• Studies 1 7 7 Iso Bootable
• Studies 1 7 7 Iso 9001

This part of ISO 7 specifies the requirements for thread form, dimensions, tolerances and designation for jointing pipe threads, sizes 1/16 to 6 inclusive, for joints made pressure-tight by the mating of the threads. These threads are taper external, parallel internal or taper internal and are intended for use with pipes suitable for threading and for valves, fittings or other pipeline. ISO/IEC JTC 1/SC 7 Software and systems engineering is a standardization subcommittee of the Joint Technical Committee ISO/IEC JTC 1 of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), that develops and facilitates standards within the field of engineering of software products and systems.

1. ISO 9001:2015, clause 7, Support, has five sub-clauses (shown below). This article is on 7.1, Resources. Support 7.1 Resources. 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the Operation of Processes 7.1.5 Monitoring and Measuring Resources 7.1.6 Organizational Knowledge. 7.2 Competence 7.3 Awareness 7.4 Communication.
2. 4.2 ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.

7.0 Support

ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret and better implement the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.

Our range of templates cover the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement your next management system.

7.2 Competence

The guidance shown on this page is relevant to ISO 9001, ISO 14001 and ISO 45001. Organizations should establish a process for assessing existing staff competencies against changing business needs and prevailing trends. Check for evidence that all staff which work under your organization’s control are competent, and that evidence continuing competence is maintained as documented information in accordance Clause 7.5. Maintain documented information such as a skills matrix; training records, personnel files, CVs, job descriptions.

Competency-based training programmes can vary greatly and are as unique as the facility and personnel working there. The distinct operations of the facility and the level of education, training, and experience of the personnel determine the necessary elements of a competency-based training programme. To establish and maintain a competency-based training programme, the following steps must be taken:

1. Identify competency-based training needs;
2. Prepare the training materials;
3. Conduct and evaluate the training.

How does your organization determine the necessary competence of person(s) doing work under its control that affect its environmental, safety and quality performance? Ensure that those competencies are possessed by the people doing the work under your organization’s control including: the organization’s own personnel, contractors and outsourced personnel working either on site or off site.

Training alone is not sufficient to demonstrate competence; this must be demonstrated through tests, observations, results, etc. Auditors need to find objective evidence in order to determine that the competency requirements have been met.

If the people are found not to be competent, your organization is required to take action. The actions taken need to be evaluated for effectiveness in raising competence to the required level. Examples of action may include remedial training, recruitment or the use of external people in order to acquire the necessary competence.

Training needs analysis

Identification of employee training needs is typically the first step in developing a competency-based training programme. In addition to existing workers, new hires, temporary workers and outside contractors must be included when identifying training needs. Your organization must demonstrate that the training needs for these employees were identified.

Your organization should operate a comprehensive training programme. All employees should receive training as identified by an initial training needs assessment. The training requirements for employees must be assessed against wider organizational policies and objectives.

Line Managers and Supervisors often determine the training required for workers under their supervision to fill the gap in training, knowledge, competence and skills of each person and the training required to satisfy any applicable hazard and task specific competencies.

Where skill deficiencies are identified or when competencies expire, appropriate training, retraining and/or supervision must be provided before work commences or continues so that employees can perform their designated duties competently and without risk to health and safety. Gaps in training, knowledge or competence must be identified and filled.

Line Managers and Supervisors should monitor the abilities of all their workers, their responsibilities and ensure the ongoing monitoring and review of employee competencies. Appropriate training requirements can be further identified through this process using a Competency Review Form. Training needs are also determined during the appraisals process where any needs identified are derived from annual appraisals and personal development reviews.

Competence matrix

The aim of the competence matrix is to support the Human Resources Manager and Line Managers to ensure that training is targeted, managed, effective and comprehensive. A suitable matrix should be produced for each workplace. After developing a list of these employees, the Management Representative or the Human Resources Manager should establish the appropriate training programme for each worker, based on the type of employee interaction with each significant impact or risk.

Other requirements for the position such as legislative requirements, including license requirements (e.g. radiation user’s license, high risk work license) should also be identified. The training needs can then be incorporated into individual annual appraisals and personal development reviews.
Where employees are unskilled in the required task, or expired mandatory and statutory competencies are identified, appropriate training or re-training should be provided prior to commencement of work. Employee training and re-training is recorded, monitored and kept up to date by their Line Manager and Supervisor.

