Case 5

The risk & opportunity documents annexure III of the quality manual was revised on 22.05.22 and
does not address the opportunity and action plan thereof

It is a NON CONFORMITY

Evidence
As per the revised QUALITY MANUAL dated 22.05.22 has not addressed opportunities and action
plan thereby not planning actions to address risks and opportunities

ISO 9001.2015 Clause and Statement 6.1.2 a)

6.1.2 The organization shall plan:

a) actions to address these risks and opportunities;

b) how to: 1) integrate and implement the actions into its quality management system processes
(see 4.4); 2) evaluate the effectiveness of these actions

CASE 6

Clients complained that the personal data of candidates sent for training was compromised.
Appendix A of yearly contract extension dated 15.1.22 mentioned in fine prints that the data has to
be confidential .The training department were not aware of the Appendix A so were not aware of
the clause which was not part of the original contract dated 1.1.20.

It is a NON CONFORMITY

Evidence
The training department was unaware of the recent changes in APPENDIX A of YEARLY CONTRACT
extension document dated 15.01.22

ISO 9001.2015 Clause and Statement 7.5.3.1 b) and 7.3b)

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this
International Standard shall be controlled to ensure:

a) it is available and suitable for use, where and when it is needed;

b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.3 Awareness

The organization shall ensure that persons doing work under the organization’s control are aware of

d) the implications of not conforming with the quality management system requirements.
CASE 7

QA register of XYZ states that PCB returned on 12.4.21 from customer ABC, the PCBs were repaired
and returned to customer in month of May 21 by two new recruits who were not given the on job
training as the supervisor was on sick leave resulting in customer complaint.

It is a NON CONFORMITY

Evidence
Two new employees who have repaired the faulty PCBs have not undergone the required training.

ISO 9001.2015 Clause and Statement 7.2 b)

7.2 Competence The organization shall:

a) determine the necessary competence of person(s) doing work under its control that affects the
performance and effectiveness of the quality management system;

b) ensure that these persons are competent on the basis of appropriate education, training, or
experience;

CASE 8

Rejection and the return data of the company indicate lot of crockery is returned by the customers
because of chipped crockery, HOD QA is aware of the problem but is not ready to address it as it
requires manpower to weed off the rejection in final inspection.

It is a NON CONFORMITY

Evidence
HOD QA is not willing to take any action and correct the non-conformity evident from the rejection
and return data.

ISO 9001.2015 Clause and Statement 10.2.1 b) 8.6

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:

1) take action to control and correct it;

CASE 9

production department communication to customer on 15.4.21 requests for change in original

specification as well as the extension of delivery time. However the sales department has accepted
the contract on 31.3.21

It is a NON CONFORMITY
Evidence
The SALES department should determine the risk behind the change in original specification
requested by the production department and the extension of delivery time which might end up in
undesired effects on the conformity of products, meeting customer delivery time and customer
requirements.

ISO 9001.2015 Clause and Statement 8.2.4 8.2.2

8.2.4 Changes to requirements for products and services The organization shall ensure that relevant
documented information is amended, and that relevant persons are made aware of the changed
requirements when the requirements for products and services are changed.