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Management Certification

AS 9100
EN-15038
FSC-COC CERTIFICATION
GLP
ISO 3834
ISO 9001
ISO 10002
ISO 13485
ISO 14001
ISO 14064 GHG
ISO 15378
ISO 15504
ISO 17712 Seal Standards
ISO 18788
ISO 20000
ISO 22000
ISO 22301
ISO 26000
ISO 27001
ISO 28000
ISO 29990
ISO 31000
ISO 39001
ISO 45001
ISO 50001
ISO TS 16949
ISO15838
ISO28001
OHSAS 18001
SA-8000

What Is As 9100?

Introduction
AS 9100 is a Quality Management System Standard developed by the International Aerospace Quality Group and it is based on ISO 9001 with additions and interpretations specific to the aviation space and defense industry sectors. AS 9100 has some associated standards, including 9110 which is designed for repair and overhaul organizations and 9120 which is designed for distributor stockholders. The 9100 standard is issued in Americas as ‘AS 9100′, in Europe as ‘EN 9100′ and in Asia-Pacific as ‘JIS Q 9100′.

Why Is As 9100/9110/9120 Important To Your Organization?
Certification against 9100/9110/9120 provides evidence that your products and services meet the demanding expectations and standards of the aviation, space and defense sector. It shows that you operate according to internationally agreed and recognized practices for quality management, and is essential to winning contracts worldwide. Benefits include:
Internationally agreed and recognized practices for quality management in the aviation, space and defense sector.
Eligibility for inclusion on OASIS – the Online Aerospace Supplier Information System database.
A common language for dealing with customers and suppliers worldwide.
Increased efficiency and effectiveness.
A model for continual and systematic improvements in quality
A model for delivering excellence for customers and other stakeholders.

As 9100/9110/9120 Benefits
We focus our assessments on the areas and issues that are important to your business. GITCHIA assessors are industry specialists and experts who understand your business needs, enabling an effective and robust assessment of your system. 9100/9110/9120 certification from GITCHIA demonstrates a clear and transparent commitment to quality and continual improvement.
Competitive advantage – improve your products, processes and service quality, leading to higher customer satisfaction levels and improved efficiency and effectiveness.
Continual improvement – our services help you to improve performance, reduce risk, reduce waste and introduce continual improvement into your organization.
Grow market share – by improving quality right across your supply chain, we help you to reassure clients, develop new market opportunities and win new business.
Show your commitment – working with GITCHIA is a clear demonstration of your commitment to quality. We are a market leader in the provision of management systems assessment, certification and training services, and over half of the world’s top 200 companies choose GITCHIA as their certification provider.
Sector expertise – Some of the biggest names in the aerospace industry are our clients, and we can help you benefit from the best practices from across the aerospace industry.

Why Certify With GITCHIA Certification?
Certification is the GITCHIA management-system certification unit. It is founded on the principles of independence and impartiality. Our end goal is to:
Help our clients achieve and demonstrate their commitment to ongoing improvement
Certify our client’s compliance with the most exacting of standards by way of second-party and third-party audits
Ensure that our clients’ products gain access to international markets.

EN-15038 certification

GITCHIA has successfully achieved renewal of its certification under the ISO-9001 and EN-15038 quality standards. These certificates ensure strict compliance with a detailed set of quality assurance procedures, including recruitment, job processing and quality control measures.

While many translation providers make vague promises of ‘high quality’, this can only be guaranteed through EN15038 certification. This is a European quality standard specific to translation services which guarantees a documented process and a standardized approach.

From November 2015, ISO 17100 supersedes UNE-EN 15038.

Any translation service under EN-15038 must include as a minimum, translation and review.

  • Translation and checking. A translator with the appropriate competences translates the documents and after finalizing the initial translation, checks his/her own work. 
  • Review. A person other than the translator reviews the translation. The standard defines review as “examining a translation for its suitability for the agreed purpose, and respect for the conventions of the domain to which it belongs and recommending corrective measures”.

Translators who take part in translation projects under EN-15038:2006 must demonstrate the professional competences specified in the standard by meeting at least one of the three requirements.

  • Advanced translation studies (recognized qualification)
  • Equivalent qualification in another specialization plus a minimum of two years documented experience in translation.
  • At least five years of documented professional experience in translation.

In addition to complying with one of the above three requirements, reviewers must have translation experience of the subject in question.

The client may also contract other services as part of the translation process such as revision, proofreading, also contemplated in the standard and other added value services such as sworn translation, terminology database creation and management, desktop publishing, etc.

EN15038:2006

The EN 15038 standard was established by the European Committee for Standardization (CEN) in 2006. This was the first international quality standard which defines specific criteria for quality translation services. It standardizes quality requirements for translations services by establishing common procedures for the entire workflow — from acceptance of an order to final delivery. These standardized requirements consist in three main components:

  1. Qualified Translators and Revisers

All translators must have proven mastery of the languages from and into which they translate. This implies high proficiency with the relevant terminology, grammar, style, cultural context and subject matter. This expertise must be backed up by a University Degree and a minimum of two years’ translation experience.

  1. Translation and Revision carried out by Two Independent Professionals

The “four eyes principle” guarantees and independent second check of all translated texts. For some jobs of a highly technical or sensitive nature, we even go a step further by having a third-party review as described in the EN 15038 standard. This ensures a multi-tiered quality assurance procedure to provide you with a publication-ready professional translation.

  1. Documented Standard Operating Procedures

Each step within the translation workflow is immediately traceable thanks to documented standard procedures. This is facilitated by state-of-the-art project management tools which ensure strict compliance with the quality requirements of EN 15038 at every step of the procedure. This includes detailed documentation of client feedback, internal evaluations, recruitment and testing, source text analysis, terminology work and compliance with the applicable style guides.

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

 

FSC COC Certification

Demonstrate The Responsible Origin Of Your Wood And Paper Products

The demand for wood, paper and other forest products sourced from well-managed forests continues to grow. Consumers and business partners want assurance that your products come from responsibly managed sources that limit their damage to the forest environment and forest-dependent indigenous communities. Your business must also prove that your goods come exclusively from legal sources as required by the EU Timber Regulation, the Lacey Act in the U.S., or similar legislative requirements.

What Is FSC Chain Of Custody Certification?

The Forest Stewardship Council™ (FSC) is a nonprofit organization that set standards for forestry practices with the aim of promoting environmentally responsible and socially beneficial forestry. Wood products such as furniture can be labelled as FSC certified if they meet the high standards set by the organization.

To be certified, the flow of the wood material – from the forest to the customer – must be monitored to demonstrate its origins. This evidence is known as Chain of Custody (CoC).

Why Is It Important?

This assures customers that your company only uses legal sources and responsibly managed forests for its material. It enables you to offer your customers better value in terms of origin of material and promotion of responsible forestry. By using FSC material, you can also open up new business opportunities for your company in markets requiring the certification.

Our FSC COC Services

We offer services to support your company at every stage of the certification process, from pre-audit throughout the entire five-year certification cycle.  

Designed for all businesses involved in the supply chain of forest-based products, FSC CoC certifications require ongoing annual audits. We can perform these audits within the five-year certification cycle to monitor how your organization has implemented requirements for the separation of certified and uncertified material, as well as identifying ways in which they might potentially get mixed. Our auditors observe your company’s separation and flow of material, its management systems, and your use of the FSC trademarks.

FSC Controlled Wood

FSC Controlled Wood covers wood that is not FSC certified but meets the specifications of the FSC Controlled Wood Standard. This includes legality of the harvest and due consideration to key social and environmental issues. FSC Controlled Wood can be mixed with certified wood for production of FSC-certified products, provided it meets respective requirements. FSC CoC and FSC Controlled Wood systems and certification is a tool to show compliance with the EU Timber Regulation.

How Can We Help You?

As an internationally accredited Certification Body for the FSC CoC (license code FSC® A000530), GITCHIA is a one-stop provider of certification services.

Our trusted audit experts understand all the technical and social complexities of CoC certification for a wide range of industries in wood processing, pulp and paper, packaging, and printing. We can offer FSC CoC audits in combination with other audit services such as ISO or other forest certification schemes.

Why Certify With GITCHIA Certification?

GITCHIA is a trusted market leader for credible CoC certification. We are known worldwide for the high quality of our certifications and the outstanding performance of our auditors.

