WordPressAdmin-PSQC

Author: psqcadmin

  • Top Facts About CE Marking

    Top Facts About CE Marking

    CE mark is a certification mark which ensures conformity to regulations and rules of safety, health and environmental aspects of products sold in the EEA (European Economic Area). CE mark is thus a symbol, declaration, proof and validation with respect to Europe.

    What does it stand for?

    CE Mark appears on many products traded in the EEA. It can be seen on technical equipment, electronics, and toys and also on medical devices.

    Basically, the CE mark serves the purpose of indicating that products sold in the EEA have been evaluated to meet stringent environmental protection, safety and health requirements. Another fact about the CE mark is that CE marking supports fair competition by holding all companies accountable as per the same rules.

    How to obtain?

    For gaining CE Marking certification, one must comply with European Commission Regulations (EU), No. 2017/745, commonly referred to as the MDR (Medical Device Regulation).

    This simply implies that you must construct a technical file as proof that your product complies with all EU regulations. If you are a medical device manufacturer, it’s your responsibility for declaring compliance with all needs.

    In case of all devices, except Class 1 (Self-certified), the company must implement a QMS (Quality Management System) as per the MDR.

    Generally, the CE mark is supposed to be imprinted on the product. But if this is not possible, then manufacturers are allowed to affix it on packaging material or data plate of the product.

    Why is CE mark vital?

    The CE Marking is important for several reasons. It is a legal responsibility. It comes from EU legislation. It guarantees that the product is conforming to stipulations of the EEA. Selling products without CE Mark is an economic offence which is punished differently by each of the EU member states.

    CE marking indicates that the product is free to enter the EEA. CE mark is mandatory for all products that are imported or exported from EEA. The manufacturer shall affix the CE marking to products but must take some obligatory steps before using it.

    By affixing the CE mark, the manufacturer takes total responsibility of the products for complying with rules and standards of the EU (European Union). This CE mark has helped the EU to improve product quality.

    Is it a passport to Europe?

    The CE marking certification amounts to a passport for a product to enter the EU market. The CE marking procedure enables the free movement of a product within the EU. For several consumers, it is a symbol of quality.

    What does it indicate?

    A CE mark is a symbol that must be affixed on products before they can be sold in the EU. This mark indicates that a product serves the needs of relevant European directives for products. Also, it ensures that it meets all the needs of applicable, recognised and harmonised European performance and safety standards. It indicates that the product is fit for its objectives and will not jeopardise property or lives.

    Facts

    • CE marking certificates are usually valid for a maximum of 5 years but maybe reviewed annually.
    • CE is an abbreviation of a French term- Conformité Européene’ which means European Conformity.

    These are all the top facts about CE marking.

  • How to Prepare for ISO 13485 Audit

    How to Prepare for ISO 13485 Audit

    No matter how confident you are in your QMS (Quality Management System), as a medical device manufacturer, you cannot be complacent about quality audits in the future. New global regulations like ISO 13485 imply that you need a tighter grip over the QMS in your facility.

    The new regulations stretch widely through the QMS, particularly for those managing huge networks of vendors and suppliers. Preparing for an audit is a crucial step for your organization. The process culminates with a 3rd party registrar conducted an external audit for gaining 13485 Certification.

    Auditors have many objectives. These are:

    • To verify that your documentation adheres to all standards and needs
    • To ensure that employees realize their role in the QMS and know about ISO 13485 needs as regards their role in the firm
    • Correct following of procedures and processes

    Being audited is costly and time-consuming, so you may desire to be well prepared.

    Following are some tips for a successful audit:

    Give Time to Prepare

    Much time and effort are involved in preparing your facility for audit. After deciding for getting certified, you must set goals and spare time for meeting the needs of the standard.

    Prepare Employees

    Before the audit, you will need to appraise all your employees about the time and scope of the audit. Every employee must know the quality objectives of the organization and how they can contribute. You can prepare most employees through ISO 13485 training online.

    Documented Information

    This is another crucial aspect of preparing for an audit. During this process, you must ensure that record lists and documents have been updated. All documents must be subject to review, approval, communication and followed by all. Also, ensure that there is the use of outdated documents.

    Procedures and Processes

    They need to be followed carefully. Your organization must make sure that all processes are adhering to the planned arrangements that you set out to accomplish and that they are being performed and followed in the right fashion by all employees.

    Preparation of Facility

    While preparing for an audit, your organization must be cleaned and well organized. A messy facility can weigh heavily. You must have a wide understanding of the facility to avoid any hidden issues. While getting organized for the audit, check drawers, counters, bulletin boards, etc. for uncalibrated measuring and monitoring instruments and unknown supplies or parts.

    Internal Audit

    An internal audit must be conducted by the firm. This is not only vital for ISO 13485 certification but also to spot non-conformances. You must take internal audits seriously. They are a good way to prepare staff for certification interviews. The aim of an internal audit is to spot weaknesses as well as areas requiring improvement.

    Management Review

    This should take place soon after an internal audit. As per this step, past internal audit findings must be reviewed, and corrective actions must be taken, where needed.

    Review of Past Findings Of Internal Audit

    Following an internal audit, findings must be reviewed in a close meeting with everyone involved. The objective of an internal audit is to correct areas of weaknesses in the path to ISO 13845 certification.

    These are the major steps towards preparing for ISO 13845 certification. Additional steps are required such as review of past internal audit findings, review of corrective action process, pre-assessment audit, 2-Stage certification audit and finally, a professional, 3rd party audit.