Six Sigma Quality International

What you will gain:
Higher Effectiveness and Efficiency on their JobExcellent 
Career Enhancement Opportunity
Internationally Recognized Qualification
Photo-identity Card from ASCB(Europe) Ltd. - UKListing among an International list of Quality Professionals.

Quality Management

Train as an ISO 9001 qualified internal auditor and guarantee future business success through the highest quality standards. Complete our ISO 9001 Internal Auditor training course and ensure your organisational quality management system achieves its full potential.

Working with our unrivalled tutors you will become confident in planning and performing an effective audit, as well as reporting and taking corrective action. You will build trust among your colleagues and customers by delivering a robust and effective quality management system that is ISO 9001 compliant.

Regular monitoring of quality standards will help you achieve and maintain international ISO 9001 accreditation and this two-day course will equip you with the skills to tailor your own internal audit framework. Workshops, presentations and role-play activities will guarantee solid knowledge of quality standards auditing.

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.

• 1GDP / GDocP standards
  • 1.1Documentation creation
  • 1.2Document approval
  • 1.3Handwritten entries
  • 1.4Copies of documents
  • 1.5Document maintenance
  • 1.6Document modification
• 2GDP / GDocP interpretation
• 3Enforcement
• 4See also
• 5References
  

  Distribution is an important activity in the integrated supply-chain of medical device.Various people and entities are generally responsible for the product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration, need to be appropriately managed and controlled to ensure the safety and performance of medical devices at the point of use.

  In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The level of risks associated with these activities may be of similar degree as those in the manufacturing environment and the lack of control over these activities may affect safety and performance of the devices. The Good Distribution Practice for Medical Devices (GDPMD) is developed to elucidate the requirements for an appropriate management and control of these activities. GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737). GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It shall be used by both the internal and external parties to determine the ability of an establishment to meet the requirements specified within.

  The certification to GDPMD is to be conducted by the registered conformity assessment body. The design and implementation of GDPMD by an establishment is dependent on the types and categories and classification of medical device, size and structure of the establishment, the processes employed it deals with. It is not the intent of the GDPMD to imply uniformity in the structure of the quality management systems or uniformity of documentation. Certification to GDPMD does not imply compliance to any written laws. It is the responsibility of the establishment to ensure that they are in compliance with all applicable laws in Malaysia. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.

  
  BENEFITS OF GDPMD

DCS & LL-C (Certification) Europe provides for exams of welders, soldering and welding operators subject to the authorization by CWS ANB (CZECH WELDING SOCIETY AUTHORIZED NATIONAL BODY). The examiners have appropriate professional qualification based on their education (IWE, EWE), many years of experience in the field and they have valid letters of appointment issued by CWS ANB. The issued authorizations and certificates of welder exams are valid worldwide.

- Issuance of authorizations, certificates, welder´s certificates about welder exams, including their duplicates
- Organization of professional workshops for welding engineers from schools and companies - the trainees receive an Welding Engineer Authorization
- Final exams of metal welders, soldering and welding operators under the Czech standards SN 050705, SN EN 287-1, SN EN ISO 9606-2, SN EN 13133, SN EN 1418 a SN EN ISO 17660-1,2 at welding schools in the CWS ANB system or directly in the companies.

• To verify a welder’s skill and ability to produce sound welds.

• To ensure welds meet mechanical and visual inspection criteria.

• To comply with project, client, or regulatory requirements (e.g. oil & gas, pressure vessels, structural steel, pipelines).

• Welders working in industries such as:

  • Oil & Gas

  • Construction & Structural Fabrication

  • Pressure Vessel Manufacturing

  • Shipbuilding

  • Aerospace

  • Power Plants

  • Pipelines and Refineries

A valid ISO 9606 Welder Qualification Certificate (WQC) typically includes:

1. Welding Test Coupon Preparation
   The welder performs a weld under test conditions.

2. Inspection and Testing

   • Visual Examination

   • NDT (Radiography, Ultrasonic, etc.)

   • Mechanical Tests (Bend, tensile, impact, hardness if required)

3. Evaluation and Certification
   If results meet ISO 9606 requirements, the welder receives a Welding Qualification Certificate (WQC).

ISO 29990:2010 specifies basic requirements for providers of learning services in non-formal education and training.

