ISO 9001-Clause 6: Resource management
ISO 9001-Clause 6.1 Provision of resources
ISO 9001 requirement:
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
Top management has the responsibility to ensure the availability of resources to develop and maintain your QMS. Clause 6.1 requires you to determine the nature and availability of such resources. This is typically done through business and quality planning. Having adequate resources is vital to ensure product conformity or satisfy customer requirements – e.g. having adequate personnel, materials and equipment to ensure timely production and delivery of product. Use business planning (clause 5.1), quality management planning (clause 5.4) and planning for QMS processes (clause 4.1), to identify and determine the nature of resource needs of QMS each process and plan for its availability. The actual amount of resources needed may vary day to day and over time. This is one reason why top management must review QMS performance regularly. Consider developing performance indicators for each major category of resources used, (e.g. machinery and equipment; human resources; facility and environment; transport; communication systems; etc.) to determine the effective use of such resources.Where the resource planning process is performed off-site (e.g. at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. Evidence of the off-site facility’s compliance may include – a copy of their ISO 9001 certification; results of their internal audits to ISO 9001; auditing the outsourced facility; etc.The expectation is to flow down to the off-site facility, the relevant ISO 9001 requirements that you would have to implement, had you carried out the process at your own facility.
ISO 9001-Clause 6.2 Human resources
ISO 9001-Clause 6.2.1 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.
NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.
ISO 9001-Clause 6.2.2 Competence, training and awareness
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity to product requirements,
b) where applicable, provide training or take other actions to achieve the necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
Top management is responsible for ensuring the availability of resources which includes HR. Clause 5.5.1 requires top management to define the organization and its responsibilities and authorities. Clause 6.1 required that adequate resources including HR be determined and provided. And here in clause 6.2 the specific requirements for controlling HR are defined. Planning for HR process controls must include determining competency criteria, skills evaluation, identification of training needs, types of training, provision of training, how training effectiveness is evaluated, methods to communicate awareness of the importance of quality requirements and meeting quality objectives, to all employees. Although training may end up being the best solution, don’t overlook other actions, such as, changing processes, improving procedures, rotating jobs, outsourcing, or recruiting fully training people. Criteria for competency must be developed based on appropriate education, skills, training and experience for activities, tasks, functions and processes. The level and detail of such qualifications, skills, training and experience will depend upon the complexity of product, process, technology and customer and regulatory requirements. It is up to your organization to determine the necessary criteria for the various functions and activities affecting product and QMS based on these factors. A “Skills Matrix” is a useful tool used by organizations to determine and manage the competency levels required by different activities and functions. Organizations undergo significant changes through growth or decline, acquisitions, new technology and new products and processes, Also, many organizations are now outsourcing their production labor to save on payroll costs and benefits. Labor related nonconformities can easily arise in such cases. Planning for your HR process must ensure that contract and agency personnel performing work affecting product quality have adequate competency and training. Appropriate records must be kept of such training.
Quality awareness must be focused on meeting customer and regulatory requirements. The process to promote quality awareness may include the use of methods such as – cross-functional teams, involvement in quality planning, quality circles, improvement suggestions, product workshops, zero defect programs, product review checklist etc. QMS personnel must be motivated to achieve the organizations quality objectives. The process to motivate employees may include the use of methods such as – employee recognition awards, ongoing training programs, performance reviews, employee surveys, poster campaigns etc,. You must determine and keep appropriate records of education, training, skills and experience. These records must demonstrate the effective operation of HR process controls. Performance indicators to measure the effectiveness of the HR process in determining competency and training needs of the workforce, could include – employee turnover, employee complaints, number of instances unqualified personnel were found performing QMS activity, number of instances competency criteria were not met and number of instances no training or competency records maintained; etc.
ISO 9001-Clause 6.3 Infrastructure
ISO 9001 requirement:
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).
Planning for the types of infrastructure resources needed for your business may include facility, production equipment, IT equipment and software, laboratory, packaging, dies, molds, tooling, jigs, fixtures, storage, transportation, communication, office, materials, labor, utilities and supplies, etc.
