Certification Process

The Certification process shall consist of the following stages:

1. Application

2. Application/Contract Review

3. Stage-1 audit

4. Stage-2 audit

5. Surveillance audit

6. Recertification audit

7. Expanding of Scope

8. Short Notice Audit

1. Application:

Enquiries may be received in several forms, by telephone, letter, and e-mail etc. In case client need the physical copy of the application form then client can write to us on certification@tplcertification.com and demand a copy of an application.

2. Application/Contract Review:

After getting the complete application, the Assessment Manager will arrange for the application review as per the established process and if the same is found to be within TPL's scope of accreditation the quotation will be prepared and will be submitted to the client. Assessment Manager shall proceed for finalizing the audit team.

3. Stage-1 audit:

3.1 In case, TPL has audited a client against a regulatory scheme that includes or goes beyond the requirements of ISO 13485, it does not need to repeat the audit for conformity with the elements of ISO 13485 previously covered, provided TPL can demonstrate that all the requirements of this document have been complied with. Some examples of regulatory schemes that include or go beyond the requirements of ISO 13485 are European Medical Device Regulations such as MDR, IVD, and MD. Other jurisdictions include Canada (Health Canada, Canadian Medical Devices Conformity Assessment System), India (Central Drugs Standard Control Organisation) and Australia (Therapeutic Goods Administration & Therapeutic Goods Regulations). Additionally other countries are adopting or considering adopting ISO 13485 in to their Medical Device Regulations.

3.2 The Stage 1 audit (FSMS, MDQMS & QMS) shall be carried out at client's site including clients where higher risk medical devices (e.g. GHTF C and D) are concerned. In exceptional circumstances part of stage 1 audit can take place off site, but it shall be fully justified and evidence provided, demonstrating that stage 1 objectives are fully achieved. Exceptional circumstances can include very remote location, short seasonal production etc. An Intimation letter (Refer TPLF09) shall be sent to client & audit team regarding stage-1 audit to be conducted on-site. Besides, Stage 1 audit plan (Refer TPLF10) shall be prepared by the team leader & shall be communicated to client & TPL and Audit plan templates shall be communicated to the team leader (with pre-filled audit objectives) by Assessment Manager (AM) in advance.

3.3 Stage 1 audit shall start with opening meeting and shall be concluded with closing meeting in which client shall be informed about the readiness for Stage 2 audit.

3.4 The Objectives of the Stage 1 audit are to:

a) Review the client's management system documented information;

b) Evaluate the client's site-specific conditions and to undertake discussions with the client's personnel to determine the preparedness for stage 2;

c) 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 management system;

d) Obtain necessary information regarding the scope of the management system, including:

• The client's site(s);

• Processes and equipment used;

• Levels of controls established (particularly in case of multisite clients);

• Applicable statutory and regulatory requirements;

e) Review the allocation of resources for stage 2 and agree the details of stage 2 with the client;

f) Provide a focus for planning stage 2 by gaining a sufficient understanding of the client's management system and site operations in the context of the management system standard or other normative document;

g) Evaluate if the internal audits and management reviews are being planned and performed, and that the level of implementation of the management system substantiates that the client is ready for stage 2;

h) Review the methodology for impact, risk analysis, significance evaluation criteria. Objectives, targets including management programs, operation control procedures and identification and compliance to applicable legal and other requirements;

i) Develop a plan for the on-site evaluation of temporary sites including where applicable -

• A representative sample of high complexity temporary sites; and

• A representative sample of medium complexity temporary sites; and

• If only low complexity temporary sites exist, then a representative sample of low complexity temporary sites.

j) To collect necessary information for on-site audit of temporary sites considering the sites as per the complexity category.

k) To collect necessary information and identify the issues which will need special attention during the stage 2 audit.

