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ISO 9001 Sample registration form

Unfortunately, I cannot provide here a sample change registration form. Please consider the usefulness of developing a change registration form where someone requests a change, explains the motivation. Someone should evaluate the implications of that request and expected results. Someone with authority should approve that change. Someone should confirm that changes were made and someone should report the results of those changes.

The following material will provide you more information:

• The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
• About conducting design and development reviews consider - ISO9001 Design Verification vs Design Validation - https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
• ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/

ISO 9001 Implementing Managment Quality and Risk-based thinking

Risk-based thinking is a great way of implementing quality management into the everyday work life of every employee within an organization. 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. You can start by mapping your processes. Then, for each process, draw it with a flowchart and ask: what can go wrong?

In the picture above the blue boxes are examples of what can go wrong. The yellow boxes are examples of what was decided to handle those risks – new activities, control plans, new documentation.

Then, for each flowchart you can see who participates:

Now, for each step, considering risks and answers to them, you can design the organizational knowledge required:

You can find more information below:

• How to manage knowledge of the organization according to ISO 9001 - https://advisera.com/9001academy/blog/2016/08/30/how-to-manage-knowledge-of-the-organization-according-to-the-iso9001/
• Using Competence, Training and Awareness to Replace Documentation in your QMS - https://advisera.com/9001academy/blog/2013/12/17/using-competence-training-awareness-replace-documentation-qms/
• Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
• How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
• 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/ - where I extensively use the process approach.

ISO 9001 Evaluation of the effectiveness of training

Can i request for a sample template for evaluating of training effectiveness

Managing ISO 9001 for Medical Device Distributors who are not manufacturers

You can implement ISO 9001 if you are a Medical Device Distributor. However, Medical device regulative MDR 2017/745, which takes full effect on May 2021, has described in Article 14 General obligations of the distributors https://advisera.com/13485academy/mdr/general-obligations-of-distributors/ 

Further, in Article 16 Cases in which obligations of manufacturers apply to importers, distributors, or other persons, it is stated in point 3 that distributors shall ensure to have in place a quality management system. The quality management system shall cover, among others, procedures which ensure that the translation of information with the manufacturer is accurate and up-to-date, and procedures ensuring that the distributor is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.

Also, manufacturers need to be in compliance with harmonized standards published by the Offical Journal of European Union as described in Article 8. On that list, the only standard that covers the quality management system is ISO 13485:2016 so it is expected that all manufacturers have implemented this standard.;

For more information, please see the following:

• EU MDR Article 8 Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• List of the harmonized standard https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

To understand what harmonized standards are, please see the article:

• What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/

For more information regarding ISO 13485 please see the following links:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• EU MDR Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons https://advisera.com/13485academy/mdr/cases-in-which-obligations-of-manufacturers-apply-to-importers-distributors-or-other-persons/
• Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

• 27001 or NIST for Local Bank

  thank for your reply, this is what i need for my guidance. 

• Applicability of 17025 to GMP analytical laboratory

  Yes, ISO 17025 is definitely applicable for your laboratory. Both the laboratory and customers will benefit from the assurance of technical competency. The context for your laboratory it seems from your question, is that there are other interested parties and certifications involved. They could in fact require your testing laboratory to be ISO 17025 accredited.

  The following articles may be of interest:

  • Six key benefits of ISO 17025 implementation at https://advisera.com/17025academy/blog/2019/10/18/six-key-benefits-of-iso-17025-implementation/
  • What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/

  Also have a look at the 17025 Expert Advice Community topic ISO 17025 for internal quality control laboratory at https://community.advisera.com/topic/iso-17025-for-internal-quality-control-laboratory/
  and the free demo of the ISO 17025 Documentation Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

• Structuring a table of interested parties

  Normally, I recommend organizations to include a column with what the organization expects or requires from the interested party. I find it particularly useful to segment interested parties. For example, there are many potential customers that are not well suited for an organization.

  With some organizations I already used three more columns: one for determine the power they have in the relationship, another to determine their interest for the organization and results column. These three columns allow to segregate interested parties this way:

  

  You can find more information below:

  • How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
  • 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/
  • 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/

• Design office ISO objectives

  Organizations, considering its strategic direction, establish a quality policy that sets orientation for the definition of quality objectives. Strategic direction defines who are the relevant interested parties. Who are the main interested parties of the design office? What do they need or expect from the design office? For example, who are the target clients? What do they value? For example, for the owners of the design office, what results do they expect?

  Some years ago, I developed this crazy metaphor of seeing an organization with all its processes as an athlete. If you compare the body of someone competing on athletics with the body of someone that competes on weightlifting, they are very, very different. The body of a soccer player is very different from the body of a basketball player. Different strategic orientations require different process content. Two different organizations with two different strategic orientations may have very different relevant quality objectives.

  The following material will provide you more information:

  • How to define Key performance indicators for a QMS based ISO 9001: https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
  • How t write good quality objectives: https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
  • Free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 -https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
  • 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/

• Writing IQA non-conformance report

  How to write IQA non-conformance report?

  I understand you want to say "Internal Quality Audit" from the abbreviation "IQA". First of all, these are the questions of internal auditor training. It is not easy to answer questions in such an environment without providing this training, because we are doing case studies for these questions. Therefore, if you have not received internal auditor training, I recommend you attend this training.

  Let me briefly try to explain. Non-conformance in internal and external audits are written against the ‘’shall’’ articles of the standard. This is the ISO 19011 standard rule and applies to all standards. While writing nonconformity, objective evidence should be clearly presented and referred to the article of the relevant standard.

  How to close?

  The relevant process owners are responsible for closing the non-conformance.

  First of all, root cause analysis should be done, they should take and apply permanent and systematic actions. After all the actions to be taken, the internal auditor should check the effectiveness and, if the finding is effective, close the non-conformance. Of course, all these studies should be documented in the corrective action form.

  For more information, see:

  • Using Corrective Actions to Drive Continual Improvement in IATF 16949  https://advisera.com/16949academy/knowledgebase/using-corrective-actions-to-drive-continual-improvement-in-iatf-16949/
  • Five Main Steps in an IATF 16949:2016 Internal Audit  https://advisera.com/16949academy/knowledgebase/five-main-steps-in-an-iatf-169492016-internal-audit/
  • Requirements for the competence of IATF 16949 internal auditors https://advisera.com/16949academy/blog/2017/10/19/requirements-for-competence-of-iatf-16949-internal-auditors/
  • How to make an Internal Audit checklist for IATF 16949:2016 https://advisera.com/16949academy/knowledgebase/how-to-make-an-internal-audit-checklist-for-iatf-16949/
  You can also check out our IATF 16949:2016 Internal Audit Toolkit at this link https://advisera.com/16949academy/iatf-16949-2016-internal-audit-toolkit/