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Integrating ISO 9001:2015 with ISO 17025


As it is the customer who pays the bill, it will be the customer who decides what standard he wants to refer, it is not uncommon that laboratories are
unfortunately saddled with maintaining both ISO 17025 and ISO 9001 certification. Although it is simpler to create and implement two QMS, and to
"merge" those activities that can be merged, it is arduous, inefficient, and prone to mistakes. To integrate both 9001 and 17025, lab activities should be
considered processes (with specific requirements for the methods and the management), under the new “Operations” section of ISO 9001:2015.

As this is a subjective view of a new standard, I welcome feedback on this cross reference. Please send feedback to: gcarroll@fasttrackaust.com

ISO 9001:2015 COMMENTS ISO 17025


4. Context of the Organization
A risk-based approach rather than Just preparing separate risk assessment documents is
putting risk into a separate clause. not only an overhead; it does not meet this
Companies are not required to do a requirement. More over risk assessment and reviews
formal risk assessment as considering need to be incorporated into existing Workflows and
risk becomes integral to the process screens. As a single integrated tool, this can be
management system as a whole. simply configured into existing screens and workflows.

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

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includes a strengthening of the Set up a register of Objectives and Obligations linked to


requirements to achieve strategic Business Plans (FT’s Strategic Management module).
alignment behind the organizational Against each Objective & Obligation specify the
objectives, as well as support of the strategic & tactical risks and rate, to effect on those
adoption of the process approach. objectives. By listing the processes under the applicable
Business Plan you now have an integrated process
approach to achieving strategic objectives.

4.1 Understanding the organization and 4.1 Organization


its context
4.2 Management system
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality 4.2 Management system
management system
4.4 Quality management system and its 4.1 Organization
processes
4.2 Management system
5. Leadership Leadership is about empowering staff (see Why
Corporate Governance is broken and how to fix it). This
The focus is on leadership rather than
means greater decentralisation of “owner”
management. Leadership includes most
responsibilities with management taking a more
of the existing “management
mandatory review role. Delegate in workflows, while
responsibility” requirements.
ensuring adequate quality gates.
A management representative is no
The Quality Manager’s role is now a facilitator not an
longer a specific requirement although
enforcer. Use the auto escalation rules and public
certification bodies will require a
traffic lights to have line management responsible for
nominated contact.
quality functions. The QM’s role is to identify

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opportunities for improvement, and develop


management capabilities initially in Risk Based Thinking.
5.1 Leadership and commitment 4.1 Organization
4.2 Management system
4.15 Management reviews
5.1.1 Leadership and commitment for the 4.1 Organization
quality management system
4.2 Management system
4.15 Management reviews
5.1.2 Customer focus 4.4 Review of requests, tenders and contracts
5.2 Quality policy 4.2 Management system
5.3 Organizational roles, responsibilities 4.1 Organization
and authorities
4.2 Management system
6. Planning for the quality Incorporate a Business Plan function in your system
management system (Governance module) down to operational department
levels. Under each Plan list risks, opportunities and
Greater emphasis on “Planning”, controls (from template libraries) and rate their effect
focusing on the identification of risks and on the plan. Link KPIs to the plan to have Traffic Lights
opportunities as they impact on the display when risks levels are threatened (upper and
scope of the system. This removes the lower).
need for preventive action as defined in
the 2008 version, but includes
strengthened requirements for the
management of change and risk
management.
6.1 Actions to address risks and 4.2 Management system
opportunities

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4.9 Control of nonconforming testing and/or


calibration work
4.11 Corrective action
6.2 Quality objectives and planning to 4.2 Management system
achieve them
6.3 Planning of changes 4.2 Management system
7. Support A much under-utilised component of FastTrack is the 5 Technical requirements
Resources module. This is a graphic drag-drop calendar
“Support” includes most of the
tool for combined schedules of people, equipment and
requirements of the previous clause 6 –
facilities with tasks and activity. Also link workflow
Resource Management and also includes
“close” steps to Lessons Learnt register. These can then
a new requirement to manage
be included as a lookup on any screen field configuring
“organizational knowledge”.
the new Eye icon against that field. This provides
“organizational knowledge” at the point of processing,
empowering staff to action or troubleshoot
immediately.
5.5 Equipment
7.1 Resources
7.1.1 General 4.2 Management system
4.3 Document control
4.4 Review of requests, tenders and contracts
4.7 Service to the customer
4.10 Improvement
5.4.2 Selection of methods
5.4.3 Laboratory developed methods
7.1.2 People 4.2 Management system