FSMS specific:

The objectives of stage 1 are to provide a focus for the planning of stage 2 of the initial audit by gaining an understanding of the organization's FSMS and the organization's state of preparedness for stage 2 by reviewing the extent to which:

l) The organization has identified PRPs that are appropriate to the business (e.g. regulatory, statutory customer and certification scheme requirements)

m) The FSMS includes adequate processes and methods for the identification and assessment of the organization's food safety hazards, and subsequent selection and categorization of control measures (combinations)

n) The FSMS includes adequate processes and methods for the identification and implementation of relevant food safety legislation

o) The FSMS is designed to achieve the Organization's food safety policy

p) The FSMS implementation programme justifies proceeding to stage 2

q) The validation of control measures, verification of activities and improvement programmes conform to the requirements of the FSMS standard

r) The FSMS documents and arrangements are in place to communicate internally and with relevant suppliers, customers and interested parties

s) There is any additional documentation which needs to be reviewed and/or information which needs, to be obtained in advance.

Where an organization has implemented externally developed elements of a FSMS, stage 1 shall review the documentation included in the FSMS to determine if the combination of control measures:

-Is suitable for the organization

- was developed in conformity to the requirements of ISO 22000 or other sets of specified FSMS requirements

-Is kept up to date.

The availability of the relevant authorizations shall be checked when collecting the information regarding the compliance to the regulatory aspects.

For FSMS, stage 1 shall be carried out at the client's premises in order to achieve the objectives stated above. In exceptional circumstances or events, all or part of stage 1 can take place off-site or remotely through the use of ICT and shall be fully justified. The evidence demonstrating that stage 1 objectives are fully achieved shall be provided.

Note: Exceptional circumstances or events can include a very remote location, a natural disaster, a pandemic, a short seasonal production and other special situations.

Any part of the FSMS that is audited during the stage 1 audit, and determined to be fully implemented, effective and in conformity with requirements, does not necessarily need to be re-audited during stage 2. In this case, the audit report includes these findings and clearly states that conformity has been established during the stage 1 of the audit.

The interval between stage 1 and stage 2 shall not be longer than six months. Stage 1 shall be repeated if a longer interval is needed.

3.5 The Team Leader will give a documented conclusion and communicate to client organization that the Objective of stage 1 is fulfilled and client organization is ready to stage 2. The Findings of the Stage 1 shall be documented in the Stage 1 audit report and the same shall be communicated to the client by signing the audit report which shall include the identification of any areas of concern that could be classified as nonconformity during the stage 2 audit.

3.6 Any part of the FSMS that is audited during the stage 1 audit, and determined to be fully implemented, effective and in conformity with the requirements may not need to be re-audited during the stage 2 audit. However, TPL shall ensure that the already audited parts of the FSMS continue to conform to the certification requirements. In this case, the audit report shall include these findings and shall clearly state that conformity has been established during the stage 1 audit.

3.7 Stage 2 audits shall be initiated within maximum 60 days (max. 6 months for FSMS) from the last day of stage 1 audit. Between the specified time client is said resolve areas of concern identified during the stage 1 audit. In case stage 2 audit is not initiated due to area of concern not been resolved within time frame or any significant changes occur which will impact the management system then stage 1 audit shall be performed again & TEXA GLOBAL CERTIFICATION Private Limited (TPL) shall also need to revise its arrangements for stage 2. The Team Leader also communicates to the client organization that the result of stage 1 may lead to postpone or cancellation of stage 2.

4. Stage-2 audit:

The stage 2 audit shall take place at the site(s) of the client. At the end of the stage 1 audit, the Team leader shall prepare an audit plan for stage 2 and discuss with the client regarding the time frame of closing of non-conformities and area of the concern, if any.

4.1 Stage 2 audit shall 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 (consistent with the expectations in the applicable management system standard or other normative document).

c) The client's management system and performance as regards to meeting of the applicable statutory, regulatory and contractual requirements.

d) Operational control the client's processes.

e) Internal auditing and management review

f) Management commitment and responsibility for the client's policies.

4.2 The audit team shall gather the audit evidences during the initial audit i.e. stage 1 and 2 and analyze and review the audit findings and agree on the audit conclusions.

