Clause 7.1.1 General

ISO 9001:2015 requires the resources needed for the establishment, implementation, maintenance and continual improvement of the management system to be determined and provided for.

Considerations need to include the capabilities of, and constraints on, existing internal resources and also external providers sourced resources.

Clause 7.1.2 People

Organisations must determine and provide the persons necessary for the operation and control of its processes and for the effective implementation of its management system.

Comment

Of all the resources essential for an organisation to operate effectively, people are a key commodity. and should be considered as such when planning. E.g. Recruitment, Welfare and Performance monitoring, Training and Succession Planning.

Clause 7.1.3 Infrastructure

In order to maximise the opportunities to maintain conformity of products and services, organisations are required to determine, provide and maintain the infrastructure necessary for the operation of their processes and to achieve conformity of products and services. A note gives the following examples of infrastructure:

Buildings and associated utilities, equipment, (including hardware and software,) transportation resources and information and communication technology.

Comment:

Infrastructure could therefore include production tooling including dies, jigs and fixtures, telecommunication / web portal provision, offices, materials, utilities, consumables provision and storage facilities (see also article 8.5.4 – Preservation.)

Maintenance of infrastructure may be executed via a planned preventive maintenance programme (PPM) appropriate and proportionate to the operations, any contingency plan requirements in the case of disruption.

Business planning processes should also determine changes to and future needs for, specific infrastructure (See also article 6.3 Planning – change)

Clause 7.1.4 Environment for the operation of processes

Organisations are also required to specifically determine, provide and maintain the environment necessary for the operation of their processes and to achieve conformity of products and services. As above, the intent is to assure conformity of products and services by also maintaining a suitable environment.

Examples given by the standard are: Social (non-discriminatory, calm, non-confrontational,) psychological (stress-reducing, burnout prevention, emotionally protective,) and physical (temperature, heat, humidity, light, airflow, hygiene, noise). Note that this list is not mandatory or exhaustive.

Comment:

Each organisation will need to establish and control and maintain, its own environmental requirements. Note that the environment examples given refer not only to the physical provision, but also an environment conducive to the mental wellbeing of employees. This of course is especially relevant in a world still adjusting to Covid-19…

Audit Check:

Through interviews with top management, appropriate process owners and the gathering of objective evidence (positive or negative) throughout the audit, auditors will look to determine compliance to these requirements.

As noted in 7.1.4 above, the standard lists psychological factors as well as the physical environment. In a world living with Covid-19, how an organisation ensures the mental wellbeing of its employees may therefore be a specific focus for auditors.