The quality program should provide for the process and requirements for changing and improving the program. Laboratories will need to demonstrate continual improvement. Take actions to address risks and opportunities. Plan actions to address risks and opportunities. Initial the records so that they are traceable and include date.Ĩ.5 Actions to Address Risks and OpportunitiesĬonsider the risks and opportunities associated with lab activities. Keep records for measurements, observations and customer information. Mistakes crossed out, corrected and initialed/signed. Observations, data and calculations are recorded at the time they are made. Technical records are retained and contain sufficient information to establish an audit trail. Records must be legible, traceable, retrievable, held secure and in confidence. Records must be identified, collected, indexed, accessed, stored, maintained and eventually disposed. Prompt removal of invalid/obsolete documents - they can't be used!Įnsure altered or new text is marked, as practical.Ĭomputerized systems may be used to maintain documents.Īn excellent solution for control of management system documentation is Omni-Assistant QMS Softwareĭocuments can be considered living.Records can be considered dead and stored.exhumed once in awhile, but generally out of sight. Unique identification, effective date and/or revision number, total number of pages, authority for issue.
#Iso 17025 2017 management review iso
There is a significant difference in the Management System Documentation outlined in ISO/IEC 17025:2017 from ISO 9001:2015.Ĩ.3 Control of Management System Documentation Option B: ISO 9001 Management System option. Option A: free-standing Management System option that allows you to retain existing structure.
The lab establishes, documents, implements and maintains a management system through a quality manual. General: The creation of the ISO 17025 Management System is outlined in this clause.
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