Our experts are committed to a fast turnaround on approvals of submitted artwork using the FSC trademark, delivering on deadlines as short as two days or even a few hours in the case of printing businesses.

To become FSC Chain of Custody (CoC) certified, companies must be audited to meet the requirements of the CoC Standard, FSC-STD-40-004.

What Does Good Laboratory Practice (GLP) Mean

The term Good Laboratory Practice (GLP) is a well-known acronym for quality in the laboratory but how much do you know about the term, its background and what does it really mean in practice?

While you may think that the “Laboratory” in GLP includes chromatography, the primary aim of the regulation does not. The main laboratories that were affected by the regulation were ones conducting clinical chemistry, histology and pathology, which are used to analyses the samples generated from toxicology studies. In addition to the FDA regulations, the Organization for Economic Cooperation and Development (OECD) has published GLP regulations that we use in Europe that have the same overall intent as the FDA regulations but with some differences that we will discuss in this article.

Aims of GLP

The aims of the GLP regulations are fairly simple and for the most part do not differ from other quality schemes:

  • Staff are trained and follow written instructions (standard operating procedures — SOPs) that reflect their actual working practices rather than being major works of artistic fiction.
  • Equipment and computer systems used in studies are fit for the purpose that they are intended (this means that each is specified, installed correctly and is shown to work against the specification).
  • Records generated during the course of any toxicology tests are verified and authenticated and can be used to reconstruct the study if required.
  • There is an independent quality assurance unit (QAU) to check that work was performed in accordance with the regulations and the laboratory’s internal procedures.

However, there are key differences:

  • Some roles and responsibilities are unique to GLP, including study director and principal investigator.
  • Studies must be planned and executed according to pre-approved plans (protocols) and changed by formal amendments or deviations.
  • A list or master schedule is maintained of all studies and protocols running in the testing facility to help coordinate the running of the studies. This must be updated on a regular basis, typically monthly, and is a key item in any GLP regulatory inspection. The master schedule is raw data in its own right.
  • Raw data is the concept used for the records generated in the course of a study.
  • There is a formal archive with an archivist who is responsible for maintaining the study records stored within it.

 

ISO 3834

Prove your welding processes go beyond ISO 9001

Introduction

ISO 3834 is the international standard for quality requirements for the fusion welding of metallic materials. ISO 9001 states that, where necessary, special processes shall be identified, and the ISO 3834 standard is an excellent way to meet this requirement. 

Because the quality of welding is manufactured into the product – not inspected – having an ISO 3834 certificate demonstrates their competence in fusion welding processes, assessed independently.

Compliance with ISO 3834 Parts 2, 3 or 4 as appropriate, is now mandatory in many EN pressure vessel and construction standards.

The ISO 3834 certification process follows five steps:

  1. System examination: An examination of the company’s welding quality management system helps identify areas which require attention and correction.
  2. Questionnaire: The scheme requires you to complete a detailed questionnaire about the capabilities of your facility. This includes qualifications and experience of the nominated welding coordination personnel.
  3. Self-audit: In the third step, you conduct a self-audit against the ISO 3834-2 audit checklist.
  4. Implementation and confirmation: The audit is a two-stage process. Stage 1 identifies the areas within the welding quality management system which require attention. Stage 2 is implementation confirmation, where the assessment team will examine specific contracts to assess compliance with customers’ expectations.
  5. Validity: Once issued, the ISO 3834 certificate is valid for five years. An annual surveillance audit by a qualified assessor is required to maintain the approval.

Need help with ISO 3834 certification?

GITCHIA is a globally accredited certification body for ISO 3834. For fabricators, having an ISO 3834 certification from GITCHIA provides an authoritative, globally recognized reference of commercial value. That value lies in our long history of certifying welders, welding operations and welding quality procedures according to several international standards.

We can certify your company to Parts 2, 3, and 4 of the ISO 3834 standard:

  • Part 2 – Comprehensive Quality Requirements
  • Part 3 – Standard Quality Requirements
  • Part 4 – Elementary Quality Requirements

Why Certify With GITCHIA Certification?

Client-focused and safety driven

We strive to be your number one choice for welding certification services. Our passion is to deliver a service of quality, integrity and a safety ethos, coupled with a technical wealth of experience, knowledge and professional academics; which in turn provides confidence for you and your stakeholders throughout the whole service.

Technical expertise

GITCHIA’s technical experts can provide first-hand insights into the requirements of ISO 3834 and the logic behind them. Our surveyors are chosen for their sector-specific knowledge and expertise, which means you can be confident that they’ll understand the manufacturing challenges you face.

Our expert assessment teams take a collaborative approach that understands the importance of a fast, efficient appraisal with minimal disruption to your business. 

Your business helps GITCHIA to help others

The profits we generate fund the GITCHIA Foundation, a charity which supports science and engineering-related research, education and public engagement around everything we do. All of this helps us stand by the purpose that drives us every single day: Working together for a safer world.

 

ISO 9001 – Quality management

Introduction

Certification of quality management systems

ISO 9001 is a global quality standard that is recognized across all sectors. It belongs to the ISO 9000 family and enables an organization to publicly demonstrate its commitment to product or service quality. Certifying to this standard helps companies to gain greater control over their processes, reduce the costs of low quality, optimize their schedules, increase productivity and assess and minimize risks. It also supports them in accessing new markets and fostering relationships of trust with new clients.

ISO 9001:2015 Update

ISO (International Organization for Standardization) amended the ISO 9001:2008 standard for quality management systems on 15th September 2015 in order to improve certain aspects of the 2008 version, such as putting increased emphasis on leadership and interested parties.

This new version also incorporates some structural changes. ISO 9001:2015 is based on a high-level structure. This is a set of 10 clauses that are now shared by all ISO management-system standards, giving them a consistent structure. All new standards with this high-level structure share a common text as well as containing discipline-specific texts tailored to the particular management system in question.

The use of this new framework offers some significant advantages to companies:

  • The standard is easier to read and understand thanks to its more accessible language
  • Multiple management systems can be more easily integrated since they all share the same basic structure: scope, normative references, terms and definitions, context of the organization, leadership, planning, support, operation, performance evaluation and improvement
  • Companies can foresee and plan for changes
  • Organizations are encouraged to improve

What Are The Benefits Of ISO 9001?

The ISO 9001 standard offers multiple advantages to companies. It is a tool with which to identify quality-related aspects that the company could improve. Its ultimate aim is organizational excellence. The implementation of ISO 9001 is of benefit to companies both internally and externally.

 At an internal level, ISO 9001:

  • Helps a company to detect and address its weak points through a risk assessment of its processes
  • Increases productivity by offering greater control over processes
  • Significantly reduces costs related to poor quality
  • Strengthens the relationships between departments as a result of the leadership and staff involvement required

At an external level, ISO 9001:

  • Offers businesses a competitive advantage over market competitors
  • Improves a company’s image in terms of quality
  • Increases confidence among clients and end users
  • Boosts access to new markets

What Types Of Businesses Can Gain ISO 9001 Certification?

 This international standard can apply to any company, regardless of sector or size. Implementation of the ISO 9001 standard is particularly recommended for companies that are striving for quality excellence, increased confidence among clients at a global level and/or access to new markets.

WHY CERTIFY WITH GITCHIA CERTIFICATION?

Certification is the GITCHIA management-system certification unit. It is founded on the principles of independence and impartiality. Our end goal is to:

  • Help our clients achieve and demonstrate their commitment to ongoing improvement
  • Certify our client’s compliance with the most exacting of standards by way of second-party and third-party audits
  • Ensure that our clients’ products gain access to international markets.

ISO 10002 – Quality Management – Customer Satisfaction Certification

Introduction

You can turn unhappy customers into positive business opportunities with effective complaints management. Satisfied customers are your best ambassadors.

An unhappy customer will tell friends and colleagues about their experiences, damaging your reputation and often you know nothing about it. Implementing a complaints handling process using ISO 10002 will help you turn unhappy customers into satisfied ones and use their input to improve the experience of future customers.

Your customer service processes need to make it simple for your customers to communicate complaints and resolve any issues arising. Complaint management is not about reducing the number of complaints, but taking the information they generate and turning it into an opportunity for improvement.

