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standard-title ISO Consultancy

ISO Consultancy


By providing essential and unique Smart Business Solutions, we aspire to continually develop and enhance our capacity to assist our customers in becoming more competitive, in a world where businesses transact at an unprecedented speed.


Total Quality Management (TQM) is a systematic approach designed to help businesses progress their practices to more predictably lead to a constantly high quality product. Training in TQM is more commonly available at certificate and graduate certificate levels, but master’s degree programs also offer training in this business philosophy.

The total in TQM applies to the complete organization. Therefore, unlike an ISO 9000 initiative which may be limited to the procedures producing deliverable products, TQM applies to each activity in the organization. Also, unlike ISO 9000, TQM covers the soft issues such as ethics, attitude and culture.

The Total Quality Management Certification Test checks your information about the significant concepts, skills and techniques associated to the art of Total Quality Management. This test covers all the aspects of the art of Total Quality Management like meaning, concepts, foundation and principles of Total Quality Management, the quality management tools, implementation of Total Quality Management in an organization, and TQM in a variety of fields.

  • Introduction to Total Quality Management
  • TQM in Various Fields
  • Quality Management Systems and Tools
  • Paving the Way for Organizational Transition to TQM
  • Important Aspects and Principles of TQM

Total quality management is a huge support when it comes to improving the performance of an organization and in ensuring that the products and services offered to the public are of the highest quality and carry on to meet the demands of end users so enrolling in the total quality management certification program from us can definitely do you a lot of good. Included in the coverage of our total quality management certification course are the following:

  • fundamentals of total quality management
  • significance of having a quality management system
  • established advantages of TQM
  • Foundations and framework behind total quality management
  • Differences between the practices used in TQM and the practices used in traditional management
  • Understanding all the major aspects and principles behind total quality management
  • Committing to give the best products and services to clients
  • Gathering data and analyzing them to start improving the quality of products and services
  • Continuous development and human resources management and their relationship to TQM
  • Vital elements of the total quality management system and quality cost system
  • Building a framework that will efficiently measure quality
  • Measuring and analyzing both performance and feedback
  • Implementing, evaluating and controlling TQM
  • Understanding the different systems and tools used in TQM and their individual functions and benefits
  • Implementing total quality management in a variety of industries and fields including the manufacturing industry, education, construction and healthcare

A GMP is a system for making sure that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP is an abbreviation for Good Manufacturing Practices. GMP is an initiative of the WHO. The main aim of GMP is to see to it that the products are good sufficient for utilization after the final outcome. GMP governs the product at each and every step of manufacturing.

Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as essential by the marketing authorization (MA) or product specification. GMP is concerned with both production and quality control.

A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites essential for the implementation of an efficient Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.

What does GMP cover?

  • Record maintenance
  • Equipment Verification
  • Personnel Qualifications
  • Sanitation
  • Procedure Validation
  • Complaint Handling
  • Cleanliness

Benefits of GMP Certificate

  • Poor quality products can damage health.
  • GMP certification helps boost export opportunities.
  • GMP certification enhances consumer confidence in your products;
  • GMP certification helps to reduce operating costs due to rework and penalties due to non-compliance
  • GMP Certification improves the food safety management system;

ISO standards are reviewed every five years and revised if required. This supports make sure they remain helpful tools for the market. The challenges faced by business and organizations today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account.

Both old and new standards cover effectively the same topics. However, there are some essential differences. Some of these are discussed below.

Structure of the standard

A general structure is possible because basic concepts such as management, client, needs, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are general to all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic needs, it may cause some disturbance in the short run as organizations get used to the new structure.

A common structure is possible because basic concepts such as management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are common to all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic requirements, it may cause some disruption in the short run as organizations get used to the new structure.

Context of the organization

Unlike the old standard, the new one expects you to understand your organization’s context before you establish its QMS. When ISO 9001 2015 asks you to understand your organization’s context it wants you to think the external and inside issues that are relevant to its reason and strategic direction and to think about the influence these issues could have on its QMS and the results it intends to get.

This means that you require understanding your organization’s external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences.

And once you understand all of this, you’re expected to use this special insight to help out you defines the scope of your QMS and the challenges it must deal with. While this will certainly help make sure that organizations develop unique quality management systems that address their own needs and requirements, doing all of this could be quite a challenge for some organizations.

Documented information

The new ISO 9001 2015 standard has also eliminate the long standing distinction between documents and records. Now they are both referred to as “documented information”. Why ISO chose to abandon two common sense concepts and replace them with one that is needlessly awkward and esoteric is not entirely clear.

