NON CONFORMANCE DOC. NO: MSSS-QP 8.

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ACTION PROCEDURE Revision No: 00

ISO /IEC 17065

MSSPACE Non-Conformance and Corrective Actions Procedure in accordance with ISO 17065

1. Purpose

The purpose of this procedure is to define the process for identifying, documenting, investigating, and
correcting non-conformities related to the product certification process at MSSPACE. This procedure
ensures that corrective actions are taken to eliminate the causes of non-conformities, preventing
recurrence and promoting continual improvement in line with ISO/IEC 17065 requirements.

2. Scope

This procedure applies to all non-conformities related to the certification process, including non-
conformities identified during audits, product testing, surveillance, internal assessments, and feedback
from clients or other stakeholders.

3. Responsibilities

 Management Representative (MR): The MR is responsible for overseeing the non-conformance

and corrective action process, ensuring that non-conformities are addressed, corrective actions
are implemented, and effectiveness is verified.

 Auditors/Assessors: Identifying and documenting non-conformities during audits or

assessments, and providing recommendations for corrective actions.

 Employees/Personnel: Ensuring compliance with procedures and reporting non-conformities to

the MR or relevant authorities within the organization.

 Top Management: Ensuring that corrective actions are effectively implemented and reviewing
the process for continual improvement.

 Clients: Notifying MSSPACE of any product certification-related issues or non-conformities

encountered during the certification process.

4. Identification of Non-Conformities

Non-conformities can be identified through:

 Audits: Internal and external audits (including surveillance audits).

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 Client Feedback: Reports, complaints, or concerns raised by clients regarding certification

processes or the product.

 Non-compliance in Certification Activities: Instances where certification processes,

requirements, or product evaluations fail to meet the necessary standards.

 Document Review: Discrepancies found in the review of documents, records, and certification
files.

 Regulatory or Legal Changes: Changes in standards, regulations, or certification requirements

that lead to non-compliance.

5. Documenting Non-Conformities

When a non-conformity is identified, the following steps should be followed:

1. Recording the Non-Conformity:

o The non-conformity should be documented in the Non-Conformance Report (NCR).

o The NCR should include details such as the nature of the non-conformity, the date of
identification, and the process or product affected.

2. Classification of Non-Conformity:

o Minor Non-Conformity: A non-conformity that does not significantly impact the ability
of the certification process to meet the requirements of ISO/IEC 17065 but requires
corrective action.

o Major Non-Conformity: A significant failure to meet ISO/IEC 17065 requirements or

MSSPACE procedures that could impact the integrity of the certification process and
require immediate corrective action.

6. Investigation of Non-Conformities

The MR will assign a responsible person or team to investigate the non-conformity. The investigation
process involves:

1. Root Cause Analysis:

The team will conduct a root cause analysis to identify the underlying causes of the non-
conformity. Techniques such as the “5 Whys” or Fishbone Diagram (Ishikawa) may be used.

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ISO /IEC 17065

2. Assessing Impact:
Evaluate the impact of the non-conformity on the certification process, product quality, or client
satisfaction. This includes reviewing any potential risks or consequences.

7. Corrective Actions

Once the root cause of the non-conformity is identified, corrective actions should be planned and
implemented. Corrective actions should address both the immediate issue and the systemic cause of the
non-conformity.

1. Developing Corrective Action Plan:

A corrective action plan should be developed, including:

o The specific corrective actions to be taken.

o The person(s) responsible for implementing the actions.

o A timeline for completion.

o Resources needed to implement the actions.

2. Implementing Corrective Actions:

The responsible person or department will carry out the corrective actions as per the plan.

3. Verifying Effectiveness:
After corrective actions are implemented, the MR or designated personnel will verify that the
actions effectively address the root cause and prevent recurrence of the non-conformity.

8. Preventive Actions

In addition to corrective actions, preventive actions may be required to prevent similar non-conformities
from occurring in the future.

1. Identifying Preventive Actions:

MSSPACE will identify preventive actions based on trends or potential risks that have been
observed. These actions may include:

o Process improvements.

o Changes to procedures or documentation.

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ISO /IEC 17065

o Additional training or awareness programs for personnel.

2. Implementing Preventive Actions:

Preventive actions should be implemented to improve processes and avoid future non-
conformities.

9. Follow-up and Verification

After the corrective and preventive actions are implemented, the MR will:

1. Monitor the Actions:

The effectiveness of corrective and preventive actions will be monitored over time to ensure
that the non-conformity is not repeated.

2. Conduct a Follow-up Audit or Review:

A follow-up audit or review may be conducted to verify that the corrective actions have been
implemented and are effective in addressing the non-conformity.

3. Update Documentation:
Documentation related to the non-conformity and actions taken will be updated accordingly. All
records will be maintained as per MSSPACE’s document control procedures.

10. Communication and Reporting

1. Internal Communication:
Non-conformities, corrective actions, and the outcomes of the follow-up audits should be
communicated to relevant personnel within MSSPACE to ensure awareness and continued
improvement.

2. Client Communication:
If the non-conformity affects a client’s product certification, MSSPACE will inform the client
about the non-conformity, the corrective actions taken, and any impact on their certification
status.

11. Records

All records related to non-conformities and corrective actions will be maintained and controlled as
follows:

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ISO /IEC 17065

1. Non-Conformance Report (NCR):

Documented reports of non-conformities will be kept in MSSPACE’s record management
system.

2. Corrective Action Plan:

A documented corrective action plan with details of actions taken and timelines.

3. Verification of Effectiveness:
Records of follow-up activities to verify the effectiveness of corrective actions.

4. Preventive Actions:
Records of preventive actions, including the rationale for their selection and their
implementation.

All records will be retained for a minimum of 3 years to ensure traceability and compliance.

12. Continual Improvement

MSSPACE will use non-conformance data and corrective actions as part of its continual improvement
process. This procedure will be reviewed periodically to identify areas for improvement, and any
necessary revisions will be made to improve the effectiveness of non-conformance management and
corrective actions.

End of Procedure