Smart complaint management will help you to improve customer service standards and deliver an effective complaint handling system to differentiate you from your competitors. Auditing by GITCHIA against ISO 10002 Quality Management: Customer Satisfaction demonstrates that your organization cares about customer feedback and receives, manages and resolves customer complaints effectively.

Certification against ISO 10002 will provide your organization with a high quality and reliable complaint management system, including the following characteristics:

  • Visibility
  • Accessibility
  • Responsiveness
  • Objectivity
  • Confidentiality
  • Customer-focused approach
  • Accountability
  • Continual improvement

Why Certify With GITCHIA Certification?

We can either conduct a gap assessment of your management system against the requirements of ISO 10002 or take you through the full certification process.

Our ISO 10002 Foundation Training is designed to provide any organization with the fundamentals of the ISO 10002 requirements. Contact your local GITCHIA representative for further details.

Partner with GITCHIA to improve customer service standards and complaint management with the implementation of ISO 10002.

 

ISO 13485 – Medical devices

Introduction

Quality management system certification for organizations working in the design, development, production, installation or sale of medical devices and related services. Quality management system certification for organizations working in the design, development, production, installation or sale of medical devices and related services. The certification of quality management systems for medical devices supports organizations in this sector to achieve regulatory compliance and to meet the needs of their clients, both for companies and for related services.

What Is ISO 13485 Certification?

The ISO 13485 standard shares its structure with that of ISO 9001 and includes important factors such as sterile manufacturing, traceability and risk assessment. This permits the monitoring of the full healthcare-product production process, from design conception to end destination.

ISO 13485 compliance enables organizations to meet quality system requirements around the world, including those set by the FDA in the United States, the Canadian authorities and the European Union.

Key Benefits

  • Ensures compliance with international regulatory schemes
  • Ensures compliance with client requirements
  • Enables the full monitoring of products, from design conception to end destination
  • Fosters recognition and confidence in the medical device industry
  • Provides access to national and global markets
  • Increases efficiency
  • Enhances the company’s reputation

Why Certify With GITCHIA Certification?

GITCHIA Certification is a prestigious independent body that was established to help organizations achieve their aim of continuous improvement. We assess the specific needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while evaluating an organization’s compliance.

 Our teams of professionals draw up customized certification plans taking into account client structures, processes and areas of activity. Our global presence, extensive product portfolio and wide-ranging accreditations enable us to provide our clients with a comprehensive, expert and tailor-made service.

 

ISO 14001 – Environmental Management

Introduction

Certification of environmental management systems; International standard ISO 14001 helps companies to control their environmental impact and achieve sustainable growth. It belongs to the ISO 14000 family of environmental management standards that were drawn up in 1996. Following the United Nations Conference on Environment and Development, also known as the Earth Summit that was held in Rio de Janeiro in 1992 ISO’s Technical Committee 207 set out to work towards achieving sustainable development.

The implementation and certification of an environmental management system demonstrates that a company is complying with current environmental legislation and assessing and minimizing environmental risks. ISO 14001 certification also supports companies in accessing new markets and fostering new client relationships. This standard can apply to any company, regardless of sector or size.

ISO 14001:2015 Update

This standard was initially published in 2004 and was then updated in 2015. Companies were given three years from the date of publication to make the transition.

The new version still helps companies to reduce waste, save energy and boost their reputation vis-à-vis clients and suppliers. The key difference is that it is now based on a high-level structure. This new framework facilitates the integration of the ISO 14001 standard with those of other management systems. This enables companies wanting to certify to several ISO standards that share the same structure to make savings in terms of both time and money.

What Are The Benefits Of ISO 14001?

The primary advantage of implementing and certifying to the ISO 14001 standard is the chance for a company to create a robust and efficient environmental management system with which it can demonstrate its commitment to sustainable development. The certification of such a system is of benefit to companies both internally and externally.

At an internal level, ISO 14001:

  • Helps a company to detect and address its weak points through a risk assessment of its environmental processes
  • Increases productivity by offering greater control over processes
  • Significantly reduces quality-related costs by guaranteeing compliance with environmental legislation
  • Strengthens the relationships between departments as a result of the leadership and staff involvement required
  • Enables improvements in product or service design through the checks carried out at every stage of their life cycle

At an external level, ISO 14001:

  • Offers businesses a competitive advantage over market competitors
  • Improves a company’s image by publicly demonstrating its environmental commitment
  • Increases confidence among clients and end users
  • Boosts access to new markets that value corporate environmental responsibility

Who Is This Standard Targeted At?

The ISO 14001 standard is designed to apply to any company, regardless of its size, sector or geographical location. It is a voluntary standard; in other words, an organization can decide for itself if it wishes to implement it. By doing so, the company’s environmental management system will offer added value to the business.

Why Certify With GITCHIA Certification?

GITCHIA Certification is the GITCHIA management-system certification unit. It is founded on the principles of independence and impartiality. Our end goal is to:

  • Help our clients achieve and demonstrate their commitment to ongoing improvement
  • Ensure that our clients’ products gain access to international markets
  • Certify our clients’ compliance with the most exacting of standards by way of second-party and third-party audits.

 

ISO 14064 GHG Validation and Verification

Introduction

A growing number of organizations are looking to voluntarily monitor and report GHG emissions and better manage their carbon footprint. ISO 14064 provides a framework for GHG accounting and verification to organizations looking to quantify and reduce GHG emissions.

Issued in three parts, each serves a unique intent:

  • Part 1 – Specifies principles and requirements at the organization level for quantification and reporting of GHG emissions and removals. It covers design, development, management, reporting and verification of an organization’s GHG inventory.
  • Part 2 – Supports multiple GHG project types, so must adequately address offset carbon credits and innovative technology projects, as well as internal projects. The second part specifies principles and requirements, and provides guidance at the project level for quantification, monitoring and reporting of activities intended to cause GHG emission reductions or removal enhancements. It covers GHG project planning; identifying and selecting GHG sources, sinks and reservoirs relevant to the project and baseline scenario; monitoring, quantifying, documenting and reporting GHG project performance; and managing data quality.
  • Part 3 – Specifies principles and requirements and guides those conducting or managing the validation and/or verification of GHG assertions. It can be applied to organizational or GHG project quantification, monitoring and reporting.

To future-proof the standard as far as possible, the ISO/TC 207/SC7 technical group continues to work closely with key bodies such as Carbon Disclosure Project (CDP), United Nations Framework Convention on Climate Change (UNFCCC), World Resources Institute (WRI), The Gold Standard Foundation and other key parties.

Benefits of ISO 14064

Showcase integrity

Verification against ISO 14064-1 and ISO 14064-2 highlights the veracity of your systems and processes to prove your GHG inventory, assertions and reports conform to the ISO 14064 standard; and are free from errors, omissions, or misstatements.

Validation against ISO 14064-2 establishes the integrity of your project baseline, design plan and supporting assumptions to ensure you realize your projected GHG reductions.

Validate success

Verification against ISO 14064-1 provides the necessary assurance of your carbon footprint declarations. Validation of GHG projects to ISO 14064-2 provides confidence that the GHG project, if implemented as planned, will help achieve the projected emission reductions. Verification of your GHG projects gives assurance to your stakeholders of the quantum of emission reductions achieved in a specified period.

Need help with ISO 14064?

Why Certify With GITCHIA Certification?

GITCHIA was one of the first verification bodies to gain accreditation to ISO 14064, allowing us to deliver accredited verification to the full ISO 14064 part 1 scope to any organization in any business sector.

Our ISO 14064 validation and verification services are designed to help you develop robust, reproducible mechanisms for quantifying, monitoring and reporting your GHG emissions at an organization or project level.

Technical Expertise

GITCHIA sits at the forefront of ISO 14064 GHG validation and verification across a range of sectors and schemes worldwide. This puts us in a prime position to share our experience and expertise with clients to gain a credible third-party verification of their assertions.

Unrivalled experience

GITCHIA has in-depth experience of validation and verification within voluntary mechanisms such as ISO 14064 and the Japanese Voluntary Emissions Trading Scheme, as well as regulated schemes at a national level with the UK Emissions Trading Scheme, regional level with the EU Emissions Trading Scheme and international level with the UNFCCC Clean Development Mechanism (CDM) and Joint Implementation.