According to ISO’s definition, the term documented information refers to information that must be controlled and maintain. So, at any time ISO 9001 2015 uses the term recognized information it implicitly expects you to control and maintain that information and its supporting medium. However, this isn’t the whole story.

An annex to the new standard (A.6) further says that “Where ISO 9001:2008 would have referred to documented procedures …
this is now expressed as a need to maintain documented information”, and “Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information”.

So, whenever the new standard refers to documented information and it asks you to maintain this information, it’s talking about what used to be referred to as procedures, and whenever it asks you to retain this information, it’s talking about what used to be called records. So sometimes it must be maintained and sometimes it must be retained (contrary to what the official definition says).

So, while the definition of the term “documented information” abandons the distinction between documents (or documented processes) and records, through the use of the words “maintain” and “retain” and because of what this means (according to Annex A) the main body of the standard actually restore this distinction.

In other words, while documents and records were kicked out the front door, they were actually permitted back in through the back door.

Risk-based thinking

According to the new standard, “risk-based thoughts has always been implicit in ISO 9001”. According to this perspective, ISO 9001 has always been about anticipating and preventing mistakes, which is what risk-based thinking is all about. That’s why we train people, why we plan our work, why we assign roles and responsibilities, why we validate and verify results, why we audit and review behavior, and why we monitor, measure, and control procedures. We do these things because we want to prevent mistakes. We do them because we’re trying to manage risk. So, if we think of risk-based thinking in this way, it’s always been an inherent part of ISO 9001. Before it was implicit; now it’s explicit.

So what kind of thinking is risk-based thinking and how is it applied? What does the new standard expect organizations to do? The new standard expects organizations to recognize and address the risks that could influence their ability to provide compliant products and services and to satisfy clients. It also expects them to identify and address the opportunities that could enhance their ability to provide compliant products and services and to satisfy customers.

The new ISO standard also expects organizations to identify the risks and opportunities that could influence the performance of their quality management systems or disrupt their operation and then it expects them to define actions to address these risks and opportunities. It then further expects them to figure out how they’re going to make these actions part of their QMS processes and how they’re going to implement, control, evaluate, and review the efficiency of these actions and these procedures.

While risk-based thinking is now an essential part of the new standard, it does not actually expect you to implement a formal risk managing process nor does it be expecting you to document your risk-based approach.

Requirements and exclusions

Section 1.2 of ISO 9001 2008 says that organizations may exclude or ignore product recognition requirements (section 7) if they cannot be applied and if doing so doesn’t interfere with its ability or responsibility to meet customer and legal requirements. The new standard takes a similar approach but, instead, appear to apply this thinking to all requirements.

Section 4.3 of ISO 9001 2015 says “The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system”. So once you’ve determined the scope of your QMS, ISO 9001 2015 says that every need must be applied within the boundaries defined by your statement of scope if it applies in your case.

However, while the new ISO 9001 2015 standard says that every requirement must be applied, section 4.3 and Annex A5 also says that any requirement may be excluded if it cannot be applied, if you can justify and explain why it can’t be applied, and if excluding it does not undermine your ability or responsibility to ensure that products and services are in compliance.

So, the message is clear: if a requirement can be applied you can’t just disregard it. You must apply it. And if you really can’t apply it, you better be able to explain why not.

Objects, outputs, products, and services

The definition of the term “object” is new. The introduction of the term “object” to mean anything conceivable or perceivable and its use in a variety of definitions (quality, design and development, innovation, review, traceability) appear to suggest that the new ISO 9001 standard can be applied to any object whatsoever. In theory at least, this greatly expands its scope.

What ISO 9000 2005 used to call a “product” the new standard now calls an “output”. The two definitions are the same. Since the term “output” was not defined in 2005, this shift in terminology suggests that the procedure approach is now even more central to the new standard.

And to further complicate things, the old definition of “product” has now been split into three separate definitions for the terms output, product, and service. “Output” is the general concept since both “products” and “services” are now thought of as “outputs”.

Other clarifications and modifications

While the earlier changes could be the most important ones, the new standard has also clarified some concepts and modified others. Some of these changes are listed below.

The old standard said that a “service” was a type of “product”. Now, the phrase “products and services” is used throughout the new standard and the term “service” has received its own definition. This should help out make it clear that ISO 9001 2015 applies not only to manufacturers but also to all types of service providers.

What used to be called “customer property” has been customized and greatly expanded to include products, services, and processes belonging to all types of external providers (including clientele). The new standard now expects you to control externally provided products and services if they are included in your products or services or if they are provided directly to clients.

The old definition of “continual improvement” has changed. When ISO 9001 2008 asked you to make continual improvements it was asking you to improve your ability to fulfill needs. Now, ISO 9001 2015 says it means enhancing performance (getting better results). This is an important shift.

