These Scheme Rules have been written in accordance with the requirements of the applicable IAF Member National Accreditation Bodies under Accredited Certification Schemes. E-Tex Solution Ltd., hereafter known as “E-Tex Solution ” also comply with all conditions.
E-Tex Solution provides independent third-party assessment and registration services for companies who have implemented management systems against the following standards/codes of practice:
- Quality Management Systems (ISO 9001)
- Environmental Management Systems (ISO 14001)
- Medical Devices Quality Management Systems (ISO 13485)
- Occupational H & S Management Systems (OHSAS 18001 / ISO 45001)
- Food Safety Management Systems (ISO 22000)
- Information Security Management Systems (ISO 27001)
- Security Management System for the Supply Chain (ISO 28000)
- Codex Alimentarius (HACCP)
- Good Manufacturing Practice (GMP)
a) E-Tex Solution agrees not to disclose any information relating to the client’s business or affairs except information, which is in their possession before the date of acceptance of the E-Tex Solution contract.
b) Where information is needed to be disclosed to a third party either by law or as required under maintenance of certification by an Accreditation Body, the client shall be informed of the information as required by law.
c) For the purposes of registration verification, information contained on all issued certificates can be verified using the registration number shown on the certificate from the certification check on the E-Tex Solution web site (www.e-texsolution.com )
4. General Conditions
E-Tex Solution basic conditions for gaining and maintaining registration with are that all applicants agree to and comply with the following rules:
a) All information deemed necessary by E-Tex Solution in order to complete the registration process shall be made available to the applicant company.
b) If E-Tex Solution are not satisfied that all requirements for registration have been met it shall inform the applicant in writing stating which requirements.
c) When the applicant can demonstrate that effective corrective action has been taken within a specified time limit, then E-Tex Solution will arrange only to repeat necessary parts that cannot be verified by the submission of documented evidence.
d) If the applicant fails to take effective corrective action within the time limit then E-Tex Solution may repeat the audit in full at additional cost.
e) Identification of conformity shall only apply to site(s) audited and within the scope of registration as shown on the E-Tex Solution certificate of registration.
f) All fees must be paid as shown on the individual quotation. No certificate shall be issued for initial assessment or re-assessment until fees have been paid in full. Registration may be suspended if annual fees are not paid in full within the time frame set out within the individual quotation.
g) In order for the registered company to demonstrate effective management reviews and internal audits these activities shall be carried out at a frequency of no less than once per year.
h) Failure to return all certificates of registration shall result in legal action being taken against the company for unauthorized use or registration and accreditation marks and on misleading and inaccurate claims of registration.
i) The applicant must allow E-Tex Solution to conduct on-going surveillance visits at the times stated within the individual quotation.
j) E-Tex Solution offices which hold national accreditation directly with a national accreditation body, or hold “critical location” status are responsible for, and retain authority for, decisions relating to accredited certification, including the granting, maintaining, renewing, extending, reducing, suspending and withdrawing of certification.
k) The management representative must be made known to E-Tex Solution, and should there be a change of management representative then E-Tex Solution shall be informed in writing.
5. Application for Assessment
E-Tex Solution will conduct a pre-contract review of the system on receipt of a completed Application for Quotation Form and a quotation shall be prepared and sent to the prospective client, together with these Scheme Rules.
6. Contract Acceptance
Prior to any arrangement being made for an assessment, the quotation is required to be signed by the Client. Signature on the quotation/contract indicates formal acceptance of these rules as stated within the quotation/contract.
7. Initial Assessment
The initial assessment is conducted in two stages, which are specified below:
a) Stage 1 Visit
Is an audit carried out on site at the client’s premises? The objectives of this visit are as follows:
- i. to audit management system documentation.
- ii. to evaluate the location, site specific conditions and to undertake discussions with personnel.
- iii. to collect information related to the scope of application and related statutory and regulatory requirements.
- iv. to evaluate if management reviews and internal audits are being planned and performed to determine preparedness for the stage 2 audit.
- v. to produce a process-based audit plan for the stage 2 visit.
Only when it has been determined that the applicant company is prepared for the stage 2, shall a date be agreed for that visit.
b) Stage 2 Visit
Is an audit carried out on site at the client’s premises to evaluate the effectiveness of implementation and covers?
- i. information and objective evidence regarding the standard.
- ii. performance monitoring, measuring, reporting and reviewing key performance objectives and targets.iii. the management system performance regarding legal compliance.
- iv. operational control of the management system processes.
- v. internal audits and management reviews.
- vi. management responsibility for policies.
- vii. links between policy and legal requirements, competence of personnel, operations, procedures and data.
All audits are based upon sampling and therefore not a guarantee of 100% conformity with the standard. Therefore, it is critical that effective internal audits are conducted on an on-going basis by the applicant company.
