Applying Risk-based Thinking - Understanding the needs and expectations of interested parties

Applying Risk-based Thinking - Understanding the needs and expectations of interested parties


Clause 4.2 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding of the requirements of interested parties. According to the requirements of the standard, following needs to carry out:

(i) Determine: Interested parties relevant to the organization
(ii) Determine: Requirements of the determined interested parties that are relevant to the organization
(iii) Monitor and review: Information about the determined interested parties and their determined requirements.

Clarification:
(i) Interested parties = Persons/organizations that can affect, be affected by, or perceive themselves to be affected by a decision or activity.
(ii) Examples of interested parties: Customers, owners, stockholders, employees, workers on contract, contractors, suppliers, bankers, unions, partners, society, competitors, opposite pressure groups, government, regulatory bodies, neighbours etc.
(iii) Why there is a requirement to understand the needs and expectations of interested parties? Because interested parties' needs and expectations can have an effect or potential effect on the organization's ability to consistently provide products/services that meet (fulfill) customer and applicable legal requirements.
(iv) Needs and expectations = Requirements

An understanding of the needs and expectations of interested parties is an important issue as this can affect the organization's quality management system. As such, it is required that the organization remains familiar with the requirements of interested parties and maintain an awareness through monitor and review and thus make the organization to respond to the requirements appropriately. Unwillingness or reluctance to recognize the needs and expectations of interested parties will hamper a robust quality management system.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to determine interested parties and their requirements.
(iii) The team should make a list of all such requirements with necessary details.
(iv) Assign responsibility to monitor and review such requirements to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'

Applying Risk-based Thinking - External and internal issues of an organization

Applying Risk-based Thinking - External and internal issues of an organization

ISO 9001:2015 QMS standard requires determining external and internal issues that are relevant to the organization's purpose and the organization's strategic direction and that affect the organization's ability to achieve the intended results of the QMS. In this connection, note given at the end of the requirements of clause 4.1 is relevant. We should understand three basic points - (i) Issues may be positive and/or negative factors/conditions. (ii) External issues may arise from external environment that can be from legal, technological, competitive, market, cultural, social and economic environments. (iii) Internal issues are issues that an organization's people face in the organization due to internal environment. These are the issues related to values, culture, knowledge and performance of the organization.

Some external issues may relate to:

- Government regulations that affect the organization's performance,
- Changes in law that has an impact on the organization,
- Economic shifts in the organization's markets,
- Competition the organization is facing,
- Events (such as business fairs, customers meet etc) that may improve or affect corporate image of the organization,
- Changes in technology (yet not adopted by the organization),
- What others (external interested parties) require from the organization, such as bankers requires timely submission of statement related to hypothecated goods, customer requires timely delivery of the product/service etc.

Some internal issues may relate to:

- Accountability of the people working in the department/ organization - whether defined or not, whether defined adequately or not,
- Coordination with different groups/people/departments in the organization,
- Performance,
- Monitoring of activities,
- Allocation of individual tasks/responsibilities/job specifications,
- Formal reporting relationships,
- Grouping of people/department/processes,
- Communication,
- Delegation of authorities,
- Availability of the procedure for the activity performance, measurement, monitoring, evaluating,
- Product/service offerings,
- Organizational structure (needs changes),
- Policies,
- Assets (such as facilities, property, equipment, technology etc.),
- Capabilities of people,
- Information system within the organization,
- Relationship of people within the organization,
- Organization's culture,
- Standards/industry guidelines/business model adopted by the organization and its awareness among people within the organization,
- Habits of people, such as late coming, leaving early, taking frequent leave from work etc.

Internal context may be anything within the organization that may influence the way in which the organization manages its internal issues..

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'

Applying Risk-based Thinking: Understanding the organization and its context

Applying Risk-based Thinking: Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding the organization and its context. According to the requirements of the standard, an organization needs to carry out the following:

(i) Determine: Internal and external issues (positive and negative factors or conditions) relevant to organization's purpose, strategic direction and that can affect organizational ability to achieve intended results
(ii) Monitor and review: Information about the determined external and internal issues (positive and negative factors/conditions)

Clarification:
(i) There are many issues that can make easier the understanding the external context of the organization. Such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local.
(ii) There are many issues that can make easier the understanding the internal context of the organization. Such issues may relate to the organization's value, culture, knowledge and performance.