According to the new standard, organizations must now recognize, acquire, and share the “knowledge” that personnel need in order to support procedure operations and achieve conformity of products and services.

The old concept of “product realization” is gone. Most of the material in the old product understanding section has been customized and moved to the new ISO 9001 2015 section on Operations.

The term “management representative” has been dropped. The management duties and responsibilities that were earlier assigned to someone called a “management representative” may now be assigned either to one person or to many people.

“Preventive action” has also disappeared. It’s been replaced by “risk-based-thinking”, evidently because both approaches try to achieve the same thing. Both try to prevent future problems. Once you introduce risk-based thinking, you no longer need a separate clause on preventive action. It’s redundant.

While the old standard asked you to use monitoring and measuring “equipment”, the new standard refers to monitoring and measuring “resources”. This is a more bendy approach to monitoring and measuring because it identify the fact that these activities can often be carried out without the use of equipment.

General topic comparison between the ISO 9001:2008 standard and the ISO 9001:2015 standard?

ISO 9001:2008 ISO 9001:2015
THE STRUCTURE Compare the old Structure Preparing for Integrated Standards
CONTEXT How the QMS relates internal issues to external issues 9001:2015 requires how an organization defines internal and external influences
DOCUMENTED INFORMATION The documents are strictly defined The new standard loosens the definition to “information” and the quality manual requirements
RISK BASED EMPHASIS Risk was implicit in ISO 9001:2015 ISO 9001:2015 explicity expects risk assessment and avoidance
EXCLUSIONS & REQUIREMENTS Excluding a standard requirement was specific to Product Realization The new standard allows for a more general way to exclude specific requirements
OBJECTS, OUTPUTS, PRODUCTS AND SERVICES Process Based Only The process model is expanded to include anything that affects quality
CLARIFICATIONS From implementing, and auditing within ISO 9001:2008, there were a number of issues that needed clarification

Clause by Clause Comparison

ISO 9001: 2015 ISO 9001:2008 DISCUSSION
4 Context of the organization 1.0 Scope
4.1 Understanding the organization and its context 1.1 General A new requirement – the organization must determine the external and internal context that affects the organization
4.2 Understanding the needs and expectations of interested parties 1.1 General
4.3 Determining the scope of the quality management system 1.2 Application 4.2.2 Quality manual The Quality Manual is no longer mandatory. The requirement remains for determining and documenting its scope.
4.4 Quality management system and its processes 4 Quality management system
4.1 General requirements
This requirements remains, the new cover risks, opportunities, and assigning authority for processes.
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment
5.1.1 Leadership and commitment for the quality management system 5.1 Management commitment
5.1.1 Leadership and commitment for the quality management system 5.1 Management commitment The new version requires top management to become accountable for the QMS’ effectivness.
5.1.2 Customer focus 5.2 Customer focus Virutally the same except the new version includes services (along with products) and also addresses government regulations.
5.2 Quality policy 5.3 Quality policy
5.3 Organizational roles, responsibilities and authorities 5.5.1 Responsibility and authority
5.5.2 Management representative
The new version details the responsibilities, roles and authorities within the QMS.
6 Planning for the quality management system 5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning 8.5.3 Preventive action
6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system planning
7 Support 6 Resource management
7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources
7.1.2 People 6.1 Provision of resources
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the operation of processes 6.4 Work environment The 2015 version focuses the provision of resources to monitor and measure. The organization must retain the evidence monitoring and measuring resources.
7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment
7.1.6 Organizational knowledge New The organization must determine the knowledge necessary to run the processes and achieve conformity of products and services
7.2 Competence 6.2.1 General 6.2.2 Competence, training and awareness The old version covered both competence and awareness in the same clause. The new clause separates them.
7.3 Awareness 6.2.2 Competence, training and awareness Separated for clarity and focus.
7.4 Communication 5.5.3 Internal communication Internal and External communication responsibilities must be defined.
7.5 Documented information 4.2 Documentation requirements
7.5.1 General 4.2.1 General
7.5.2 Creating and updating 4.2.3 Control of documents 4.2.4 Control of records Documents and records are now considered in the same category (i.e. documented information)
7.5.3 Control of documented Information 4.2.3 Control of documents 4.2.4 Control of records
8 Operation 7 Product realization
8.1 Operational planning and control 7.1 Planning of product realization
8.2 Determination of requirements for products and services 7.2 Customer-related processes The new version emphasizes documenting the treatment of customer property.
8.2.1 Customer communication 7.2.3 Customer communication
8.2.2 Determination of requirements related to products and services 7.2.1 Determination of requirements related to the product
8.2.3 Review of requirements related to the products and services 7.2.2 Review of requirements related to the product
8.3 Design and development of products and services 7.3 Design and development
8.3.1 General New
8.3.2 Design and development planning 7.3.1 Design and development planning
8.3.3 Design and development Inputs 7.3.2 Design and development inputs
8.3.4 Design and development controls 7.3.4 Design and development review 7.3.5 Design and development verification
7.3.6 Design and development validation
The new clause aggregates of the three 2008 clauses, and emphasizes the nature, duration of design and development processes.
8.3.5 Design and development outputs 7.3.3 Design and development outputs
8.3.6 Design and development changes 7.3.7 Control of design and development changes
8.4 Control of externally provided products and services 7.4.1 Purchasing process
8.4.1 General 7.4.1 Purchasing process
8.4.2 Type and extent of control of external provision 7.4.1 Purchasing process 7.4.3 Verification of purchased product
8.4.3 Information for external providers 7.4.2 Purchasing information The 2015 version emphasizes monitoring and control of external providers.
8.5 Production and service 7.5 Production and service provision
8.5.1 Control of production and service provision 7.5.1 Control of production and service provision
8.5.2 Identification and traceability 7.5.3 Identification and traceability
8.5.3 Property belonging to customers or external providers 7.5.4 Customer property Describes extending requiments for property belonging to external providers (as well as customers).
8.5.4 Preservation 7.5.5 Preservation of product
8.5.5 Post-delivery activities 7.5.1 Control of production and service provision The new standard separates to a new clause.
8.5.6 Control of changes 7.3.7 Control of design and development changes A new separate clause is used to highlight the importance of change control.
8.6 Release of products and services 8.2.4 Monitoring and measurement of processes 7.4.3 Verification of purchased product
8.7 Control of nonconforming process outputs, products and services 8.3 Control of nonconforming product
9 Performance evaluation New
9.1 Monitoring, measurement, analysis and evaluation 8 Measurement, analysis and improvement
9.1.1 General 8.1 General
9.1.2 Customer satisfaction 8.2.1 Customer satisfaction
9.1.3 Analysis and evaluation 8.4 Analysis of data
9.2 Internal audit 8.2.2 Internal audit The new standard does not require a documented procedure
9.3 Management review 5.6 Management review
10 Improvement 8.5 Improvement
10.1 General 8.5.1 Continual improvement
10.2 Nonconformity and corrective action 8.3 Control of nonconforming product 8.5.2 Corrective action
10.3 Continual Improvement 8.5.1 Continual improvement The 2015 standard emphasizes the use of all available information for continually improving the Quality Management System

Benefits of ISO 9001:2015 Certificate

The new version of the standard brings the user a number of benefits:

  • Addresses supply chain management more effectively
  • Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity
  • Puts greater emphasis on leadership engagement
  • Supports address organizational risks and opportunities in a structured manner
  • Is more user-friendly for service and knowledge-based organizations

Section Changes in ISO 9001:2015

Section 1: Scope Scope
Section 2: Normative Reference Normative References
Section 3: Terms and Definitions Terms and Definitions
Section 4: General Requirements Context of the Organization
Section 5: Management Responsibility Leadership
Section 6: Resource Management Planning
Section 7: Product Realization Support
Section 8: Measurement, Analysis and Improvement Operation
Section 9: Performance Evaluation
Section 10: Improvement

BIFMA’s sustainability certification program for furniture which includes performance necessities that address economic, environmental, and social responsibility throughout the supply chain. BIFMA e3 is applicable to manufacturers of business and institutional furniture and looks for to provide measurable market-based definitions of increasingly more sustainable furniture. BIFMA e3 certification is necessary by many organizations including the U.S. Government, who now needs e3 Gold standard certification from all suppliers of office furniture. The e3 standard (Economy, Energy and the Environment) was initiated by the U.S. government to encourage more environmentally sustainable practices in the manufacturing sector. Certification also applies toward points in the EPA Leed Certificate program.

Furniture in office environments can take a lot of mistreatment. That’s why furniture manufacturers voluntarily conduct third-party testing for presentation and durability characteristics, to make sure that their products maintain their integrity in the toughest environments.

BIFMA level certification is a voluntary standard for business and institutional furniture manufacturers. The standard establishes measurable criteria for multiple levels of achievement and presentation for manufacturers at different stages of their sustainability journey. Manufacturers that achieve level certification demonstrate to the market that their products, manufacturing facilities and company policies have met stringent third-party sustainability needs.

BIFMA level certification is a voluntary standard for business and institutional furniture manufacturers. The standard started measurable criteria for many levels of achievement and performance for manufacturers at different stages of their sustainability journey. Manufacturers that achieve level certification demonstrate to the market that their products, manufacturing facilities and company policies have met stringent third-party sustainability necessities.

Benefits of BIFMA Certification

  • Establishes your leadership qualifications in the office furniture industry
  • Helps your internal sustainable management objectives
  • Establishes a path for constant development.
  • Assures clients and stakeholders that your certified products are held to industry-leading social, environmental and economic standards
  • Helps you meet state and federal procurement necessities

Basically put, GREENGUARD Certification makes sure that a product has met some of the world’s most rigorous and comprehensive standards for low down emissions of volatile organic compounds (VOCs) into indoor air.

The GREENGUARD Certification Program (formerly known as GREENGUARD Indoor Air Quality Certification) gives assurance that products designed for use in indoor spaces meet strict chemical emissions limits, which contribute to the creation of healthier interiors. Achieving GREENGUARD Certification gives credibility to manufacturers’ sustainability claims, backing them with empirical technical data from an unbiased, third-party organization.

If a product has been GREENGUARD Certified, it has been tested and systematically proven to have low chemical emissions, says Scott Steady, product manager for indoor air quality at UL Environment. In other words, it’s guaranteed to provide off only low levels of volatile organic compounds, or VOCs.

GREENGUARD Certification standards have established performance-based standards to describe products and procedures with low chemical and particle emissions for use indoors. The standards are primarily for structure materials, finishes, interior furnishings, furniture, cleaning goods and electronic tools. The standards establish certification procedures including test methods, permissible emission levels, product trial collection and handling, testing type and frequency as well as program application procedures, toxicity limits and acceptance.

Benefits of Greenguard Certification

The Green Guard Certification Program gives you with the confidence that the goods made for use in indoor spaces meet strict chemical emissions limits, which gives healthier interiors. This means that manufacturers are capable to develop and clients are able to recognize products and materials having low chemical emissions which support develop air quality and the environment as a whole.

Achieving Green Guard Certification adds credibility to manufacturers’ sustainability claims, supporting them with systematic firsthand data from an unbiased, third-party organization.

Muslims commonly use two terms to explain every subject as Halal or Haraam. Halal is a Arabic word which means allowable, lawful with respect to which no restriction exists, and the doing and consuming of which the Law-giver, Allah has permitted.

Halal means the opposite-unlawful that which the Lawgiver completely prohibited; anyone who engages in it is liable to incur the penalty of Allah in the Hereafter as well as a legal punishment in this world.

Halal is universal terms that affect to all facets of life. However, we use these terms only in relation to meat products, food ingredients, cosmetics, food products, personal care products, and food contact materials. There are some things which are not clear are considered questionable or suspect and more information is required to categorize them as Halal or Haram. If a muslim consumes Haram foods and materials, he would be sinful.

Halal in terms of food means that food must be:

  • Does not stem from or consists any part or item from animals that are forbidden (pig, carrion, having claws, talons or fangs, etc.) to Muslims by Islamic Law.
  • Food when prepared, processed, manufactured, packaged, stored or transported does not come in get in touch with or stored near any food that is forbidden and contain impurities as defined by Islamic Law.
  • Animals that are allowable and been slaughtered according to Islamic Law, not killed by strangulation or killed by wild animals.
  • Food that is ready processed or manufactured using tools or utensils that are free from infections as defined by Islamic Law.
  • Food, be it animal, vegetable, fruit or grain must be healthy and does not contain any substance that is considered impure (alcohol) in Islamic Law.

What is GOST R Certification?
The GOST R certification system concerns the majority of products sold or/and used in Russia, namely: consumer products such as foodstuff, textiles, cosmetics and toys, mechanical and electrical goods, industrial equipment for food, chemical, oil & gas, construction and other industries.

Is Russian Certification required for my products?
Russia is an unique country and has unique requirements of safety. If you plan to trade with Russia, you should know and understand the Russian requirements for certification.

Your products have to meet Russian standards which are different and mostly not harmonized with the European or International standards. CE self-declaration is not sufficient in Russia and cannot replace the Russian Certificate of Conformity.

Basically, almost all consumer products require the mandatory certification. It includes all building materials, shoes, furniture, tableware and kitchenware, packaging materials, household and industrial equipment, etc.

Why is GOST certification necessary?
Usually “GOST Certificate” is necessary for:

Customs house
Selling and using at Russian market

Certification process for products and services might be obligatory or voluntary. GOST Certification system had been created to protect Consumer’s rights and avoid import of low quality products. Certification law establish standards and norms which have to be met to receive GOST-R certificate. There are also regulations saying which products are subjects to obligatory certification and which might possess voluntary certificate.

