ISO 9001 Standard / ISO 9001 Standards – ISO 9000 Standard / ISO 9000 Standards Certification & Implementation

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements needed in a good quality system:

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continuous improvement
7. Factual Approach to Decision-Making
8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

• Using well-defined processes and procedures to build stable processes
• Training in the audit and certification process
• Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

Read more on ISO 9001 Standards at http://www.iso-9001-store.com

Quality system design is an essential foundation for successful quality management, but quality systems training – for all employees – maybe the key to successful implementation and maintenance.

For most life science companies, maintaining a quality system has become a way of life. However, it probably isn’t these companies’ quality systems that keep their products and services afloat.

Yes, the manner in which a quality system is designed is duly important but the reality of the situation is that many quality system designs can work equally well in the same (or similar) environments. For example, one life science company may implement a well-known and highly recommended quality system design (ISO 9001 for example) and find great success while another very similar company may implement the same system and fail miserably.

The ability to get company employees to “buy into” a quality system is likely to make a big difference in a “pass or fail” quality system trial even, when a well known quality system design has been implemented. Whether it is change control, CAPA management, internal audits, customer complaints management, document control or deviations management, every company employee needs to know the following regarding his or her company’s quality system:

1. What the quality system policies are (at least those that will directly or indirectly affect him or her);
2. What the company’s objectives are in relation to the quality system policies, especially those objectives which the employee may be contributing to directly or indirectly;
3. What the company’s plans are to achieve those objectives especially those plans that will directly or indirectly affect the employee involved.

Every company should also take steps towards the testing of every employee’s comprehension of policies, objectives and plans related to quality system management. Measuring comprehension does NOT infer that a written exam be administered to employees. Perhaps simple observation from employee supervisors will be sufficient to determine whether one employee has a sufficient grasp of the policies objectives and plans that he or she should be aware of.

According to the FDA’s guidance document: Quality Systems Approach to Pharmaceutical cGMP Regulations, “Policies, objectives, and plans under a modern quality system provide the means by which senior managers articulate their vision of and commitment to quality to all levels of the organization.”¹

The FDA guidance also states that “senior management should incorporate a strong commitment to quality into the organizational mission.”²This of course can be accomplished by writing a “commitment to quality statement” in the company’s organizational mission. However, without training, employees are unlikely to care about or even think about quality management ideals and expectations.

To remedy this common dilemma, quality managers need to consider taking the following steps:

1. Ask Questions – Quality managers need to take time to talk, and most importantly, ask questions of every employee involved in quality. Well thought out questions regarding quality will at the very least get employees considering the endeavors they are involved in.
2. Delegate – More and more, quality is becoming less of a department and more of a group effort. That may seem scary for quality professionals but the reality is that delegation to numerous people (and/or departments) – combined with consistent follow through – always results in better business and better relationships between those who lead and those who follow.
3. A Quality Example – If quality managers don’t take quality seriously then it is less likely that other department employees will take the time to contribute to a company “quality cause.”

In short, quality management system may at times seem complex but it’s actually like most managerial responsibilities – primarily a people process.

The International Organization for Standardization (abbreviated to ISO) conducts standards for institutes which are organized in more than 159 countries across the globe. The ISO has its head office in Geneva, Switzerland. In simple terms ISO certification is given to an organization in order to indicate that the organization has good standards and it is working well with its employees and its customers. The International Organization for Standardization is not a Government organization. It acts as a bridge in between the private and the public sector and brings out good standards for many organizations across a variety of industries.

There are many standards that are released by the ISO. One of the standards is the ISO 9001 certification. The reason why an organization may require the ISO 9001 certification is to ensure that the company has a very good quality management system in place and can then confirm this to their customers. Also, if an organization has ISO 9001 certification it can ensure to its suppliers that it is following a good standard regarding it’s quality management system. The main two reasons for going for the ISO 9001 certification are to show how effective a company’s production is as well as helping to give good recognition for other new markets concerning their company standards.

The main aspects of ISO 9001 certification are maintaining good quality of products and also to maintain low cost and high efficiency for the production process. The primary thing that is checked with ISO 9001 certification is to confirm that the quality goals that are set out in the company’s quality management system are met. It is also important that once a company gets its ISO 9001 certification they should be seeking to improve all the time. There should be an increase in productivity as well. The goals of ISO 9001 certification are to increase the efficiency, increase the revenue, establish proper decision making, achieve good supplier relationships and prepare documentation work about the company plans, a regular improvement process should be in place and on the whole a complete customer satisfaction system should be implemented.

The ISO 9001:2008 certifications have a few revised benefits and let us see a few of them in detail. The goals of the ISO 9001 are the same for all year where as a few enhancements will be added for every year. Likewise the ISO 9001:2008 certification’s benefits include cost reduction in the production of goods, greater customer satisfaction, improved product efficiency and improved productivity, reduction in the scrap and waste products. The aim is to prepare a quality product which passes the goals of the quality management system. The ISO 9001 certification itself should result in the reduction of customer claims, a proper delivery to the customer on time, providing great reliability, safety and quality to the products. So on the whole the ISO 9001 certification has many good policies for the organization and they are also ensuring that the quality of the product should be good, efficient and cost effective, with an increase in the productivity.

Kindly visit http://www.iso9001store.com for more information.