For all high-risk areas where there can be a direct risk to human health, safety and well-being the audit team may be required to take photographs to provide evidence of effective implementation of safety measures. All such photographs shall remain confidential.
- a) On completion of the on-site assessment the lead auditor reports back to E-Tex Solution. The File Reviewer of E-Tex Solution shall review the report and supporting information, including the recommendations made by the lead auditor and decide whether to grant certification.
- b) For any non-conformities raised, the client shall conduct root cause analysis and send details of corrections, corrective action and preventive action to E-Tex Solution within 30 days from the last day of the assessment visit. This information shall be reviewed by a qualified lead auditor and the client shall be informed of the result via email and/or having access via the E-Tex Solution client portal. Upon acceptance of the proposed actions the File Reviewer shall review the full report and make a decision on certification.
- c) Certification shall only remain valid on the basis of continued conformity by the registered client. For any non-conformity or other situation that may lead to suspension the lead auditor shall report to E-Tex Solution and the suspension process shall take effect as defined within these rules.
- a) After the issue of the certificate of registration, surveillance visits shall be carried out at the client’s premises. If substantial areas of concern are identified then extra visits may be scheduled at the discretion of the File Reviewer. The client agrees to meet the extra costs relating to such additional surveillance. Should surveillance not take place when required then registration shall be removed and published in the public domain. Surveillance audits shall be conducted at least once a year. The date of the first surveillance audit following initial certification shall not be more than 12 months from the last day of the Stage 2 audit.
- b) For any non-conformities raised, the client shall conduct root cause analysis and send details of corrections, corrective action and preventive action to E-Tex Solution within 30 days from the end of the surveillance visit.
- c) The certificate holder shall allow E-Tex Solution the right of access for the purposes of maintenance of certification.
- a) A re-certification audit shall be planned and conducted at the client`s premises to evaluate the continued fulfilment of all of the requirements of the relevant management system standard.
- b) For any non-conformities raised, the client shall conduct root cause analysis and send details of corrections, corrective action and preventive action to E-Tex Solution within 30 days from the end of the re- certification visit. In all cases where non-conformities have been raised timescales for corrections and corrective actions to be implemented shall be prior to the expiry of the certificate.
- c) Prior to a review being undertaken by the File Reviewer the details sent by the client shall be reviewed by a qualified lead auditor. The client shall be informed of the results of this review via email and/or the E-Tex Solution client portal.
- d) The File Reviewer shall then review the full file and decide whether to accept the lead auditor’s recommendations. Should the File Reviewer accept the actions supplied and the report, then certification shall be granted.
- e) All re-certification visits shall be carried out prior to the expiry date of the current certificate. Any non- conformity raised at the re-certification visit shall be closed-out prior to a new certificate being issued.
- f) The decision on whether to grant re-certification shall be based upon the audit results over the period of certification plus complaints from users.
11. Use & Mis-Use of Certificates, Logos & Certification
Once a Certificate has been issued, then the client has the right to publish the fact and to apply the logo on their stationery and promotional material. The marks can only be used as specified with clause 23 of these Scheme Rules. Other conditions are as follows related to certification:
- a) That no misleading statements are implied or made regarding certification.
- b) That no certification document is used in a manner that would mislead clients or registered companies or the public in general.
- c) Upon suspension, withdrawal or cancellation cease with immediate effect to use of the marks on advertising, such as brochures, letterheads, business cards, web sites, etc., and return the certificate to E-Tex Solution.
- d) Should a scope of registration be reduced, amend all advertising materials where details of the scope have been published. For all reductions or increases in scope the original certificate to be returned to E-Tex Solution , prior to any updated certificate being issued.
- e) That nothing is implied or an impression is given that certification activities are outside of the scope of certification.
- f) Not to use certification in any way as to bring into disrepute the credibility of E-Tex Solution or of Accredited Certification that could affect public trust and confidence.
12. Suspension, Scope Extension, Scope Reduction & Withdrawal
Following a successful assessment and subsequent Certification of a Client’s System to the relevant Management System Standard. Some of the following activities may apply as follows:
- I. as a result of continued mis-use of a certificate or logo.
- II. failure to implement corrective action within the specified time scale as a result of concern identified at Assessment, Surveillance or Re- Assessment visits.
- III. any other breach of the E-TEX SOLUTION quotation and/or Rules of Registration.
- IV. when a major non-conformity is raised during any visit, after the original Assessment.
- V. under suspension it is not permitted to use any logos on any advertising materials until the suspension has been lifted.