4.3 The audit team shall provide the following information to TPL for the certification decision:

a) The audit reports of stage 1 and stage 2,

b) Non conformities raised with comments and correction and corrective action taken by client, if any,

c) Confirmation of the information provided to the TPL used in the application review and

d) A recommendation whether or not to grant certification, together with any conditions or observations.

4.4 TPL shall make the certification decision on the basis of an evaluation of the audit findings and conclusions and any other relevant information (e.g. public information, comments on the audit report from the client).

5. Surveillance audit:

5.1 Surveillance audit shall be conducted once in every calendar year.  The TPL shall ask the client organization to provide the updated data before planning of the surveillance audit. First and second Surveillance audit shall be perform with in 12 and 24 months respectively from the date of certification decision. Therefore the surveillance audit shall be identified 1 month prior to the due date. The client shall be communicated through a Notice of Surveillance about the due date and proposed date of Surveillance audit. M-MC/AM shall monitor the effectiveness of Surveillance audits on monthly basis. If the client does not confirm the Surveillance Audit on due date then a Notice of suspension shall be served to the client company. In case client doesn't response then after 15 days letter of suspension is send to client. Suspension shall be valid for the next 3 months. After lapsing of the Suspension period the Notice of Withdrawn shall be issued to client. In case there is still no response from client or client is not complying with the certification terms and conditions, the Letter of Withdrawn shall be issued and the name of the client shall be removed from the Client Directory. Any valid justification provided by the client for the postponement of the audit can be considered and shall be recorded which has to be approved by M-MC/AM and shall be communicated to the client.

5.2 Surveillance audits shall be on-site audits, but are not necessarily full system audits and the TPL shall plan the surveillance activities together with the other surveillance activities in such a way that representative areas and 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 and assessing and creating the confidence the certified client's management system's fulfillment of specified requirements with respect to the standard to which the certification is granted between recertification audits.

5.3 Other Surveillance Activities includes:

a) Enquiries from the TPL to the certified client on aspects of certification,

b) Reviewing of the promotional material, websites, letter head etc. of any client's statements with respect to its operations,

c) Requests to the client to provide documents and records in any medium whether on paper or electronic media), and

d) Other means of monitoring the certified client's performance.

5.4 The surveillance audit is to ensure following:

a) Internal audits and management review

b) A review of actions taken on nonconformities identified during the previous audit

c) Complaint Handling

d) Effectiveness of the management system with regard to achieving the objectives and intended result of applicable management system.

e) Progress of planned activities aimed at continual improvement

f) Continuing operational control

g) Review of any changes

h) Use of TPL and Accreditation Body Logo

i) Verify the OHS for the respective objectives and targets

j) Hazard Identification & Assessment Controls

k) Compliance towards Legal & Other requirement including customer requirements

l) Review of actions taken for notification of adverse events, advisory notices, and recalls.

6. Recertification audit:

6.1 Re-Certification Audit Notice shall be communicated to the client before the 90 days
of the expiry of the certification. Recertification audit shall be planned and completed before the expiration of the certificate.  The TPL shall ask the client organization to provide the updated data before planning of the recertification audit. The recertification audit shall be conducted onsite and shall be planned to evaluate the continued fulfillment of all of the requirements of the relevant management system standard or other normative document.

6.2 During the Recertification if any nonconformity or lack of evidence of conformity are identified then correction and corrective action shall be implemented within 30 days of the recertification audit or before the date of expiry of certification whichever is earlier.

6.3 TPL shall take 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 recent certification cycle and complaints received from party interested in certification.

6.4 In case of the major non conformity found during the recertification audit the correction and corrective action shall be taken with 60 days but before the expiration of the certification. The expiry date of new certification shall be based on expiry date of existing certification. The issue date on new certificate shall be on or after the recertification decision. In case the TPL has not completed the recertification audit or the TPL is unable to verify the implementation of the correction and corrective action for any major non conformities prior to the expiry date of the certification, then recertification shall not be recommended and the validity of the certification shall not be extended. The client organization shall be informed and the consequences shall be explained.

