Understanding Section 7.1

Resources

This is an educational article on Section 7.1 of ISO 9001, entitled “Resources.” This section addresses resource planning.

The purpose of this article is to give you a basic understanding of what section 7.1 requires.

This article is directed towards:

• Those responsible for compliance to section 7.1.
• Those responsible for resource planning activities generally.
• Others interested in understanding section 7.1.

Section 7.1 is entitled “Resources” and it requires you to:

• Determine and provide the resources needed for the quality management system.

When planning your resource provision, you are required to consider:

• The capabilities and constraints of internal resources.
• What needs to be obtained from external providers.

A good example of this is when you chose to use Evata’s services. You sized up your capabilities for implementing an ISO 9001 project and realized that there were limitations that could be resolved by turning to an external provider. When you did so, you avoided overloading your resources needlessly, and improved the quality of your results. ISO 9001 wants you to seek out and take advantage of such relationships.  

We just discussed the general requirements, but now section 7.1 dives into more specific requirements. It basically requires the same resource planning efficiency for each of the following:

• Section 7.1.2 – People,
• Section 7.1.3 – Infrastructure,
• Section 7.1.4 – Work environment,
• Section 7.1.5 – Data collection (aka Monitoring and measuring resources), and
• Section 7.1.6 – Organizational knowledge.

Section 7.1.2, the people section, requires you to:

• Provide the persons necessary to support the QMS and operations.

When determining sufficiency of personnel, you might consider:

• Growth forecasts.
• The current workload of personnel.
• The skills and capabilities of existing personnel.
• The physical, mental, and psychological limits of personnel.
• What personnel might be obtained from external sources.

Section 7.1.3, the infrastructure section, requires you to:

• Provide the infrastructure necessary to support operations.

When determining sufficiency of infrastructure, you might consider:

• Growth forecasts.
• Buildings and utilities.
• Equipment.
• Software.
• Transportation resources.
• Information technology.

Section 7.1.4, the work environment section, requires you to:

• Provide the work environment necessary to support operations.

When ensuring an effective work environment, you might consider:

• Human factors
  • Social and psychological factors
• Physical factors
  • Light, temperature, airflow, hygiene, noise, etc.

Section 7.1.5, the data collection section, requires you to:

• Provide the resources needed to ensure valid and reliable data collection.

When ensuring valid and reliable data collection, you might consider:

• Whether the data collected is sufficient to verify conformity with requirements.
• Whether the data collected is suitable for evaluating performance.
• The continuing relevance, validity, and reliability of the data analyzed.
• The suitability and reliability of resources used to measure and collect the data.

Section 7.1.5 also requires you to:

• Retain documented information as evidence that data collection is suitable for its purpose.

Evidence may include simply conducting the data collection activities and retaining the data analysis and evaluation results to show suitability. It may also include data from monitoring the data collection mechanisms and equipment. It may also include a finding by management in the management review minutes that the data analyzed was suitable for its purpose.

Evidence may include:

• Simply conducting the data collection activities and retaining the data collected.
• Retaining the data analysis and evaluation results to show suitability.
• Retaining data on operability and reliability of measuring resources.
• Management review minutes with a finding by management that the data reviewed was suitable for its purpose.

Section 7.1.5.2 requires you to:

• Calibrate measuring equipment against traceable standards,
• Identify measuring equipment to identify status, and
• Safeguard measuring equipment from invalidation.

When measuring equipment is found to be unfit, section 7.1.5.2 requires you to:

• Determine whether previous measurement results were invalid, and
• Take action to remedy the situation.

Section 7.1.6, the organizational knowledge section, requires you to:

• Provide the knowledge necessary to support operations.

When ensuring sufficient organizational knowledge, you might consider:

• Attrition rates.
• Succession plans.
• Competency of workforce.
• Documented information.
• Backups.

Section 7.1.6 requires you to:

• Consider organizational knowledge when addressing changes.

Section 7.1.6 requires you to:

• Make organization knowledge available to all relevant parties.

Aside from the documentation requirements related to data collection, there are no documentation requirements related to resource planning. However, you may determine that documentation is necessary as an internal requirement.

For more information about resource planning, watch our implementation video for section 7.1, and review our template library for examples of implementation methods.