- VI. the File Reviewer of E-TEX SOLUTION shall write to the registered client outlining the suspension conditions and how the suspension can be lifted.
b) Scope Extension
For all extensions to scope the registered client has to make a request to E-TEX SOLUTION in writing. The request shall be reviewed and a new quotation sent out. Upon acceptance E-TEX SOLUTION shall decide the action required to verify and validate the scope extension.
c) Scope Reduction
Reductions to scope could be a result of an initial assessment, which shall be confirmed within the assessment report. Should a reduction in scope be recommended by a E-TEX SOLUTION Lead Auditor at a surveillance or re-assessment visit this has to be noted in the report and the File Reviewer informed.
Such withdrawals could be as a result of:
I. failure to respond to requests/time scales made by E-TEX SOLUTION after suspension of Certification.
II. failure of a client to settle an account with E-TEX SOLUTION within 1 month of formal notification of a failure to settle an account.
III. voluntary withdrawal, in such a case E-TEX SOLUTION require this in writing.
IV. the certificate of registration shall be returned to E-TEX SOLUTION when E-TEX SOLUTION has informed the client that withdrawal has been complete. No copies of certificates shall be used or logos displayed after withdrawal has taken place.
If the client is not in agreement with the Lead Auditor’s recommendation after an Assessment, Surveillance or Re- Assessment then they are at liberty to lodge an appeal with the Standard Manager and CEO of E-TEX SOLUTION . The Client shall support his reasons by objective evidence.
All appeals will be heard by a Sub-Committee of the E-TEX SOLUTION Impartiality Committee. The Sub-Committee may hear evidence from the client’s representative and the Lead Auditor. The decision of the Sub-Committee is final and binding on both the Client and E-TEX SOLUTION . No counter claim will be allowed by either party. No costs, for whatever reason, will be allowed for either party as a result of an appeal.
a) General Requirements
All clients are required to maintain a log of all customer complaints raised against them. This log must be available for review during all Assessment and Surveillance Visits. This log shall also be available to E-TEX SOLUTION Staff upon request.
b) Complaints from Clients Regarding Auditors
If a client has a complaint about the conduct of any E-TEX SOLUTION Auditor then this should be sent in writing to the E-TEX SOLUTION Standard Manager and CEO. If the complaint involves the Standard Manager or File Reviewer then the complaint is to be addressed to the Chairman of the Impartiality Committee of E-TEX SOLUTION .
c) Complaints from Users of Clients Products & Services
For complaints received from users of clients’ products and/or services shall be lodged and then acknowledged to the complainant. Follow-up shall then be taken with the registered company in question.
d) Serious incidents and breach of legal requirements
The client must inform, without delay, E-TEX SOLUTION of any occurrence of a serious incident or breach of regulation necessitating the involvement of the competent regulatory authority.
In the event that E-TEX SOLUTION becomes aware of a nonconformance relating to the client being in breach of a relevant regulatory requirement, it shall notify the client without delay.
In such circumstances, E-TEX SOLUTION may deem it necessary to conduct a special audit focusing on the incident or breach and to determine that the management system has not been compromised.
15. Witnessed Visits
As part of the on-going surveillance of E-TEX SOLUTION , the client agrees to allow representatives from national accreditation bodies the right to witness E-TEX SOLUTION conducting their audit duties. The fact that an Accreditation Body representative attends an audit will not affect the audit. Also, from time to time E-TEX SOLUTION may have to have trainee auditors or internal audits on an assessment team.
16. Short Notice Audits
For clients that have been suspended or where E-TEX SOLUTION has received complaints then a short notice audit maybe required for follow-up and verification/validation of the implementation of corrective and preventive measures. In such cases the client agrees to co-operate with E-TEX SOLUTION audit team members and allow the required access.
For ISO 13485 short notice audits may take place for the following reasons:
a) external factors apply such as: available post-market surveillance data known to E-TEX SOLUTION on the subject devices indicate a possible significant deficiency in the quality management system. significant safety related information becoming known to E-TEX SOLUTION .
significant changes occur which have been submitted as required by the regulations or become known to E-TEX SOLUTION and which could affect the decision on the client’s state of compliance with the regulatory requirements.
The following are examples of such changes which could be significant and relevant to E-TEX SOLUTION when considering that a special audit is required, although none of these changes should automatically trigger a special audit:
I. QMS – impact and changes:
– new ownership
– extension to manufacturing and/or design control
– new facility, site change
– modification of the site operation involved in the manufacturing activity (e.g. relocation of the manufacturing operation to a new site or centralizing the design and/or development functions for several manufacturing sites).
– new processes, process changes
– significant modifications to special processes (e.g. change in
production from sterilization through a supplier to an onsite facility or a
change in the method of sterilization).
– QM management, personnel.
– modifications to the defined authority of the management representative that impact quality management system effectiveness or regulatory compliance.
