laboratory quality management ...... sept 2015 laboratory quality management software integrating...

www.fasttrack365.com

Sept 2015

Laboratory Quality Management Software

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: [email protected]

ISO 9001:2015 COMMENTS ISO 17025

4. Context of the Organization

A risk-based approach rather than putting risk into a separate clause. Companies are not required to do a formal risk assessment as considering risk becomes integral to the management system as a whole.

The introduction of a requirement to understand the “Context of the Organization” as well as the expectations of interested parties and how it impacts on the objective of the system, which is to achieve customer satisfaction.

Greater integration with strategic direction and business processes

Just preparing separate risk assessment documents is not only an overhead; it does not meet this requirement. More over risk assessment and reviews need to be incorporated into existing Workflows and process screens. As a single integrated tool, this can be simply configured into existing screens and workflows.

This is to remove the existing “silo” method of each department carrying out its own functions. Context is about achieving the purpose of their existence not just their function. Include an “Involved” list on activity screens and set up notification rules to improve 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.


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includes a strengthening of the requirements to achieve strategic alignment behind the organizational objectives, as well as support of the adoption of the process approach.

Set up a register of Objectives and Obligations linked to Business Plans (FT’s Strategic Management module). Against each Objective & Obligation specify the strategic & tactical risks and rate, to effect on those 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 its context

4.1 Organization

4.2 Management system

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system


4.4 Quality management system and its processes

4.1 Organization


5. Leadership

The focus is on leadership rather than management. Leadership includes most of the existing “management responsibility” requirements.

A management representative is no longer a specific requirement although certification bodies will require a nominated contact.

Leadership is about empowering staff (see Why Corporate Governance is broken and how to fix it). This means greater decentralisation of “owner” responsibilities with management taking a more mandatory review role. Delegate in workflows, while ensuring adequate quality gates.

The Quality Manager’s role is now a facilitator not an enforcer. Use the auto escalation rules and public traffic lights to have line management responsible for quality functions. The QM’s role is to identify

http://www.fasttrack365.com/blog/why-corporate-governance-is-broken-and-how-to-fix-it

http://www.fasttrack365.com/blog/why-corporate-governance-is-broken-and-how-to-fix-it


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opportunities for improvement, and develop management capabilities initially in Risk Based Thinking.

5.1 Leadership and commitment 4.1 Organization


4.15 Management reviews

5.1.1 Leadership and commitment for the quality management system

4.1 Organization


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 and authorities

4.1 Organization


6. Planning for the quality management system

Greater emphasis on “Planning”, focusing on the identification of risks and opportunities as they impact on the scope of the system. This removes the need for preventive action as defined in the 2008 version, but includes strengthened requirements for the management of change and risk management.

Incorporate a Business Plan function in your system (Governance module) down to operational department levels. Under each Plan list risks, opportunities and controls (from template libraries) and rate their effect on the plan. Link KPIs to the plan to have Traffic Lights display when risks levels are threatened (upper and lower).

6.1 Actions to address risks and 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 achieve them


6.3 Planning of changes 4.2 Management system

7. Support

“Support” includes most of the requirements of the previous clause 6 – Resource Management and also includes a new requirement to manage “organizational knowledge”.

A much under-utilised component of FastTrack is the Resources module. This is a graphic drag-drop calendar tool for combined schedules of people, equipment and facilities with tasks and activity. Also link workflow “close” steps to Lessons Learnt register. These can then be included as a lookup on any screen field configuring the new Eye icon against that field. This provides “organizational knowledge” at the point of processing, empowering staff to action or troubleshoot immediately.

5 Technical requirements

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


4.10 Improvement


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 processes

5.3 Accommodation and environmental 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 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.

4.1 Organization

5.2 Personnel

5.5 Equipment

7.4 Communication 4.1 Organization

7.5 Documented information Shift from an explicit need for traditional documents 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


7.5.3 Control of documented information 4.3 Document control


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 Product Realisation clause 7, however contains most of the previous requirements. The intention is to make it more relevant to the service sector.

documents and processes reflect online system workflows and review the Neural Network links to ensure they are comprehensively networked to aspects of your systems.

8.1 Operational planning and control 4.1 Organization


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 products and services





8.2.1 Customer communication 4.4 Review of requests, tenders and contracts

4.5 Subcontracting of tests and calibrations


4.8 Complaints

8.2.2 Determination of requirements related to products and services



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8.2.3 Review of requirements related to products and services





8.3 Design and development of products and services



8.4 Control of externally provided products and services

Outsourcing and purchasing is now combined. 4.6 Purchasing services and supplies

8.4.1 General 4.6 Purchasing services and supplies

8.4.2 Type and extent of control of 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 provision



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4.5 Subcontracting of tests and calibrations

5.1 General

5.2 Personnel



5.5 Equipment


5.7 Sampling



8.5.2 Identification and traceability 5.8 Handling of test and calibration items

8.5.3 Property belonging to customers or external providers

4.1 Organization


8.5.4 Preservation 4.6 Purchasing services and supplies




8.5.5 Post-delivery activities 5.1 General

5.2 Personnel


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5.5 Equipment


5.7 Sampling



8.6 Release of products and services 4.5 Subcontracting of tests and calibrations



5.5 Equipment



8.7 Control of nonconforming process outputs, products and services


9. Performance Evaluation

The focus on performance rather than procedures of the organization. “Performance Evaluation” replaces the previous clause 8 and withdraws the need for preventive action which has now been subsumed into clause 6 Planning.

Apart from setting KPIs and implementing FT’s new Pivot Table analyses to allow operational management to focus on performance, look at Audit scoring. Include in performance and effectiveness ratings in the audit checklist templates in addition to the standard conformance measure (see How to Implement Risk Based Audits & Inspections).

http://www.fasttrack365.com/blog/bid/how-to-implement-risk-based-audits-inspections

http://www.fasttrack365.com/blog/bid/how-to-implement-risk-based-audits-inspections


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9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General 4.10 Improvement

4.14 Internal audits



9.1.2 Customer satisfaction 4.10 Improvement

9.1.3 Analysis and evaluation 4.10 Improvement


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


10.2 Nonconformity and corrective action 4.9 Control of nonconforming testing and/or calibration work

4.11 Corrective action


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10.3 Continual Improvement 4.10 Improvement


laboratory quality management ...... sept 2015 laboratory quality management software integrating...

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