Iso 9001 clause 7.2.2

Customer related processes must include controls for determining customer and regulatory requirements, a review of such requirements, and communication with the customer. Customer requirements extend beyond product specifications and may include on-time delivery, packaging, labeling, mode of delivery, documentation, communications, QMS requirements, after sales servicing, etc. Many of these requirements may also come from regulatory, industry or from within your own organization.

You must consider all laws and regulatory requirements that may affect your product, materials, labor, production processes, your facility and work environment, etc. Where some or all of the processes — for determining customer requirements; for contract review and customer communication; etc.

The nature of requirements review may be different for different types of product or services. Your review records must show the basis of review. Make sure you do your due diligence and risk analysis before you commit to contractual arrangements. I have seen many companies get into serious financial trouble, for taking on products transferred from another supplier, because they did not assess all the risks.

Risk analysis should include timing, resources, development costs and investments, potential for, and effects of, possible failures in processes, including suppliers. You should also consider financial and profitability risk. Sometimes it may take a few months to receive an order or contract from the customer, after you have sent them your quotation. Your customer relations management process must include a sub-process for change control and must include — a review of the change either from customer or internal from organization and its impact on fit, form, functionality, other processes, financial, delivery, etc.

Have a process for change control. For significant issues or changes, obtain customer approval in writing for any waivers or changes of contractual or QMS requirements. Customer communications may take many forms such as software and interfaces for design and development, logistics, customer satisfaction feedback, etc. You must ensure that personnel at all levels have the competency and training to use these communications media and tools.

You must identify and document all processes addressing this clause as part of your QMS. For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities. These documents may include — contracts, specifications, orders, product quality plans, work instruction, a documented procedure etc.

Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have.

Performance indicators to measure the effectiveness of customer-related processes in meeting requirements and achieving quality objectives should focus on reducing variation in and improving these processes and related use of resources. Indicators may include reduction in quote cycle time, pre and post-award review cycle time, order-entry errors and omissions etc.

Mandatory Procedure : Not applicable Mandatory record: Records of the results of the review and actions arising from the review shall be maintained- Contract Review. Customer requirements extend beyond product specifications and include — on-time delivery, packaging, labeling, mode of delivery, documentation, communications, QMS requirements, after sales servicing, etc.

Documents are needed for effective planning, operation and control of production activities: contracts, specifications, orders, product quality plans, work instructions, a documented procedure, etc. Additionally, the company must also be able to approve that this information is being both managed and properly maintained. Apart from simply defining a plan of action for communication with customers, it must actually be carried out in order to be effective.

In summary, the customer communications requirement within the Products and Services clause should consist of a plan for the business to be able to communicate directly with customers, in whichever way that may be.

Some of the other most important individual requirements within the Products and Services clause are the ones that outline how products should be created and distributed, as well as how they are identified and traced after the fact.

The control of production and service provision requirement provides guidelines to businesses in order to provide their product or service under the most controlled of circumstances. These strict guidelines help them to avoid as many mistakes as possible from the time the product is brainstormed to when it is executed.

Since there are so many things that can potentially go wrong when it comes to designing, developing, and distributing a product, the ISO standards work to minimize mistakes in this aspect of a business. Along with the list of controlled conditions that are provided by ISO regulations to maintain the quality of each product, there are customized conditions for each individual product or service, since no business or industry is exactly the same.

Additionally, the companies in question must always document all of the information that is being established, modified, or changed during all of these processes in order to maintain accuracy.

The equipment that is being used in the control of production and services must be kept track of, as well as the resources and materials that are being used to outsource products.

The company is also responsible for maintaining a stable workplace environment that will be able to easily follow all specified ISO standards. In order to be able to control production of products and services, the business must also have control over the employees that represent them. As a result, all employees must be completely compliant with ISO guidelines, to avoid any mistakes or violations of the mandatory requirements. The final steps in the control of production and service provision requirement are the delivery and post-delivery actions.

In the event that anything needs to be done after the product or service has already been delivered to and received by the customer such as warranty claims, maintenance, or disposal of a product, it will be under this section. After the initial stage of planning and developing the product or service, businesses in some industries will need to be able to identify and trace their product long after they have been distributed to the consumers. For instance, products like food must be able to be identified and traced for safety reasons after they have been spread out into supermarkets.

On the other hand, cars and planes need to have parts that are identifiable and traceable in the case that something needs to be repaired, or that something was stolen from the vehicle. This new requirement replaces ISO Clause 7.

When I was working as an ISO certification body auditor I always took a great deal of interest in the competence and awareness clauses. I would ask what gaps the organisations had in their skills matrix and the importance of those gaps. Then I would go out and look at those gaps and the processes around them. All of this was real auditor fodder because the gaps are a goldmine for a non-conformances or recommendations.

All too often I saw companies only listing the training that employees had received whilst under their employ, with no mention of prior experience, or other education or training received whilst they were employed elsewhere. Not listing experience, education or prior training is a big mistake. These aspects are valuable cultural capital that you ignore at your peril, because like financial capital, the health of your business is built on it.

The key here is that you need to ensure that staff are fully aware of their responsibilities. This awareness could occur through various means such as:. Once staff are clearly aware of their responsibilities, the next step is to make them conscious of how those responsibilities and their actions can contribute to the company meeting and achieving its objectives. For example, at Mango, we defined the operational procedures in a few simple documents. We then discussed those procedures in staff training sessions.

Every month we have management meetings to run through those procedures again to ensure staff still have a clear understanding of their responsibilities.

Identification of employee training needs is typically the first step in developing a competency-based training programme. In addition to existing workers, new hires, temporary workers and outside contractors must be included when identifying training needs. Your organization must demonstrate that the training needs for these employees were identified.

Your organization should operate a comprehensive training programme. All employees should receive training as identified by an initial training needs assessment. The training requirements for employees must be assessed against wider organizational policies and objectives.

Line Managers and Supervisors often determine the training required for workers under their supervision to fill the gap in training, knowledge, competence and skills of each person and the training required to satisfy any applicable hazard and task specific competencies. Gaps in training, knowledge or competence must be identified and filled. Line Managers and Supervisors should monitor the abilities of all their workers, their responsibilities and ensure the ongoing monitoring and review of employee competencies.

Appropriate training requirements can be further identified through this process using a Competency Review Form. Training needs are also determined during the appraisals process where any needs identified are derived from annual appraisals and personal development reviews. The aim of the competence matrix is to support the Human Resources Manager and Line Managers to ensure that training is targeted, managed, effective and comprehensive. A suitable matrix should be produced for each workplace.

After developing a list of these employees, the Management Representative or the Human Resources Manager should establish the appropriate training programme for each worker, based on the type of employee interaction with each significant impact or risk. Other requirements for the position such as legislative requirements, including license requirements e.

The training needs can then be incorporated into individual annual appraisals and personal development reviews.

Where employees are unskilled in the required task, or expired mandatory and statutory competencies are identified, appropriate training or re-training should be provided prior to commencement of work. Employee training and re-training is recorded, monitored and kept up to date by their Line Manager and Supervisor. A register containing information on specified levels of education, training, and experience must be established for each employee whose work is involved with any significant impact and safety hazard.

The planned training programme for each individual then should be listed. The training sessions should, at a minimum:.