Your business helps GITCHIA to help others

The profits we generate fund the GITCHIA Foundation, a charity which supports science and engineering-related research, education and public engagement around everything we do. All of this helps us stand by the purpose that drives us every single day: Working together for a safer world.

 

ISO 15378 Quality Management System For Medical Devices

Meet Quality Objectives For Your Primary Packaging Materials For Medicinal Products

Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, aluminum containers/components, films, foils and laminate containers. As these materials come in direct contact with medicinal products, they need to comply with safety, efficacy and reliability requirements. Suppliers of primary packaging materials have to meet the expectations of medicinal product manufacturers and demonstrate compliance with expected quality levels by integrating quality management systems (QMS) and good manufacturing practice (GMP) in their production processes. 

 

What Is ISO 15378?

ISO 15378:2011 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products.

 

WHY IS IT IMPORTANT?

The ISO 15378 standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as Code of Federal regulations (U.S.), European directives and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes. The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life. 

 

How Can You Prepare?

You can understand the requirements of ISO 15378 by performing a GAP analysis, and implementing QMS and GMP requirements as per ISO 15378.

 

GITCHIA ISO 15378 Expertise

GITCHIA offers auditing and certification services to support manufacturers of primary packaging materials in addressing specific requirements to meet the quality objectives as per ISO 15378. We assist the pharmaceutical and medical device industries to assess suppliers of primary packaging materials and increase overall product quality, thus enabling them to develop business excellence.

 

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

Your Benefits At A Glance

  • Save money and time – with a service provider that eliminates the need for multiple assessments and improves productivity through process optimization.
  • Minimize risk – by achieving documented compliance with safety standards, thereby avoiding costly liability.
  • Gain a competitive edge – by demonstrating the ISO 15378 compliance of your organization to all stakeholders with a trusted third-party certification partner.
  • Profit from an expert partnership – with GITCHIA’s global network of highly skilled experts in Medical and Health Services (MHS).
  • Benefit from complete solutions – with GITCHIA’s comprehensive support, from testing to auditing and certification.

ISO/IEC 15504 — SPiCE

 

History of ISO/IEC 15504

ISO/IEC 15504 — also known as SPiCE (Software Process Improvement and Capability determination) is an international norm of  the ISO-Institute to assess and evaluate the business processes of software and electronic development (embedded systems).
SPiCE initially stood for “Software Process Improvement and Capability Evaluation”, but in consideration of French concerns over the meaning of “evaluation”, SPiCE has now been renamed “Software Process Improvement and Capability Determination”. SPiCE is still used for the user group of the standard, and the title for the annual conference. Subject of ISO/IEC 15504 is the assessment of software development processes and related assessment requirements, as well as the application of the norm.

The process reference model (PRM) of ISO/IEC 15504 defines the central processes being relevant to be assessed in any software embedded system development. The process assessment model (PAM) defines how the capability of the processes in the organization should be evaluated.

ISO/IEC 15504 is the European equivalent of the US maturity model Capability Maturity Model Integration (CMMI).

Evolution of ISO/IEC 15504

Technical Report Released

ISO/IEC 15504 was pre-released 1998 as technical report (TR) of a project of the Joint Technical Subcommittee between the ISO and the IEC organizations.

International Standard Released

Since 2003/2004 the technical report was substituted by the international standard (IS) incrementally.

Currently 2015 the standard consists of 10 parts. But, only the second part is normative. The remaining parts have illustrative, exemplar, and informational character only.

  • ISO/IEC 15504-1 — Part 1: Concept and vocabulary — general introduction into the notion of process assessments and a glossary of assessment related terminology.
  • ISO/IEC 15504-2 — Part 2: Performing an assessment — minimal requirements to perform an assessment to get consistent and repeatable evaluations; part 2 is the  (normative) core of the norm, the others have more interpretative character.
  • ISO/IEC 15504-3 — Part 3: Guideline to perform assessments — guide to interpret the assessments requirements defined in part 2 to perform assessments.
  • ISO/IEC 15504-4 — Part 4: Guideline to apply process improvement and process assessments — guide to perform process assessments in a process improvement program or process capability evaluation.
  • ISO/IEC 15504-5— Part 5: Example of a process assessment model  —  example of a process assessment model to perform assessments in compliance to the requirements stated in part 2.
  • ISO/IEC TR 15504-6 — Part 6: An exemplary system life cycle process assessment model — Based on the requirement PAM of system life cycle processes in ISO/IEC 15504-2, exemplary guidance is provided in this part. This part also describes the overall structure of the PAM and the capability dimension from ISO/IEC 15288 and ISO/IEC 15504-2 respectively.
    Apart from this, this part also provides detailed descriptions of work products and steps for defining additional assessment indicators.
  • ISO/IEC TR 15504-7  — Part 7: Assessment of organizational maturity — Organizational maturity relates to the degree the organization implements processes, in order to achieve its business goals, within a defined scope. ISO/IEC 15504-7 defines the conditions for the assessment of organizational maturity and provides a framework which helps to conduct assessments of organizational maturity.
  • ISO/IEC TS 15504-8 — Part 8: An exemplar process assessment model for IT service management — This technical specification (TS) is a preliminary version of a process assessment model of the norm. The fundamental processes are compliant to ISO/IEC 20000.
    With this it is possible to assess a capability level for these induvial processes and an organizational maturity level.
  • ISO/IEC TS 15504-9 — Part 9: Target process profiles — this technical specification (TS) is a preliminary version of the norm describing target process profiles.
  • ISO/IEC TS 15504-10 — Part 10: Safety extension — this technical specification (TS) is a preliminary version of the norm covering safety issues.

 

ISO/IEC 15504 Process Reference Model

ISO/IEC 15504 defines in a reference model the central processes relevant to be inspected and to be performed in any software/embedded system development.

The process reference model of ISO/IEC 15504 defines the processes of a product development project at three distinct organizational levels:

  • Primary Life Cycle Processes: central processes for technical product development.
  • Organizational Life Cycle Processes: organization-wide processes for project support.
  • Supporting Life Cycle Processes: individual processes for project support.

 

 

The ISO/IEC 15504 engineering processes stated in part 5 are software-centered. Thus, after the official release several process assessment models and extensions of process reference model were developed for other application domains:

  • Automotive: Automotive SPICE
  • Medicine: Medi SPICE
  • Testing: Test SPICE
  • Space Technology: S4S – SPICE for SPACE Part 1: Framework, Part 2: Assessor instrument, ESA bulletin 107
  • Tailoring and Extension: SPiCE in Action – Experiences in Tailoring and Extension

 

 

ISO 17712 Seal Standards

 

What Is ISO 17712?

ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. ISO International Standards ensure that products and services are safe, reliable, and of good quality.

The ISO 17712 establishes “uniform procedures for the classification, acceptance, and withdrawal of mechanical freight container seals. It provides a single source of information on mechanical seals which are acceptable for securing freight containers in international commerce.”

 

ISO Standards For Security Seals

The current ISO 17712 standard requires independent confirmation in three areas:

 

  1. Testing to determine a security seals physical strength (as barriers to entry). ISO 17712 defines three types of classes of seal strength or barrier capacity: “I” for Indicative; “S” for Security; and “H” for High Security. C-TPAT requires the use of “H” class seals. Suppliers must use independent third party test laboratories to validate a seal’s classification. Labs must be accredited according to ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) to perform testing specific to ISO 17712.
  2. Auditing of manufacturer’s security-related business processes.

Poor security-related practices can undercut the effectiveness of a high-quality security seal. ISO 17712’s Annex A defines over two dozen required practices, such as facility risk assessments and access controls to production and storage areas. Suppliers’ conformance with Annex A should also be demonstrated through an independent certification provider that is accredited to audit compliance with the ISO standards.

 

  1. Seals be designed and constructed with tamper indicative features that generate tell-tale evidence of tampering.

Security Seal manufacturers must be able to demonstrate to, and obtain certification from, an accredited auditor from an independent third party organization that their high security seals have built-in tamper evidence features. If an independent third party organization accredited to ISO 17020 verifies conformity, it will provide the manufacturer with a certificate of compliance that documents that the seals submitted for review do reflect tell-tale evidence of tampering generated by attempts to defeat a correctly closed and affixed seal.