The ISO 29990 : 2010 was published as an ISO standard in September 2010 and adopted in December 2010 as the DIN standard DIN ISO 29990 "Learning services for training and further education - Basic requirements for service providers". ^[1] On December 19, 2018, the standard was officially withdrawn because it no longer met the modern demands of quality management in education. In addition, the standard is not compatible with ISO''''s strategy of high level structure . ^[2]The structure of ISO 29990 maps both service requirements and management requirements. With the high level structure, however, ISO would like to achieve a strict separation of these two requirements. Since 2015, a distinction has been made between service and management standards / norms. ^[3] However, ISO 29990 is a hybrid standard that forms a combination between these two standards. For this reason, it was withdrawn and replaced by two adequate successions: ISO 29993: 2018 and ISO 21001: 2018. ^[4]The ISO 29993 maps the requirements of a service standard. ISO 21001 places requirements on a management system. Both in addition replace ISO 29990 in a significantly improved form, but do not have to be used together. Depending on the interests of the user of the standard, they can be combined or used separately. ^[5]

The international norm was a service standard for learning services and at the same time a quality management system for learning service providers in training and further education. The aim of ISO 29990 was to create a general quality model for professional practice and service provision as well as a common reference for learning service providers and their customers for planning, developing and implementing training and further education and for promoting development. The standard focused on the learner, the learning outcomes, the learning service and the competence of the learning service provider. Organizations and individuals should be supported by the International Standard in the selection of a suitable learning service provider who corresponds to the needs and expectations of the development of competencies and skills.

This document gives guidelines for defining and implementing processes to monitor and measure customer satisfaction.

This document is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus of this document is on customers external to the organization.

NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer

ISO 39001:2012 specifies requirements for a road traffic safety (RTS) management system to enable an organization that interacts with the road traffic system to reduce death and serious injuries related to road traffic crashes which it can influence. The requirements in ISO 39001:2012 include development and implementation of an appropriate RTS policy, development of RTS objectives and action plans, which take into account legal and other requirements to which the organization subscribes, and information about elements and criteria related to RTS that the organization identifies as those which it can control and those which it can influence.

ISO 20121:2012 specifies requirements for an event sustainability management system for any type of event or event-related activity, and provides guidance on conforming to those requirements..

ISO 20121:2012 is applicable to any organization that wishes to:

establish, implement, maintain and improve an event sustainability management system;

1. ensure that it is in conformity with its stated sustainable development policy;
2. Demonstrate voluntary conformity with ISO 20121:2012 by

1. first party (self-determination and self-declaration),
2. second party (confirmation of conformance by parties having an interest in the organization, such as clients, or by other persons on their behalf), or
3. independent third party (e.g. a certification bEvery event – from a village barbecue to a major sporting event like the Olympics – will have economic, social and environmental impacts. Water and energy resources are put under pressure, significant amounts of waste and carbon emissions can be generated. Sometimes events can put a strain on local communities. By 2005, practitioners within the events industry were becoming aware of the need for more sustainable practices.

   Specifically, the Head of Sustainability at the London 2012 Olympic and Paralympic Games, David Stubbs, was looking for a way to make good on the sustainability promises made in the London Games bid.^[1]

   He raised the issue with the British Standards Institution (BSI) in the UK. This led to the creation of BS 8901:2007 Specification for a sustainable event management system with guidance for use.^[2] After a period of review, the second version of BS 8901 was published in 2009.^[3]

   BS 8901 was received very positively by the international event industry, and was soon being widely used. For example, COP15, the United Nations Conference on Climate Change, was certified as compliant with BS 8901 in December 2009.^[4] The Microsoft Corporation achieved certification to BS 8901 at its Microsoft Convergence® 2009 event in New Orleans, Louisiana, in March 2009.^[5]

   Development of ISO 20121[edit]

   Responding to this international enthusiasm for BS 8901, in May 2009 a proposal for an international sustainable event management standard was jointly submitted to the International Organization for Standardization (ISO) by BSI Group and ABNT, the Brazilian national standards body.^[6]

   Delegations of experts of the national standards institutions of 25 countries developed the standard, with another 10 countries as observers. Eight stakeholder organizations from the event industry, or with a strong interest in sustainability, also participated.^[7] Members of the sustainability team of the London 2012 Olympic and Paralympic Games were among the stakeholders who provided input into the development of the standard.^[8]

   Subsequently, ISO 20121:2012 Event sustainability management systems –- Requirements with guidance for use was published in June 2012.^[9]

   How ISO 20121 works[edit]

   ISO 20121 is relevant to all members of the event industry supply chain including organizers, event managers, stand builders, caterers and logistics suppliers.

