Search results

ISO 9001:2015 statistical requirements of Clause 9

According to clause 9.3 Analysis and evaluation, organizations should consider how frequently it will analyze and evaluate data that will help determine areas for improvement. The organization should use methods and control data quality (to ensure that it is representative, unbiased, and accurate, for example) in order to promote fact-based management decisions. ISO 9001:2015 does not prescribe specific statistical techniques. Each organization should evaluate those that can be useful.

Please, consider this 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/ where you find examples of statistical techniques used to help in making decisions

The following material will provide you more information about measurement:

• How to implement the Check phase (performance evaluation) in the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/17/how-to-implement-the-check-phase-performance-evaluation-in-the-qms-according-to-iso-90012015/
• Analysis of measuring and monitoring requirements in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/analysis-of-measuring-and-monitoring-requirements-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/"

Internal and external issues

Please check this Case study for ISO 9001:2015 transition in a construction company where you can find a sample of how to document such issues in a SWOT matrix: https://info.advisera.com/hubfs/9001Academy/9001Academy_FreeDownloads/Case_study_for_ISO_9001_2015_transition_in_construction_company_EN.pdf?t=1493297551317 

You can find more information about context 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 webinar on-demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope -
• Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book – (where I use the process approach this way) - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/"

Quality control in engineering

They can flowchart their activities and then apply the risk-based approach to determine where quality issues can occur. After evaluating those risks, the most relevant ones can generate a set of action plans in order to:

Design quality – for example, change a product in order to reduce failure modes;
Prevent quality – for example, by improving people competence or by working with better suppliers;
Control quality – establish control points and control plans

The following material will provide you more information about measurement:

• How to use quality control tools to improve your QMS - https://advisera.com/9001academy/blog/2017/04/18/how-to-use-quality-control-tools-to-improve-your-qms/
• 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/

IATF Document Hierarchy

According to clause number of 7.5.1 of the IATF 16949:2016  standard; the quality manual shall be documented. Although it is not a requirement, the quality policy generally continues to be documented in the quality manual.
With this new standard, the word  ‘’procedure’’ is not used. Also, there is no definition for the Level 1 document.

To learn more about the mandatory documents, see this free white paper: Checklist of Mandatory Documentation Required by IATF 16949:2016 https://info.advisera.com/16949academy/free-download/checklist-of-mandatory-documentation-required-by-iatf-16949

ISO 13485 and ISO 9001

Basic aspects of Quality management systems in ISO 9001 and ISO 13485 are very similar: documentation control, internal audits, corrective actions, management of non.conforming products, management review. From  medical devices point of view, ISO 13485: 2016 is more important.

To understand better what are similarities and differences between these two standards, please read an article on the following link: Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

On this link you can find several white papers about the planning process for implementation od ISO 13485, project proposal and similar: https://advisera.com/13485academy/free-downloads/

Opportunities and challenges of the application of standards

Here are few articles that discuss ITIL/ISO 20000 implementation and it's benefits i.e. challanges:

5 key benefits of ISO 20000 implementation https://advisera.com/20000academy/blog/2016/02/09/5-key-benefits-of-iso-20000-implementation/

4 Crucial Techniques for Convincing your top Management to Implement ISO 20000 https://advisera.com/20000academy/blog/2017/10/31/4-crucial-techniques-for-convincing-your-top-management-to-implement-iso-20000/

What are the most common ISO 20000 implementation myths? https://advisera.com/20000academy/blog/2016/02/23/what-are-the-most-common-iso-20000-implementation-myths/

5 excuses why IT organizations avoid ITIL implementation https://advisera.com/20000academy/blog/2015/08/25/5-excuses-why-it-organizations-avoid-itil-implementation/

How ITIL can help cloud services https://advisera.com/20000academy/blog/2015/07/28/how-itil-can-help-cloud-services/

Risk management process

This order follows exactly the sequence of requirements of ISO 27001.

Please note that the Risk Treatment Plan defines the actions, resources, responsibilities, and dates for the implementation of risk treatment options (e.g., risk transfer and risk mitigation), and you first need these options to be approved, generally as part of the SoA approval, so you can minimize risks of rework or loss of time if a treatment option is not approved.

These articles will provide you further explanation about the risk management process:

• ISO 27001 risk assessment & treatment – 6 basic steps https://advisera.com/27001academy/knowledgebase/iso-27001-risk-assessment-treatment-6-basic-steps/
• Risk Treatment Plan and risk treatment process – What’s the difference? https://advisera.com/27001academy/iso-27001-risk-assessment-treatment-management/#treatment

ISO 9001 Clauses for Construction Companies

Let us start by what clauses could be candidate to non-applicability:

• Does your organization receive project from customers or designs projects? If only receive project from customers, then clause 8.3 is not applicable
• Does regulation, customers, or your internal policy determine traceability requirements? If not, traceability is not applicable
• For construction companies, clauses 8.5.1 f) and 8.5.3 are normally applicable.
   

The following material will provide you more information about non applicable clauses:

• What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/ 
• 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/

Incident Priority Levels & Classes

ITIL doesn't explicitly define priority levels. Priority matrix should be applied based on your SLA's, type of services/business, tool you use, etc.

Here is the article where you can find more details: All about Incident Classification https://advisera.com/20000academy/knowledgebase/incident-classification/

as well as this free webinar

ITIL Incident Management Process Demystified https://advisera.com/20000academy/webinar/itil-incident-management-process-demystified-free-webinar-on-demand/

Documents for distribution company

From ISO 13485:2016 Documentation toolkit, in my opinion, you can exempt the following documents: Design and development, Sterilization and Adverse event investigation. Procedure Production and service provision in your case will be Service provision.