ISO 9001:2015, 7.1

ISO 9001:2015, clause 7, Support, has five sub-clauses (shown below). This article is on 7.1, Resources.

7. Support
7.1 Resources

7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the Operation of Processes
7.1.5 Monitoring and Measuring Resources
7.1.6 Organizational Knowledge

7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information

7.1.1 General

Requirements:

Determine and provide resources needed to establish, implement, maintain, and continually improve the quality management system. And, consider:

a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.

Comment: There are other references to resources throughout the standard, for example:

4.4.1.d – resources needed for processes
5.1.1.e – top management ensure resources are available
6.2.2.b – resources needed to achieve quality objectives
6.3.c – consider availability of resources for changes
8.1.c – resources needed to achieve conformity
8.3.2.e – resource needs for design and development
8.5.1.b – availability of monitoring and measuring resources
9.3.2.d – management review of adequacy of resources
9.3.3.c – decisions and actions related to resource needs

Changes:

  • This clause updates the ISO 9001:2008 clause 6.1 on Resources
  • It removes any mention of resources for customer satisfaction
  • Customer satisfaction is mentioned at multiple clauses, including 9.1.2
  • Adds consideration of internal resources and external providers

7.1.2 People

Requirements:

Determine and provide the persons necessary to effectively implement the quality management system and to operate and control its processes.

Changes:

  • Clause focuses on people resource from old clause 6.1, Provision of Resources
  • Adds need for people to operate and control the processes

People are addressed in more actionable ways in 7.1.6 Organizational knowledge, 7.2 Competence, 7.3 Awareness, and 7.4 Communication.

7.1.3 Infrastructure

Requirements:

Determine, provide, and maintain the infrastructure necessary for the operation of the processes 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.

Changes:

  • This clause updates the old clause 6.3 on Infrastructure
  • The reworded infrastructure examples are now in a NOTE

7.1.4 Environment for the Operation of Processes

Requirements:

Determine, provide, and maintain the environment necessary for the operation of processes and to achieve conformity of products and services.

NOTE: Suitable environment can be 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 depending on products and services.

Changes:

  • This clause updates the old clause 6.4 on Work Environment
  • Clarifies that now covers the operation of processes

The clause NOTE adds social and psychological environments, and adds physical factors of heat, airflow, and hygiene.

7.1.5 Monitoring and Measuring Resources

Requirements:

7.1.5.1 General

Determine and provide the resources needed to ensure valid and reliable monitoring and measuring results (when monitoring or measuring is used to verify the conformity of products and services to requirements).

Ensure that the provided resources are:

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

Retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources.

7.1.5.2 Measurement Traceability

Where measurement traceability is a:

  • requirement, or
  • considered by the organization to be an essential part of providing confidence in the validity of measurement results;

measuring instruments must be:

a) Calibrated or verified (or both) at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.

Retain the basis used for calibration or verification as documented information if no such standard exists.

b) Identified in order to determine their status;

c) Safeguarded from adjustments, damage, or deterioration that would invalidate calibration status and subsequent measurement results.

Determine if validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for intended purpose.

Take appropriate action as necessary.

Changes:

  • Replaces old clause 7.6 on control of monitoring and measuring equipment
  • Adds verification of conformity of “services”
  • General clause 7.1.5.1 refers to “resources” instead of equipment
  • Humans may carry out activity w/o equipment
  • Resources must be “suitable” and maintained for “fitness for purpose”
  • Software version control now in clause 7.5.2

7.1.6 Organizational Knowledge

Requirements:

Determine the knowledge necessary for the operation of processes and to achieve conformity of products and services.

Maintain this knowledge and make it available to the extent necessary.

Consider current knowledge and determine how to acquire or access the necessary additional knowledge and required updates (when addressing changing needs and trends).

NOTE 1: Organizational knowledge is knowledge specific to organization and gained by experience. It is information used and shared to achieve objectives.

NOTE 2: Organizational knowledge can be based on:

a) Internal Sources (e.g., intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; results of improvements in processes, products, and services);

b) External Sources (e.g., standards, academia, conferences, gathering knowledge from customers or external providers).

Changes:

  • New requirement includes “tribal” knowledge
  • Should be an input to 7.2 on Competence
  • See Annex A.7 on Organizational Knowledge
  • Safeguard from loss of knowledge, e.g.,
    • staff turnover
    • failure to capture and share information
  • Encourage knowledge acquisition, e.g.,
    • learning from experience
    • mentoring; benchmarking

You can enroll in one of our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” public classes at this web page.

You can arrange for the course to be taught onsite at your facility by contacting Larry Whittington at larry@whittingtonassociates.com, or 770-862-1766770-862-1766.