ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

4.1 QMS General Requirements - Continued

ISO 9001 Training - Key Explanation Points and Tips:

4.1 QMS General Requirements - Continued

Under 4.1d - resources for QMS processes may include - facility, material; equipment; labor; supplies; utilities; etc. Every QMS process will require a different combination of resources. Resource details may be identified in specifications; production schedules; bill of materials; production travelers or routers, work instructions, etc. The planning of resources will be determined in MOP’s (clause 5) and provision and control of resources will be determined by SOP’s (clause 6).

Clause 4.1d- information for QMS processes will vary from process to process and may include - production schedules; bill of materials; product acceptance and process performance criteria; production traveler or router; work instructions; etc. Use clause 4.2.3 and other relevant clauses to control process information.

Clause 4.1e requires you to monitor and measure your QMS processes. Clause 8 provides requirements to plan and implement these controls for monitoring and measuring conformity to process performance criteria determined in 4.1c above. Ways to monitor and measure QMS processes may include - tracking against process parameters, goals and objectives, using tools and records such as process check-sheets; product acceptance criteria; SPC records; production records; maintenance records; labor records, etc. More details on monitoring and measuring controls are covered in clause 8. QMP’s typically perform this function. (see section 0.2 Process Approach of this document).

Clause 4.1e - Analysis of QMS processes may be done through a review of measurement and monitoring records and performance indicators for each process. These reviews must identify opportunities to improve QMS processes, use of resources and product quality.

Under clause 4.1.f, when process nonconformities occur (as shown by process performance indicators), then corrective action is required to bring the QMS process under control. Remember, the corrective action process is not just for product related nonconformities.

Processes must be continually improved (see clause 4.1f) through setting of incrementally realistic, measurable (see clause 5.4.1) objectives- Planning for continual improvement requires a review of process data, resources and controls to bring about the desired change. More on this when we look at clause 8.4.

Clause 4.1a - 4.1.f must be applied to all QMS processes. Note also that many ISO 9001 clauses (e.g. clause 7.2; 7.4; 7.6; etc.), require specific processes to be established within your QMS, These processes must also be identified and controlled in your QMS. I will highlight all these process as we cover the standard.

Make sure you include all outsourced processes affecting product quality, in the scope of your QMS. An outsourced process is any value-adding or conversion activity related to your product or service, that is performed by an external organization such as a subcontractor, sister facility, etc.  Note that the external organization may perform the outsourced activity at their facility or yours. A manufacturing company may outsource welding, heat treatment or painting of product. A software company may outsource software development. A bank may outsource check clearing services.

You must define the appropriate control (see paragraph below) and be able to demonstrate (be able to show evidence of effective subcontractor performance) sufficient controls over outsourced processes to ensure that such processes are performed according to the relevant requirements of ISO 9001:2008. The nature and scope of such control will depend on the nature of the outsourced or subcontracted process and the risk involved.

Outsourced processes may be controlled in any number of ways, e.g., providing the outsourcer with product specifications; your supplier quality manual that they must meet; providing them with specific process related checklists that relate to your product and requiring them to implement those controls; asking for inspection and test results or certificates of compliance; validation of outsourced process; conducting product and QMS audits of your outsourcer; etc. The expectation here is that you flow down to your outsourcer, the relevant ISO 9001requirements that you would have to implement, had you performed the process at your own facility.

One last thing before we leave this all important clause. In systematically applying clause 4.1 requirements to each QMS process, we are intuitively using the PDCA approach to development of QMS processes.

PLAN will call upon sub-clauses 4.1.a - 4.1e as well as other applicable ISO 9001 clauses as shown above; 

DO is required by 4.1.f as well as other applicable ISO 9001 clauses

CHECK is controlled by 4.1.e as well as other applicable ISO 9001 clauses;

ACT is governed by clause 4.1.e-f as well as clause 8.

Please review clause 4.1 and section 0.2 Process Approach of this document several times as you go through the rest of this standard. The clause is the backbone for all the other clauses of this standard.

With a bit of PDCA process-mapping practice with the different types of QMS processes, you will understand better the above explanation points and tips and will be able to develop and implement an effective QMS. There are also many useful tools available to facilitate this.