Clause 5: Management Responsibilities (2024)

ISO 13485 Clause 5 focuses on the responsibility of Management, this section has 6 Subclauses:

  • 5.1 Management Commitment
  • 5.2 Customer Focus
  • 5.3 Quality Policy
  • 5.4 Planning
  • 5.5 Responsibility, Authority and Communication
  • 5.6 Management Review

5.1 Management Commitment

When it comes to top management, ISO requires management to participate in the implementation and the maintenance of the QMS. Management plays a critical role, and therefore they need to be involved and ready to lead.

Management has key responsibilities such as meeting on a regular basis, communicating to the organization, establishing QMS policies, making sure that objectives are established, conducting reviews, and also determining that resources needed to meet the QMS are available.

5.2 Customer Focus

Management is responsible to make sure that customer requirements and any relevant regulatory requirements are met.

5.3 Quality Policy

Management is also responsible for quality policy and needs to make sure that the QMS is applicable to their organization, and that the organization is committed and complies with all the requirements of the QMS. Additionally, management needs to provide a framework for establishing and reviewing their QMS. Furthermore, management needs to make sure that the QMS is adequately communicated throughout the organization and understood. Lastly, the QMS must be reviewed for continuing suitability.

5.4 Planning

Top management needs to make sure that the any QMS goals, including regulatory requirements and requirements for products are met, and that they are measurable.

Referring to 4.1, top management must make sure that the QMS is carried out adequately. Also, when changes occur within the organization, they need to make sure that the QMS is being maintained.

5.5 Responsibility, Authority and Communication

Top management needs to be well organized and define all responsibilities and authorities are defined and communicated. There needs to be documentation of each person, and their responsibilities of managing, performing and verification of work done in regard to the QMS.

Top management is in charge of appointing responsibilities to other staff and management to ensure that the QMS is being met. They also need to be responsibility for communicating internally.

5.6 Management Review

Management review is critical, and therefore making the most of it will be extremely beneficial for your business. These reviews are necessary to maintain your QMS and to see the most improvements. Management review is great and can help bring together all aspects of the QMS in your business and create cohesiveness.

Clause 5: Management Responsibilities (2024)

FAQs

What is the clause 5 management responsibility? ›

ISO 9001:2015 Clause 5 mandates that top management must ensure the QMS is aligned with the needs and expectations of customers. This involves: Establishing a customer-focused culture within the organisation. Ensuring that customer requirements are integral to the QMS processes.

What is the key requirement of Clause 5? ›

Key Requirements:

Top management must manage, not delegate, quality. Leadership has defined responsibilities for ensuring quality execution. Emphasis on customer focus with specific applications ranging from support for customer regulatory requirements, risks, and enhancing customer satisfaction.

What is management responsibility section 5 in ISO 9001 2008? ›

Clause 5: Management responsibility

Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements; Establishing the quality policy; Ensuring that quality objectives are established; Conducting management reviews; and.

What is the purpose of Clause 5? ›

Clause 5 emphasizes the importance of top management's active involvement in shaping the organization's quality culture and driving the QMS forward. It sets the tone for the organization's commitment to quality and lays the groundwork for the subsequent clauses of ISO 9001.

What is management 5 definition? ›

That is, planning, organising, staffing, directing and controlling. On the other hand, effective implies completing the given task and work while, efficient means successfully completing the task with minimum possible cost.

What is considered a management responsibility? ›

Responsibilities of management include, planning, organizing, directing and controlling. Controlling, including monitoring, is a process to ensure what is supposed to be done is being done.

What is the top management clause? ›

Here are some of the guidelines defined by ISO 9001 in Clause 5 on the role of the top management is leading this initiative. Top Management shall: take accountability and responsibility for the effectiveness of the Quality Management System and ensure that it meets its purpose.

What is the top management commitment? ›

The top management commitment represents the commitment of management, including the CEOs of each operating company, to the promotion of DEI to all stakeholders.

What is the management commitment to quality? ›

Management commitment is one of the most critical aspects of any quality management system. It is a key factor in ensuring that the organization remains committed to its quality goals and objectives, and it is also an essential component of achieving the benefits of implementing a quality management system.

What are the management responsibilities regarding ISO 9001 requirements? ›

According to ISO 9001, leadership is responsible for establishing quality objectives that fit with operational requirements and organizational goals. Management must also assign appropriate roles to execute these objectives and ensure clear communication of expectations and standards within the industry.

What are the management responsibilities of ISO 9001 2008? ›

The ISO 9001:2008 standard allocates three duties: ensure Quality Management System processes are “established, implemented and maintained”, report to “top management” on the QMS performance and where improvements are needed, ensure that everyone in the organisation is aware of customer requirements.

What is the management responsibility in QMS? ›

Management has key responsibilities such as meeting on a regular basis, communicating to the organization, establishing QMS policies, making sure that objectives are established, conducting reviews, and also determining that resources needed to meet the QMS are available.

What is a clause 5 examples? ›

Examples of Clauses and Phrases
PhrasesClauses
Best friendBecause he gave her a puppy
On the horizonWhen the saints go marching in
After the devastationI waited for him
Because of her glittering smileHe wants to become an engineer
2 more rows

What is a clause Class 5? ›

A clause is also a part of a sentence that consists of a subject and a verb, unlike phrases. They can be divided into two main types depending on how they behave in a sentence. The different types of clauses are: Main Clause or Independent Clause. Subordinate Clause or Dependent Clause.

What is the clause 5 of the contract? ›

Clause 5 defines a 'nominated Subcontractor' as either a Subcontractor who is stated in the Contract as being 'nominated'; or who the Engineer instructs the Contractor to employ as a Subcontractor under clause 13. The Contractor may object to employing a nominated Subcontractor.

What is the duties and responsibilities clause? ›

Employment Contract Clause: Duties and Responsibilities (Executive) | Practical Law. A Standard Clause to be inserted into a written executive employment contract, detailing the executive's employment job duties, position in the employer's reporting structure and obligations to the company over the course of employment ...

What is an example of a responsibility clause? ›

Although this agreement may be signed below by more than one person, each of the undersigned understands that they are each as individuals responsible and jointly and severally liable for paying back the full amount.

What is the management review clause in ISO? ›

Management review is a regular evaluation exercise where the performance of the quality management system is reviewed to check if the systems are producing the desired results.

Under which clause is the top management bestowed decision making responsibility? ›

Here are some of the guidelines defined by ISO 9001 in Clause 5 on the role of the top management is leading this initiative. Top Management shall: take accountability and responsibility for the effectiveness of the Quality Management System and ensure that it meets its purpose.

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