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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Thursday, May 28, 2015

ISO/DIS 9001 - SUPPORT - Competence, Awareness and Communication



ISO/DIS 9001 - SUPPORT - Competence, Awareness and Communication

Keshav Ram Singhal



COMPETENCE

Competence is defined as the ability to apply knowledge (available collection of information, i.e. meaningful data being a justified belief and having a high certainty to be true) and skills to achieve desired outputs or intended results. When competence is demonstrated, it sometimes referred to as qualification. Competence is a standardized requirement for an individual to properly perform a specific job. It encompasses a combination of knowledge, skills and behaviour to improve performance. Competence can be measured by the achievement of results.

Clause 7.2 of ISO/DIS 9001 deals with the requirements for competence. As per requirements, the organization is required to: (i) determine the necessary competence of people, who work under organization's control and whose work affects quality performance of the organization, (ii) ensure that the people working in the organization are competent on the basis of appropriate education, training or experience, and (iii) retain documented information as evidence of competence. Where there is need to acquire the necessary competence, the organization is required to take actions (such as providing training, mentoring of people, reassignment of people, hiring, contracting of competent persons) to acquire the necessary competence and evaluate the effectiveness of actions taken. It should be noted that the documented information should provide information on (i) determined necessary competence, and (ii) competence of people.

AWARENESS

Awareness is common knowledge or understanding about any issue and training is a way to foster awareness and competence. Organizations need to check their employees' competence, awareness and training regularly.

Clause 7.3 of ISO/DIS deals with the requirements of awareness. As per the requirements, people working in organization (for example - employees, contract workers, contractors) must be aware of the (i) quality policy of the organization, (ii) relevant quality objectives established at relevant functions, levels and processes, (iii) their individual contribution to the effectiveness (i.e. successful in achieving the desired results) of the quality management system, (iv) benefits of improved quality performance (action or process of performing a task). and (v) implications (conclusions that can be drawn) of non-conformance (non fulfillment) of requirements.

How to improve competence and awareness?

Organizations can compare the current competence of the people, working in the organization, against what they require. This may be termed as 'awareness and competence gap analysis'. The gaps determined should be filled through training or by acquiring additional awareness and competence. Training may be at the actual workplace (as on the job training), in-house or at some external location. It is not sufficient to just provide (and record) training, the organization must evaluate it.


COMMUNICATION

Effective communication is significant in an organization to perform its planning and functioning in a systematic way. Communication helps employees to perform their jobs and responsibilities. It serves as a foundation for planning. Communication promotes motivation. It is a source of information and information is very essential for every organization. In brief, we can say that communication (i) establishes effective leadership, (ii) helps toward motivation and morale development, (iii) helps in smooth working, (iv) promotes cooperation among people and teams, (v) acts as a basis of coordination and cooperation, (vi) acts as a basis for decision making, and (vii) increases managerial and employees efficiency.

Clause 7.4 of ISO/DIS 9001 deals with the requirements of communication. As per ISO/DIS 9001, the organization needs to determine appropriate (suitable and proper) internal and external communication processes relevant to the quality management system of the organization by determining the following:
- Contents of the communication
- Time of the communication
- Receivers of the communication
- Mechanisms of the communication

Although ISO/DIS 9001 states to determine 3Ws1H (What, When, Whom and How) with regard to communication, however we suggest to determine the following 2Ws (where to communicate and why to communicate) also, so that your communication becomes significant, effective and purposeful.

ISO 9001:2008 QMS standard has two clauses relevant to communication:
Clause 5.5.3 - Internal communication
Clause 7.2.3 - Customer communication

Customer communication is a part of external communication, and now ISO/DIS 9001 has one clause (titled communication) instead of two (titled internal communication and customer communication) as in ISO 9001:2008 QMS standard.

Mechanism of communication may include periodic meetings, email,, bulletin boards, suggestion boxes, circulars, product information brochures, catalogues, specifications, information etc.

To be continued ....


