Standard Requirements 

The new ISO 9001:2015 text for reference

 

7 Support

7.1 Resources

7.1.1 General

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.

The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers."

7.1.2. People

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

7.1.3. Infrastructure

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

NOTE Infrastructure can include:

a) buildings and associated utilities; 
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.

7.1.4. Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

NOTE - A suitable environment can be a combination of human and physical factors, such as:

a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); 
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

7.1.5 Monitoring and measuring resources 

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. 
The organization shall ensure that the resources provided:

a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

7.2 Competence 

The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence.

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons.

7.3 Awareness

Training and subsequent communication ensure that staff are aware of:

a)    the quality policy;
b)    relevant quality objectives;
c)    their contribution to the effectiveness of the management system, including the benefits of improved performance;
d)    the implications of not conforming with the management system requirements.

7.4. Communication

The organization shall determine the internal and external communications relevant to the quality management system, including: 
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates

7.5. Documented information

The organization's quality management system shall include:

a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.