Certification Process

Introduction

In today’s fiercely competitive environment of the global market place, it has become imperative for companies over a wide range of manufacturing and service sectors to provide assurance of the quality of their products or services through an implementation of a variable ISO 9001/14001/22000/OHS 18001 and other management systems.

International standards ISO 9001, 14001, 22000 & OHS 18001 and other series stipulate the minimum requirements for a documented

Quality / Environmental / Food Safety/Occupation Health Safety system to be established and a Certificate of Compliance to these standards has now become an international criteria of assessing a company’s credibility and capability to consistently meet quality standards to the customer satisfaction.

Purpose

The purpose of this description of the EACS / Partner CB certification Rules is to provide relevant information regarding EACS / Partner CB Services for conducting our impartial and competent assessment of a company’s management system for issue and maintenance of an accredited certification ISO 9001, ISO 14001, OHSAS 18001, 22000 & other Standards

Scope

The accredited certification scheme operated by EACS / Partner CB is a third party system certification scheme with an objective of giving recognition to companies who have effectively implemented and operate a verifiable documented system. It covers the following scope

  • Medical Device Directive
  • Preliminary meeting to establish scope of registration and the applicable standard.
  • Conduct of independent audits for certification
  • Issue of accredited certifications as per accredited scope sectors
  • Surveillance visits for verification of conformance of quality systems to certification standard.

The organization need to develop a system in respect to ISO 9001:2008 / ISO 14001:2004/IS 18001:2007/ ISO 22000:2005 & other standard as per the applicable management system for which they need the certification

Application

The services of assessment from EACS / Partner CB are available to all applicants. Every applicant need to authorize a representative from its management or staff, who can provide necessary information to EACS / Partner CB as mentioned in the application form, which covers the following:

(a) The desired scope of the certification on the desired standard.
(b) Name, address, location of the unit or units needs to be included for assessment, significant aspects of its process and operations, and any relevant legal obligations.
(c) Field of certification applied for, activities, human resources and relationship in a larger corporation if any.
(d) Outsource processes used by the applicant organization, that will affect conformity to requirement
(e) Information concerning the use of consultancy relating to the management system or other information.
(f) Information concerning to any previous certification on the same standard.

Application Review:

Before proceeding with the audit for concerning standard, EACS / Partner CB conduct a review of the application and supplementary information provided by the applicant for certification to ensure that:

(a) The information about the applicant organization and its management system is sufficient for conduct the audit.
(b) The requirements for certification are clearly defined and documented, and have been provided to the applicant organization.
(c) Any known difference in understanding between EACS / Partner CB and applicant organization is resolved.
(d) The EACS / Partner CB have the competence and ability to perform the certification activity.
(e) The scope of certification sought, the location(s) of the applicant organization operations, time required to complete audit and any other point influencing the certification activity are taken in to account.
(f) Records of the justification for the decision to undertake the audit are maintained in application.

After this review EACS / Partner CB either accept or decline the request for certification. When EACS decline an application for certification as a result of review of application, the reason for declining the application will be documented and will be communicated, making it clear to the applicant organization.

As a result of this review EACS / Partner CB determine the competences needed to be included in audit team and for certification decision.

The audit team will be appointed and composed of auditors and technical experts if necessary, who or between them, have the totality of the competences identified during application review by the technical manager. The selection of the audit team be performed with reference to the designations of competence of auditors and technical experts and may include both internal and external human resources.

The individual(s) who will be conducting the certification decision will be appointed to ensure appropriate competence is available. The individuals may change during the course of process depending on the availability of the person, but the competence will not be compromise.

Initial Certification Audit:

The initial certification audit of the management system will be conducted in two stages: Stage 1 and stage 2.

Stage 1 Audit:

(a) The stage 1 audit will be performed to
(b) Audit the client’s management system documentation
(c) Evaluate client’s location and site specific conditions and to undertake discussions with the client’s personnel to determine the preparedness for the stage 2 audit.
(d) Review the client’s status and understanding regarding requirements of the standard, in particular with respect to the identification of key performance or significant aspects, processes, objectives and operation of the management system.
(e) Collect necessary information regarding the scope of the management system, processes and location(s) of the client and related statutory & regulatory aspects and compliance.
(f) Review the allocation of resources for stage 2 audit and agree with the client on the details of the stage 2 audit.
(g) Provide a focus for planning the stage 2 audit by gaining a sufficient understanding of the client’s management system and site operations in the context of possible significant aspects.
(h) Evaluate if the internal audits and management review are being planned and performed and that the level of implementation of the management system substantiates that the client is ready for the stage 2 audit.
(i) Stage 1 audit findings will be documented and communicated to the client, including identification of any areas of concern that could be classified as non-conformance during stage 2 audit.
(j) In determining the interval between stage 1 and stage 2 audits, consideration will be given to the needs of the client to resolve areas of concern identified during the stage 1 audit. EACS may also need to revise its arrangement for stage 2 audit.

