X

QMAC Management Consultants

Mira Road, Thane, Maharashtra

| GST  27ADUPT9866C1ZM

| Verified Supplier

View Mobile Number
Hi
I agree to the terms and privacy policy
Verifying...
1

Have a requirement?
Get Best Price

ISO and ISI Consultancy

We offer a wide range of ISO and ISI Consultancy Services. Strictly adhering to norms and regulations specified by authorities, we meet all the accreditations & certification requirements of our clients in a timely and cost effective manner. Our team is competent in offering these services with their extensive knowledge base and untiring efforts.

ISO 15189 Consultancy
Interested in this product?
Get Best Quote

ISO 15189 Consultancy

Get Latest Price

In january 2003, the international organization for standardization (iso) published the world’s first harmonized clinical laboratory practice standard.


Laboratories wishing to have some verification of their quality and performance, ISO 17025 (general requirements for the competence of calibration and testing laboratories) is used. While this standard provided a generic framework for a laboratory quality management system, essential elements relative to clinical laboratories were missing. Consequently, the laboratory community approached the iso secretariat about creating a standard specifically for the unique requirements of clinical laboratory practice.

The standard that was published is known as ISO 15189 (medical laboratories – particular requirements for quality and competence). Since its publication this standard has gained rapid and widespread acknowledgement and adoption in many countries.

In 2007, the second edition of ISO 15189 was published, with the intent to align it further with ISO 17025.

 

Purpose of ISO 15189

ISO 15189 - main objective is to allow laboratories to organize their operational procedures efficiently, meets the expectations of their clients and improves their service.

  • Laboratories accredited to ISO 15189 are formally recognized to be competent, thus providing a ready means for customers to identify and select medical testing and clinical analysis services.
  • Compliance to ISO15189 aids the laboratories to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence.
  • Compliance to ISO 15189 is an effective marketing tool for medical and clinical laboratories and a passport to submit tenders to contractors that require independently verified laboratories.

View Complete Details

Yes, I am interested!

ISO 13485 Certification Services
Interested in this product?
Get Best Quote

ISO 13485 is a Management Systems Standard specifically developed for the organization who manufactures Medical Devices.

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers

Its primary objective is to facilitate harmonized medical device regulatory requirements.

The standard contains specific requirements for manufacture, installation and servicing and calls for:

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realization
  • Validation of processes Compliance with statutory and regulatory requirements 
  • Effective product traceability and recall systems

Benefits of ISO 13485

  • Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
  • Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
  • Improved stakeholder relationships - including staff, customers and suppliers
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management - through greater consistency and traceability of products and use of risk management techniques
  • Proven business credentials - through independent verification against recognized standards
  • Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

View Complete Details

Yes, I am interested!

ISO 9001 Consultants
Interested in this product?
Get Best Quote

ISO 9001 Consultants

Get Latest Price

ISO 9001 is the international standard for quality management system requirements. ISO 9001 is an internationally recognized standard and is recognized as the benchmark for quality management systems certification. ISO 9000 quality systems standards were developed in 1987 based on the results learned during the second world war, while, us military came out with mil q 9858 a. It was essential to develop and publish a series of standards having three objectives: universal acceptance, compatibility and flexibility. ISO 9000 series of standards, developed by is0/tc 176 in 1987 fulfills all such requirements. The standard has undergone four revisions, in 1984, 2000 and recently in 2008. The standard is:

 

  • Applicable to all product/ service categories, in all sectors and to all sizes of organization
  • Simple to use, clear in language and easily understandable
  • Significant reduction in documentation
  • Based on quality management principles
  • Aimed to improve organizational process
  • Greater orientation towards continual improvement & customer satisfaction
  • Compatible to environmental management system

View Complete Details

Yes, I am interested!

ISO 14001 Certification Services
Interested in this product?
Get Best Quote

ISO 14001 (Environment Management System)

An EMS is a system for evaluating environmental risk so it can be managed in a consistent way.

The EMS is systematic and comprehensive; it encompasses all things that affect the environment, at all levels and everyone has a role and responsibilities to this.

Following a worldwide standard such as ISO14001 provides the organizations a consistent, recognized way to merge environmental considerations into our strategic planning process. 

ISO 14001 is the defining specification for an EMS. There are 5 main parts to an EMS

  • Policy
  • Planning
  • Implementation & Operation
  • Checking & Corrective Action
  • Management Review

These 5 parts form the continual improvement cycle of ISO14001

View Complete Details

Yes, I am interested!

ISI Marking
Interested in this product?
Get Best Quote

ISI Marking

Get Latest Price

ISI Marking is basically voluntary in nature. Some of the items brought under mandatory certification on consideration of health and safety are milk powder, packaged drinking water, LPG cylinders, oil pressure stoves, clinical thermometers etc. All foreign manufacturers of products who intend to export to India are required to obtain a BIS product certification license. Towards this, BIS launched its Product Certification Scheme for overseas manufacturers in the year 1999. Under the provisions of this scheme, foreign manufacturers can seek certification from BIS for marking their product (s) with BIS Standard Mark.

View Complete Details

Yes, I am interested!
Tell us what you need, and we’ll help you get quotes
Tell us what you
need
Receive seller
details
Seal the deal
Pay with IndiaMART
Tell us what you need, and we’ll help you get quotes
I agree to the terms and privacy policy