ISO 9001: 2015 Requirements and How to Start

How is the standard structured and interpreted for small or micro businesses? How to get started with ISO 9001:2015?

There are 8 key ISO 9001:2015 clauses that you require to cover to achieve conformance to ISO 9001 certification requirements. You might find it lengthy and hard to interpret when reading the standard. Actually, you only need to understand the principle and objective of each clause .

Below is the outline of the clauses and provides a small or micro business-specific interpretation:

There are 10 clauses in ISO 9001:2015 and the organization needs to fulfill clause 4 until clause 10.

Clause 1 is explaining the scope of the ISO 9001 standard

Clause 2 is the normative reference

Clause 3 is the term and definition of the standard

Clause 4: Context of the organization

Clause 4 is regarding the context of the organization in ISO 9001. It covers understanding the organization and its context, understanding the needs and expectations of interested parties, and determining the scope of the quality management system. The steps in implementing this clause could be:

1. Identify external and internal problems that are relevant to its mission to achieve the quality management system’s intended outcomes. For example, an external issue could be the issue related to culture, market, environment, political, etc while an internal issue could be an issue related to internal like available resources, internal politics, staff performance, etc.
2. Understand the needs of interested parties, which refer to the people who may be interested affected in the organization, including suppliers, employees, clients, local authorities, and etc. The organization needs to determine and review the interested parties and their requirements.
3. Determine the scope of the quality management system, with deciding the boundaries and applicability of the quality management system while considering the external and internal issues as mentioned, and its products and services. The scope can be the business nature of the organization and the location or branches that need to include.
4. Quality management system and its processes, this is the ideal opportunity for the organization to create and develop the correct SOP/procedures, particularly those that have a significant impact on product and service quality.

Clause 5: Leadership in Organization

Clause 5 is regarding the leadership and commitment, quality policy, and organizational roles.

For leadership and commitment, the top management shall demonstrate leadership and commitment by establishing the quality policy and quality objectives, and promoting continual improvement. Without the commitment from the top management, the implementation of QMS will become challenging.

Top management is responsible for developing a quality policy with a defined scope of QMS which:

1. Appropriate to the purpose and context of the organization (clause 4)
2. Include a commitment to satisfy applicable requirements,
3. Include a commitment to the continual improvement of the quality management system.

Top management shall assign roles and responsibilities for all staff for ensuring that the QMS complies with the requirements of this International Standard and for reporting on QMS performance.

Clause 6: Planning

Clause 6 is regarding the actions to address risks and opportunities, and quality objectives and planning to achieve them. Under the actions to address risks and opportunities, the organization needs to determine the risk and opportunity for the organization (with reference to external & internal issues and needs & expectation of the interested parties). Then, plan action to address the risk and opportunities and finally evaluate the effectiveness of these actions. The example of addressing risk can be avoiding risk, eliminating risk, taking risks to pursue an opportunity and etc. While the example of addressing the opportunities can be following new practices to grab the opportunity, opening new markets, using new technology, building partnership, etc.

The organization needs to establish quality objectives and monitor the achievement. The quality objective needs to be measurable, consistent with the quality policy, relevant to enhance product or services quality. It also needs to communicate to the relevant parties. Once quality objectives have been set up, the organization need to plan how to achieve them based on :

• what will be done,
• what resources will be required,
• who will be responsible,
• when it will be completed and
• how the results will be evaluated.

Clause 7: Support

Clause 7 is regarding the support needed for the Quality Management System. The organization shall consider the resources, competence, awareness, communication, and control of documents. Generally, the company needs to:

• Provide the resources needed for the establishment such as people, infrastructure, suitable environment.
• Monitoring and measuring the performance of the resource
• Measuring equipment or tool need to be calibrated and verified
• Determine the knowledge for the operation. Knowledge can be Intellectual properties, formula, experience, standard, etc.
• Determine the competencies needed for each role
• Ensure the workers of organizations are aware of the quality policy, quality objectives
• Establish the process needed for internal and external communications
• Follow and maintain the documented information required by this International Standard as evidence of conformance.

Clause 8: Operation

Clause 8 is regarding the Operational Planning and Control, Design and Development Planning, and Production Service Provision with control of the non-conforming output.

Generally, they shall carry out production and service provision under controlled conditions. The organization needs to communicate with the customer to get requirements of the products or services they required, comply with the legal or statutory requirements.

The organization that has Design and development need to establish a process for planning, control and ensure that design and development outputs meet expectations. Besides, outsourced processes or external products need to monitor and evaluate. The monitoring can through methods like a supplier or Subcon evaluation.

This clause also looks into the identification and traceability of property belonging to customers or external providers, preservation-imposed delivery activities, and control of changes to ensure the continuity of conformity to the requirements.

Clause 9: Performance evaluation

Clause 9 mainly is regarding monitoring, measurement, analysis, and evaluation of the performance and evaluate the effectiveness of the quality management system. Generally, the organization needs to determine what and the methods for monitoring, and the frequency on how the compliance will be evaluated.

The organization is required to monitor customers’ perceptions, the method can include customer feedback, customer survey, complaint, warranty claim, etc. The result of monitoring needs to be analyzed and evaluated. The methods to analyze data can include statistical techniques. Besides, the organization is required to conduct an internal audit and management review at least once a year.

Clause 10: Improvement

Clause 10  is regarding the non-conformity and corrective actions, and continual improvement. The organization needs to determine the opportunities for improvement. Improve customer satisfaction, improving the performance and effectiveness of the quality management system. Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation, and re-organization.

When non-conformity happened, the organization needs to take action to control, correct it, find the root cause, take corrective action to prevent/reduce the non-conformity happened again.