Step 1 Part 1

Top Management Commitment and Responsibility

The top manager (CEO, president, proprietor, etc..) shall provide a written statement as evidence of his/her commitment to the development and implementation of the quality management systems program, and to the continual improvement and effectiveness of the system.

The commitment should include:

(a) communicating to the organization the importance of meeting customer, statutory and regulatory requirements,

(b) establishing a quality policy,

(c) ensuring that quality objectives are established,

(d) conducting management reviews, and

(e) ensuring the availability of resources.

Step 1 Part B

(Note: This step is optional) Appoint a Quality Manager

The CEO, president, proprietor etc.. may opt to delegate the general management of all quality related activities to a quality manager (who will keep the CEO, president, proprietor etc.. continually up-to-date on all activities affecting the quality system), or he/she may choose to maintain the quality management position his/herself. Either way, the CEO, president, proprietor etc.. is ultimately responsible for the quality management systems program.

Step 2

Organizational Structure (Responsibility by Quality Manager.)

Ensure that a suitable organizational Structure (Chain-of-Command) is in place. This is essential for an efficient and effective Quality Management Systems Program to function.

Note: In arranging the organizational structure, it is important for management to recognize and reward employees for their dedication, hard work, work experience and education.

Step 3

ISO 9001 Awareness Training (Overseen by the Quality Manager)

The quality manager, or his/her qualified representative shall conduct ISO 9001 awareness training/seminars with all personnel/employees  to provide them with general knowledge of what is required for a quality system.

Step 4

Internal Quality Assessment (Conducted by qualified company personnel.)

Conduct an initial quality assessment to establish a baseline. The internal audit is a form of self assessment.

Step 5

Develop a Quality Manual (Involving input from key personnel.)

Develop a Quality Manual that identifies the management and the representative responsible for all applicable activities.

The Quality Manual and related Procedures should include:

(a) Quality Procedures,

(b)Control Plans, and

(c) Work Instructions.

Step 6

Special Processes (Involving input from key personnel.)

Prepare the organization to meet any unique process control requirements (Special Processes).

Note: A special process relates to any type of activity that cannot be checked/inspected for deficiencies after that particular manufacturing stage has been completed. Special processes must occure during the specific timeframe that the manufacturing/assembly process is taking place in order to prove that they meet planned objectives. Eg. sealed electronic component packs!

Step 7

Quality Management Systems Training In-depth (Overseen by the Quality Manager)

Ensure adequate and specific training of personnel regarding:

(a) Quality Manual,

(b) Procedures,

(c) Work Instructions,

(d) Special Processes,

(e) Control Plans.

Step 8

Ongoing Quality Surveillance (Conduct by qualified company personnel.)

Ongoing Surveillance of the quality program should be conducted to ensure compliance with contractual and regulatory requirements.

Step 9

Internal Quality Audit In-depth  (Conduct by qualified company personnel.)

An Internal audit of the Quality  Program shall ensure compliance of the new/current implemented Quality Program. 

Note: The internal audit should be handed (if possible) by personnel that do have direct involvement with the activity being audited.

Step 10

Corrective Action (Conducted by the internal quality auditor.)

Resolve Corrective Action findings resulting from the internal audit.

Step 11

Conduct the Complete/General Audit (Conducted by a non-company/independent Quality Auditor)

Have a third party with the appropriate qualifications Audit your Quality System to ensure the effectiveness and suitability of the Quality Management Systems Program.

The Audit :

(a) conduct audit interviews.

(b) evaluate objective evidence (using an audit checklist).

(c) write and communicate QMS audit report/findings.

(d) indicate corrective action (if required).

(e) continual actions.

Step 12

Improve the Program:

Review the effectiveness and suitability of the Quality Management Systems Program in order promote the principles of continual improvement.