According to the resolution of the State Customs Committee of Russia from 01.10.2000, production of foreign manufacturers imported into FR should meet the national quality standards, therefore is a subject to certification.

Certification GOST refers to specified products or industrial activity of the company. Certificates are issued on a base of expertise results, so products which well went through certification process have no difficulties while registering at customs.

All above information shows why Russian companies and organizations cannot work with products with didn’t receive ‘GOST-R certificate’.


The cost of certification services depends on several key factors:

Specification and type of product
Availability of earlier received certificates
Test requirements
Quantity of products (a batch, certain quantity according to the contract, serial production) and their specific features.
Complexity of laboratory tests norms or recipes.

Our prices are the most convenient and reasonable on the market. We always establish them to the product specifications, type of certificate, term of validity and other factors.

Time of certification:
There are know there are several kinds of GOST certificates: Hygienic, GOST-R, GOSSTROY etc.

What does CE marking mean? What do the initials CE stand for?
CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain “European Directives”. “CE marking” gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directives.

Does my product require the CE marking?
You need to establish first which, if any, of the New Approach Directives or older Global Approach Directives applies to your product. CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives.

The European Commission’s lists Directives where the CE Marking will be applicable. It is available for purchase from the above website. For specific information on the Directives, please read our relevant guidance documents (see below).

The same principles above apply to imported products. It is the responsibility of the importer / person placing the product on the market to ensure that the product is correctly CE-marked.

How do I go about getting a CE marking?
It is necessary first to establish which Directives apply to the product. It is impossible to draw up hard-and-fast rules, and it is important to seek independent and impartial advice if you are in any doubt. Guidance booklets on many of the EC Directives that contain CE marking requirements are available. The directive details can be taken from www.cemarking.co.in

It is important also to understand that not all EC Directives relating to products, e.g. the General Product Safety Directive, require CE marking, nor that a particular Directive applies to all products that could be described by its title e.g. the Machinery Directive does not apply to every conceivable product that might be termed a machine. Most of the Directives set out ‘scopes’ i.e. the range of products to which they apply.
You should therefore study the regulations implementing the Directives.

Must the CE marking appear on any packaging, in manuals or other supporting literature?
In general CE marking must appear on the product but see the individual guidance for exceptions. It may also appear on the packaging, in manuals or other supporting literature, but again it is best to study the guidance.

What is the design of the CE marking, and how big / small must it appear? 
The CE mark must not be less than 5mm in its vertical height, and the proportions maintained. It is generally shown on a grid in the guidance booklets, as at the top of this page (the grid does not form part of the marking and is for information only).

This mark looks the same as some previous marks, but there are subtle changes, and it should be studied closely. It should be noted, for example, that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.
Who enforces – and what would happen if I don’t CE mark a product? 
Enforcement varies according to the Directives. Some are enforced by local Trading Standards Departments , others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency.

Enforcement Procedures/Penalties: Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly CE-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment.

What requirements do I have to meet to export my product? 
CE-marking applies to the circulation of a product within the EEA. It is not required for exporting a product to non-EEA countries. You need to check on the particular regulatory requirements or standards that apply to your product in the country in question. The same standards may apply but they may also be different.

What are Notified / Approved / Competent Bodies? How can I find one?
These are bodies appointed by each member State under the appropriate national regulations to conduct third-party conformity assessment procedures to the product in question or its production processes, as required by the Directives, in order that it may be CE-marked. The procedures vary according to the Directives and third-party involvement is not compulsory for all products. Manufacturers can use the services of Notified/Approved/Competent Bodies in anymember State of the European Community. Some listings of these Bodies can be obtained from the our webpages – or from the European Commission’s website.

ISO standards are reviewed and revised on a regular cycle, typically every 5-10 years, and 2015 sees ISO 14001:2004 reaching the end of that review procedure. A draft international standard (DIS) was published, and after extensive review the final draft international standard (FDIS) was published in July. The ISO 14001:2015 standard was published in September 2015.

ISO 14001 Environmental Management Systems Revision

ISO 14001 Environmental management systems, one of ISO’s most extensively used standards, has recently been revised.

Why was ISO 14001 revised?

All ISO standards are reviewed every five years to launch if a revision is needed in order to keep it present and relevant for the market. ISO 14001:2015 is designed to respond to newest trends and make sure it is compatible with other management system standards.

What is the main modifying to the standard?

The key changes relate to:

  • Increased reputation of environmental management within the organization’s strategic planning procedures
  • Greater focus on management
  • Addition of proactive initiatives to protect the environment from harm and degradation, such as sustainable resource make use of and climate change mitigation
  • Humanizing environmental performance added
  • Lifecycle thinking when considering environmental aspects
  • Addition of a communications strategy

In addition, the revised standard follows a common structure, with the same terms and definitions as a number of other management system standards such as ISO 9001. This create them easier, cheaper and faster for those companies who use more than one, not to mention helping out the auditors.

Who was responsible for the revision?

The revision was conducted by an ISO technical committee called ISO/TC 207/SC 1, which is comprised of specialist selected by their National Standards Bodies and liaison organizations.

I am certified to ISO 14001:2004. What does this mean for me?

Organizations are granted a three-year transition period after the review has been published to migrate their environmental management system to the new edition of the standard. After this transition period, companies that opt for third party certification will have to look for certification to the new version of the standard. The former version, ISO 14001:2004, and any certification to it, will be out of date.

Do I have to be certified to the new standard?

No, certification is not essential.

Key Improvements to ISO 14001:2015

  • Utilizing ISO 14001:2015 as the environmental pillar of sustainability
  • Life-cycle thinking, considering each stage of a product or service, from development to end of life
  • An increased alignment with strategic direction
  • Emphasis on environmental performance and measurement
  • Greater protection for the environment, with a focus on proactive initiatives
  • A greater commitment from leadership
  • More effective internal and external communication, driven through a communications strategy

Structure Comparison of ISO/DIS ISO 14001:2015 and ISO 14001:2004

ISO/DIS ISO 14001:2015 ISO 14001:2004
1. Scope 1. Scope
2. Normative References 2. Normative References
3. Terms and Definitions 3. Terms and Definitions
4. Context of the organization 4. Environmental management system requirements
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
Annex A: Guidance on the use of this standard Annex A: Guidance on the use of this international standard
Annex B: Correspondence of ISO 140001:2015 and ISO 14001:2004 Annex B: Correspondence of ISO 140001:2004 and ISO 9001:2000

ISO 13485: 2012 is an international standard that represents the needs for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry’s quality system expectations and regulatory necessities, an organization does not require being actively manufacturing medical devices or their components to look for certification to this standard. ISO 13485: 2012 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet customer and legal needs.

ISO 13485 is based on the ISO 9001:2008 procedure model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory needs.

The EN ISO 13485:2012 certification was awarded by the International Organization for Standardization, the world’s largest developer and publisher of worldwide quality and safety standards. This certification outlines specific needs to establish and execute a structured quality management system for medical devices across all areas, from development to deliver.

Benefits of ISO 13485 Certificate

  • Optimization of costs – reduction of operating costs, decrease of nonconforming products costs, raw materials, energy and other resources savings,
  • Simplifying the procedure of attestation of conformity to needs of EU directives and corresponding Government Orders;
  • Improving trust of public and public monitoring bodies in respect of the medical devices manufacturer.
  • Attestation of efficiency and helpfulness of the established quality management system by an self-governing third party;
  • Guarantee of production procedure stability and thus steady and high quality of services and products supplied to clientele;

What is ISO 27001?

ISO 27001 is an international standard published by the International Standardization Organization (ISO), and it depicts how to handle information security in a company. The latest revision of this standard was published in 2013, and its full title is now ISO/IEC 27001:2013. The first revision of the standard was published in 2005, and it was developed based on the British standard BS 7799-2.

ISO 27001 can be implemented in any kind of organization, profit or non-profit, private or state-owned, small or large. It was written by the world’s best specialists in the field of information security and offers methodology for the implementation of information security management in an organization. It also allows companies to become certified, which means that an independent certification body has confirmed that an organization has implemented information security compliant with ISO 27001.

Advantage of establishing an ISMS:

  • Awareness of information security risks
  • Security of the assets according to the needs
  • Establishing business continuity through effective incident management
  • Competitiveness
  • Profitability
  • Corporate image
  • Legal and statutory compliance

History of the ISO/IEC 27001 ISMS:

  • BS7799:1995; part 1 issued
  • BS7799-2:1998; part 2 issued
  • BS7799-2:1999; part 2 revised
  • ISO/IEC 17799:2000; issued
  • BS7799-2:2001; part 2 improved
  • BS 7799-2:2002 : harmonized with the other management system standards , Plan-Do-Check-Act (PDCA) model intruduced (ISO 9001:2000 and ISO 14001:1996)
  • ISO/IEC 27001:2005 ; Information security management system; replaced BS 7799-2
  • ISO/IEC 27002:2005 ; Code of practice, replaced ISO/IEC 17799:2005

Principals of the ISO/IEC 27001 ISMS

ISO/IEC 27001 specifies the requirements for establishing,implementing, operating, monitoring, reviewing, maintaining and improving a documented ISMS within thecontext of the organization’s overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.