 

 

 

ISO17712:2013 Compliant High Security Seals

May 15, 2014, the deadline date for all High Security Seals to be compliant with the new requirements of ISO17712:2013 – the international standard for mechanical seals. For seals to be compliant they must be categorized and marked “H” as High Security Seals when undergoing mechanical testing by an independent ISO 17025 accredited laboratory (Clause 5) and the manufacturer must be certified to both ISO9001 and ISO17712:

The new requirement for High Security Seals is that they must also be compliant with Clause 6: Evidence of Tampering. Clause 6 requires the manufacturer to have a documented and audited process and test specification in place in its quality manual for all High Security Seals in its product range. Clause 6 is a valuable addition to the seal standard emphasizing the importance of continuous improvement of tamper resistance and tamper indicating features on security seals.

Which Security Seals Are Iso17712 Certified?

2K KLICKER BOLT SEAL

The 2K Klicker is the first container bolt seal in the world to feature a unique two colors in its design. The 2K Klicker is a high security bolt seal, certified to ISO 17712 Clause 5 and 6.

MCLZ 500 CABLE SEAL

The introduction of Mega Fortris’ new MCLZ range of cable security seals is a major step towards improving the security of the global supply chain.

MF BAR SEAL

ISO 17712 “H” High Security Seal Typical applications of the MF Bar seal include shipping and inter-modal containers.

In order to verify that a High Security Seal is certified as ISO 17712:2013, contact your security seal supplier and ask them to submit the ISO certificates mentioned:

  • The manufacturer of the seal has to be ISO 9001 certified.
  • The manufacturer of the seal has to be ISO 17712:2013 Annex a (Best Practices) certified.
  • The mechanical strength of the seal has to meet or exceed the requirements of ISO 17712 Clause 5 High Security Seal category. This is documented by ISO 17712:2013 “H” laboratory report / certificate for the seal.
  • ISO17712: 2013 Clause 6 Tamper Evidence Compliance Letter
  • The test laboratory performing the strength tests must be ISO 17025 accredited to perform ALL 5 mechanical tests according to ISO 17712:2013 Clause 5.

ISO 18788 Standard For Private Security Operations Certification

 

ISO 18788 standard provides a Management System framework for Private Security Operations through elaborating on the principles and requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving the management of safety operations. ISO 18788 provides a business and risk management framework for the effective conduct of security operations. It places a strong importance in identifying your stakeholders, including employees, customers, local communities and subcontractors. Moreover, this standard provides assurance in the quality and expertise of security organizations working in complex and fragile environments.

ISO 18788 is unlike almost any other standard, it is based upon the ethos of the United Nations Guiding Principles of Business & Human Rights. Certification provides clients, governments and communities with assurance. As a Private Security service provider or client, certification to ISO 18788 provides credibility, demonstrating effective Corporate Governance – from Board level, to physical delivery. You are able to demonstrate sustained improvement to clients through opening up operations to ongoing and regular independent scrutiny; certification is a value for money ‘assurance’ investment.

 

Benefits Of Iso 18788 Certification To Your Organization

  • Imposes credibility and helps protect your reputation
  • Boosts the probability of operational success
  • Provides assurance for customers, governments, and communities
  • Demonstrates accountability to law and respect for human rights
  • Increases organizational productivity with the best practice “Plan, Do, Check, Act” approach
  • Presents consistent and comprehensive means of demonstrating effective corporate governance from board level to physical delivery

 

ISO 18788:2015 provides framework for establishing, implementing, operating, monitoring, reviewing, maintaining and improving the Security Operations Management System (SOMS). ISO 18788 gives business and risk management the framework for SOMS, while demonstrating conduct of professional security operations to meet clients’ and other stakeholders’ requirements, in addition to accountability to law and respect to Human Rights and consistency with voluntary commitments to which subscribes.

ISO 18788 draws on provisions from and provides mechanism to demonstrate compliance with relevant principles, legal obligations and voluntary commitments and good practices of:

  • The International Code of Conduct for Private Security Providers (ICoC) 2010 
  • The Montreux Document on Pertinent International Obligations and Good Practices for States Related to Operations of Private Military and Security Companies During Armed Conflict, 2008
  • Guiding Principles on Business and Human Rights, Implementing the United Nations “Protect, Respect and Remedy” Framework, 2011

Benefits of ISO 18788 and PSC.1 to your organization:

  • Implements and maintains an effective SOMS
  • Gives your organization creditability within the private security industry
  • Shows your organization’s respect for human rights

Intertek is the first international certification body accredited by UKAS to provide certification services for Private Security Company (PSC) Operations against the ANSI/ASIS PSC.1 Standard, an extension of scope against ISO 18788. Intertek has helped organizations around the world achieve ISO 18788 certification. We provide more than just a certificate; our PSC.1/SOMS auditor team is a leading Total Quality Assurance provider to organizations worldwide.

 

Benefits Of ISO 18788 To Your Customers:

  • Helps your customers protect their reputation
  • Provides a commitment to security operations best practices
  • Demonstrates compliance with legal obligations and relevant principles
  • Provides adherence to human rights and fundamental freedoms

 

 

ISO 20000 – IT Service Management

 

Introduction

Information technology service management certification:

It is increasingly important for organizations to certify that the IT services they provide or receive from a third party comply with internationally recognized good practices.

What Is ISO 20000?

ISO 20000 standard covers the management of IT services, allowing an organization to focus its information technology services on the needs of internal or external clients, to ensure quality service and efficiency. This standard is based on a set of internationally recognized concepts and practices for information technology services (ITIL) management. The basic and fundamental reason for adopting this standard is to provide the highest quality service, either to the organization itself or to its external clients.

The ISO 20000 certification helps ensure that IT services comply with a set of minimum requirements, focused on the organizations’ business, while also providing external recognition by an independent third party.

 

Benefits Of ISO 20000 Certification

  • Protect the image and manage IT service risks regarding third parties
  • Improve the management of the IT services within the organization itself
  • Speed up response times in the event of an incident and improve the results and operation of technological applications
  • Prove there are adequate procedures and controls in place to provide consistent, cost effective and quality IT service

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

Iso 22000 – Food Safety Management System

 

Introduction

Food safety management systems certification:

The food industry supply chain is increasingly complex and global, requiring the adoption of common food quality and safety standards, which allow increasing the fluidity of relationships and ensure some common criteria for all the parties in the chain.

 

What Is ISO 22000?

The ISO 22000 certification in food and agriculture sector companies helps ensure food safety throughout the food chain to the end consumer or sales outlet.

This international standard applies to organizations involved in primary production, food producers, retailers, catering companies, and service companies related to the field of food safety (cleaning and disinfection, transportation, storage and distribution, etc.).

 

Benefits Of ISO 22000 Certification

Manage and control food safety risks in all the supply chain’s parties:

  • Help compliance with the food legislation applicable to each organization
  • Provide effective communication with the parties involved in food safety and an increase in clients’ and consumers’ trust
  • Integrate the food safety management system with the company’s quality management system (ISO 9001)
  • Achieve an industry-recognized certification
  • Increase your organization’s competitiveness

 

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

ISO 22301 – Business Continuity Management

 

Introduction

ISO 22301 is applicable to any type of organization, large or small, and within any industry sector. It is particularly important for organizations operating in high risk environments like utilities, financial services, oil and gas, transportation, telecom and food production, or where continued operation is critical, like in the public sector. ISO 22301 is published by the International Organization for Standardization (ISO).

An organization needs to take precautions and be prepared in order to continue business regardless of the nature of a challenge. Implementing business continuity management systems and standards enables your organization to handle any situation.

 

Benefits

  • Safeguard key assets and maintain your reputation
  • Identify impacts of operational disruption and crucial improvements
  • Encourage cross-team collaboration
  • Reap cost benefits from reduced insurance premiums
  • Demonstrate commitment to key stakeholders
  • Gain a competitive advantage against competitors in case of a major industrial crisis
  • Keep your promises, even when facing a crisis, and maintain delivery of products or services

The business continuity management process helps create a clear understanding of how your organization operates, and where failure might occur, and provides improvement points for your business processes. Additionally, applying business continuity management to your organization can help you get a competitive advantage, benefit your reputation and contribute to continual business improvement.

Through the certification process you will:

  • Obtain a better understanding of the organization.
  • Implement a business continuity strategy with proper response tactics.
  • Maintain the continuity management plan through exercises and reviews into the organizational culture.
  • Learn how to embed the business continuity approach.