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation and control of its processes.
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of, and justification for, any exclusions
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

ISO 9001:2008 standard defines requirements for a process-oriented Quality Management System. This means that desired results are achieved more efficiently when the related resources and activities, together with encompassing customer needs and satisfaction, are managed as a process. Quality Management System isspecified in a Quality Manual document featuring a three-tier structure, which consists of Quality Processes (including Quality Policies), Quality Proceduresand Work Instructions. The problem is that Work Instructions are sometimes too bureaucratic. A good example of that approach is Tricker’s book on ISO 9000. According to it, a Work Instruction takes about 16 pages. Half of them contains purelyadministrative data (document data sheet, distribution list, amendments, list of annexes etc.). That makes the whole Quality Management System documentation superfluously thick.

Another drawback of  Tricker’s approach is form-orientation: Work Instructions focus on how to fill-in the forms used by the Quality Procedures. What we propose is to make Work Instructions shorter (some elements can be omitted,some, e.g. terminology, can be put together and placed in one section). Moreover,Work Instructions should describe practices specific for a given methodology ofsoftware development.In our opinion, quality organization needs two things: general Quality Management System operating on a high abstraction level and a Thesaurus (knowledgedatabase), which should materialize company’s knowledge. In the thesaurustemplates of e.g. Quality Plans, historical data concerning past projects etc can be deposited. This information will be indispensable during planning and improving software processes. The clauses of ISO 9001:2008 can be split into two parts. One part describes the general Quality Management System (chapters 4, 5, and 6) while the other part specifies requirements for a methodology to be adopted by an ISO-9000 company (chapters 7 and 8 of ISO 9001:2008). In the remaining part of the paper we will focus on requirements imposed by chapters 7 and 8 of the ISO9001:2008.

History of ISO Standards and its New Direction

ISO’s evolution continued with another turning point a decade later. In 1993, with the creation of ISO/TC 207 to develop the ISO14000 Environmental Management standards, ISO took its most notable step into the public policy arena, extending its influence beyond industry and their customers, and into issues of general public interest.

Six decades after its creation, ISO has grown into the world’s largest and most widely recognized standards development organization. ISO’s influence is exercised not solely through its size and popularity, but also because of the status of its outputs as the world’s “trade-legal” standards as recognized by the World Trade Organization (WTO).  Once nationalized, these international standards can become market requirements (even for companies without foreign operations), for instance, as part of government procurement criteria, as has happened in the case of the ISO 9000 and ISO 14000 series standards.

There is, therefore, little doubt that any new ISO standards in the social or environmental field can and will have a sizable influence on businesses, governments, and civil society around the world.

Currently, a total of 148 countries participate in the ISO confederation, either as a member body (97 countries, with active participation and voting rights), as a correspondent member (36 countries, without voting rights but full information access), or as a subscriber member (15 countries, with reduced membership fee and limited access to the information).

What Should Be Documented In Quality Management System?

Clause 4.2.1 in ISO 9000 Standards requires quality management system documentation to include 5 types
of document:
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and control of processes
(e) Records
Other than the requirements in clause 4 for documentation, there are 14 other references requiring documentation. These are as follows:
(a) The output of the planning
(b) The quality manual
(c) A documented procedure for document control
(d) A documented procedure for the identification, storage, retrieval, protection, retention time and disposition of records.
(e) Planning of the realization processes
(f) Inputs relating to product requirements
(g) The outputs of the design and development process
(h) Design and development changes
(i) The results of the review of changes and subsequent follow up actions
(j) A documented procedure for conducting audits that includes the responsibilities and requirements
(k) Evidence of conformity with the acceptance criteria characteristics of the product
(l) A documented procedure for nonconformity control activities
(m)A documented procedure for corrective action
(n) A documented procedure for preventive action
This list is somewhat inadequate for documentation purposes because it does not tell us what types of things we should document or provide criteria to enable us to decide what we need to document. ISO 9000 clause 2.7.2 includes a more useful list of document types that are classified as follows:
(a) Quality manuals
(b) Quality plans
(c) Specifications
(d) Guidelines
(e) Procedures, work instructions and drawings
(f) Records

Clause 4.2.1 in ISO 9000 Standards requires quality management system documentation to include 5 types
of document:
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and control of processes
(e) Records
Other than the requirements in clause 4 for documentation, there are 14 other references requiring documentation. These are as follows:
(a) The output of the planning
(b) The quality manual
(c) A documented procedure for document control
(d) A documented procedure for the identification, storage, retrieval, protection, retention time and disposition of records.
(e) Planning of the realization processes
(f) Inputs relating to product requirements
(g) The outputs of the design and development process
(h) Design and development changes
(i) The results of the review of changes and subsequent follow up actions
(j) A documented procedure for conducting audits that includes the responsibilities and requirements
(k) Evidence of conformity with the acceptance criteria characteristics of the product
(l) A documented procedure for nonconformity control activities
(m)A documented procedure for corrective action
(n) A documented procedure for preventive action
This list is somewhat inadequate for documentation purposes because it does not tell us what types of things we should document or provide criteria to enable us to decide what we need to document. ISO 9000 clause 2.7.2 includes a more useful list of document types that are classified as follows:
(a) Quality manuals
(b) Quality plans
(c) Specifications
(d) Guidelines
(e) Procedures, work instructions and drawings
(f) Records

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation and control of its processes.
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of, and justification for, any exclusions
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.