ISO 9001 (All scope), ISO 31000 & Internal Auditor 19011

WHY ISO 9001?

ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. 

ISO 31000

The long-term success of an organization relies on many things, from continually assessing and updating their offering to optimizing their processes. As if this weren’t enough of a challenge, they also need to account for the unexpected in managing risk. That’s why we’ve developed ISO 31000 for risk management.

 

In addition to addressing operational continuity, ISO 31000 provides a level of reassurance in terms of economic resilience, professional reputation and environmental and safety outcomes. In a world of uncertainty, ISO 31000 is tailor-made for any organization seeking clear guidance on risk management.

INTERNAL AUDITOR ISO 19011

This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams. It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme. The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.

Our benefits: We give example of documents for implementation, standard reference and high qualified trainer/consultant (Global Approved)

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REI Consultant can give your organization the best service for set-up and or training for ISO 9001, ISO 31000 & Internal Auditor 19011

 

Medical Devices, Packaging For Medicinal Product & GSDP, System for Pharma

ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

 

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ISO 15378

ISO 15378 specifies requirements for a quality management system when an organization:

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

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

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

NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.

In ISO 15378 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.

ISO 15378: is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

 

Good Distribution Practices (GDP) Certification for Pharmaceuticals

 

Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Various people and entities are generally responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The objective of these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record-keeping practices.

Others standard for Pharmaceutical Industry:

1. CPOTB (Cara Produksi Obat Yang Baik)

2. GMP Pharmasi

3. ISO 9001 for Pharmaceutical

4. Validation Process

5. Calibration of Measuring Devices

REI Consultant can give your organization the best service for set-up and or training for Medical Devices, Packaging for medicinal product and GDP for pharmaceutical 

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GMP Cosmetic Products & EFfCI

REI Sistem Indonesia berpengalaman dan sudah banyak membantu untuk Cosmetic standard seperti ISO 22716, EDfCI & GMP Cosmetic.

ISO 22716:

ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for thepersonnel engaged in the plant, nor do they cover aspects of protection of the environment. The guidelines in ISO 22716 are not applicable to research and development activities and distribution of finished products.

EFfCI:

The European Federation for Cosmetic Ingredients, we advocate the collective interests of more than 100 cosmetic ingredients companies in Europe

 

REI Consultant can give your organization the best service for set-up and or training for GMP/ISO Cosmetic products

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