In our audits we use our Risk Based Certification™ methodology, allowing us to tailor each audit to your unique needs. By focusing on the most significant business continuity management issues for your organization, our audits help you identify and concentrate your efforts on key improvement areas while also checking compliance against ISO 22301.

Why Certify With GITCHIA Certification?

GITCHIA Certification is a prestigious independent body that was established to help organizations achieve their aim of continuous improvement. We assess the specific needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while evaluating an organization’s compliance.

 

Our teams of professionals draw up customized certification plans taking into account client structures, processes and areas of activity. Our global presence, extensive product portfolio and wide-ranging accreditations enable us to provide our clients with a comprehensive, expert and tailor-made service.

 

What Is ISO 26000 – Guidance On Social Responsibility?

 

Introduction

ISO 26000 is defined as the international standard developed to help organizations effectively assess and address social responsibilities that are relevant and significant to their mission and vision; operations and processes; customers, employees, communities, and other stakeholders; and environmental impact.

Was published in 2010 by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standards bodies of more than 160 countries

Was written by a unique multi-sectoral group representing governments; non-governmental organizations (NGOs); industry; consumer groups; labor; and academic, consulting, and other organizations around the world

More than 400 experts and 200 observers from 99 countries and 42 international organizations contributed to the development effort

 

Last reviewed for possible revision in 2014

The ISO 26000 standard provides guidance on:

  • Recognizing social responsibility and engaging stakeholders
  • Ways to integrate socially responsible behavior into the organization
  • The seven key underlying principles of social responsibility:

Accountability

Transparency

Ethical behavior

Respect for stakeholder interests

Respect for the rule of law

Respect for international norms of behavior

Respect for human rights

  • The seven core subjects and issues pertaining to social responsibility:

Organizational governance

Human rights

Labor practices

The environment

Fair operating practices

Consumer issues

Community involvement and development

In addition to providing definitions and information to help organizations understand and address social responsibility, ISO 26000-2010 emphasizes the importance of results and improvements in performance on social responsibility.

 

Who Should Use ISO 26000?

  • Assist organizations in addressing their social responsibilities while respecting cultural, societal, environmental, and legal differences and economic development conditions
  • Provide practical guidance related to making social responsibility operational
  • Assist with identifying and engaging with stakeholders and enhancing credibility of reports and claims made about social responsibility
  • Emphasize performance results and improvement
  • Increase confidence and satisfaction in organizations among their customers and other stakeholders
  • Achieve consistency with existing documents, international treaties and conventions, and existing ISO standards
  • Promote common terminology in the social responsibility field
  • Broaden awareness of social responsibility

Why Certify With GITCHIA Certification?

GITCHIA Certification is a prestigious independent body that was established to help organizations achieve their aim of continuous improvement. We assess the specific needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while evaluating an organization’s compliance.

Our teams of professionals draw up customized certification plans taking into account client structures, processes and areas of activity. Our global presence, extensive product portfolio and wide-ranging accreditations enable us to provide our clients with a comprehensive, expert and tailor-made service

 

 

 

ISO 27001 – Information Security Management

 

Introduction

Certification of information security management systems

Information is one of the most important of any company’s assets. Organizations handle and store a vast amount of confidential or sensitive data in their systems, which must remain accessible as well as secure at all times.

 An information security management system (ISMS) allows organizations systematically and efficiently to understand, manage and minimize information-security risks. The appropriate implementation and certification of such a system provides an assurance of the confidentiality, integrity and availability of stored data.

 Certified information security management systems foster confidence among clients and improve company efficiency. ISO 27001:2013 is currently the most widely recognized standard for managing information security. This international standard was drawn up by ISO (International Organization for Standardization) in 2005 in order to safeguard the security of company-held information. It was revised in 2013 in response to needs that had become apparent during the eight years the standard had been in use. One change made was the standard’s alignment with Annex SL, bringing it into line with a high-level structure. This new structure permits organizations to enhance their health and safety and environmental performance and also facilitates the standard’s integration with other management systems.

 

What Are The Objectives Of An ISO 27001:-Certified ISMS?

 

  • To protect data and guarantee its security
  • To identify risks resulting from data storage
  • To facilitate understanding of the standard and its integration with other management systems

What Are The Benefits Of ISO 27001?

 

  • Reduced information-security risks (data loss, theft, corruption, etc.)
  • Legal compliance
  • Reduced costs and improved functioning of processes
  • Enhanced client confidence that data entrusted to the organization will be handled appropriately
  • An improved competitive advantage
  • Increased staff awareness of the importance of information security
  • Improved organizational efficiency
  • Simpler integration with other management-system standards such as ISO 9001, ISO 14001 and ISO 45001

Who Is This Standard Targeted At?

Any organization can certify its ISMS under ISO 27001, regardless of its size or sector. At the moment, this standard is implemented most frequently by IT, insurance, retail and transport companies, as well as public sector bodies.

 

Why Certify With GITCHIA Certification?

GITCHIA Certification is a prestigious independent body that was established to help organizations achieve their aim of continual improvement. We assess the individual needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while assessing an organization’s compliance.

Our team of professionals draw up customized certification plans taking into account the client’s structure, processes and area of activity. Our global presence, extensive product portfolio and wide-ranging accreditations enable us to provide our clients with a comprehensive, expert and tailor-made service.

 

Iso 28000 Standard: Supply Chain Security Certification

 

Introduction

The ISO 28000 supply chain security management systems standard can protect your goods from point of manufacturing to point of sale.

As global trade expands, so do the opportunities for criminal elements to infiltrate your supply chain. Reduce the risks with ISO 28000 certification.

Supply chain security management systems based on the ISO 28000 certification standard identify the risk levels across your supply chain operations. This information then enables your organization to carry out risk assessments and apply the necessary controls with supporting management tools (i.e. document controls, key performance indicators, internal audit and training).

An ISO 28000 audit from GITCHIA enables your supply chain security management system to be managed as a business process and its effectiveness to be measured and improved. This means resources can be focused on areas with high-risk concerns. It is also possible to benchmark against international standards.

 

What Are The Benefits?

                It will help your organization link security management to many other aspects of your business activities. Our ISO 28000 audit will look at all activities controlled or influenced by organizations that impact your supply chain security, including transportation of goods along the supply chain.

We can audit your organization’s systems against the ISO 28000 standard performing a gap analysis and if desired taking you through the full certification process.

As the world’s leading verification and certification body, we perform audits against all global and regional security requirements, including:

  • TAPA FSR (also certifiable)
  • TAPA TSR and
  • C-TPAT

 

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities.

Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

 

ISO 29990

 

What is ISO 29990

Note: – This Standard has been Withdrawn & Replaced by ISO 29993:2017

ISO 29990 sets out the criteria for a Quality Management System standard for providers of education and training services. ISO 29990 provides a unified standard for learning service providers, including corporations, vocational institutions, and life-long learning centers, around the globe. It promotes the design of suitable services & evaluation of learning results.

The aim of ISO 29990 is to provide a generic model for quality professional practice and performance for teach service providers (LSPs) in the development and delivery of education, training.

The standard follows a process-based structure to ensure its implementation leads to continual improvement. The standard’s ultimate aim is assuring the implementation of high-quality tutorial programs and processes.

 

Requirements of Standard

This standard has clauses as follows:-

  1. Scope
  2. Terms & Definitions
  3. Learning Services
    • Determining Learning Needs
    • Design of Learning Services
    • Provision of Learning Services
    • Monitoring the delivery of the Learning Services
  4. Management of the Learning Service Provider
    • General Management Requirements
    • Strategy & Business Management
    • Management Review
    • Preventive Actions & Corrective Actions
    • Financial Management & Risk Management
    • Human Resource Management
    • Communication Management (External/Internal)
    • Allocation of Resources
    • Internal Audits
    • Feedback from Interested Parties

BENEFITS of ISO 29990:2010

 

Advantages for Learning Service Providers:-

    • Outstanding performance during tendering work from official bodies.
    • Globally marketability.
    • Enhancement in internal quality potential.
    • Transparently defined & documented processes.
    • Enthusiastic and active trained experts’ participation in the development.
    • Work on (PDCA) Cycle.