Tuesday, May 5, 2015

ISO/DIS 9001 - SUPPORT




Keshav Ram Singhal

Clause 7 of ISO/DIS 9001 provides requirements related to support. It includes requirements related to resources (including human resources, infrastructure, environment for the operation of processes, monitoring and measurement resources, organizational knowledge), competence, awareness, communication and documented information. More or less similar requirements under the heading 'Resource management' are mentioned in clause 6 of ISO 9001:2008 QMS standard. Documentation requirements of clause 4.2 of ISO 9001:2008 QMS standard are now part of the support requirements in clause 7.5 of ISO/DIS 9001.

Clause 7 of ISO/DIS 9001 now deals with support requirements, whose relevant sub-clauses are as under:

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 - Documented information
7.4.1 - General
7.4.2 - Creating and updating
7.4.3 - Control of documented information

RESOURCES

Clause7.1 of ISO/DIS 9001 deals with the requirements of resources needed for the quality management system. As per requirements, the organization is required to determine and provide the resources (such as people, infrastructure, environment, monitoring and measuring resources, organizational knowledge) needed for implementing, maintaining and continually improving the quality management system of the organization. The organization needs to consider:
- the capabilities of existing internal resources available in the organization,
- the constraints on existing internal resources, and
- resources needs to be sourced from external providers.

The organization needs to ensure to consistently meet customer and applicable legal (statutory and regulatory) requirements to achieve conformity of products and services for which the organization is required to provide:
(i) competent persons for effective operation of the quality management system including the processes needed for the quality management system,
(ii) infrastructure for the operation of processes,
(iii) environment (including physical, social, psychological, environmental and other factors such as temperature, humidity, ergonomics and cleanliness) necessary for the operation of the processes,
(iv) monitoring and measuring resources to ensure valid and reliable results.

Infrastructure needed may include:
- buildings and associated utilities,
- hardware and software equipments,
- transportation,
- information and communication technology.

Evidence of conformity of products and services to specified requirements are essential for a robust quality management system for which there are instances where monitoring and measuring resources are used for collection the evidence of conformity of products and services to specified requirements. In such instances the organization needs to determine the resources needed (such as monitoring and/or measuring equipments) to ensure valid and reliable monitoring and measuring results. The organization needs to ensure that the monitoring and measuring resources are suitable and fit (useful) for the purpose they are being used and the organization needs to retain appropriate documented information as evidence of fitness of such resources.

There may be instances where measurement traceability (history) may be a legal (statutory or regulatory) requirement, customer expectation, relevant interested party expectation or organization's consideration to be necessary of providing confidence in the measurement results' validity. In such instances the organization must (i) verify or calibrate the measuring instruments at specified intervals or prior to use against national or international measurement standards, or where no national/international standard exists, retain as documented information the basis used for calibration or verification, (ii) identify the measuring instrument in order to determine its calibration status, (iii) safeguard from adjustments, damage or deterioration that may invalidate calibration status or measurement results.

The organization must: (i) determine if the validity of previously measurement results has been adversely affected, (ii) determine when a monitoring/measuring instrument is found to be defective during its planned verification or calibration or during its use, and (iii) take appropriate corrective action as required.

ISO/DIS 9001 has included new requirements related to organizational knowledge. As a resource, organizational knowledge (such as information on intellectual property and lessons learned) may be necessary for the operation of organization's processes and to achieve conformity of products and services to specified requirements, for which the organization is required to: (i) determine the knowledge, (ii) determine ways or methods to acquire or access the necessary additional knowledge, (iii) maintain the knowledge, (iv) make available the knowledge to the extent necessary, and (v) consider its current knowledge when addressing changing needs and trends.

When team knowledge from several subunits, departments or groups of an organization is combined and used to create new knowledge, the resulting knowledge can be called organizational knowledge.

The organization is required to:
- determine the knowledge necessary for the operation of organization's processes and to achieve conformity of products and services to requirements,
- maintain the knowledge, and
- make available the knowledge to the extent necessary.

When addressing changing needs and trends, there is a need to acquire or access the additional knowledge for which the organization needs to consider the organization's current knowledge and determine the ways to acquire or access the necessary additional knowledge. The organization can consider internal and external sources. Internal sources may include learning within the organization from failures and successes, capturing knowledge that is not documented and experience of local experts. External sources may include standards, academic references, conferences, knowledge from customers or others, such as suppliers, providers.

To be continued ....