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4.3 Document control


4.7 Service to the customer
4.10 Improvement
5.4.2 Selection of methods
5.4.3 Laboratory developed methods
7.1.3 Infrastructure 4.1 Organization
4.6 Purchasing services and supplies
4.12 Preventive action
5.3 Accommodation and environmental
conditions
5.5 Equipment
5.6 Measurement traceability
5.6.3 Reference standards and reference
materials
5.8 Handling of test and calibration items
5.10 Reporting of results
7.1.4 Environment for the operation of 5.3 Accommodation and environmental
processes conditions
7.1.5 Monitoring and measuring resources 5.4 Test and calibration methods and method
validation
5.5 Equipment
7.2 Competence 4.1 Organization
5.2 Personnel

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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

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“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

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5.4 Test and calibration methods and method


validation
5.9 Assuring the quality of test and calibration
results
5.10 Reporting of results
8.2.3 Review of requirements related to 4.4 Review of requests, tenders and contracts
products and services
5.4 Test and calibration methods and method
validation
5.9 Assuring the quality of test and calibration
results
5.10 Reporting of results
8.3 Design and development of products 5.4 Test and calibration methods and method
and services validation
5.9 Assuring the quality of test and calibration
results
8.4 Control of externally provided Outsourcing and purchasing is now combined. 4.6 Purchasing services and supplies
products and services
8.4.1 General 4.6 Purchasing services and supplies
8.4.2 Type and extent of control of 4.6 Purchasing services and supplies
external provision
8.4.3 Information for external providers 4.6 Purchasing services and supplies
8.5 Production and service provision
8.5.1 Control of production and service 4.2 Management system
provision

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4.5 Subcontracting of tests and calibrations


5.1 General
5.2 Personnel
5.4 Test and calibration methods and method
validation
5.4.2 Selection of methods
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration
results
8.5.2 Identification and traceability 5.8 Handling of test and calibration items
8.5.3 Property belonging to customers or 4.1 Organization
external providers
5.8 Handling of test and calibration items
8.5.4 Preservation 4.6 Purchasing services and supplies
4.12 Preventive action
5.8 Handling of test and calibration items
5.10 Reporting of results
8.5.5 Post-delivery activities 5.1 General
5.2 Personnel

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5.4 Test and calibration methods and method


validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration
results
8.6 Release of products and services 4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.9 Control of nonconforming testing and/or
calibration work
5.5 Equipment
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration
results
8.7 Control of nonconforming process 4.9 Control of nonconforming testing and/or
outputs, products and services calibration work
9. Performance Evaluation Apart from setting KPIs and implementing FT’s new
The focus on performance rather than Pivot Table analyses to allow operational management
procedures of the organization. to focus on performance, look at Audit scoring. Include
“Performance Evaluation” replaces the in performance and effectiveness ratings in the audit
previous clause 8 and withdraws the checklist templates in addition to the standard
need for preventive action which has conformance measure (see How to Implement Risk
now been subsumed into clause 6 Based Audits & Inspections).
Planning.

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9.1 Monitoring, measurement, analysis


and evaluation
9.1.1 General 4.10 Improvement
4.14 Internal audits
5.4 Test and calibration methods and method
validation
5.9 Assuring the quality of test and calibration
results
9.1.2 Customer satisfaction 4.10 Improvement
9.1.3 Analysis and evaluation 4.10 Improvement
5.9 Assuring the quality of test and calibration
results
9.2 Internal audit 4.14 Internal audits
9.3 Management review 4.15 Management reviews
9.3.1 Management review 4.15 Management reviews
9.3.2 Management review 4.15 Management reviews
10. Improvement
Increases the focus on “Improvement”
and includes non-conformities and
corrective action previously in clause 8.
10.1 General 4.10 Improvement
4.12 Preventive action
10.2 Nonconformity and corrective action 4.9 Control of nonconforming testing and/or
calibration work
4.11 Corrective action

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4.12 Preventive action


10.3 Continual Improvement 4.10 Improvement
4.12 Preventive action

Sept 2015

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