 

Advantages for Learner:-

    • Adequate resources, including trainers with suitable competence, infrastructure and learning environment.
    • Evaluating criteria for Education.
    • Advanced & Authentic processes.
    • Transparency/comparability of services.
    • Assuring quality, transparency and comparability in educational institutions.

Benefits for Global Cooperation

Base of development for international cooperation in the area of education and training

    • Globally comparable benchmarks for existence of quality.
    • No deformation of the globally competitive market.
    • Common unified standards/common understanding of quality.

 

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

ISO 31000 Risk Management – Principles and Guidelines

Introduction 

ISO 31000 is an international standard issued in 2009 by ISO (International Organization for Standardization), and it is intended to serve as a guide for the design, implementation and maintenance of risk management. All types and sizes of organizations face internal and external factors and influences that make it uncertain whether and when they will achieve their objectives. The effect this uncertainty has on an organization’s objectives is risk.

 Risk is involved in any activity of an organization. ISO 31000 describes a systematic and logical process, during which organizations manage risk by identifying it, analyzing and then evaluating whether the risk should be modified by risk treatment in order to satisfy their risk criteria.

 Risk management can be applied to an entire organization, at its many areas and levels, at any time, as well as to specific functions, projects and activities.

 An overview of ISO 31000

ISO 31000 provides principles and generic guidelines to assist organizations in establishing, implementing, operating, maintaining and continually improving their risk management framework.

 It is not specific to any industry or sector, so it can be used by any public, private or community enterprise, association, group or individual. This standard can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services and assets.

 This standard is not intended to promote uniformity of risk management across organizations. The design and implementation of risk management plans and frameworks will need to take into account the varying needs of a specific organization, its particular objectives, context, structure, operations, processes, functions, projects, products, services, or assets and specific practices employed.

 

What is risk management? 

Risk management is defined as a set of coordinated activities to direct and control an organization with regard to risk.

 

Implementation of risk management with GITCHIA risk management framework 

Making the decision to implement a risk management framework based on ISO 31000 is often a very simple one, as the benefits are well documented. By following a structured and effective methodology, an organization can be sure to cover all minimum practices required for the implementation of risk management programme.

There is no single blueprint for implementing ISO 31000 that will work for every company, but there are some common steps that will allow you to balance the often conflicting requirements and prepare you for a successful certification audit.

 

GITCHIA has developed a framework for risk management. It is called “GITCHIA Risk Management Framework” and is based on applicable best practices.

 

Choosing the right certification 

The certified ISO 31000 Risk Manager credential is a professional certification for professionals needing to demonstrate the competence to implement, maintain and manage a risk management program according to ISO 31000.

 

 

 

ISO 39001 – Road Traffic Safety

 

Introduction

Road safety management system certification – helping organizations to reduce their risks.

According to data from the Spanish Red Cross, road traffic accidents are the primary cause of death in Spain for certain age groups of the population. At a global level, 1.3 million people die each year in road accidents, with another 50 million suffering some level of injury. It is forecast that road accidents will be the world’s third most common cause of death by the year 2020.

The social and economic impact of such incidents provides the context for the development of UNE ISO 39001, the standard for road traffic safety (RTS) management systems. The standard has a clear goal: to help organizations reduce the rate of road accidents related to their professional activity. 

What Is UNE ISO 39001 Certification?

UNE ISO 39001 provides guidelines for an organization’s behavior with regards to road safety systems, helping companies to identify their risks and coordinate the various elements of such a system so as to establish, evaluate and comply with accident-reduction policies.

UNE ISO 39001 certification clearly demonstrates a company’s commitment to reducing its rate of road accidents. It is also important to note that Spanish Royal Decree 404/2010 sets out a system of social security bonuses for companies demonstrating such a commitment.

The UNE ISO 39001 standard for RTS management systems shares the same structure as, and is therefore compatible with, other better-known management systems including ISO 9001 and ISO 14001 – in particular occupational health and safety and social responsibility systems.

 

Key Benefits

  • Contributes to reducing the rate of road accidents related to the organization’s professional activity
  • Demonstrates a commitment to road safety
  • Gives employees the highest possible guarantees of road safety
  • Ensures the suitability of the organization’s road safety policies
  • Minimizes the direct costs of road accidents
  • Offers customers and potential customers enhanced service guarantees

 

Why Certify With GITCHIA Certification?

GITCHIA Certification is a prestigious independent body that was established to help organizations achieve their aim of continuous improvement. We assess the specific needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while evaluating an organization’s compliance.Our teams of professionals draw up customized certification plans taking into account client structures, processes and areas of activity. Our global presence, extensive product portfolio and wide-ranging accreditations enable us to provide our clients with a comprehensive, expert and tailor-made service.

 

ISO 45001 – Occupational health and safety

 

Introduction

The new, international ISO 45001 standard supersedes the British OHSAS 18001 standard. Both share the same objective: helping businesses to prevent accidents and manage health and safety in the workplace. In 2015, ISO (International Organization for Standardization) began work on ISO 45001 with a view to developing a truly international standard that could bridge the divide created by OHSAS 18001. The main aim of this new standard is to protect all workers around the world with a single version of the standard. The final draft of ISO 45001 was approved in January 2018 and the standard was published in March. Companies have 3 years to make the transition to the new standard before OHSAS 18001 is repealed.

 

What Are The Benefits Of Iso 45001?

 

Occupational accidents and illnesses not only affect worker health and safety, but also have a major impact on organizations as a whole. ISO 45001 certification offers companies a variety of advantages, including:

  • Improved management of incidents and a subsequent reduction in lost time
  • Reduced insurance premiums and general cost savings related to health and safety incidents
  • Reduced absenteeism and turnover rates
  • Simplified communication with overseas suppliers, clients and partners
  • Enhanced company image through a demonstration of social responsibility
  • Improved competitive advantage

 

Who Is This Standard Targeted At?

Any organization can implement and certify a management system under ISO 45001, regardless of its size or sector. The standard is particularly aimed at companies wanting to:

  • Minimize risks to staff and other stakeholders through the implementation of an internationally recognized health and safety management system
  • Maintain and constantly improve on performance levels in the area of health and safety
  • Adjust all operations to comply with the health and safety policies set out in this international standard

 

Transition From OHSAS 18001 To ISO 45001

The new standard was published on 12th March 2018 and there is a transition period in force for all companies wishing to remain certified. As of 11th March 2021, occupational health and safety management systems will need to be certified under ISO 45001.

Understanding the principal aspects of the new standard is vital to ensuring a successful transition.

GITCHIA Certification runs training courses to help clients understand how the changes will affect them and to explain the benefits of certifying to ISO 45001 standard. Our highly experienced team of auditors can also offer clients a professional audit of their management systems and certify their compliance with the new requirements.

 

How Does The New Standard Differ From OHSAS 18001?

 

The new ISO 45001 standard differs from OHSAS 18001 in a number of key respects, principally in terms of structure and content. The following are some of the new features to be found in ISO 45001:

  • Terms and definitions. ISO 45001 provides more definitions, including new concepts such as “Performance evaluation”, “Context of the organization”, “Support”, “Leadership”, “Operation”, “Improvement”, “Planning” and “Worker participation”.
  • Context of the organization. To implement ISO 45001, a company’s internal characteristics –its structure, objectives, policies and strategies, amongst other things – must first be taken into account. It is also a prerequisite to consider any external context that may impact on the management system – the cultural, social and economic climates, for example – as well as to assess competencies.
  • Leadership and worker participation. While OHSAS 18001 refers only to leadership, clause 5 of the ISO 45001 standard brings in worker participation and consultation. It also places greater emphasis on the responsibility of management throughout the process.
  • Planning. The new standard more clearly defines the requirement to identify hazards by assessing risks and opportunities. This facilitates the prediction and mitigation of undesired effects on processes.
  • Support. Here, the primary difference between the new standard and OHSAS 18001 is that in ISO 45001, resources are listed under “Documented information” and not “Documents and records”.
  • Operation. ISO 45001 incorporates controls on all processes and includes the identification of potential emergency scenarios so that an appropriate response can be planned.
  • Performance evaluation. The new standard also covers the management system’s monitoring and measurement. The aim is to make it easier to meet the compliance obligations. This assessment is also fundamental as it feeds into both the internal audit and the management review.
  • Improvement. This section is divided into two parts. The first refers to incidents, nonconformity and corrective action. The second details continual improvement, with objectives defined and the process of achieving them explained.

