ISO 9001 Quality Systems

Organizations make and deliver services and products using methods which are normally controlled by the utilisation of a compilation of approved procedures and policies. All of these methods and standards are actually the basis for an enterprise's QMS or quality administration process.

An excellent QMS can certainly bring rewards to organizations of all sizes and over all markets, from a logistics facility putting to use thousands to a modest producer of female's clothes. The quality administration process must be tailored to the needs of your company and the services or product that you produce, but the ISO 9001:2015 requirement supplies a series of criteria in order to help make sure that you does not overlook all important facets which a QMS needs to be highly effective.

Among the foremost reasons the  ISO 9001 cost requirement was modified was actually to render it more suitable to service enterprises along with manufacturers. At this moment in time, organisations throughout more than one hundred and seventy nations around the entire world and upwards of one million enterprises are recognised to ISO 9001:2015.

ISO 9001:2015 can be employed by any type and size of operation regardless of what its goals and objectives are or the sector it works in. That is because it establishes logical standards criteria for a world class quality management system.

This particular ISO 9001 criterion is founded on a variety of quality management principles including a strong client focus, the motivation and drive of senior management, the methodical approach as well as continuing advancement. What type of benefits will it bring to my company or enterprise?

Introducing a ISO 9001:2015 quality monitoring process will help examine the entire framework of your enterprise to identify who is influenced by your work and what clients want from you. This will definitely allow you to accurately declare your intentions as well as discover brand new business prospects. Place your patrons in the forefront of your organisation's thinking, making sure you continuously meet their demands as well as boost their contentment. This can easily lead to repeat business, brand new clients and increased business for your business. 

ISO 9001 will help organisations work in a more effective way as all methods will be coordinated as well as understood by everyone in the business or enterprise. This boosts performance and efficiency, bringing internal expenses lower, satisfying important statutory and regulatory requirements, making it possible for growth into brand new niche markets (certain industries and clients require ISO 9001 before doing business) and lastly, discover and attend to the threats associated with the organisation.

ISO 14001

The ISO 14000 collection is a variety of ecological management specifications put together and released by the International Organization for Standardization (ISO) specifically for companies.

The ISO 14001 standard has indeed come to be the worldwide norm with regard to designing as well as employing an environmental control system. The ISO 14000 criteria give a guideline or structure for business organizations which may want to systematize as well as improve their green supervision endeavors.

ISO 14000 norms aren't meant to assist the administration of eco regulations and do not moderate the environmental undertakings of small business. Adherence to the specifications is voluntary. The processeses and components of ISO 14001 certification are founded on well-founded ecological control concepts. ISO 14001 contains just those criteria which can be objectively scrutinized and deals with the key facets of a firm's operations.

It can be used to consolidate the environmental system together with the whole business organization structure so as to greatly enhance effectiveness as well as continual development. The nature of an EMS or environmental management system is specified within the ISO 14001. This is the most relevant process which oversees the organisation's enviromentally friendly endeavors and makes it possible for third party auditors to obtain the vital info needed in order to analyze the overall performance of its environmental supervision procedures. 

A really good EMS (environmental management system) contains meticulously documented procedures that accurately describe a group's ecological targets and also the activities needed inside an organization's procedures to guarantee that it really delivers on its eco goals.  For the Environmental Management System (EMS) to be successful, it needs to permit virtually any scale as well as style of business to oversee the environmental impact that its operations, product or services has on the world.

Routine analyses of the Environmental Management System in order to pinpoint non-compliance throughout enterprise procedures ought to be performed frequently and remedial procedures carried out. 

Higher managers must also perform a vital role in frequently reviewing the effectiveness of their operation's ISO 14001 implementation. The ISO 14001 standard is the only green specification that could be registered, certified or accredited by unbiased bodies validating compliance to the ISO 14001 standard. 

Depending on the size as well as complexness of the enterprise, the execution time period can involve a number of years or maybe only a few months.

Quality Management

The implementation, design, and development of a service or product forms part of a method called quality management. This method (quality management) ensures that all the activities necessary (implementation, design, development) are both efficient and effective with respect to the performance of the system. The focus of any successful organization should thus always be to achieve more consistent quality. The responsibilities, quality policy, and objectives of an organization are determined and implemented by quality management. Four main components are concerned with quality management. These are:

• Quality assurance
• Quality planning
• Quality improvement
• Quality control

One of these components, quality control, will be discussed in more detail further in this article.

Total Quality Control

Total Quality Control is one of the most important components of Quality Management. In a nutshell it can be defined as the most necessary inspection control of all. Even though statistical quality control techniques and quality improvements are implemented, it does not guarantee an increase in a company’s sales. On the contrary, sales might even decrease.

If sales decrease, a total quality control should be launched. A total quality control incorporates a number of “characteristics”. These are:

• Reliability
• Maintainability
• Safety

Thus, in order to improve manufacture and overall business performance, a lot of careful planning, attention and detail must be given to the above characteristics. If this is done correctly, part of the total quality control was done.

Something else which forms part of a total quality control is the implementation of some refinements into all aspects of business. These include the following:

The marketing department must define the customer’s specifications.

Specifications should conform to certain requirements.

The quality levels of products should not be affected if workers are on holiday or on sick leave.

Inspections and tests should be carried out regularly on the products.

All complaints/feedback from customers should be dealt with by management.

The ISO 13485 Standard is widely used in the medical device manufacturing industry as a means of establishing compliance with Canadian Medical Device Regulation, European Medical Device Directive and other regulations. Since the majority of medical device manufacturers comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 Quality Management System (QMS).

Documentation Structure

To establish an integrated QSR and ISO 13485 QMS, an organization may use approaches outlined in the ISO 10013 Standard, Guidelines for Developing Quality Manuals. Among other suggestions, this standard gives an example of a documentation structure that can be used for QSR and ISO 13485 quality management systems. While the standard suggests using a three-level documentation structure, most organizations implement four-level structures to include quality records, as required by both QSR Subpart M - Records and ISO 13485, element 4.2.4. A typical four-level documentation structure includes: Quality Manual, Procedures, Instructions, and Records.

Actually, the documentation structure for an organization should most likely start from the quality policy, as the policy, among other commitments, defines the regulations and standards that a company intends to comply with. If you choose to use this approach, your QMS will have five levels, as shown below:

Quality Policy - level 1

Quality Manual - level 2

Procedures - level 3

Instructions - level 4, and

Records - level 5

Quality Policy

QSR, section 820.20 (a) and ISO 13485, element 5.3 require the establishment of a quality policy. To satisfy these requirements an organization may develop a quality policy that meets requirements of both QSR and ISO 13485 standards. While QSR requires a quality policy to include a commitment to quality and be "...understood, implemented, and maintained at all levels of the organization", ISO 13485 requirements are somewhat broader. Therefore, an organization can adhere to the requirements of ISO 13485 which requires that a quality policy include: