company profilethe organization process of a company which applies iso 90001 as well as all related...

COMPANYPROFILE

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WHAT WE DOIntegerated Certification Services is third party certification body orginated and situated in city Karachi,Sindh, Pakistan since 2017 to perform independed audit representing any accredited body globally to serve local customer.

The existing status of company is assessing and certifying the interested oranizations to get management system certification by following the audit process to flourish their organization.

HOW DO WE DO-


ADDRESSSuite310, 3rd Floor,Jilani Tower, JilaniTowe, M. A Jinnah,Road, Karachi. Pakistan.

STANDARDS


ISO 9001:2015The ISO 9000 family of quality management systems standards designs to help organizations ensure that they meet the needsof customers and other stakeholders, while meeting statutory and regulatory requirements related to achieve ISO 9001 certification.

ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based.

ISO 9000 family, as well as all related QMS’s, focuses on a continual improvement process to achieve the objectives related to theoverall performance of an organization such as service delivery, production lines, administration, etc.

The Organization process of a Company which applies ISO 90001 as well as all related QMS’s principles and requirements, follows a plan – do – check – act approach (Plan-Do-Check-Act, PDCA):

ISO 14001:2015

ISO 14000 is a family of standards related to Environmental Management that aims to help organizations to achieve certification:

Minimize how their operations (processes, etc.) negatively affect the environment (i.e., cause adverse changes to air, water or land);Comply with applicable laws, regulations and other environmentally oriented requirements; Continually improve in the above.

Since; ISO 14000 is similar to ISO 9000 quality management, in what both pertain to the process of how a service or product delivered or produced rather than to the product or service quality itself for sure;

Since; as common practice; with ISO 9000 auditing process, Swiss Approval International evaluation and certification for ISO 14001.

Performed in a similar way according ISO 19011 audit standard and when auditing, performed for both management systems, 9000 and 14000, compliance at once achieved.

Though; ISO 14001; sets out the criteria for an Environmental Management System (EMS). It does not state requirements for environmental performance. Since; maps out a framework that a company or organization can follow to set up an effective EMS. Not only it can used by any organization that wants to improve resource efficiency but also; reduce waste, and drive down costs. Therefore; using ISO 14001 can provide assurance to company management and employees as well as external stakeholders. Environmental impact measurement and improvement; indeed.


ISO 45001:2018ISO 45001 is a first ISO standard for health and safety during occupation to the workers involved during work. Yes it is not new since we all know the existence of OHSAS 18001 to cover the same scope for two decades in which many organizational internationally successfully implementing and getting certified to ensure their arrangements for suitable controls against their health and safety risksto achieve ISO 45001 Certification. SO, WHATS NEW IN IN THIS ISO ADOPTED STANDARD TO MAKE DIFFERENCE.

The answer is ‘Proactive Approach’ instead of ‘Reactive Approach’ which has become obsolete in today’s era for any organization to survive. This ISO standard called OHSMS – Occupational Health & Safety Management System.

The ISO 45001 is consisted of two specifications:

– Annex-SL– Risk Based Thinking

ISO 45001 sets itself apart from other health and safety standards in multiple ways:

Company leaders required to consult with non-managerial workers or their representatives. Leaders need to demonstrate that they actively involved in the integration of the OH&S system. The ISO 45001 standard is more process-based rather than procedure-based. It incorporates the identification of risk and opportunities for improvement and includes participation and feedback from all interested parties.

ISO 45001 allows for occupational health and safety easily integrated with other management systems throughout the organization, eventually becoming part of the company’s identity. Prevention emphasized rather than reaction. Prevention must become a fundamental requirement of the OH&S management system. When incidents do occur, compliant organizations should determine why the incident occurred and act to assure it does not re-occur. The management system should drive and encourage a continual improvement cycle and culture within the organization.


ISO 22000:2018 & HACCPISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. It is a general derivative of ISO 9000.

Food safety is linked to the presence of food-borne germs at the point of consumption. Since food safety hazards can occur at any stage in the food chain it is essential that adequate control be in place. Therefore, a combined effort of all parties through the food chain is required.

The ISO 22000 international standard specifies the requirements for a food safety management system that involves the following elements:-interactive communication-system management-prerequisite programs-HACCP principlesThe most effective food safety systems are established, operated and updated within the framework of a structured managementsystem and incorporated into the overall management activities of the organization. This provides maximum benefit for the organization and interested parties. ISO 22000 has been aligned with ISO 9001 in order to enhance the compatibility of the two standards.ISO 22000 can be applied independently of other management system standards or integrated with existing management system requirements.ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed the Codex Alimentarius Commission.By means of auditable requirements, it combines the HACCP plan with prerequisite programmes. Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures. ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not.


OHSAS 18001 is an internationally applied British Standard for occupational health and safety management systems.

It exists to help all kinds of organizations put in place demonstrably sound occupational health and safety performance. It is a widely recognized and popular as occupational health and safety management system.

Organizations worldwide recognize the need to control and improve health and safety performance and do so with occupational health and safety management systems (OHSMS).

The OHSAS 18000 Series consisted of two specifications:

– 18001 provided requirements for an OHS management system and– 18002 gave implementation guidelines.

OHSAS 18001:2007


ISO 27001:2013; is an information security standard for organization willing to improve their information to secured at any means forcertification; organizations have to study, implement and audited for the standard; finally.

Indeed; it supersedes ISO/IEC 27001:2005 and published by the International Organization for Standardization (ISO) andthe International Electro-technical Commission (IEC) under the joint ISO and IEC subcommittee. Since; it is a specification for an information security management system (ISMS). So; organisations which meet the standard may gain an official certification issuedby an independent and accredited certification body on successful completion of a formal audit process; indeed.