   The standard takes a management systems approach to running more sustainable events. It provides a framework to help identify the potentially negative social, economic and environmental impacts of events. Organizers can then remove or reduce negative impacts through improved planning and proce

ISO/IEC 33001 is a standard developed jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It forms part of the ISO/IEC 330xx family, which defines a comprehensive framework for assessing the capability of processes, especially in IT and software engineering contexts.

To establish the core concepts and terminology used in process assessment so that organizations can consistently:

• Evaluate how well their software development, systems engineering, or IT services processes are performing

• Identify areas for process improvement

• Provide a common language for describing process capability

1. Process Assessment – Evaluation of processes against a defined model

2. Process Reference Model (PRM) – Defines the set of processes to be assessed

3. Process Assessment Model (PAM) – Provides indicators and attributes for evaluating process capability

4. Capability Levels (0 to 5) – Scale to measure how mature or capable a process is

• ISO/IEC 33002 – Performing process assessments

• ISO/IEC 33003 – Requirements for process measurement frameworks

• ISO/IEC 33004 – Requirements for process reference and assessment models

• ISO/IEC 33020 – Measurement framework for assessing process capability

• ISO/IEC 33061/33063 – Related to agile or software-specific assessments

• Software Process Improvement (e.g., replacing ISO/IEC 15504 / SPICE)

• IT governance & quality assurance

• Supplier capability assessment

• Internal process audits

If you're personally interested in certifications related to ISO/IEC 33001, look into:

• Certified ISO/IEC 330xx Process Assessor training

• SPICE Assessor (based on ISO/IEC 15504/330xx)

• Training from organizations like:

  • Six Sigma Quality International

  • Deming certification services Pvt. Ltd,Ukjas Accreditation Pvt. Ltd., or other ISO training bodies

ISO 13687-1:2017 establishes minimum requirements for commercial and non-commercial harbours for leisure craft in order to define the basic level to deliver services to the boating community for all types of recreational boating activities, excluding the standardization of sports activities.

The scope does not cover specifics of boat yards, dry stacks, dry-docking areas, dry storages, fuel stations and nearby beaches.

ISO 13687-1:2017 does not cover risks in case of abnormal weather conditions above windforce 9 on the Beaufort scale and extreme sea conditions or rogue waves.

his document gives guidelines for an organization to establish, implement, maintain and improve systems for competence management and people development to positively affect outcomes related to the conformity of products and services and the needs and expectations of relevant interested parties.

This document is applicable to all organizations regardless of their type or size. It does not add to, change or otherwise modify requirements for the ISO 9000 family or any other standards

Welder Quali cation needs to be performed to confirm the welder’s ability to deposit sound weld metal for a specific type of weld, material and weld position.

WPS qualification serves the purpose of determining whether the welds are capable of providing the required characteristics for its application.

The extent of testing required to qualify the WPS will depend on whether pre-qualified weld preparations and consumables are used. In some instances (e.g. where standard pre-qualified welds are used), minimal or no testing may be required. Where WPS qualification is required, weld test pieces (also called weld coupons) are fabricated according to the WPS and the compliance standard. Non Destructive Testing (NDT) and Destructive Testing (DT) is then carried out on the test pieces to check for weld defects and the properties of the joint. A Procedure Qualification Record (PQR) or Welding Procedure Qualification Record (WPQR) is used to document the weld qualification.

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

The ISO/IEC 27000-series (also known as the 'ISMS Family of Standards' or 'ISO27K' for short) comprises information security standards published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).^[1]

The series provides best practice recommendations on information security management—the management of information risks through information security controls—within the context of an overall Information security management system (ISMS), similar in design to management systems for quality assurance (the ISO 9000 series), environmental protection (the ISO 14000 series) and other management systems.^[2][3][4]

The series is deliberately broad in scope, covering more than just privacy, confidentiality and IT/technical/cybersecurity issues. It is applicable to organizations of all shapes and sizes. All organizations are encouraged to assess their information risks, then treat them (typically using information security controls) according to their needs, using the guidance and suggestions where relevant. Given the dynamic nature of information risk and security, the ISMS concept incorporates continuous feedback and improvement activities to respond to changes in the threats, vulnerabilities or impacts of incidents.