Stage 2 audit:

The purpose of the stage 2 audit is to evaluate the implementation, including effectiveness of the client’s management system. The stage 2 audit will take place at the site(s) of the client. It will include at least the following:

(a) Information and evidence about conformity to all requirements of the applicable management system standard or other normative document.
(b) Performance monitoring, measuring, reporting and reviewing against key performance objectives and targets.
(c) The client’s management system and performance as regards legal compliance.
(d) Operational control of the client’s processes.
(e) Internal auditing and management reviews
(f) Management responsibility of the client’s policies.
(g) Links between the normative requirements, policy, performance objectives and targets, any applicable legal requirements, responsibilities, competence of personnel, operations, procedures, performance data and internal audit findings and conclusions.

Initial Certification audit conclusions:

The audit team will analyze all information and audit evidence gathered during the stage 1 and stage 2 audits to review the audit findings and agree on the audit conclusions.

Information for granting initial certification:

The information provided by the audit team leader to EACS / Partner CB head office for the certification decision will include but not limited to the following:

(a) The audit report
(b) Comments on the nonconformities and where applicable, the correction and corrective actions taken by the client.
(c) Conformation of the information provided to the EACS / Partner CB head office used in the application review.
(d) A recommendation whether or not to grant certification, together with any conditions or observations.
(e) Then EACS head office shall make the certification decision on the basis of an evaluation of the audit findings and conclusions and any other relevant information and that the decisions are not influenced by other interests or by other parties.

Issue of Certificate

Upon completion of the review of all audit documentation and corrective actions being closed out, EACS / Partner CB will issue the Certificate of Registration to the company. VALIDITY AND RENEWAL OF CERTIFICATE: Certificates issued by EACS / Partner CB remain valid for three years subject to the conformance of the quality management systems to the certification standards being verified and found satisfactory during periodical surveillance audits. Upon expiry, Certificate of Registration is renewed for a further term of three years after conduct of a satisfactory reassessment.

Surveillance Activities

General

EACS / Partner CB developed its surveillance activities so that representative areas of functions covered by the scope of the management system are monitored on a regular basis and take into account changes to its certified client and its management system.

Surveillance activities of EACS / Partner CB include on-site audits, assessing the certified client’s management system’s fulfilment of specified requirements with respect to the standard to which the certification is granted. Other surveillance activities include the following:
(a) Enquiries from EACS / Partner CB to the certified client on aspects of certification
(b) Reviewing any client’s statements with respect to its operations like: promotional material, website.
(c) Requests to the client to provide documents and records on paper or electronic media,
(d) Other means of monitoring the certified client’s performance.

Surveillance Audit:

Surveillance audits are on-site audits, but are not necessarily full system audits, and will be planned together with the other surveillance activities, so that the EACS / Partner CB can maintain confidence that the certified management system continues to fulfil requirements between recertification audits. The surveillance audit program includes at least but not limited to:

(a) Internal audits and management reviews
(b) Any change in Scope of Certification
(c) A review of actions taken on nonconformities identified during the previous audit
(d) Treatment of complaints
(e) Effectiveness of the management system with regard to achieving the certified client’s objectives,
(f) Progress of planned activities aimed at continual improvement
(g) Continuing operational control,
(h) Review of any changes
(i) Use of marks and or any other reference to certification.
(j) Surveillance audit will be conducted at least once a year. The gap between two audits will not be more than 12 months from the last day of the stage 2 audit.

Maintaining certification:

The EACS / Partner CB maintain certification based on demonstration that the client continues to satisfy the requirement of the management system standard. It may maintain a client’s certification based on a positive conclusion by the audit team leader without further independent review, provided the following:
(a) For any nonconformity or other situation that may lead to suspension or withdrawal of certification, the EACS / Partner CB has a system that requires the audit team leader to report to the EACS / Partner CB head office need to initiate a review by appropriately competent personnel, different from those who carried out the audit, to determine whether certification can be maintained.
(b) Competent personnel of EACS / Partner CB monitors its surveillance activities, include monitoring the reporting by its auditors, to confirm that the certification activity is operating effectively.

