Bill Beck
(Alabama) - ISO 9001, ISO 14001
Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), and clause 6 (Planning for the Quality Management System).
Clause 7, Support, has five sub-clauses (shown below). This article is on the six sub-clauses of 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 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.d – needed resources being made available for system
5.1.1.f – top management ensure resources are available
6.2.2.b – resources needed to achieve quality objectives
6.3.c – consideration of availability of resources for changes
8.1.c – resources needed to achieve conformity
8.3.3.d – resource needs for design and development
8.5.1.e – availability of monitoring and measuring resources
9.3.1.c.6 – management review of adequacy of resources
9.3.2.b – management review of resource needs for changes
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:
Provide the persons necessary for the effective operation of the quality management system and its needed processes. Ensure the organization can consistently meet customer and applicable legal requirements.
Changes:
Clause focuses on people resource from old clause 6.1, Provision of Resources.
Must meet applicable legal requirements, not just customer requirements.
7.1.3 Infrastructure
Requirements:
Determine, provide, and maintain the infrastructure 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;
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 environment necessary for the operation of processes and to achieve conformity of products and services.
NOTE: Environment for operation of processes can include physical, social, psychological, environmental, and other factors (for example, temperature, humidity, ergonomics, and cleanliness).
Changes:
This clause updates the old clause 6.4 on Work environment.
Environment section now covers the operation of processes.
The clause NOTE adds social and psychological environments, adds factors of ergonomics and cleanliness, and drops the examples of noise, lighting, and weather.
7.1.5 Monitoring and Measuring Resources
Requirements:
Determine the resources needed for valid and reliable monitoring and measuring results (where monitoring or measuring is used for evidence of conformity of products and services to specified requirements).
Ensure that the resources provided are:
a) suitable for 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.
Where measurement traceability is a:
- statutory or regulatory requirement, or
- customer or relevant interested party expectation; or
- considered by the organization to be an essential part of providing confidence in the validity of measurement results;
measuring instruments must be:
- verified or calibrated 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.
Measuring instruments must be:
- Identified in order to determine their calibration status;
- 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 an instrument is found to be defective:
- during its planned verification or calibration, or
- during its use,
and take appropriate corrective action as necessary.
Changes:
This clause replaces old clause 7.6 on Control of Monitoring and Measuring Equipment.
Use of the term “equipment” has been changed to “resources”.
Need evidence of the fitness for purpose of the resources.
Humans may carry out the activity without equipment.
Calibrated equipment now termed “instruments”.
Requirements no longer mention software confirmation.
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 (when addressing changing needs and trends).
NOTE 1: Organizational knowledge can include information such as intellectual property and lessons learned.
NOTE 2: To obtain the knowledge required, consider:
a) Internal Sources
(e.g., learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization);
b) External Sources
(e.g., standards, academia, conferences, gathering knowledge with customers or providers).
Changes:
This clause on organizational knowledge is a new requirement.
It should be an input to clause 7.2 on Competence.
See Annex A.7 on Organizational Knowledge.
“Knowledge” is defined in the terms section as the available collection of information being a justified belief and having a high certainty to be true.
