Here comes part 2 of how to memorise ISO 9001:2015 requirements. Previously in part 1, we divided the requirements according to the PDCA, as below.
Let's start with plan. It consists of the fourth requirement, context of the organization, which is defined under article 4 as follows:
4.1 Understanding the organization and understanding the context of the organization
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
Requirement 5 Leadership, which in this section is required under Article 5:
5.1 Leadership and commitment (Leadership and commitment)
5.2 Policy
5.3 Duties relating to organizational roles, responsibilities and authorities
Requirement 6 Planning, which is required under Article 6, is as follows:
6.1 Activities to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
In this section, the information can be obtained from the top management or from the QMR: Quality Management Representative, perhaps from the management team, but article 6 is a little special because each department is not involved in the preparation.
Provision 7 Support, which is required under Article 7:
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
In this section, departments such as HR, Maintenance, QC (InstrumentAtion Control) and DCC, document controllers, will be involved.
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What is coming next ?
This kind of division will make it easier for us to remember the requirements. There are a few more tips.
When we talk about resources, we can look at the information in the management's review meeting because it is a review of the inputs that are forced into the requirements that must be reviewed in the meeting.
There's still Do, Check and Action to follow in part 3.
This kind of division will make it easier for us to remember the requirements. There are a few more tips.
When we talk about resources, we can look at the information in the management's review meeting because it is a review of the inputs that are forced into the requirements that must be reviewed in the meeting.
There's still Do, Check and Action to follow in part 3.
Article by : Mr. Pakpisit Pongchak (Chief Auditor)