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Integrating ISO 9001:2015 with ISO 17025

Laboratory Quality Management Software

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@

ISO 9001:2015

COMMENTS

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.

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.

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

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.

ISO 17025

Sept 2015



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.

Laboratory Quality Management Software

4.1 Understanding the organization and

4.1

its context

4.2

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality

4.2

management system

4.4 Quality management system and its

4.1

processes

4.2

5. Leadership

Leadership is about empowering staff (see Why

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

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.

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

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

Organization Management system

Management system Organization Management system

Sept 2015



5.1 5.1.1 5.1.2 5.2 5.3 6.

6.1

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

Leadership and commitment

4.1

4.2

4.15

Leadership and commitment for the

4.1

quality management system

4.2

4.15

Customer focus

4.4

Quality policy

4.2

Organizational roles, responsibilities

4.1

and authorities

4.2

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).

Actions to address risks and

4.2

opportunities

Laboratory Quality Management Software

Organization Management system Management reviews Organization Management system Management reviews Review of requests, tenders and contracts Management system Organization Management system

Management system

Sept 2015



Laboratory Quality Management Software

4.9

6.2 6.3 7.

7.1 7.1.1

7.1.2

Quality objectives and planning to achieve them Planning of changes Support

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

Resources General

People

4.11 4.2

4.2

A much under-utilised component of FastTrack is the

5

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.

5.5

4.2 4.3 4.4 4.7 4.10 5.4.2 5.4.3 4.2

Control of nonconforming testing and/or calibration work Corrective action Management system Management system Technical requirements

Equipment

Management system Document control Review of requests, tenders and contracts Service to the customer Improvement Selection of methods Laboratory developed methods Management system

Sept 2015

 7.1.3 Infrastructure

7.1.4 7.1.5

Environment for the operation of processes

Monitoring and measuring resources

7.2 Competence

Sept 2015

Laboratory Quality Management Software

4.3 4.7 4.10 5.4.2 5.4.3 4.1 4.6 4.12 5.3

5.5 5.6 5.6.3

5.8 5.10 5.3

5.4

5.5 4.1 5.2

Document control Service to the customer Improvement Selection of methods Laboratory developed methods Organization Purchasing services and supplies Preventive action Accommodation and environmental conditions Equipment Measurement traceability Reference standards and reference materials Handling of test and calibration items Reporting of results Accommodation and environmental conditions Test and calibration methods and method validation Equipment Organization Personnel



7.3 Awareness

7.4 Communication 7.5 Documented information

7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information 8. Operation

5.5

Senior managers need to be able to demonstrate an

4.1

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

5.5

4.1

Shift from an explicit need for traditional documents

4.2

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.

4.2

4.3

4.12

4.3

4.12

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

Laboratory Quality Management Software Equipment Organization

Personnel Equipment Organization Management system

Management system Document control Preventive action Document control Preventive action

Sept 2015



"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

4.2

5.1

5.4

5.9

8.2 Determination of requirements for

4.4

products and services

5.10

5.4

5.9

8.2.1 Customer communication

4.4

4.5

4.7

4.8

8.2.2 Determination of requirements

4.4

related to products and services

Laboratory Quality Management Software

Organization Management system General Test and calibration methods and method validation Assuring the quality of test and calibration results Review of requests, tenders and contracts

Reporting of results Test and calibration methods and method validation Assuring the quality of test and calibration results Review of requests, tenders and contracts Subcontracting of tests and calibrations Service to the customer Complaints Review of requests, tenders and contracts

Sept 2015



8.2.3 Review of requirements related to products and services

8.3 Design and development of products and services

8.4

8.4.1 8.4.2

8.4.3 8.5 8.5.1

Control of externally provided products and services

General

Type and extent of control of external provision

Information for external providers

Production and service provision

Control of production and service provision

Outsourcing and purchasing is now combined.

Sept 2015

Laboratory Quality Management Software

5.4

Test and calibration methods and method

validation

5.9

Assuring the quality of test and calibration

results

5.10 Reporting of results

4.4

Review of requests, tenders and contracts

5.4

Test and calibration methods and method

validation

5.9

Assuring the quality of test and calibration

results

5.10 Reporting of results

5.4

Test and calibration methods and method

validation

5.9

Assuring the quality of test and calibration

results

4.6

Purchasing services and supplies

4.6

Purchasing services and supplies

4.6

Purchasing services and supplies

4.6

Purchasing services and supplies

4.2

Management system

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