ISO 9001:2015 Quality Management System Consultancy

ISO 9001 states the requirements for your Quality Management System (QMS). There are 10 sections (clauses) in ISO 9001, with additional sub clauses related to the Plan-Do-Check-Act system. However, only sections 4-10 contain requirements that are auditable. To successfully implement ISO 9001:2015 within your organization, you must satisfy the requirements within clauses 4-10 along with meeting customer and applicable statutory and regulatory requirements.

The purpose of this standard is for the organization to demonstrate its ability to provide a product that meets customer and regulatory requirements and to enhance customer satisfaction. This purpose is accomplished by evaluating and continually improving the system, rather than the product. The requirements of the standard are intended to be applicable to all types and sizes of the organization.

ISO 9001:2015 Clauses:

Implementation

There are a number of steps that are necessary to implement a Quality Management System

1. Top Management Commitment

The most important step in implementing a quality system that will meet or exceed an ISO 9001 standard is to acquire the full support of upper management

2. Appoint the Management Representative

Once the commitment has been made, the process can proceed by adopting a project team approach and treating it the same as any other business undertaking. The next step is the appointment of a Management Representative.

3. Awareness

This step acquires an awareness program.

4. Appoint an Implementation team

After everyone has been informed about the organisation’s intentions to develop the quality system, an implementation team should be assembled.

5. Training

The implementation team, supervisors, and internal audit team should be trained.

6. Time Schedule

This activity develops a time schedule for the implementation and registration of the system.

7. Select Element Owners

The implementation team selects owners for each of the system elements.

8. Review the Present System

Perform a review of the present quality system.

9. Write the Documents

Prepare written quality policy and procedure manuals. Write appropriate work instructions to maintain the quality of specific functions.

10. Install the New System

Integrate the policies, procedures, and work instructions into day-to-day workings of the organisation.

11. Internal Audit

Conduct an internal audit of the quality system.

12. Management Review

Conduct a management review.

13. Pre-assessment

This step is optional. If a good job has been done on the previous steps, pre-assessment is not necessary.

14. Registration

This step has three parts: Choosing a certification body, submitting an application, and conducting the certification body’s system audit.

ISO 9001:2015 Quality Management System Consultancy