Ensure that your organisation has determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the management system.
Check that your organisation has identified which resources it needs to make available in order to ensure the effective operation of the management system. Resources will often include raw materials, infrastructure, finance, personnel and IT, all of which can be either internally or externally provided.
Most organisations determine resource requirements during management review meetings. You may look at your budgets to check that the organisation has really identified all types of resources required and that it has taken action to ensure that those resources are available as needed.
People
Describe how your organisation allocates its staff in order to achieve the required outcome - dependent on its size, this may be one or two people, or an entire project team.
Infrastructure
Has your organisation provided the infrastructure necessary for the effective implementation of the management system and for the operation and control of its processes? Identify how your organisation determines, provides, and maintains the infrastructure for the operation of processes to achieve product and/or service conformity. Consider all the things needed in order to deliver a product and/or service to the customer. This needs to include:
- Buildings and workspaces;
- Gas, water, electricity, etc.;
- Tools and process equipment, e.g. hardware or software;
- Supporting services, e.g. transport, IT and communication.
Environment for the operation of processes
Confirm that your organisation has identified, provided and maintained the infrastructure necessary for achieving product and/or service conformance. Ensure that your organisation provides a work environment that allows the achievement of product conformity, by considering and implementing the following human physical factors:
- Safe working environment with good lighting, ventilation, safe passageways, stairs and corridors;
- Safe working equipment, tools and process;
- Safe methods of work;
- Provision of training and instruction;
- Cascade of information to employees;
- Provision of safe means of handling, storage, use and transportation of equipment, materials and chemicals.
All employees must:
- Protect themselves and co-workers who may be affected by their actions and behaviour;
- Use appropriate personal protective equipment (PPE) and/or clothing provided;
- Report any unsafe acts or conditions and follow procedures and work instructions.
Monitoring and measuring resources
Confirm that where measurement traceability is a requirement, instruments which are used for measurement are subjected to the following controls:
- Devices are calibrated at intervals or prior to use, based on recognised standards;
- Devices are adjusted as necessary in accordance with manufacturer’s instructions;
- Devices are identified to enable calibration status to be determined;
- Devices are safeguarded from adjustment, which may invalidate results;
- Devices are protected from damage during handling, maintenance or storage;
- The validity of results from a non-confirming device are re-checked with a conforming device;
- Devices are calibrated by competent external providers e.g. certified to ISO 17025;
- Records of calibration and verification are maintained;
- Computer software which is used for monitoring/measuring is validated prior to initial use;
- Computer software used for monitoring and measuring is re-validated where necessary.
If measurement traceability is not required, verify that those monitoring and measuring resources used by your organisation are suitable. You should ensure that documented information is maintained in order to demonstrate suitability of monitoring and measuring equipment. All equipment requiring calibration must be identified and must be:
Calibrated or verified at specific intervals, or prior to being used. Equipment must be calibrated using measurement standards traceable to international or national measurement standards. Where there is no standard available for the device the basis for calibration or verification must be recorded.
Adjusted or readjusted as necessary. Adjusted/re-adjusted calibration should be done by qualified personnel and the validity of the previous measuring results should be accessed when equipment is found to be out of calibration and appropriate action should be taken (this may include recall of a product). Ideally you need a process to provide traceability of each piece of equipment to the process/product that the equipment was used on.
Identified to show calibration status. Each piece of equipment should be identified in such a way that the user can determine that the device has current calibration. This may be accomplished by the equipment’s unique serial number traceable to the calibration record, however a calibration status label is good practice. Where the environment is not conducive to the use of stickers, status may be identified by colour-coding, identification numbers with associated calibration record, and/or calibrated prior to every use.
Safeguarded from adjustment. You really need a process in place to ensure that users outside the calibration process do not adjust equipment. Methods to safeguard may include locking materials for setscrews, tamper-proof seals, limited entrance to calibration areas, and other methods.
Protected from damage during handling, maintenance and storage. You should ensure that measuring equipment is handled and stored in a manner to protect the equipment from damage.
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