What Records Must Be Kept to Meet ISO 9001:2015 Requirements?
Introduction:
Documentation is just as important to the standardization process as it is to achieving ISO 9001:2015 certification. One may argue that the two ends constitute the same thing. A certification application is only as strong as the ISO 9001 documentation services and records detailing the processes, methods, and standards it is based on.
How do you define recorded data?
According to clause 3.8. of ISO 9000, records are useful for providing evidence of actions taken and conveying information. It's useful for businesses to look back at their plans and see how much they managed to carry out. It also facilitates communication and the exchange of information. The organization's nature, products, processes, and formality have considerable sway over the documentation style. Equally important are the company's internal communication practices and the heart of the workplace. Paper, magnetic forms, electronic media, optical computer discs, photos, and a master sample are all examples of documents.
Under clause 5.4.6 of ISO 17025:2017, laboratories are required to know, document, and use procedures to reasonably estimate the ISO 17025 Uncertainty of measurement.
Why is it important to have things written down?
• Provides a medium for the dissemination of knowledge
• The Documentation of Efforts Taken and Completed
• Spread information around the company.
• Term of art for technical purposes
• Helpful for developing and designing products
What Matters:
The documentation needs of a Quality Management System (QMS) can be determined by the processes employed to achieve the organization's objectives. Existing documentation can be utilized if demonstrated to support the QMS processes properly. If not, the necessary effort should be taken to change or re-purpose the documentation to the intended use.Numbers obtained from measuring devices like scales, thermometers, stopwatches, and rulers are all that can be said to constitute aMeasurement uncertainty training.
Despite this leeway, the company must still be able to demonstrate that it is succeeding in its quality management objectives. Several examples of where the standard requires proof of compliance were already mentioned. Because of this, all relevant documentation must be correct, objective, and up-to-date to withstand the examination of a well-conducted external audit. However, the discipline used to compile the requirements for the previous revision of the quality management system may still be applicable, even though ISO 9001:2015 is more lenient about documentation directives.
Some of the ISO 9001 standard language is utilized here for explanatory purposes only. Standard Stores is aware of and adheres to the intellectual property and copyright regulations established by the International Organization for Standardization (ISO).
Methods are required to fulfill your article 7.5 responsibility by:
• Sign off on paperwork
• Documents must be reviewed, revised, and resubmitted for approval.
• Recognize shifts
• Provide access to records.
• Make sure every piece of paperwork can be easily read and identified
• Locate and regulate third-party paperwork
• Don't allow old records to get out there.
• Determine which outmoded records, if any, must be kept
The following activities require that you create documented procedures:
• Locating relevant documents
• Archiving documents
• Safeguarding documents (which includes making sure they can be read)
• Obtaining Files
• Keeping detailed records
• Destruction of files
Conclusion
The primary goals of the ISO 9001:2015 revision was to create a more universally applicable set of standards and to give businesses more leeway in deciding which documents were most important to their operations.
Most of the prerequisites listed above, as should the documentation supporting them, sound familiar. The next step is to ensure consistency by adding additional supporting documentation for your Quality Management System.
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