readiness review and stage 2) and no reduction shall be applied.

   

• Standard approach/Framework for meeting all Quality clauses

  APQP meetings should be held with team participation for both product design and development, as well as process design and development. 

  There is no standard application, it is made according to customer-specific requirements. My recommendation is to use AIAG's APQP and PPAP manuals which are Ford, GM, Chrysler and most of automotive customer project management requirements. 

  You can organize meetings according to the requests in the clauses 8.1-8.2-8.3 of the   IATF 16949: 2016 standard and the project management phases in these manuals.

  For more information feel free to visit the following:

  • What are the five core tools of IATF 16949? https://advisera.com/16949academy/blog/2017/08/23/what-are-the-five-core-tools-of-iatf-16949/

  • ISO 9001 Defining the procedures

    Unfortunately, I do not believe that there is a best way to precisely define what procedures should be implemented in organizations. Organizations are complex adaptive systems, even if we could define the best set of procedures at a moment in time, sooner or later that set would become obsolete due to the changes in the system and in the context.

    We will always be guessing what the best set is. What I can give you is a list of topics that should be considered when thinking what procedures are needed or not. Consider that procedure may be useful or needed because of:

    • Complexity of tasks – complex tasks are more prone to errors and mistakes;
    • Staff rotation – if staff rotation is high, people have not much experience and a procedure that someone can use as guide in case of doubt is very useful;
    • Staff training – if staff training is very poor;
    • Performance – if performance results show a bad performance perhaps procedures can help people in their work;
    • Complaints – a particular case of performance;
    • Risk analysis - risk-based thinking is a great way of implementing prevention and control into a quality management. ISO 9001:2015 promotes the process approach and in this free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ I show how to relate processes, risks, training, documentation and control
    • Requirement – if a law, or a standard, or a contract requires a procedure.
       

    You can find more information about documents and records below:

    • List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
    • How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
    • 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/
    • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
    • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/