It does not matter what systems you have in place when thinking about ISO 9001 certification. ISO 9001 has a standard set of guidelines for implementing, maintaining and improving a Quality Management System (QMS) for your organisation. These are applicable to any type of organisation of any size.
The requirements are broken down into sections called clauses. The first three clauses are not mandatory but the rest are except for clause 8 which may not be relevant to your organisation.
Clause 4 – Context of the organisation
Context of the organisation deals with the internal and external factors. These affect the objectives you set and how you meet them. External factors can include legal and financial and internal factors include the structure and governance of your organisation. Clause 4 also includes identifying the needs and expectations of stakeholders such as employees and suppliers.
Clause 5 – Leadership
Clause 5 focuses on the commitment of top management to implementing a QMS. The requirements include:
- Developing and implementing a Quality Policy that gives clear direction.
- Instilling a culture of customer focus throughout the organisation.
- Determining the roles and responsibilities and authorities for the QMS.
- How you will communicate objectives and policies across the organisation.
Clause 6 – Planning
For an effective QMS, risk-based thinking is essential. It includes the requirements for determining risks and opportunities, and quality objectives that align with the Quality Policy and how you plan you meet them.
Clause 7 – Support
Clause 7 is all about top management providing adequate resources to implement and maintain the QMS. These include:
- Human resources.
- Work environment such as lighting, dust and temperature control.
- Infrastructure such as equipment, building facilities, software and hardware.
It also details the importance of communication, competence, awareness, and creating, maintaining and controlling documentation for the QMS.
Clause 8 – Operations
You can choose to exclude sections clause 8. For example, your company may not do design work, so you can exclude the design requirements. Clause 8 deals with planning products and services for customers. These include:
- Determining and reviewing service and product requirements.
- Testing and monitoring the quality of goods and services.
- Creating procedures for controlling nonconformities.
- Processes for generating and storing company records.
Clause 9 – Performance evaluation
In Clause 9 contains the requirements for evaluating the performance of the QMS. These include:
- Assessing customer satisfaction.
- Monitoring, analysing, and evaluating the performance of your processes.
- Internal audits.
- Inputs and outputs of management review meetings.
- Retaining documentation as evidence.
Clause 10 – Continuous improvement
Clause 10 is all about corrective actions to continually improve your QMS to increase customer satisfaction. So you need to implement procedures and policies to investigate incidents, nonconformities and for corrective action. Continually improving quality in your business will benefit you over the long term.
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