Understanding ISO 9001:2015 (article3)

??Leadership

? Leadership and commitment

General

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

• a) taking accountability for the effectiveness of the quality management system;
• b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
• c) ensuring the integration of the quality management system requirements into the organization’s business processes;
• d) promoting the use of the process approach and risk-based thinking;
• e) ensuring that the resources needed for the quality management system are available;
• f) communicating the importance of effective quality management and of conforming to the quality management system requirements;
• g) ensuring that the quality management system achieves its intended results;
• h) engaging, directing, and supporting persons to contribute to the effectiveness of the quality management system;
• i) promoting improvement;
• j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for-profit, or not-for-profit.

? Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

• a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
• b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
• c) the focus on enhancing customer satisfaction is maintained.

? Policy

Establishing the quality policy

Top management shall establish, implement and maintain a quality policy that:

• a) is appropriate to the purpose and context of the organization and supports its strategic direction;
• b) provides a framework for setting quality objectives;
• c) includes a commitment to satisfy applicable requirements;
• d) includes a commitment to continual improvement of the quality management system.

? Communicating the quality policy

The quality policy shall:

• a) be available and be maintained as documented information;
• b) be communicated, understood and applied within the organization;
• c) be available to relevant interested parties, as appropriate.

??Organizational roles, responsibilities, and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.

Top management shall assign the responsibility and authority for:

• a) ensuring that the quality management system conforms to the requirements of this
• International Standard;
• b) ensuring that the processes are delivering their intended outputs;
• c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;
• d) ensuring the promotion of customer focus throughout the organization;
• e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Clause 5

? ISO 2015 – All rights reserved

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Leadership and commitment

You should seek and record evidence that Top Management is taking a ‘hands-on’ approach to the management of the QMS.

Be prepared to constructively challenge Top Management’s commitment to quality management principles and show their commitment to ISO.

Auditing this tier of management is likely to be a new experience for many people, so it is important that you have a good understanding of management activities in order to effectively engage with them.

If it is evident that the Top Management is not involved with the quality system and ISO standards, a major non-conformance is likely.

Evidence of Top Management involvement may be found in:

• Management Reviews - meeting minutes
• Business strategy plans and meetings
• Environmental goals and communications
• Information provided on the organization’s website
• Annual reports

Management involvement must now be demonstrated and cannot be simply confined to annual management reviews. During internal audits, Auditors should ensure that they are well prepared to interview the Top Management in respect of their commitment to the QMS. A good understanding of management-related processes and language used by Top Management can be helpful to engage with management on a range of issues.

Without rock-solid management commitment, you will not have a successful quality management system.?Communicating the importance of Leadership commitment and active involvement in quality is essential.

This is not a commitment in words; it is a continuous and active demonstration to everyone in the organization that the need to meet customers' expectations is vital. Top Management commitment towards the QMS to demonstrate that they have a presence in the organization, are providing direction, are leading by example, are making informed decisions, and:

1. Taking accountability for the effectiveness of the QMS?e.g. established measures, system/process performance monitoring, management review, realization of planned activities, achievement of planned results, and taking action when process performance is not meeting intended results
2. Establishing and maintaining the quality policy and?quality objectives?aligned to the strategic direction e.g. context of your organization, external/issues?
3. Integrated quality, environmental, and health and safety requirements into your organization’s business processes e.g. system architecture, business model, process model, organization footprint, functional alignment (Engineering, Purchasing, IT, Finance, HR, etc.)
4. Promoting the process approach and risk-based thinking?e.g. process modeling, process mapping, inputs, outputs, activities, interactions, interfaces, resources, controls, risk management (identification, severity, ownership, treatment, etc.)
5. Supporting process owners?in their process management activities e.g. deployment, governance, process evaluation, process improvement
6. Enabling resources, including people, required for an effective QMS e.g. resource planning, workload, priorities, constraints, balance, organization flexibility, business benefits, organization growth
7. Communicating?the importance of conformity to the QMS and effective quality management e.g. meetings, briefs, e-mail, intranet, campaigns, roadshows, focused training, the voice of the regulator or customer, consequence of?non-conformity
8. Creating an environment for?continual improvement, e.g. proactive - product/service/process implementation and improvement initiatives, improvement projects, waste reduction, process re-engineering, cost reduction, etc., and reactive - acting on process performance results, audit findings, and complaints
9. Supporting other relevant management roles?e.g. organization hierarchy, trust, empowerment, responsible delegation, coaching, sharing knowledge, removing barriers, route to escalation

Customer Focus

Customer focus?involves determining customer requirements and ensuring that processes exist to meet the requirements and achieve customer satisfaction.

