Certification

Since July 2022, in the context of increasing globalization and the growing number of standards to comply with, QMS Vietnam has partnered with MS Certification Services to further expand the scope of assessments in accordance with international standards, thereby bringing greater value to Vietnamese enterprises as well as countries in the region.

MS Certification Services Pvt Ltd. is a certification body capable of providing internationally recognized certifications accredited by JAS-ANZ (Australia) and IAS (USA), with headquarters in India and Italy. MS CERT operates across various territories including Vietnam, Italy, India, USA, South Korea, Thailand, Taiwan, and more.
Additionally, MS CERT offers international certification training courses accredited by EXEMPLAR GLOBAL.

Certification by MS Certification Services not only helps you demonstrate your commitment to operational efficiency but also enables you to achieve international recognition from JAS-ANZ (Australia) and IAS (USA) for your quality and excellent services.

Years of experience in this field have driven QMS Vietnam to innovate its approach in certification assessment activities.
Incorporating a review of the organization’s Strengths, Weaknesses, Opportunities, and Threats (SWOT) at the conclusion of the assessment process demonstrates this new approach.

Moreover, QMS goes beyond merely evaluating “conformity” to standards; it also provides insights aimed at supporting the organization’s future development journey.

This is precisely our direction to “add value” to our services for our customers.

Certification Process

Certification Objectives and Scope

Objectives:
This procedure aims to provide information to QMS Vietnam’s customers and other related parties by outlining an overview of the certification process, including some definitions of key principles in certification.
Scope:
This procedure applies to the Management System Certification Process according to one of the following standards or their recognized equivalents:
ISO 14001, ISO 9001, ISO 45001, HACCP, ISO 13485, ISO 22000, ISO/IEC 27001, etc.
Definition:
CAR = Corrective Action Request

Assessment Content

QMS VN is committed to its customers and stakeholders by working professionally and impartially.

Organizations certified by QMS VN must demonstrate ongoing conformity in their operations with the requirements of the certification standards and the applicable legal requirements relevant to the organization. QMS VN will assess and verify the conformity of the system.

QMS VN will carry out the following activities regarding the customer’s management system:

Document and Organization Review
Reviewing the customer’s quality management system documentation and organization to enable QMS VN to make a general assessment of its conformity with the certification standard requirements and to prepare adequately for the certification audit.

Stage 1 Audit
Collecting and verifying the organization’s self-assessment of their management system. Approval of the Stage 1 audit report is required before proceeding to Stage 2.

Audit Planning
QMS VN will prepare an audit program specifying the audit scope, location, and necessary timing and send it to the customer for mutual agreement.

Audit
This process involves reviewing the entire management system of the customer and recording any nonconformities found, referred to as CAR (Corrective Action Request). A summary audit report will be prepared, including recommendations on certification at the time of the audit.

The customer will receive a consolidated report including recommendations regarding the possibility of certification at that time.

During the audit, the following points must be considered regardless of whether they are included in the audit standard or audit program:

  • A documented mechanism to identify the purchaser when the product is manufactured or supplied, including outside the audit scope.

  • All customer complaints.

CAR Forms
During the audit, each “finding” will be recorded and documented as a Corrective Action Request (CAR). The findings are categorized as follows:

  • Non-Conformance (Major Nonconformity): Serious errors related to the quality system that disrupt the integrity of the customer’s quality management system and cause it to be non-compliant with the certification standards. Errors that obstruct meeting customer requirements are also considered non-conformities.

  • Improvement Request (Minor Nonconformity): Any aspect of the system that does not meet audit criteria but is not severe enough to be classified as a non-conformance.

  • Observation: Findings that have the potential to become “improvement requests” for the system.

If one or more “non-conformities” exist, the customer will not be granted a certificate until these are fully corrected and re-verified by QMS VN (see the section on Review of Corrective Actions).

Repeated “improvement requests” that remain uncorrected after two surveillance audits will be treated as “non-conformities.”

Approval and Certification
After the audit is completed and approved, QMS VN will submit the report to the Head Office to request issuance of the certificate for the customer. The certificate is valid for 3 years. Customer details will be published on the official JAS-ANZ website. This list is provided by QMS VN to purchasing organizations and other relevant parties to assist customers in expanding their market. After the 3-year validity period, customers must undergo a recertification audit to maintain certification.

Certificates issued by QMS VN do not imply that the customer’s products or services are recognized by any certification board or government ministry/agency in Vietnam.

System Surveillance
From the date of certification, the customer’s management system will be subject to surveillance to ensure the certificate remains valid and that any changes to the system are reviewed for conformity with audit criteria.

Changes to the surveillance cycle will be decided by the Lead Auditor and must be supported by a well-organized and clear internal audit system.

Review of Corrective Actions
This review may be required (prior to the next audit) to evaluate the customer’s corrective actions if major non-conformities were identified during the Certification or Surveillance audit.

In some cases, this review may be conducted via correspondence between the customer and MS Cert.

If non-conformities are found during the Certification audit, the customer must submit a corrective action plan to QMS VN within 14 days of the audit and complete all corrective actions within a maximum of 1 month.

Failure to fully correct the non-conformities may result in QMS VN requesting a complete reassessment of the system.

Suspension or Withdrawal of Certificate
Once certified, if a “non-conformity” is identified during system surveillance, certification recognition will be suspended until the “non-conformity” is fully corrected.

During the suspension period, the customer is not permitted to advertise their certification; however, their name and details will remain on the List of Certified Customers, and the certificate will be retained. If the “non-conformity” is not fully corrected within 1 month, certification recognition will be withdrawn and the certificate revoked. The customer will lose the right to use the certificate and recognition marks.

If the customer is unable to perform the activities within the specified scope, fails to fulfill obligations committed to QMS VN, or requests it, the certificate may also be suspended or withdrawn. To be re-certified after withdrawal, at least a partial reassessment of the system (as required by QMS VN) must be conducted.

DỊCH VỤ

  • Chứng nhận
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TIN TỨC

ISO 13485

ISO 13485: Quality Management System for Medical Devices Introduction to

HACCP

Step 1: Establish the HACCP Team Team members must be