Assessment 3 Project management

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Assessment 3 Project management

Assessment 3

Requirement Specification Document

Quality management system

General Requirements

The Quality Management System (QMS) is the collection of processes, documents, resources, and monitoring systems that direct the work of an organization regarding product and service quality. The organization needs to establish, document, carry out, and maintain this system to meet the requirements of ISO 9001:2000.

Documentation requirements

General

The organization needs to document – either electronically or on paper – the quality policy, quality objectives, and quality manual. Written procedure, plans, and operations need to describe how product and service quality is attained.

Quality manual

The quality manual describes the extent of the QMS and may exclude certain sections of the Standard that don’t pertain to the organization. All of the quality procedures are either included in the quality manual or are referenced by it. The interaction between processes making up the QMS is also described.

Control of documents

All of the documents in your QMS must be legible, identified, reviewed, authorized, up-to-date,  issued, distributed, and periodically updated. Obsolete documents have to be identified and protected from unintended use. Documents that come from outside the organization also have to be identified and controlled.

Control of records

Certain records need to be kept to demonstrate how the QMS is operating. These records must be legible, and  easy to identify and retrieve. A written procedure must describe how they are identified, stored, protected, retrievable, and define their retention and disposal times.

Management responsibility

Management commitment

The Standard recognizes that an effective quality program requires the involvement and commitment of the organization’s top management. Therefore, the Standard assigns top management the following responsibilities:

  • Overseeing the creation of the Quality Management System (QMS),
  • Communicating the importance of meeting requirements, including customer, legal, and regulatory requirements,
  • Establishing the quality policy and the quality objectives,
  • Communicating with parties responsible for product and service quality,
  • Providing adequate resources for the operation of the QMS
  • Reviewing the operation of the QMS.
  • Customer focus

    Top management must ensure that customer requirements are understood and met with the goal of improving customer satisfaction.

    Quality policy

    The quality policy identifies the main goals of the QMS. The quality policy must be:

  • Appropriate to the organization’s purpose,
  • Include a commitment to meet customer, legal and regulatory requirements,
  • Create a background for establishing quality objectives,
  • Communicated throughout the organization,
  • Reviewed for ongoing suitability to the needs of the organization and its customers
  • Planning

    Quality objectives

    Establish measurable quality objectives that support the quality policy and communicate them throughout the organization.

    QMS planning

    Plan the QMS so that the quality objectives are met and so the system continues to work as it is changed to incorporate improvements.

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    Assessment 3 Project management
    Last updated: Feb 2024

    Page 1

    quality objectives are met and so the system continues to work as it is changed to incorporate improvements.

    Responsibility, authority and communication

    Responsibility and authority

    Effective work depends on a clear understanding of each persons responsibility and authority. Therefore responsibility and authority must be defined and communicated.

    Management representative

    Top management must appoint a manager to have ongoing operational responsibility for the QMS. This person is referred to as the Management Representative. The duties of the Management Representative include:

  • Ensuring that processes needed for the QMS are established, implemented, and maintained,
  • Reporting on the performance of the QMS and any improvements needed,
  • Promoting awareness of customer requirements throughout the organization
  • Internal communication

    Top management needs to set up an effective system of communication to ensure effective operation of the QMS.

    Management review

    General

    Top management is required to regularly review certain aspects of the QMS to make sure that the goals are being achieved and to look for ways to improve the QMS. The review must cover suitability, adequacy, and effectiveness of the QMS. The review also includes assessing opportunities for improvement and needed changes to the QMS, quality policy, and quality objectives. Records of these review must be kept.

    Review input

    These meetings must address the following areas:

  • Internal audit results,
  • Customer feedback,
  • How well processes have been working,
  • How well products have been meeting requirements,
  • Status of previously identified problems,
  • Items identified for follow-up in previous management reviews,
  • Planned process or product changes that could affect quality,
  • Recommendations for improvement generated through the operation of the QMS
  • Resource management

    Provision of resources

    Provide the people, equipment, tools, and materials need to:

  • build and maintain the QMS,
  • continually improve the effectiveness of the QMS, and to
  • meet customer requirements
  • Human resources

    General

    People performing work affecting product and service quality must be competent to carry out that work. This competency is attained through a combination of education, training, skills, and experience.

    Competence, awareness and training

    The organization must:

  • Identify the talents, skills, knowledge, and capabilities each person needs to carry out their assigned responsibilities,
  • train or otherwise assist people to meet these identified competencies,
  • assess the competency of each person to carry out their responsibilities,
  • make sure each person understand how their work contributes to the quality of products and services and to meeting quality objectives.
  • keep records of each person’s education, training, skills, and experience
  • Infrastructure

    The…

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    Assessment 3 Project management
    Last updated: Feb 2024

    Page 2

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