Enhance customer satisfaction by ensuring that customer requirements are identified. The principal message that Top Management must convey is that the objective of the business is to satisfy your customers by ensuring a process exists to achieve the following:

• Identifying customer requirements
• Meeting customer requirements
• Enhancing customer satisfaction

You should determine how customer satisfaction is evaluated and whether appropriate actions are taken, based on available performance information (e.g., nonconformity data, corrective action requests, results of satisfaction surveys, complaints regarding product quality, service provision, responsiveness to customer and internal requests) provided by your customers (e.g., scorecards, report cards).

Top Management commitment towards customer focus can be demonstrated by ensuring that:

• External requirements are determined understood and met e.g. contracts, legislation, benchmarking, surveys, customer satisfaction, market intelligence, future trends, customer expectations
• Risks and opportunities (see 6.1) e.g. competition, capability, resourcing, barriers to market, investment, business continuity, innovation, future trends, planning for changes, new technology, new products/services, and building on current strengths are determined and addressed
• Focus on enhancing customer satisfaction (see 9.1.2) is maintained e.g. building relationships, conducting surveys, customer feedback, customer communication, customer performance, complaint profile, evaluation of repeat business, and identifying opportunities for strengthening the organization's reputation and market presence
• Customer perception (determined by the customer) and customer satisfaction (measured by the organization) are aligned
• Product and service conformity and on-time delivery performance are measured e.g. defining performance criteria, flow down across the organization, setting targets, data capture, data reporting, management review
• Action is taken when product and service conformity and on-time delivery performance are not achieved e.g. ownership, containment, root cause, resources are available, nonconformity and corrective action, continual improvement

Quality Policy

The first step in establishing the Quality Management System is to define the quality policy and quality objectives. The intent of the Quality policy is to provide top management’s vision on quality management of the organization. Quality Policy is a way through which top management can project its commitment toward quality to internal as well as external stakeholders.

The Quality Policy should capture the purpose and context of the business and provide a framework for setting up the Quality objectives. The Quality Policy should specify your commitment to ‘satisfy applicable requirements’ and ‘continually improve the effectiveness of your QMS’.

The quality policy represents the organization’s core values and it strengthens the company’s commitment to quality; it is important that it is understood well within the organization and each employee is aware of the quality policy. This can be achieved when the quality policy is documented, communicated, and understood within the organization.

Communicating the Quality Policy

It can be made available on your website, your employee handbook/quality manual, or displayed at various locations in the office so that employees read and imbibe its values in day-to-day work. It can also be made available when onboarding new employees and made part of the onboarding process.?It is also important to make the quality policy available to external interested parties, like customers/suppliers, etc. This can be done through your website/marketing material or communicated through emails, whenever requested.

Quality Policy shall be reviewed periodically by top management based on changes in the context of the organization. This can be done during management reviews.

Organizational roles, responsibilities, and authorities

This sub-clause of ISO 9001 requires that the top management provide adequate resources and assign responsibilities and authorities necessary to implement QMS effectively.

A simple method of doing this is to define the organizational structure and associated hierarchies.

Various methods like job descriptions, organization maps/ charts, procedures, work instructions, etc can be used to define organizational structure and responsibilities within the organization.

A sample organization chart of a small training institute is given below:

The intent of the clause is to ensure that each employee understands their role with respect to the implementation and reporting of elements of the QMS and to maintain focus on customer requirements.

Job Descriptions is an easy mechanism through which you can specify what training, qualifications, and experience each job role requires.

This will help you in getting the right candidates while hiring for a position and also ensure that the employee is clear on the job requirements and his /her responsibilities.

These organizational structures/roles and responsibilities need to be communicated and deployed throughout the organization via orientation programs, training, meetings, or through procedures, or work instructions.

Additionally, the top management needs to continuously work towards optimizing the processes and bringing in changes and improvements to the QMS. Employees shall be encouraged to also suggest opportunities for improvements and the top management shall ensure that the integrity of QMS is maintained when these changes are planned and carried out.

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Understanding ISO 9001:2015:

• Article (1)
• Article (2)