The process approach for information security management presented in the Standard encourages companies to emphasize the importance of:

  • understanding an organization’s information security requirements and the need to establish policy and objectives for information security;
  • implementing and operating controls to manage an organization’s information security risks in the context of the organization’s overall business risks;
  • monitoring and reviewing the performance and effectiveness of the ISMS; and
  • continual improvement based on objective measurement.

ISO/IEC 27002:2005 provides implementation guidance that can be used when designing controls.


  • 0 Introduction
  • 0.1 General
  • 0.2 Process approach
  • 0.3 Compatibility with other management systems
  • 1 Scope
  • 1.1 General
  • 1.2 Application
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Information security management system
  • 4.1 General requirements
  • 4.2 Establishing and managing the ISMS
  • 4.2.1 Establish the ISMS
  • 4.2.2 Implement and operate the ISMS
  • 4.2.3 Monitor and review the ISMS
  • 4.2.4 Maintain and improve the ISMS
  • 4.3 Documentation requirements
  • 4.3.1 General
  • 4.3.2 Control of documents
  • 4.3.3 Control of records
  • 5 Management responsibility
  • 5.1 Management commitment
  • 5.2 Resource management
  • 5.2.1 Provision of resources
  • 5.2.2 Training, awareness and competence
  • 6 Internal ISMS
  • 7 Management review of the ISMS
  • 7.1 General
  • 7.2 Review input
  • 7.3 Review output
  • 8 ISMS improvement
  • 8.1 Continual improvement
  • 8.2 Corrective action
  • 8.3 Preventive action
  • Annex A (normative) Control objectives and controls
  • Annex B (informative) OECD principles and this International Standard
  • Annex C (informative) Correspondence between ISO 9001:2000, ISO 14001:2004 and this International Standard

Social Accountability is the registered trademark of Certification and acknowledgment of SA 8000 activities in the organization, a company, branch, an area consistent with SA 8000 standards. Currently there is no official certification agency, but you can request prestigious organizations to audit, certify and issue SA 8000 certificate for your requirements.

Adopting SA 8000 certification means an organization must think the social impact of their operations in addition to the conditions under which their employees, partners and suppliers operate. It can be applied to any company, of any size, worldwide. Certifying your organization against SA 8000 with our audit will support you develop and progress social accountability across your operations. Working with our experienced auditors to put into practice the most internationally accepted place of work standard demonstrates social accountability when bidding for contracts and expanding your organization.

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

  • Child Labour
  • Disciplinary Practices
  • Forced Labour
  • Working Hours
  • Health & Safety
  • Compensation
  • Freedom of Association & Collective Bargaining
  • Management systems
  • Discrimination

Benefits of SA8000 Certificate

  • Enables you to demonstrate proper social accountability when bidding for international contracts or expanding locally to accommodate new business
  • exposure and achievable litigation
  • Proves your promise to social accountability and to treating your employees ethically and in compliance with worldwide standards
  • Helps your corporate vision and build and reinforce the loyalty of your employees, clients and stakeholders
  • Improves the management and performance of your supply chain
  • Allows you to make sure compliance with global standards and decrease the risk of negligence, public

ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electro technical Commission (IEC). It is the single most important standard for calibration and testing laboratories around the globe. Laboratories that are accredited to this international standard have demonstrated that they are technically competent and capable to produce precise and accurate test and/or calibration data.

ISO/IEC 17025:2005 specifies the general necessity for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

Reasons Why ISO 17025 Is Important?

ISO 17025 is a regular and extensive review of a vendor’s quality management system.

ISO 17025 is not necessary. To enlarge trust, calibration labs volunteer to be reviewed by a third-party accreditation body based on their adherence to ISO 17025 standards.

ISO 17025 certifies that a lab has demonstrated an ability to produce correct tests and calibration data and has displayed excellence in technical and management competence. (It is silent, however, on the methods and processes that must be used to calibrate since it is device agnostic.

Benefits of ISO 17025 Certificate

  • Enhanced national and worldwide reputation and image of the laboratory.
  • Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
  • constantly improving data quality and laboratory effectiveness.
  • Potential enhance in business due to enhanced client confidence and pleasure.
  • Savings in terms of time and money due to decrease or elimination of the require for re-testing of products.
  • Clients can search and recognize the laboratories accredited by The Accreditation Member Body for their exact needs from their website or Directory of Accredited Laboratories.
  • Increase of confidence in Testing/ Calibration data and of personnel performing work.
  • Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
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