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement.

We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities.

Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

 

ISO 50001:2018 – Energy Management System

 

Introduction

ISO 50001 is based on the management system model of continual improvement also used for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management.

ISO 50001:2018 provides a framework of requirements for organizations to:

  • Develop a policy for more efficient use of energy
  • Fix targets and objectives to meet the policy
  • Use data to better understand and make decisions about energy use
  • Measure the results
  • Review how well the policy works, and
  • Continually improve energy management.

 

Who Is This Standard Targeted At?

This document specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The intended outcome is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance and the EnMS.

This document:

  • Is applicable to any organization regardless of its type, size, complexity, geographical location, organizational culture or the products and services it provides;
  •  Is applicable to activities affecting energy performance that are managed and controlled by the organization;
  • Is applicable irrespective of the quantity, use, or types of energy consumed;
  • Requires demonstration of continual energy performance improvement, but does not define levels of energy performance improvement to be achieved;
  • Can be used independently, or be aligned or integrated with other management systems.

 

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance. Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

 

 

ISO TS 16949 – Automotive Quality Management

 

Introduction

The automotive industry’s demands throughout its supply chain have required the establishment of their own standard for the mass production of components and replacement parts. This certification is essential for direct suppliers of vehicle manufacturers and may be a requirement for any supplier within the supply chain.

What Is ISO TS 16949?

The ISO 16949 standard is the quality management standard recognized in the automotive industry and includes a process management model that is specific, approved by consensus and recognized in the automotive industry. Any company that produces components or systems that will end up in cars, trucks, motorcycles or buses, is susceptible to this certification.

The ISO TS 16949 certification must be performed by an independent entity accredited by the International Automotive Task Force (IATF). For proper implementation and maintenance, the certified organization must have staff trained in the interpretation of IATF’s standard.

 

Benefits Of ISO TS 16949

  • Contribute to the compliance with the entry requirements for the automotive industry supply chains
  • Ensure a management model with proven effectiveness and efficiency
  • Reduce or eliminate non-quality costs
  • Reduce client audits
  • Promote continuous improvement dynamics within the organization
  • Enhance management and staff involvement in the quality system and improves the relationship between departments and/or processes

 

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance. Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

Quality management system certification for customer contact center

Certification according to the EN 15838 standard deals with customer contact centers that provide services to customers. (call centers, direct marketing, customer phone lines etc.)

Description:

The EN 15838 certificate issued by an independent, accredited certification body guarantees that a quality management system has been implemented, documented, used, maintained and improved by the supplier of customer contact services. Certified organizations can promote themselves as certificate holders in their promotional materials and can include the URS certification logo free of charge.

Why EN 15838 – Quality management system certification for customer contact center?

  • Guarantees high quality of provided services and products
  • Implements an international standard in the company
  • Reduces operational costs
  • Increases effectiveness across the whole organization
  • Increases customer trust in your organization as a safe supplier of services

ISO 28001 – Security Management Systems For The Supply Chain

ISO 28001 defines the requirements for the implementation of a security management system along the supply chain (Supply Chain Security).

The standard is applicable to all sectors, from manufacturing to services, from logistics to transport and covers every stage of production or supply. In fact, considering the management system as a whole, it includes not only the production but also the distributive chain.

Benefits Of Iso 28001 – Security Management Systems For The Supply Chain

  • manage security as an organic process
  • adopt a risk management approach
  • integrate a security system with other aspects of the organization
  • reduce customs times and make administrative procedures more efficient
  • strengthen the trust relationship with stakeholders and insurance companies.

OHSAS 18001 – Occupational Health & Safety

Introduction

Certification of your organization’s Occupational Health & Safety (OHS) management system:

Employee health and safety are the employer’s inherent responsibility in a particularly sensitive environment, due to both the large level of social awareness and the existing legislation. Therefore, organizations have to control and manage the occupational hazards that affect their workers.

 

What Is OHSAS 18001 Certification?

OHSAS 18001 certification helps companies systematically integrate and manage their Occupational Health & Safety policies. This standard specifies the necessary requirements for a better control of the risks arising from normal or exceptional work conditions. To achieve this certification, the organization subjects itself to an audit by an independent body, thus gaining internationally valid public recognition.

 

Benefits Of OHSAS 18001

  • Helps minimize the risks of occupational incidents and accidents
  • Conveys peace and trust to your employees, shareholders, clients or users
  • Lowers the possibility of penalties for legal violations
  • Increases the controls and warranties in your occupational health and safety management system

 

 Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.

Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

 

SA8000 Audits

International Associates is accredited by Social Accountability Accreditation Services (SAAS)/IDA to certify companies to SA8000. Social Responsibility can strengthen your company’s reputation, in the current global business environment is motivating organizations to consider the full social and ethical impacts of their activities. Companies that prove a responsible approach to social and ethical issues will gain a vital competitive edge and build confidence in its clients, investors, local communities and consumers.

                                                                     

Who is SAAS?

 SAAS stands for Social Accountability Accreditation Services (SAAS) which is an Accreditation Agency which was founded to provide Accreditation and monitor Organizations as Certifiers of Social Standards who comply with the requirements of SA8000. SAAS was started as a department within SAI, which stands for Social Accountability International, in 1997, and was established as a non-profit organization ten years later in 2007.

What kind of standards does social accountability ensure?

Those organizations who gain social compliance certification will ensure that their employees and those employees of their suppliers do not work for more than 48 hours per week or more than six days per week. Wages throughout the supply chain must be at worse equal to legal or industry minimum levels and must leave the employee with some discretionary income. The final requirement governing management systems sets out the procedures and structures that companies must adopt to ensure compliance with the standard is continuously reviewed.

What is SA8000?

SA8000 was the first audible standard in this field. In particular, it is compatible with ISO 9001, ISO 14001, OHSAS 18001 structures and based on conventions of the International Labor Organization (ILO), the Universal Declaration of Human Rights and the UN Convention on the Rights of the Child. The worldwide-recognized certification to the SA8000 standard involves the development and auditing of management systems that promote socially acceptable working practices bringing benefits to the complete supply chain.

Why get certified?

Having a robust and effectively implemented social accountability management will benefit your business by:

  • Enhancement of your brand, image and reputation
  • Improving worker morale and thus effectiveness
  • Creation of new opportunities
  • Giving you an edge over non-approved competitors
  • Attracting new customers
  • Attracting ethical investment
  • Demonstrating transparency to stakeholder

 

 

What are SA8000 main requirements?

There are nine key areas to Social Compliance and SA8000, which are:

Child Labor

Forced Labor

Health & Safety

Freedom of Association & Collective Bargaining

Discrimination

Disciplinary Practices

Working Hours

Compensation

Management systems

 

Within the key areas there is specific focus on 

  • A ban on child labor and forced labor
  • Demanding and introducing humane working conditions
  • The guarantee of a living wage
  • No discrimination on the grounds of race, gender, or religion
  • The systematic improvement of working conditions
  • External verification (through certification)
  • The right to freedom of association, to organize in trade unions and engage in collective wage negotiations
  • Commitment to a maximum working period of 48 hours per week with one free day.

What is the assessment process?

Initial Enquiry

Please complete our online application and we will contact you if there are any clarifications. We shall then issue a quotation which will cover the assessment and certification processes.

Assessment Process

Once the contract has been agreed with us, the social accountability assessment is conducted:

  • Assessment team appointed and communicated
  • Stage 1 Visit on-site
  • Stage 2 Visit on-site

Certification Process

Recommendations from the Lead Auditor to the Decision Maker regarding award of Certification.

Benefits Of SA 8000 Certification Standard

  • Proves your commitment to social accountability and to treating your employees ethically and in compliance with global standards
  • Improves the management and performance of your supply chain
  • Allows you to ensure compliance with global standards and reduce the risk of negligence, public exposure and possible litigation
  • Supports your corporate vision and build and reinforce the loyalty of your employees, customers and stakeholders
  • Enables you to demonstrate proper social accountability when bidding for international contracts or expanding locally to accommodate new business

 

Surveillance Process

It is a requirement under our Accreditation that continual monitoring visits take place. These visits will be agreed in advance, with the exception of visit 2 in the certification cycle which shall be unannounced.