A register containing information on specified levels of education, training, and experience must be established for each employee whose work is involved with any significant impact and safety hazard. The planned training programme for each individual then should be listed. The training sessions should, at a minimum:

1. Make the employee aware of the aspects and hazards, and the impacts and risks associated with their work;
2. Include training required by applicable regulatory requirements and management system requirements;
3. Include training necessary to obtain/retain required licenses or registrations;
4. Emphasize responsibility for minimizing significant impacts and risks associated with their work;
5. Identify potential consequences of departures from specified operating procedures;
6. Address the benefits of improved personal performance.

Even though some personnel may have the same job, the type or level of training may vary according to each person’s past education, training, and experience. Training options may be as simple as on-the-job training, administered by senior, or more experienced members; formal training, including classroom instruction; training provided by external consultants.

For some situations, commercially available training courses may be another alternative. Additional or customized training activities specific to individual needs, job descriptions, regulations and goals may be necessary depending on the existing skill level of each employee.

Specialist training

Additional specialist training for particular workers may be identified through the training needs analysis with input from job safety analysis forms and risk assessments, and may include hazard-specific training (e.g. hazardous chemicals, electrical safety, manual handling, confined spaces, etc.), prescribed training for licensing requirements (e.g. ionizing radiation, diving, forklift) or health and safety responsibilities training (e.g. H&S, first aiders, or emergency control personnel).

Staff with specific roles such as First Aiders, Fire Wardens or Health and Safety Representatives must attend nominated training for that specific role. The Human Resources Manager and the Line Managers and Supervisors should be responsible for sourcing suitable training from approved providers and for pre-course arrangements and administration.

On-the-job training

On-the-job training should bes provided by a more experienced employee or by an external trainer, skilled in the requirements of that particular activity as indicated by their training record. The responsible person, together with the employee, ensures that the required level is achieved after undergoing training. Line Managers and Supervisors should be responsible for:

• Nominating training mentor;
• Devising basic training plan;
• Ensure training is provided;
• Evaluation of the effectiveness of the training (during the appraisal process).
• Training records should be updated when a competence is attained.

Contractor training

Line Managers and Supervisors who engage contractors are responsible for providing a local area induction and for ensuring that the contractors are provided with information about potential known hazards of the environment in which they work. Records of contractor’s competency or licenses, their induction must be retained. Your organization must not allow a contractor to start work unless they have completed the following:

1. General health and safety induction training;
2. General safety induction;
3. Work or task specific briefings.

The selection, engagement and management of suitably trained and competent contractors is often managed by the Health & Safety Manager in conjunction with Line Managers and Supervisors, and any related guidelines.

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ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. It should be considered to be a first step or the base level of a quality system.

ISO 9000 Vs. 9001

ISO 9000 is a series, or family, of quality management standards, while ISO 9001 is a standard within the family. The ISO 9000 family of standards also contains an individual standard named ISO 9000. This standard lays out the fundamentals and vocabulary for quality management systems (QMS).

ISO 9000 series of Standards

The ISO 9000 family contains these standards:

• ISO 9000:2015: Quality Management Systems - Fundamentals and Vocabulary (definitions)
• ISO 9004:2018: Quality Management - Quality of an Organization - Guidance to Achieve Sustained Success (continuous improvement)

ASQ is the only place where organizations can obtain the American National Standard Institute (ANSI) versions of these standards in the ISO 9000 family.

ISO 9000 history and revisions: ISO 9000:2000, 2008, and 2015

ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standards bodies of more than 160 countries. The standards underwent major revisions in 2000 and 2008. The most recent versions of the standard, ISO 9000:2015 and ISO 9001:2015, were published in September 2015.

ASQ administers the U.S. Technical Advisory Groups and subcommittees that are responsible for developing the ISO 9000 family of standards. In its standards development work, ASQ is accredited by ANSI.

ISO 9000:2000

Studies 1 7 7 Iso 9001

ISO 9000:2000 refers to the ISO 9000 update released in the year 2000.

The ISO 9000:2000 revision had five goals:

1. Meet stakeholder needs
2. Be usable by all sizes of organizations
3. Be usable by all sectors
4. Be simple and clearly understood
5. Connect quality management system to business processes

ISO 9000:2000 was again updated in 2008 and 2015. ISO 9000:2015 is the most current version.

ISO 9000:2015 principles of Quality Management

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management principles that senior management can apply to promote organizational improvement.

