THE ISO 9001 QUALITY STANDARD FUNDAMENTALLY CONTAINS FIVE KEY ELEMENTS THAT

MUST BE INCLUDED INTO EVERY COMPLIANT ISO 9001 QMS

When you build a ISO 9001 quality management system (QMS) you must address all clauses
related to the product Planning, Designing, Supply and Manufacture, Information Management
and Process Management aspects of ISO 9001 methodology.

Here is a strategy and checklist for developing a quality management system (QMS) based on ISO
9001. Fundamentally the ISO 9001 system requires the following five elements.

Planning
1. Provide a Structured Process that takes Client requirements through to a working solution
which fully satisfies the Client intent, while meeting all legal and statutory obligations.
2. Allocation of responsibilities and authorities in the process.

3. A means for planning of how the solution will be achieved, and altering the plan as new
information becomes available.

4. The use of Standard Operating Procedures to manage, monitor and control the activities done
in the process.

5. A means to monitor and measure the Structured Process steps are delivering required
outcomes and to instigate appropriate controls when outcomes are unacceptable.

6. The means to control the competence of the human resources used for the design, supply,
making, delivery and post-delivery service of the product/service.

7. The means to control the adequacy and accuracy of the physical resources used for the
design, supply, making delivery and post-delivery service of the product/service.

Designing
1. A means to communicate with the client to learn what they want, and to seek input on any
changes affecting the product/service use.
2. Conduct the designing of the solution, along with the use of regular design reviews of the
evolving solution’s suitability and adequacy for the Client purpose.

3. The provision of all information needed to correctly design the solution, or to purchase
materials/services, or needed to make the solution, or needed by the client.

4. A means to proactively detect errors in design, and possible failures when used, and then
make appropriate design changes.

5. A means to confirm that the solution (and any changes) will achieve all the requirements of
the design, and of the client’s purpose, prior to despatching the product.

6. A means to correct non-conformances and problems in the design, in the supply, in the
manufacture and in the final product/service, unless a non-conformance is formally accepted
by the client.

Supply and Manufacture

 1. A means to insure that purchased goods and services are correctly selected for their
service/duty, and are capable of meeting the necessary service/duty.
2. A means to prove that purchased goods and services are as specified and can be used as
intended.

3. A means to identify and track items, work and services when specified by the client, or due to
statutory or company self-imposed requirements.

4. A means to suitably protect customer property given to the company.

5. A means to protect the product/service so it is safe and usable at every stage through the
Structured Process, including when delivered to the client.

Information Management
1. A means to manage all documents needed for the design, or developed during designing, or
developed for product/service making, or needed for the correct use of the solution.
2. A means to manage all records used in the designing, making and use of the solution.

3. A means to protect against the loss of information, documents and reports used in the
Structured Process.

4. A Management of Change methodology.

5. A means to communicate to designers, suppliers and solution-makers of changes that impact

them, and the effects of the change on the Structured Process.

Process Management
1. Client needs exist that the Company can profitably satisfy to 100% client satisfaction.
2. Company Management have specific purpose and objectives for the Structured Process.

3. Provision of suitable workplaces and equipment to do the work undertaken.

4. The auditing of the Structured Process to confirm activities are being correctly done.

5. A means of monitoring, measuring and analysing the effectiveness of the steps in the
Structured Process, and of the whole Structured Process.

6. A means to continually improve the Structured Process and its steps.

7. Company Management calculatedly adjust the Structured Process to better meet objectives.

The above list is universal and applies regardless for what the QMS is to be used.

My best regards to you,

Mike Sondalini
Director
Lifetime Reliability Solutions