Though; the official title of the standard is Information technology— Security techniques — Information security management systems Requirements.

Since; information security management system is not only the need of every organization to secure their all types of informationirrespective of documented or non-documented but also; with categorization of level of importance of information to arrange the security controls to that information. Therefore; certification audit ensures the obtained mechanism of organization during auditreference to the standard of ISMS and witness the implementation through audit reporting which remains valid till next audit.

ISO 27001:2013; has ten short clauses, plus a long annex like ISO 9001, which cover:

- Scope of the standard- How the document is referenced- Reuse of the terms and definitions in ISO/IEC 27000- Organisational context and stakeholders- Information security leadership and high-level support for policy- Planning an information security management system; risk assessment; risk treatment- Supporting an information security management system- Making an information security management system operational- Reviewing the system’s performance- Corrective action; finally.

ISO 27001:2013


ISO 50001:2011 EnMS – International Organization for Standardization specifies requirements with guidance for use of EnMS standard to achieve ISO 50001 Certification; indeed.

The standard specifies the requirements for establishing, implementing, maintaining and improving an energy management system. Therefore; the purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy security, energy use and consumption. As a result; The standard aims to help organizations continually reduce their energy use, and therefore their energy costs and their greenhouse gas emissions.

June 2011 ISO releases ISO 50001 standard and is suitable for any organization – whatever its size, sector or geographical location.

The system is modeled based on the ISO 9001 Quality Management System (QMS) and the ISO 14001 Environmental Management System (EMS). Adding the significant feature of improving the «Energy Management System» and the resulting energyperformance». Improving of quality and environmental performance does not describe the ISO 50001 as a requirement.

OBJECTIVE OF ENMSOrganizations of all types and sizes increasingly want to reduce the amount of energy they consume. For the need or desire to:-reduce costs,-reduce the impact of rising costs,-meet legislative or self-imposed carbon targets,-reduce reliance on fossil fuels,-enhance entity’s reputation as a socially responsible organization.

In tandem, governments increasingly want to reduce the Greenhouse Gas Emissions of their citizens and industries, and are imposing legislative mechanisms to compel carbon reduction more and more frequently.

ISO 50001 also drew on existing national and regional energy management codes and standards, including ones developed in China, Denmark, Ireland, Japan, Republic of Korea, Netherlands, Sweden, Thailand, the USA and the European Union.

ISO 50001:2018


The GMP refers to Good Manufacturing Practices regulations promulgated by national and international guidelines or standards to achieve GMP Certification. i.e. WHO.

These requirements, require that manufacturers to ensure that their products are safe, pure and effective.

This in turn, protects the consumer from purchasing a product which is not effective or even dangerous.

STRUCTUREGMP follows the structure of QMS – ISO 9001.

REQUIREMENTGMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling.

Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.

This provides not only much flexibility but also; requires that the manufacturer interpret the requirements in a manner which as a result; makes sense for each individual business.

GMP 0R CGMP

Since; GMP is also sometimes referred to as “cGMP“. The “c” stands for “current,” reminding manufacturers that they must employtechnologies and systems which are up-to-date in order to comply with the requirements of standard.

Systems and equipment used to prevent contamination, mix up and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

cGMP - Current Goods Manufacturing Practices


Organizations that involved in manufacturing, wholesaling, distribution and importing Medical Devices required to implement aQMS and obtain GDPMD certificate applying for licence to their establishment through GDPMD Certification.

MD companies required to implement QMS which include procedures and provide suitable facilities and people to handle the medical devices.Companies can use the resources on this website as well as the links to develop their GDPMD certification QMS or can employ GDP consultant to assist.

We can assistant for any query relevant to certification purpose and initial guidelines to achieve this certification.

GDPMD Certification that part of quality assurance which ensures that products consistently stored, transported and handledunder suitable condition. In order to provide such assurance, companies will require more than just a set of quality manuals, it requires a comprehensive system to “give assurance”.

GDPMD SYSTEM TO COMPLIANCEThis may include appropriate procedures, suitably trained and qualified personnel, correct processes and facilities. Further more equipment as well as clear to credibly demonstrate the consistency of quality assurance.Companies who currently certified toISO 9001 will find that they have partially fulfilled the GDPMD requirements.

However; there are differences between ISO 9001 and GDPMD which companies will need to reconcile before going for the audit.In addition; companies who have implemented similar QMS in other countries may not 100% compliant as the requirements are not identical.

CERTIFICATION TO GDPMDCompanies are encourage to prepare early and be ready to apply for their licence before the mandatory deadline to avoid a last minute panic and potential business interruption.

Companies who have not implemented a system which complies with the GDPMD requirements will need time to implement the system. Generate records through the normal business process and test out their systems.

GDPMD- Good Distribution Practices for Medical Devices


Steps to Apply for Certification HOW TO APPLY

Step 01 Inquiry

Submit the inquiry form with detail of organization as per required questions in the form. The correct information shall enable us to provide the cost effective and competitive proposal of certification of three years.

Step 02 Proposal

An official proposal for financial and technical terms shall be offered to customer.

Step 03 Contract

A contract is released upon acceptance of proposal or quotation previously issued to customer. The contract covers terms of referencesof certification nature, period and payment.

Step 04 Certification Audit

A request or signal from customer is generated to perform their audit. Please the process flow of entire certifcation process in‘How Do We Do’ section.

company profilethe organization process of a company which applies iso 90001 as well as all related...

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