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Version: 2.0

7. Support

7.1 Resources​

7.1.1 General​

Resources at AAPMC include human resources and specialised skills, infrastructure, technology, work environment and financial resources. The resource requirements for the implementation, management, control and continual improvement of the quality management system, and activities necessary to enhance customer satisfaction, are defined in our operational procedures, work instructions and the following sections of this QMS manual:

  • Planning; Section 6.0
  • Management review; Section 9.3
  • Human resources; Section 7.1.2
  • Infrastructure; Section 7.1.3
  • Work environment; Section 7.1.4
  • Planning of product realisation; Section 8.1
  • Determination of customer requirements; Section 8.2

7.1.2 People​

To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications, experience and responsibilities that are required for each position that affects product and system conformity. Qualifications include desired requirements for education, skills and experience. Appropriate qualifications, along with the provision of any required training, provide the competence required for each position.

Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. The Human Resources Manager maintains records of employee qualifications. If any differences between the employee’s qualifications and the requirements for the job are found, training or other action is taken to provide the employee with the necessary competence. The results of training are then evaluated to determine if it was effective.

All employees are made aware of the relevance and importance of their activities and how they contribute to the achievement of our policies and objectives. The company operates a formal system to ensure that all employees within the Organisation are adequately trained to enable them to perform their assigned duties.

Staff training records are maintained to demonstrate competency and experience. The Human Resources Manager maintains and reviews the training records to ensure completeness and to identify possible future training needs. Training records are maintained and include as a minimum; copies of certificates for any training undertaken to date, current job description and resumes.

7.1.3 Infrastructure​

AAPMC is responsible for planning, providing and maintaining the resources needed to achieve product and process conformance, including buildings, workspace and associated utilities; process equipment (hardware and software); and supporting services. Top management has overall responsibility for managing our services.

7.1.4 Environment for the operation of processes​

AAPMC ensures that our office complies with relevant health and safety regulations. The Compliance Manager carries out regular compliance audits to ensure that appropriate standards are maintained. Top management is committed to providing:

  • A place of work that is safe, including all equipment and methods of work;
  • Training, instruction, information and supervision for employees;
  • A means of safe handling, storage, use and transportation of equipment, materials and chemicals;
  • Safe working environment with good lighting, ventilation, safe passageways, stairs and corridors.

In-house Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements

7.1.4.1 Telecommute or Remote work​

In the event of a pandemic, calamity, or political turmoil, AAPMC shall determine which functions and departments could properly conduct their tasks even in a remote/telecommute setting. AAPMC shall then assign affected employees to a remote/telecommute work environment for their safety until it is determined that the pandemic, calamity or political turmoil is finished.

AAPMC shall provide necessary equipment such as laptops and mobile devices to the employees for them to conduct their work.

7.1.5 Monitoring and measuring resources​

7.1.5.1 General​

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organization shall ensure that the resources provided:

  • are suitable for the specific type of monitoring and measurement activities being undertaken;
  • are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

7.1.5.2 Measurement traceability​

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

  • calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
  • identified in order to determine their status;
  • safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results..

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

7.1.6 Organizational knowledge​

AAPMC recognises that organisational knowledge is a valuable resource that supports our quality management activities and ensures continual product and service conformity. There is a strong link between Organisational knowledge and the competence of our people, the latter being peoples’ ability to apply knowledge to their work.

To ensure that Organisational knowledge is retained and transferred, Organisational knowledge is recorded in documented information, and is embedded in our processes, products and services. Examples of Organisational knowledge include:

  • Documented information regarding a process, product or service;
  • Previous specifications and work instructions;
  • The experience of skilled people and their processes and operations;
  • Knowledge of technologies and infrastructure relevant to our Organisation.

Sources of internal knowledge also include our intellectual property; knowledge gained from experience and coaching; lessons learnt from failures and successes; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services.

Sources of external knowledge often include other ISO standards; research papers; webinars from conferences; or knowledge gathered from customers, stakeholders or other external parties. AAPMC determines and reviews internal and external sources of knowledge, such as:

  • Lessons learned from non-conformities, corrective actions, and the results of improvement;
  • Gathering knowledge from customers, suppliers and partners, benchmarking against competitors;
  • Capturing knowledge existing within the Organization, e.g. through mentoring/succession planning;
  • Sharing knowledge with relevant interested parties to ensure sustainability of the Organisation;
  • Knowledge from conferences, attending trade fairs, networking seminars, or other external events.

7.2 Competence​

Top management identifies emerging competency needs during management reviews. Emergent competency needs are converted into job descriptions for the type and number of positions that need to be filled through internal or external recruitment.

Where required; competency training and monitoring is conducted in-house, although for more specialist skills, external courses are utilised. The effectiveness of training is evaluated and recorded. The company induction includes an introduction to our policies and objectives. Future competency training needs are identified as part of the Management Review process.

7.3 Awareness​

All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of our policies and objectives. The company operates a formal system to ensure that all employees within the Organisation are adequately trained to enable them to perform their assigned duties.

Where required; awareness training and monitoring is conducted in-house, although for more specialist skills, external courses are utilised. The effectiveness of awareness training is evaluated and recorded. The company induction includes an introduction to our Organisation’s policy statements and objectives. Future training needs are identified as part of the management review process.

7.4 Communication​

The organization shall determine the internal and external communications relevant to the quality management system, including:

  • on what it will communicate;
  • when to communicate;
  • with whom to communicate;
  • how to communicate;
  • who communicates.

7.5 Documented Information​

7.5.1 General​

The organization’s quality management system shall include:

  • documented information required by this International Standard;
  • documented information determined by the organization as being necessary for the effectiveness of the quality management system.

NOTE The extent of documented information for a quality management system can differ from one organization to another due to:

  • the size of organization and its type of activities, processes, products and services;
  • the complexity of processes and their interactions;
  • the competence of persons.

7.5.2 Creating and updating​

When creating and updating documented information, the organization shall ensure appropriate:

  • identification and description (e.g. a title, date, author, or reference number);
  • format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
  • review and approval for suitability and adequacy.

7.5.3 Control of documented information​

7.5.3.1​

Documented information required by the quality management system and by this International Standard shall be controlled to ensure:

  • it is available and suitable for use, where and when it is needed;
  • it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2​

For the control of documented information, the organization shall address the following activities, as applicable:

  • distribution, access, retrieval and use;
  • storage and preservation, including preservation of legibility;
  • control of changes (e.g. version control);
  • retention and disposition.

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations. NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.