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Laboratory Quality Management Software
As this is a subjective view of a new standard, I welcome feedback on this cross reference. Please send feedback to: gcarroll@fasttrackaust.com
The introduction of a requirement to This is to remove the existing “silo” method of each
understand the “Context of the department carrying out its own functions. Context is
Organization” as well as the expectations about achieving the purpose of their existence not just
of interested parties and how it impacts their function. Include an “Involved” list on activity
on the objective of the system, which is screens and set up notification rules to improve
to achieve customer satisfaction. communication and feedback. Include a review of
“Related Items” to increase the Neural Network on
records to allow easy identification of the effect of, and
on, other areas of operation.
Greater integration with strategic
direction and business processes
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
5.5 Equipment
7.3 Awareness Senior managers need to be able to demonstrate an 4.1 Organization
understanding of the wider business environment,
social, cultural and regulatory, and how that impacts or
could impact on the organization’s ability to meet
customer requirements.
Using the Obligations register, schedule reporting
requirements for managers to record reviews of social,
cultural and regulatory impacts.
5.2 Personnel
5.5 Equipment
7.4 Communication 4.1 Organization
7.5 Documented information Shift from an explicit need for traditional documents 4.2 Management system
such as a quality manual to a broader requirement for
‘documented information’.
This acknowledges that the electronic workflows
embodied in modern software are a more functional
expression of an organization’s processes than tradition
descriptive paper documents. Utilising extensive user
definable tooltips, the online tool doubles as the
process documentation.
7.5.1 General 4.2 Management system
7.5.2 Creating and updating 4.3 Document control
4.12 Preventive action
7.5.3 Control of documented information 4.3 Document control
4.12 Preventive action
8. Operation To recap Product Realisation is about the processes for
planning, and verifying the production and delivery of
operations. The main thing here is to ensure existing
Sept 2015
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Laboratory Quality Management Software
“Operations” replaces the previous documents and processes reflect online system
Product Realisation clause 7, however workflows and review the Neural Network links to
contains most of the previous ensure they are comprehensively networked to aspects
requirements. The intention is to make it of your systems.
more relevant to the service sector.
8.1 Operational planning and control 4.1 Organization
4.2 Management system
5.1 General
5.4 Test and calibration methods and method
validation
5.9 Assuring the quality of test and calibration
results
8.2 Determination of requirements for 4.4 Review of requests, tenders and contracts
products and services
5.10 Reporting of results
5.4 Test and calibration methods and method
validation
5.9 Assuring the quality of test and calibration
results
8.2.1 Customer communication 4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.7 Service to the customer
4.8 Complaints
8.2.2 Determination of requirements 4.4 Review of requests, tenders and contracts
related to products and services
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015
www.fasttrack365.com
Laboratory Quality Management Software
Sept 2015