Thursday, May 12, 2022

Quality management system (QMS) ISO 9001

What are the standards for ISO 9001?

ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.


What are the 10 clauses of ISO 9001?


Top 10 Clauses in ISO 9001:2015

·         Clause 0-3 Introduction and scope of the standard.

·         Clause 4 Context of the organization.

·         Clause 5 Leadership.

·         Clause 6 Planning.

·         Clause 7 Support.

·         Clause 8 Operation.

·         Clause 9 – Performance evaluation.

·         Clause 10 Improvement.

 

 

 

ISO 9001 Requires the Following Forms:

 

1.      Customer property

2.      Design and development verification

3.      Purchasing process

4.      Management Reviews

5.      Identification and traceability

6.      Internal audit

7.      Monitoring and measurement of the product

8.      Control of production and service provision

9.      Design and development output

10.  Competence, awareness, and training

11.  Design and development inputs

12.  Design and development validation

13.  Planning of product realization

14.  Design and development changes

15.  Control of monitoring and measurement equipment

16.  Design and development review

17.  Design planning output


18.  Review of requirements

19.  Corrective action

20.  Validation of processes for production and service provision

21.  Control of nonconforming product

22.  Preventive action

23.  Analysis of data

 

There are six procedures for ISO 9001

 

·         Control of Documents

·         Control of Records

·         Internal Audit

·         Control of Nonconforming Product

·         Corrective Action

·         Preventive Action


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