6.5 After the expiration of the certification the TPL can restore the certification within 6 months subject to the outstanding certification activities are completed otherwise at least the stage 2 shall be conducted.

6.6 The effective date on the certificate shall be on or after the recertification decision and expiry date shall be on the basis on the previous certification cycle.

6.7 Recertification shall include the following:

a) The performance of the management system over the period of certification, and include the review of previous surveillance audit reports.

b) Stage 1 audit shall be conducted in the Recertification audit in the situation when there are significant changes to the client, management system, changes in the legislation or the context in which the management system operating.

c) In case of multisite or Integrated Management system the planning of the audit shall ensure adequate onsite coverage to provide a confidence in the certification.

d) The effectiveness of the management system in its entirety in the light of internal and external changes and its continued relevance and applicability to the scope of certification.

e) Commitment to maintain the effectiveness and improvement of the management system in order to enhance overall performance.

f) The effectiveness of the management system with regard to the achieving the certified client objectives and the intended results of the respective management system demonstrated.

g) Compliance towards Legal & Other requirement including customer requirements

h) The nonconformities that are found to exist at previous surveillance and reassessment audited effectively corrected within a time agreed by the TPL and the client organization. In case correction is not made within the time agreed then Has TPL reduced the scope of certification or the certificate suspended or withdrawn.

7. Expanding of Scope:

TPL shall expand the scope as getting the application for expanding the scope of a certification already granted. After getting the application, TPL shall plan a full audit or Limited audit. The audit can be in the conjugation with the surveillance audit. After the result of the audit the TPL shall take the decision that the scope can be extended or not. In case of refusal of the extension of scope the full reason shall be intimated to the client organization.

8. Short Notice Audit:

8.1 The AM can conduct an audit on short notice or unannounced audit to verify handling of customer's complaints, important modification within the organization or any reason leading to withdrawal or suspension of the certificate.

8.2 The AM, based on the nature of complaint, shall take decision on the time frame within which the audit is to be conducted. In case of Short Notice Audit because of Customer Complaint, the audit team shall not disclose the name of the complainant.

8.3 The AM shall assign an auditor to perform the short notice audit and informs the organization about the identity of the auditor. The organization may refuse the appointed auditor and request once for a substitute. After the audit, the auditor shall report about the results of his investigation and shall make his recommendation to the AM.

Short notice or unannounced audits may be required when:

a) External factors apply such as devices in scope of certification indicate a possible significant deficiency in the quality management system and significant safety and performance related information becoming known to TPL.

b) Significant changes occur which have been submitted as required by the regulations or become known to the CAB, and which could affect the decision on the client’s state of compliance with the regulatory requirements.

c) When required by legal requirements under public law or by the relevant Regulatory Authority.

The following are examples of such changes which could be significant and relevant to TPL when considering that a short notice or unannounced audit is required, although none of these changes should automatically trigger a short term or unannounced audit:

1. QMS – impact and changes: i) New ownership  ii) Extension to manufacturing and/or design control iii) New facility, site change a) 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) iv) New processes, process changes a) Significant modifications to special processes (e.g., change in production from sterilization through a supplier to an on-site facility or a change in the method of sterilization)  v) QM management, personnel        a) Modifications to the defined authority of the management representative that impact: 1 Quality management system effectiveness or regulatory compliance.
2. The capability and authority to assure that only safe and effective medical devices are released. B) Product related changes: i) New products, categories
3. 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 haemodialysis equipment, or the addition of magnetic resonance imaging to an existing scope limited to ultrasound equipment)
4. C) QMS & Product related changes:   i)Changes in standards, regulations                    ii) Post market surveillance, vigilance

An unannounced or short-notice audit may also be necessary if the CAB has justifiable concerns about implementation of corrective actions or compliance with standard and regulatory requirements.