We see that the requirements of ISO 9001:2015 QMS standard starts with asking for determination of all issues that can enhance or interrupt achievement of the quality management system outcomes. The organizational issues may be internal and/or external that may be well defined, substantially subjective or not so well defined. We need to understand them. A subjective issue may be internal issue within and among groups/people in an organization. It is required for the organization to monitor and review all those issues that can affect achievement of defined goals. With monitoring and reviewing internal and external issues, an organization is better prepared to make improvements and thus leads to a success path. The management of the organization should identify persons, who are well-versed with the organization and its processes and who understand the standard's requirements very well. These persons should be encouraged to create a suitable, adequate and effective quality management system by monitoring and reviewing internal and external issues. The persons in the organization should make their best efforts to understand related issues and process details, so that they may contribute to achievement of the defined goals.

Step-by-step process:
(i) Make a team of identified persons in the organization.
(ii) The team should be asked to think and identify all positive and negative factors and conditions that are relevant and that can affect achievement of organizational goals.
(iii) The team should make a list of all such issues with necessary details.
(iv) Assign responsibility to monitor and review such issues to different persons or groups in the organization, so that effective decisions can be taken for improvement.

ISO 9001:2015 QMS standard in its clause 4.1 makes an emphasis on clear understanding of the organization's context. The standard requires organization to:
(i) determine external and internal issues (positive and negative factors or conditions) that are relevant to its purpose and its strategic direction and that affect organization's ability to achieve the intended result(s),
(ii) monitor and review information about the determined external and internal issues (positive and negative factors or conditions).

The intent of above requirements is to understand important issues that can affect, either positively or negatively, the way the organization manages its quality management system to achieve the desired result(s). Requirements mentioned in clause 4.1 is too general and one may think as many issues that may not be relevant. Consider only those issues that are relevant to the quality management system.

Why an organization need to determine external and internal issues? one may answer, it is a requirement. But why is this a requirement? Because (i) the organization needs to take better decisions based on evidence, (ii) the potential benefits of implementing ISO 9001:2015 QMS standard to an organization is addressing risks and opportunities associated with its context and objectives. This leads to improvement in the quality management system.

Addressing risks and opportunities lead to proactively managing uncertainties that lead to better decisions based on evidence. This reminds 'evidence-based decision making' principle among the seven quality management principle on which ISO 9001:2015 QMS standard is based. Clause 0.1 also has a reference of the potential benefits of implementing ISO 9001:2015 QMS.

Internal context of an organization is the environment, in which organization targets to achieve its objectives. Issues that need to be considered are related to culture, beliefs, values, or principles inside the organization, as well as the complexity of processes and organizational structure. Typical examples of internal context related issues may be - Products/services offerings, Governance, Organizational structure, Roles, Responsibilities and authorities, Organizational assets (facilities, building, machinery, equipment, technology), Information system and decision making process, Relationship of staff, Perception of internal stakeholders (owners, suppliers, partners), Organization culture, Guidelines etc.

External context of an organization relates to the issues that may arise from legal, cultural, social, technological, competitive, economic environment that can be global, national, regional or local. Typical examples of external context related issues may be - Government regulations, changes in law, market competition, events (such as trade fairs), etc. These factors should be considered, while managing risks, uncertainty and opportunities and also at the time when you make decisions that may affect quality of the product/service your organization provides.

ISO 9001:2015 QMS standard does not speak on the method to determine such issues. It is for the organization to apply its own suitable method. One such method to determine the internal and external issues may consists following steps - (i) The top management of the organization should constitute a team of identified persons, who are well-versed with organization and its processes, (ii) The team members should think individually as well as collectively and identify positive/negative factors and conditions that are relevant and that can affect achievement of organization's goals/objectives, (iii) All such identified issues should summed-up, (iv) the team should also monitor and review identified issues from time to time.

While auditing the standard's requirements, auditor should look into the objective evidence how the organization determined the issues related to the context of the organization.

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'