The key strategic business factors to be considered for infrastructure planning include future needs, current availability and capacity, cushion for growth, contingency planning, linkage to current and future product programs. This planning may be done through business planning (clause 5.1); quality management planning (5.4) and planning for QMS processes Clause 4.1). The actual deployment of such resources may be determined by each process owner.
You are required to maintain your infrastructure. Your planned preventive maintenance program should include controls for schedule and timing, availability and training of personnel, types and scope of maintenance, maintenance and competency/training records, tracking to maintenance objectives, use, storage and control of spare parts, control of any maintenance outsourcing etc.
ISO 9001-Clause 6.4 Work environment
ISO 9001 requirement:
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
NOTE The term “work environment” relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
Work environment include controls for ergonomics, personnel safety and facility conditions that are conducive to achieving product quality. Some of the factors to consider in determining and managing the work environment include ergonomics (worker movement; fatigue; manual effort and loads, etc), workplace location, heat, light, humidity, airflow, noise, vibration, hygiene, cleanliness, pollution, adequate facilities (lockers, lunchroom, cafeteria, washrooms etc); health and safety regulations; cleanliness of premises; etc. the extent to which the above environmental factors may apply to any organization will vary based on size, risk and other considerations. The focus should be employee safety, welfare and product conformity. Performance indicators to measure the effectiveness of processes that determine and control the effective use of infrastructure may include equipment maintenance – uptime / downtime; productivity – equipment and workforce; accident and safety incidents; non-value added use of floor space; excessive handling and storage; number of instances specific resources were not available or delayed;
For Clause 6.1:
- How are resource needs identified and provided, for all areas of the quality management system?
- Are resources determined and provided for implementing, maintaining and improving the processes of the quality management system?
- Are resources determined and provided for enhancing customer satisfaction by meeting customer requirements?
- Are resources directed towards improving the effectiveness of the quality management system? How? (Obtain examples)
- How have resources been provided to “enhance” Customer satisfaction levels? (Obtain examples)
Keep in mind that to audit Clause 6.1 you need an overall perspective of the entire QMS in order to make an informed assessment here.
For Clause 6.2:
- Are personnel assigned responsibilities defined in the QMS competent on the basis of applicable education, training, skills/qualifications and experience?
- Are competency needs for personnel performing activities affecting quality identified?
- Are training provided to satisfy the competency needs?
- Is effectiveness of training provided evaluated?
- Are appropriate records of education, experience, skills/qualifications and training maintained?
- How do you ensure that a person is competent in their job? How is this checked? How often does this check occur?
- How are competency gaps identified? How are gaps closed?
- How do you know that the action that was taken actually closed the gap?
- How are employees advised on how they can individually contribute to achieving any of the Quality Objectives?
For Clause 6.3:
- How does the organization identify a need to add to the current infrastructure? (i.e. new buildings or additions, new or replacement process hardware or software, enhanced support services such as new or upgraded information technology)
- Is there a capital expenditure budget process? What has been done to the infrastructure in the past 12 months? Once the proper infrastructure is in place, how is it maintained?
- Any Customers orders being affected by lack of a proper infrastructure?
For Clause 6.4:
- How are employees provided with a suitable work environment for supplying the products and services being offered by the company?
- Are work areas properly controlled for lighting and climate conditions?
- Are work areas organized and provide safe working conditions?
|Example of format for List of Employees|
For Clause 6.3 : Not applicable
For Clause 6.4 : Not applicable
Implementation document ( Not mandatory but helps in fulfillment of requirement):
For Clause 6.1:
- List of employees showing records of education, training, skills and experience
- Competency Matrix
For Clause 6.2:
- Competency Matrix
- Induction training record
- Training record
- Training needs
- Skills matrix
|Example of format for Employee Training Plan &Record|
|Example of format for Staff Induction Program|
|Example of format for Competency Matrix|
|Example of format for Skill Matrix|
|Example of format for Training Need Identification|
For Clause 6.3:
- Site layout plan
- Equipment list
- Transport list
|Example of Plant layout plan|
|Example of format for List of Machine/Equipments|
For Clause 6.4:
- Accident record
- Housekeeping record
|Example of format for Accident Record|
|Example of format for Housekeeping Checklist|
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