How To Write ISO 9001 Standards Procedures?

How To Write ISO 9001 Standards Procedures?

Step 1
Place the following sub sections into your procedure:
Purpose, Scope, Definitions, Associated Documentation, Responsibility/Authority, Procedure, Record Retention and Attachments. Leave blank spaces between each to add the required information.
Step 2
First, start with the Purpose Section. Describe the reason why the procedure exists. If we use the purchasing procedure as an example the Purpose might read:
“This procedure defines the process for obtaining raw materials and supplies for XYZ Company and the matter with which the requirements of these purchases are flowed down to XYZ Company’s suppliers.”
Step 3
ScopeNext, define the scope of the document. This is to what extent the process will reach within the company. For example:
“This procedure shall include all purchases directly used in the manufacture or processing of XYZ Company’s product.”
Step 4
Next make a list of terms and definitions. These should not be common terms that anyone reading the document should already know; but, should be technical terms that pertain to the procedure or common terms that may have added meaning to the company. For example:
“Supplier – XYZ Company defines a supplier as an approved company that supplies items used to produce and/or manufacture our product. This term does not include companies that supply general office product not used to produce or process XYZ Company’s products.”
In this example the common term supplier has added meaning to XYZ Company that could differ from another company’s definition of supplier. To avoid confusion a definition of the term is listed in the definitions section of the ISO 9001 procedure.
Step 5
Define the supporting document that are needed to create a complete process. If you product calls out t use only approved suppliers it may be nice to reference the supplier management procedure and the approved supplier list; because, they will be needed to complete the purchasing process.
Step 6
Now define the responsibilities and authorities. This is similar to a job description where as it defines the person that will manage and/or carry out the tasks described in the procedure. For example:
“The purchasing manager will be responsible for managing this procedure and coordinating purchases. Managing shall include the implementation and enforcement of this procedure throughout XYZ Company.”
Step 7
Define the procedure. This is the bulk of the procedure and is where the company will define the actual process. This can be detailed or simply call out what work inspection are to be used at each step of the purchasing process. It is important that all the elements of the quality standard that pertain to the procedure are defined in this part of the document. This section is usually broken into subsections. In our “Purchasing Procedure” example this might include “General procedures”, “Purchasing Components and Raw Materials” and “Purchasing Outside Services”. Usually some kind of outline method is used to layout this section.
Step 8
Next is the record retention section. This usually defines the method of controlling records related to this process. Where they will be kept, How long they will be kept, in what type of media for which they will be stored.
Step 9
Finally, the attachments section of the procedure will be defined. This will be references to other procedures, external information sources or other media used to supplement that procedure itself.

ESTABLISHING THE INITIAL STATE OF THE QUALITY MANAGEMENT SYSTEM

The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.

According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.

However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the

existence and functionality the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results. A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:

1. Complete Death: No documentation, no functioning This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product. Relatively few companies will find themselves in this situation.

2. Informally Alive: No documentation, some level of functioning Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” . SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.

3. Formally Death: Some level of documentation, no functioning SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.

4. Formally Alive: Some level of documentation, some level of functioning Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. As illustrated in Figure 2, this situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality

Integrating Management Systems Within The ISO 9001 Standards

Integrating Management Systems Within The ISO 9001 Standards

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8?700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)