Quality Policy

Policy Statement

We, PLEASURE LATEX PRODUCTS SDN. BHD., manufacturer of natural rubber latex male condom and related products is committed to our customers by providing quality products with prompt delivery through good communications.

Missions

In tandem with our quality commitment, it is our policy to:-

Pursue towards meeting customer requirements with good professional practice in compliance with relevant statutory, regulatory and accreditation requirements.

Liase closely the quality management system, which include the quality manual and procedures to ensure that is communicated, understood, implemented and maintained within the organisation.

Provide training to familiarize and continually improve the effectiveness of the quality management system and quality policy.

Strive for continual improvement in practical new technologies and process performance towards meeting quality objectives which are to be reviewed for continuing suitability.

Build customer satisfaction in fulfilling customer contractual requirements for quality.

Objectives

Our objectives towards the Quality policy shall be established, measured and revised annually at management review meeting for continuing suitability.

Goals

To achieve the fundamental goals of this Quality Policy, all manufacturing activities in the organisation shall comply with the following quality system requirements:-

  • ISO 9001
  • ISO 13485 and its regulatory variants
  • US FDA's Quality System Requirement (QSR)

 

Certificates

ISO 9001 2015
(2022.07.22 - 2025.07.21)
ISO 14001-2015 Certificate
(2021.12.20 - 2024.12.19)
Notice of WHO_UNFPA Prequalification_Pleasure Latex
MDA PLP Brand
(2023.06.01 - 2028.05.31)
SIRIM Mark Certificate
CFDA China Certificate for Male Latex Condom
Malaysia MDA Registration Certificate Sure Brand
(2024.06.24 - 2029.06.23)
MDA Kingdom brand Registration Certificate
(2022.12.28-2027.12)
MDA VIP brand Registration Certificate
(2022.12.28 - 2027.12.27)
CE Mark certificate for lubricant gel
MDA Cheers brand Registration Certificate
(2022.12.28 - 2027.12.27)
Malaysia MDA Registration Certificate - Sure Personal Lube
FDA 510(K) Premarket Notification Device List
ISO 13485
(2023.06.08 - 2026.04.29)
EC Certificate of Conformity
SIRIM ISO 4074: 2015
(2023.05.01 - 2026.04.30)
MDA Sure Personal Lube Registration Certificate
(2019.10.07 - 2024.10.06)
SIRIM ISO 4074: 2015
(2016.01.29 - 2025.01.29)

IFU

Condom, Probe Cover & Personal Lubricant Gel

Condom

Condom - EN ISO 4074
2015 With CE Mark
Condom - EN ISO 4074 : 2015
Condom - WHO

Probe Cover

Ultrasonic Probe Cover
In House With CE Mark
Ultrasonic Probe Cover
In House Without CE Mark

Personal Lubricant Gel

Personal Lubricant Gel
In House

Product Mark

  • CE Mark
    Europe
  • SIRIM Mark
    Malaysia

Registered With

  • FDA 510(k)
    USA

  • MDA
    Malaysia

  • CFDA
    China

Testing Standard

  • ISO 4074
    Well-Recognised International Standard

  • WHO
    World Health Organisation Tender Specification

  • ASTM
    United State ASTM Standard

  • GB 7544
    China National Standard