– the capability and authority to assure that only safe and effective medical devices are released.
II. Product related changes:
– new products, categories
– addition of a new device category to the manufacturing scope within the quality management system (e.g. addition of sterile single use dialysis sets to an existing scope limited to hemodialysis equipment, or the addition of magnetic resonance imaging to an existing scope limited to ultrasound equipment).
III. QMS & Product related changes:
– Changes in standards, regulations.
– Post market surveillance, vigilance
An unannounced or short-notice audit may also be necessary if E-TEX SOLUTION has justifiable concerns about implementation of corrective actions or compliance with standard and regulatory requirements.
17. Terms of Payment
Payment shall be made in accordance with the
individual invoice and the quotation/contract document.
In respect of any claim, loss, damage or expense however arising, E-TEX SOLUTION ‘s liability to the client shall in no circumstances exceed the amount of E-TEX SOLUTION ’s fees paid by the client. Under no circumstance shall E-TEX SOLUTION be liable for any consequential loss.
E-TEX SOLUTION or any E-TEX SOLUTION representative shall NOT:
a) provide management system consultancy which includes: preparation or production of manuals or procedures, or give specific advice, instructions or solutions towards the development, structure and implementation of a quality management system, environmental management systems and food safety management system.
b) allocate auditor(s) for a client in where provided internal audit, hazard analysis, FSMS or other related management system consultancy on the management system, within two years following the end of the consultancy.
c) certify a quality management system, environmental management systems, food safety management system on which it provides any consultancy. offer certification when relationships that threaten impartiality cannot be eliminated or minimized.
d) certify another certification body for management systems.
e) certify a client when a relationship with a management systems consultancy poses an unacceptable threat to impartiality. Provide an internal audit service to any certified clients.
f) outsource any audits to a management consultancy company involved in management systems as described with the scope of these scheme rules.
g) have within any marketing materials any linkage to management
For any threats to impartiality that are discovered or reported, then the impartiality committee shall be informed and responses shall be made and communicated.
20. Intellectual Property
The ownership of all issued audit reports remains the property of E-TEX SOLUTION .
21. Organisational & Management System Changes
Should there be any significant changes with the client organisation such as change of address, ownership, scope or management rep. Then E-TEX SOLUTION should be informed. Such changes will be reviewed and may require follow-up at the next scheduled surveillance visit.
22. Amendments to Scheme Rules
a) E-TEX SOLUTION reserves the right to amend these Scheme Rules without prior notification. Should the Scheme Rules be updated the latest version shall be put on the web site and all OSPs and clients informed.
b) Client should record the Scheme Rules as an “external document” within their management system for document control.
23. Use of Certification Marks
Only E-TEX SOLUTION certificated clients are authorised to use the certification marks, whilst registration is active, under the following conditions:
a) Holders of certificates issued by E-TEX SOLUTION may use the appropriate logo in accordance with the requirements of these scheme rules on stationery and publicity material or other items relevant to the certificate of registration.
b) That the registration number as shown on the certificate of registration is displayed underneath the outside of the outer box, in the center.
c) Embossed, relief, or die-stamped versions may be used. The marks may also be produced as water marks as long as clarity is maintained. Electronic reproduction of the marks is permitted provided that the organisation’s certificate number is shown for traceability and verification purposes and that the logo only relates to information on the certificate of registration.
d) Reversed image versions of the accreditation marks are allowed. When the marks are printed on an advertising or stationery the marks shall be no less than 20mm in height, however, regardless of the minimum height restriction all logos shall be legible.
e) The marks must always be shown next to the E-TEX SOLUTION logo. The accreditation body logos are not permitted to be displayed on their own without the E-TEX SOLUTION logo both inside the outer box.
f) The logo is not permitted to be used on any product as this could be misleading and give the impression that the product has been approved under a product certification scheme.
g) The national accreditation marks shall not be used on vehicles and flags. If additional certificates are required then the client should request this in writing from E-TEX SOLUTION .
h) Should certification be withdrawn or cancelled then the original certificate(s) must be returned to E-TEX SOLUTION ? From the date of cancellation, no web sites can display the logo nor stationery be issued displaying the logo which could mislead clients and potential clients regarding the registration status. In cases of scope reduction or increase the certificate(s) shall be returned to E-TEX SOLUTION for re- issue.
i) At all times certificate(s) remain the property to E-TEX SOLUTION and can be recalled upon request.
j) The certification marks shall not be used on laboratory test reports, calibration certificates and inspection reports.
24. Privacy Notice
We take the privacy and the protection of personal information seriously. Our Privacy Notice sets our details about we gather, use and share personal information and about individual privacy rights. How we use personal infromation depends upon the context in which it is made available to us.