ISO 9001 7.1 Resources
In ISO 9001 7.1 Resources, this section outlines the requirements for ensuring that the organization has the necessary resources to establish, implement, maintain, and improve its QMS continually. To me customer and regulatory requirements for products and services these resources are essential. Follow along as we dive deeper into this clause and its sub-clauses.
7.1 Resources ensures that the organization provides sufficient resources to achieve quality objectives and maintain an effective QMS.
This includes sub-clauses 7.1.1 – 7.1.6 stated below:
· 7.1.1 General
· 7.1.2 People
· 7.1.3 Infrastructure
· 7.1.4 Environment for Process Operation
· 7.1.5 Monitoring and Measuring resources
· 7.1.6 Organizational Knowledge
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
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.
7.1.6 Organizational knowledge
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
This knowledge shall be maintained and be made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s 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; the results of improvements in processes, products and services);
b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).
7.1.1 General
Determine and provide the resources needed to:
· Implement and Maintain the QMS
· Continually improving the effectiveness of the QMS
· Enhance customer satisfaction
Involves identifying the resources required based on:
· Risk and opportunities
· Process requirements
· Product or service requirements
· Current and future needs
7.1.2 People
The organization must ensure that it has the appropriate personnel for:
· Having an effective operational QMS process
· Having consistent delivery of products and services that meet requirements
This includes:
· Having sufficient staffing levels
· Assigning competent and well-trained individuals to specific roles
7.1.3 Infrastructure
The organization provides and maintains the infrastructure necessary for operating its processes and achieving product/ services conformity.
Infrastructure includes:
· Facilities – Buildings, workspace and utilities
· Equipment – Tools, Machines, vehicles and hardware
· Technology – IT systems, software, networks
· Support Services – Maintenance services, external providers and logistics
7.1.4 Environment for Process Operation
The organization provides a suitable environment for process operations to achieve product/ service conformity.
The environment can be:
· Physical – Temperature, lighting, humidity and noise
· Social – Safe and positive working conditions
· Psychological – Stress management, motivation, trust and morale
7.1.5 Monitoring and Measuring resources
The organization must ensure product/ service conformity by managing resources used for monitoring and measuring.
· Suitability of Resources (7.1.5.1):
o Ensuring monitoring and measuring equipment is appropriate for the specific activities
o Equipment must be calibrated or verified at specified intervals to maintain accuracy
· Traceability of Measurement (7.1.5.2):
o For equipment requiring traceability:
Calibrate against national or international standards
Retain calibration records
Identify and address any out-of-calibration conditions
7.1.6 Organizational Knowledge
The organization must determine and maintain organizational knowledge necessary for the operation if its process and achieving product/ service conformity.
Including:
o Gained knowledge from experience, lessons learned and internal sources
o Gained knowledge from external sources, such as industry standards, research or customer feedback
The organization must make this knowledge available where needed and address knowledge gaps. These can be due to employee turnover or technological changes.
In conclusion, 7.1 resources emphasizes that an organization must assess its needs to allocate appropriate resources to operate its processes efficiently. These include human, physical and knowledge-based resources. This ensures that the QMS achieves its intended outcomes and satisfies customer requirements consistently. In the next blog post we will be diving deeper into Clause 7.2 Competence.
Related blog posts –
ISO 9001 – 7 Support Overview Clause 7: 7.1 – 7.5
How to determine your QMS Scope of Certification
Improvement- The Seven Quality Management Principles
4 Steps to Achieving ISO 9001 Quality Management System Certification
Contact:
Email: info@wilkshireconsulting.com
Phone: (248) 890-9283
Writing a nursing paper can be challenging, especially when juggling multiple responsibilities. That’s where write my nursing paper at Studyprofy becomes a game-changer. With Studyprofy's professional assistance, you can get a well-researched, structured, and plagiarism-free nursing paper tailored to your specific requirements. Their team of experts understands the nuances of nursing assignments, ensuring top-notch quality and timely delivery. Whether it's a case study, research paper, or reflective journal, they provide comprehensive support. Trusting Studyprofy means you save time while achieving academic excellence.
Distribution logistics refers to the process of efficiently moving goods from a manufacturer or producer to the end consumer. It involves various tasks such as managing warehouses, transportation, inventory, and the entire supply chain to ensure products are delivered in the right quantity, at the right time, and in the right condition. Our integrated customer engagement and finance solutions allow companies to turn leads and meaningful opportunities into recurring business while keeping tight control on fast-moving inventory, storage costs and forecasted bottlenecks.