Recertification:

Re-certification audit planning:

(a) A recertification audit will be planned and conducted to evaluate the continued fulfilment of all of the requirements of the relevant management system standard or other normative documents. The purpose of the recertification audit is to confirm the continued conformity and effectiveness of the management system as a whole and its continued relevance and applicability for the scope of certification.
(b) The recertification audit will consider the performance of the management system over the period of certification, and include the review of previous surveillance audit reports.
(c) Recertification audit activities may need to have stage 1 audit in situations where there have been significant changes to the management system, the client or the context in which the management system is operating.
(d) In the case of multiple sites or certification to multiple management system standards being provided by EACS / Partner CB, the planning for the audit will ensure adequate on-site audit coverage to provide confidence in the certification.

Information for granting recertification

The EACS / Partner CB will make decisions on renewing certification based on the results of the recertification audit, as well as the results of the review of the system over the period of certification and complaints received from users of certification.

Special Audits:

Extensions to scope: EACS / Partner CB will, in response to an application for extension of the scope of a certification already granted, undertake a review of the application and determine any activities necessary to decide whether or not the extension may be granted. This may be conducted in conjunction with a surveillance audit.
Short- notice audits: It may be necessary for EACS / Partner CB to conduct audits of certified clients at short notice to investigate complaints, or in response to changes, or as follow up on suspended clients. In such cases
EACS / Partner CB will describe and make known in advance to the certified clients the conditions under which these short notice visits are to be conducted
EACS / Partner CB will exercise additional care in the assignment or the audit team because of the lack of opportunity for the client to object to audit team members.

Suspending, withdrawing or reducing the scope of certification:

EACS / Partner CB has a policy for suspension, withdrawal or reduction of the scope of certification and will specify the subsequent actions by EACS / Partner CB.
EACS / Partner CB will suspend certification in cases when, for example but not limited to the following:
(a) The client’s certified management system has persistently or seriously failed to meet certification requirements, including requirements for the effectiveness of the management system
(b) The certified client does not allow surveillance or recertification audits to be conducted at the required frequencies
(c) The certified client has voluntarily requested a suspension.
Under suspension, the client’s management system certification is temporarily invalid. The EACS / Partner CB has an enforceable arrangement with the client to ensure that in case of suspension the client refrains from further promotion of its certification by the way of certification audit contract. EACS / Partner CB make the suspension status of the certification publicly accessible. It is available on the official web site of EACS / Partner CB and other wise anybody can ask member secretariat for the relevant information.
Failure to resolve the issues that have resulted in the suspension in a time established by EACS / Partner CB will result in withdrawal or reduction of the scope of certification. In most of the cases suspension would not be more than 6 months.
EACS / Partner CB reduce the client’s scope of certification to exclude the parts not meeting the requirements, when the client has persistently or seriously failed to meet the certification requirements for those parts of the scope of certification. Any such reduction will be in line with the requirements of the standard used for certification.
EACS / Partner CB has enforceable arrangements by signing the certification audit contract with the certified client concerning conditions of withdrawal ensuring upon notice of withdrawal of certification that the client discontinues its use of all advertising matter that contains any reference to a certified status.
EACS / Partner CB has system for availability of information, upon request by any party and paying USD 50 Only, EACS correctly state the status of certification of a client’s management system as being suspended, withdrawn or reduced.

Records of applicants and clients:

EACS / Partner CB maintain all records of applications, all organizations audited, certified or with certification suspended and withdrawn.
Records on certified clients include the following:
(a) Application information and initial surveillance and recertification audit reports.
(b) Certification audit contract
(c) Justification of methodology used for sampling if any.
(d) Justification for auditor time duration if not matching to IAF guidelines
(e) Verification of correction and corrective actions
(f) Records of complaints and appeals, and any subsequent correction or corrective action.
(g) Committee deliberations and decisions, if any
(h) Documentation of the certification decision
(i) Copy of certificate including scope of certification with respect to product, process or service, as applicable.
(j) Related records necessary to establish the credibility to the certification, such as evidence of the competence of auditors and technical experts.
EACS / Partner CB Keep the record of all applicants and clients secure to ensure that the information kept confidential. Records are transported, transmitted or transferred in the supervision of manager technical and above to maintain confidentiality.
EACS / Partner CB has a policy and procedure on the retention of records. That is defined on procedure control of records document no.

Certification Document

The certified client gets the certificate and the policy for usage of certification mark and accreditation marks.