How to Meet the Leadership Requirements in ISO 9001:2015 – Part 2

In part 1 we defined the role top management and talked about some ways of demonstrating management commitment. In part 2 we’ll look at the differences between management and leadership and discuss in detail what is involved in demonstrating the commitment mentioned in part 1. Note: The shift from management to leadership brings with it the concept that the Standard is a business model; that the QMS is not just for quality, but instead, a‘management system.’

Difference between Management and Leadership:
Management is concerned with process, leadership with attitude and behavior. Management relies on measurable capabilities, effective planning, organizational systems and the use of appropriate communications. Leadership relies on soft skills like trust, inspiration, decision-making, and personal character. These are the skill-sets needed to achieve the quality objectives.

Introduction:
Clause 5 “Management Responsibilities” in ISO 9001:2008 is broken into two clauses in ISO 9001:2015 – “Clause 5 Leadership” and “Clause 6 Planning.” The planning elements (5.4.1 & 2) in ISO 9001:2008 are now in sub clause 6.2. Sub clause 5.6 “Management Review” is now in sub clause (9.3) and sub clause 5.5.3 “communication” is now in sub clause 7.4. The appointing of Management Representative is no longer required because the responsibilities of implementing and maintaining the management system rest with top management alone.

Leader 2

Initially, clause 5 appears to be nothing more than a re-statement of what has come before; policy, organizational roles, responsibilities and authorities, etc. However, there is a noticeable emphasis on leadership, not just management. If we look closer, there is a lot going on here. Top management must now take ownership of management system. They must make sure that the management system is not a stand-alone entity but is incorporated into the business processes. In addition, management must demonstrate commitment by making sure that there are adequate resources such that the management system can achieve its intended outcome(s). Additionally, they must inform staff that the management system is important and that everyone should participate in its effective implementation. The role of top management has finally grown up, has finally grown into that something originally envisioned so many revisions ago.

Clause 5.1 Leadership and commitment
5.1.1 General
Top management must demonstrate leadership and commitment to the management system. This can be done by assuming responsibility and accountability for its effectiveness. The 2008 revision required top management to ensure the organization’s quality policy and quality objectives be established compatible with the overall strategic direction and organizational context. This is still true today except now there is the additional requirement to make the policy available to interested parties, as appropriate.

When establishing quality policies, directives and objectives, top management must ensure they are consistent with the purpose and capabilities of the organization. Quality objectives should be deployed annually and have regular updates, as milestones are met. This is to be done by the top management and not delegated to an ‘underling’ or to an outside consultant. Top management can be assisted by, but not abdicate responsibility to someone else.

Top management must ensure that the requirements of the management system are integrated into the organization’s business practices, that they promote the use of risk based thinking and use a process approach. Awareness of the process approach may require a paradigm shift and help of an expert to guide staff, including the top management to implement. However, this responsibility still lies with top management. They are the ones who need to be trained, bring the concepts to the ‘front lines’ and then insist others follow.

Top management must ensure that the importance of effective quality management is communicated throughout the organization as well as conforming to the management system requirements. Top management must ensure that the management system achieves its intended outcomes by engaging, empowering, and supporting staff to contribute to its effectiveness and to promote continual improvement. Top management must additionally support other relevant management roles to demonstrate leadership as it relates to those areas of responsibility. Top management must establish the organizational structure and internal environment that motivates personnel to achieve the organization’s quality management goals and objectives.

Top management should communicate regularly on the importance of meeting customer and regulatory requirements. The communication process should define what needs to be communicated, to whom, the methods used, the frequency and the means for determining communication effectiveness. Top management may communicate in any number of ways including meetings, documented policies, memos, directives, email, etc.Top management must ensure that the resources needed for effective implementation, maintenance and improvement of the management system are available. They must periodically review QMS performance to determine it suitability, adequacy and effectiveness. Auditors are expected to review documents and records showing top management’s role in planning and implementing the processes that apply to clause 5 requirements. The processes within the organization that relate to these activities must be identified. These processes would typically include – quality planning, management review, internal communication, organization structure etc.

Top management must ensure that the resources needed for effective implementation, maintenance and improvement of the management system are available. They must periodically review QMS performance to determine it suitability, adequacy and effectiveness. Auditors are expected to review documents and records showing top management’s role in planning and implementing the processes that apply to clause 5 requirements. The processes within the organization that relate to these activities must be identified. These processes would typically include – quality planning, management review, internal communication, organization structure etc. Top management would be the process owner of all these processes.

Ensuring that the management system achieves its intended outcomes/outputs requires the clear identification of key areas for achieving the objectives, preparing the action plans, reviewing the action and results, and taking suitable corrective and preventive actions. Top management is the driving force to educate, guide, coach, encourage, review, and be a role model in implementing the systems. If the top management is not committed and does not work within the boundaries of the system, it cannot expect the same to be implemented by others. Hence, engaging, directing, and supporting persons to contribute to the effectiveness of the quality management system become its prime directive.

Effectiveness may be measured by asking – how much did we get done? Or to what extent did we achieve planned results? Clause 5.1 does not require “documented Information,’ however, you must identify and document the processes (e.g. process map, process flow diagram etc. the processes for business planning; quality planning; management review; internal communication; organization structure; etc.) as part of the QMS. You must also identify what specific documents are needed for effective planning, operation and control of these processes. These documents may include a procedure, business plan, statement of policies and objectives etc. Look at the risks related to your business, products, processes and resources in determining the nature and extent of documented controls you need to have for this clause. Where some of clause 5 activities are performed off-site (i.e. at headquarters,) your QMS must identify the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. 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.

We will continue this discussion with Customer Focus in part 3.

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