ISO 7101 Healthcare Services Quality Management System

  • Refined quality of healthcare delivery
  • Improved patient safety
  • Enhanced operational effectiveness.
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What is ISO 7101?

ISO 7101 :2023 is a standard that outlines requirements for management systems for quality in healthcare organizations. It provides a framework for healthcare providers to implement and maintain high-quality care practices. The standard aims to create a culture of quality, emphasizing people-centered care, risk management, patient and workforce safety, process control, performance evaluation, and continuous improvement.

ISO 7101 is designed to help healthcare organizations:

  1. Consistently meet service user, stakeholder, and regulatory requirements
  2. Enhance user experience and improve healthcare quality
  3. Implement processes for timely, safe, effective, efficient, equitable, and people-centered care

The standard is based on recognized best practices and is applicable to all types and sizes of healthcare organizations such as ministries of health, public and private healthcare systems, hospitals, clinics, non-governmental organizations and agencies that provide healthcare services.

What is ISO 7101 for

  • Competitive Edge: Certification can boost an organization’s credibility with patients and stakeholders by demonstrating a commitment to high-quality care
  • Patient-Centered Focus: ISO 7101 focuses on improving the quality of healthcare delivery, which leads to better patient experiences and clinical outcomes. This patient-centered approach not only boosts the organization's reputation but also significantly increases overall patient satisfaction and loyalty.
  • Risk Management : ISO 7101 helps organizations identify and address potential risks, contributing to improved patient and workforce safety and overall organizational resilience
Steps

ISO 7101 Consultancy Service

We established 4 different milestones for monitoring purpose and described our activities in consultancy services from zero to certification.
Phase 1

System Review

  • Understand the existing operation and documentation.
  • Identify key gap against ISO 7101 requirements.
Phase 2

Documentation

  • Establish management system framework.
  • Establish required procedures and forms
Phase 3

ISO 7101 Implementation

  • Prepare a session of ISO 7101awareness training
  • Prepare various records required by documentation
  • Check the preparation via regular advisory visit
Phase 4

ISO 7101 Certification Audit

  • Liaise with Certification Body for audit arrangement.
  • Support the whole Certification Audit.
  • Provide suggestion for closing non conformity.
What we offer

Features

Saving Time & Money

No hidden cost. Completion within budget and timeframe.

Easy to follow

Straight forward & Simple ISO 7101 documentation. Minimum workload is required.

Precise Training

Precise ISO 7101 trainings to client for quick glance

Flexible schedule

Arranging meeting schedule up to Client request
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Frequent Asked Question

The time to get ISO Certification depend on company size, number of locations, business nature and operation complexity.

For Company (Staff < 20), it take 5 months on average.

For Company (Staff ~50), it take 7 months on average.

For Company (Staff ~100), it take 9-10 months on average.

You may take below steps :

1) ISO 7101 Gap Analysis.

2) Establishment of ISO 7101 Documentation.

3) Attend ISO 7101 Training.

4) Implementation of ISO 7101 System.

5) Arrange an Internal Audit

6) External ISO 7101 Audit by Certification Body.

There are two major Fees.
1) ISO 7101 Certification Fee charged by Accredited Certification Body such as SGS, LRQA, BV, BSI, ACI, DW..
2) Consultant Fee charged by us.
The Fees depend on company size, number of locations, business nature and operation complexity.

No. Because of conflict of interest. Certification Body can provide ISO 7101 Standard generic training only but cannot tell you how to implement ISO 7101 System in your company.

Absolutely Yes. In general, ISO Consultant will draft documentation, guide your company to implement ISO 7101 system until passing in ISO 7101 Certification Audit.

In general, the company can put the ISO 9001 logo in the website, name card and letterhead after receipt of corresponding ISO 7101 Certificate.

Clients are saying...

Testimonials

Highly recommended anyone seeking for ISO management consultancy service….
ISO 9001 Certification
Steve Smithers
COO, IBI
delivers exceptional expertise and support throughout the certification process."
ISO 27001 OmniChat
Alan Chan
Founder, OmniChat
doesn't just guide us through ISO certification—steering us to success with unparalleled skill and unwavering support.
ISO 27001
Kenny Kwan
Global Technology Leader, LifeHikes
We are looking forward to your continuing support in maintaining the system…
ISO 9001 Consultant Gabriel Consultant Hong Kong
Keith Cheong
Executive Director , NV5
….we will plan to get more certifications through your professional service….
Brian Cha
Founder, Brian Cha Motivation
…..they gave us full support and professional guidance …..
May Chan
QA Manager, Ocean Park

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Our Consultant Team

Committed to providing quality consultancy services.

Lotto Lo

Senior Consultant

Over 10 Years in ISO Certification and Consultancy industry and completion over 400+ Projects.

Pauline Lin

Senior Consultant

Over 16 years of experiences in the fields of ISO 9001, ISO 14001, ISO 45001, ISO 37001, ISO 39001, FSC and PEFC.

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