ISO 9000 Quality Management Principles

1. Customer focus
   • Understand the needs of existing and future customers
   • Align organizational objectives with customer needs and expectations
   • Meet customer requirements
   • Measure customer satisfaction
   • Manage customer relationships
   • Aim to exceed customer expectations
   • Learn more about the customer experience and customer satisfaction
2. Leadership
   • Establish a vision and direction for the organization
   • Set challenging goals
   • Model organizational values
   • Establish trust
   • Equip and empower employees
   • Recognize employee contributions
   • Learn more about leadership
3. Engagement of people
   • Ensure that people’s abilities are used and valued
   • Make people accountable
   • Enable participation in continual improvement
   • Evaluate individual performance
   • Enable learning and knowledge sharing
   • Enable open discussion of problems and constraints
   • Learn more about employee involvement
4. Process approach
   • Manage activities as processes
   • Measure the capability of activities
   • Identify linkages between activities
   • Prioritize improvement opportunities
   • Deploy resources effectively
   • Learn more about a process view of work and see process analysis tools
5. Improvement
   • Improve organizational performance and capabilities
   • Align improvement activities
   • Empower people to make improvements
   • Measure improvement consistently
   • Celebrate improvements
   • Learn more about approaches to continual improvement
6. Evidence-based decision making
   • Ensure the accessibility of accurate and reliable data
   • Use appropriate methods to analyze data
   • Make decisions based on analysis
   • Balance data analysis with practical experience
   • See tools for decision making
7. Relationship management
   • Identify and select suppliers to manage costs, optimize resources, and create value
   • Establish relationships considering both the short and long term
   • Share expertise, resources, information, and plans with partners
   • Collaborate on improvement and development activities
   • Recognize supplier successes
   • Learn more about supplier quality and see resources related to managing the supply chain

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30 Years of ISO 9000

The ISO 9000 series of standards celebrated its 30th anniversary in 2017

First published in March 1987, ISO 9001: Quality management systems - Requirements has become the most successful standard in the history of the International Organization for Standardization.

The popularity of the ISO 9000 series paved the way for other management system standards, including:

ISO 9001 certification

ISO 9001 is the only standard within the ISO 9000 family to which organizations can certify. Learn more about ISO 9000 training and certifications with ASQ’s ISO 9000 courses and learning materials.

Get started with ISO 9000

ASQ is the only place to get ANSI/ISO/ASQ Q9001-2015, the American National Standard version of ISO 9001:2015.

Available formats include:

• E-standard for immediate download and viewing (Please note, e-standards cannot be printed.)
• Site license for posting an electronic version to your Local Area Network or Intranet.

Visit Standards Central for more resources.

Resources for ISO 9000 and Other Standards

You can also search articles, case studies, and publications for ISO 9000 resources.

AS9100 Keeps Bosch Communications Flying High in Aerospace Industry (PDF) In just 11 months, Bosch Communications earned certification to both ISO 9001 and AS9100, the international quality management system standard for the aerospace industry.

Certifying the Certifier (PDF) Over a three-year period, Quality Management Company (QMC) improved itself from the inside out—and became ISO certified in the process. ISO 9001 provided QMC with a logical framework for developing a quality management system.

Prescription for Community-Based Healthcare Includes ISO 9001 (PDF) The Community Anticoagulation Therapy Clinic demonstrates how ISO 9001 principles can provide a framework for a community model of care delivery and patient safety. Customer and provider surveys demonstrate 100% satisfaction with the clinic, which uses a controlled document system based on ISO 9001, internal and external auditing, and preventive and corrective action plans.

Agricultural Firms Gain Competitive Edge With USDA’s ISO 9001-Based Verification Program (PDF) The U.S. Department of Agriculture’s Process Verified Program uses the ISO 9001:2000 standard to evaluate the quality management systems of agricultural businesses.

U.S. Air Force Earns High-Flying Results with Quality Management Specifications for Suppliers (PDF) Adopting ISO 9001 compliance as a sourcing criterion in its supplier selection process and requiring suppliers' quality management representatives to become ASQ Certified Quality Auditors have saved the Air Force millions of dollars and nearly eliminated critical defects in supplier products and services.

Continuous Improvement in Public Schools Through ISO 9001:2000 (PDF) Since Racine Unified School District achieved ISO 9001:2000 certification, the district has made notable progress in closing the achievement gap between demographic groups in reading and math, decreasing truancy and suspensions and increasing parent satisfaction.