Friday, December 25, 2009
Document Review In ISO 9000 Standards
BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
Tuesday, December 22, 2009
Establishing Quality Objectives In ISO 9000 Standards
ISO 9000 Standards – Quality Management Principles
ISO 9000 Standards – Quality Management Principles
A quality management principle is defined by ISO/TC 176 as a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other interested parties. Eight principles have emerged as fundamental to the management of quality.
All the requirements of ISO 9001:2008 are related to one or more of these principles. These principles provide the reasons for the requirements and are thus very important. The quality management principles can be listed as below:
1. Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
The customer focus principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Communication with the customer
b. Care for customer property
c. The determination of customer needs and expectations
d. Appointment of a management representative
e. Management commitment
2. Leadership
Leaders establish unity of purpose and direction for the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
The leadership principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The setting of objectives and policies
b. Planning
c. Internal communication
d. Creating an effective work environment
3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
The involvement of people principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Participation in design reviews
b. Defining objectives, responsibilities and authority
c. Creating an environment in which people are motivated
d. Internal communication
e. Identifying competence needs
4. Process approach
A desired result is achieved more efficiently when related resources and activities are managed as a process.
The process approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The identity of processes
b. Defining process inputs and outputs
c. Providing the infrastructure, information and resources for processes to
function
5. System approach to management
This principle is expressed as follows:
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
The system approach principle is reflected in ISO 9001 through the requirements addressing:
a. Establishing, implementing and maintaining the management system
b. Interconnection, interrelation and sequence of processes
c. The links between processes
d. Establishing measurement processes
6. Continual improvement
This principle is expressed as follows:
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
The continual improvement principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Improvement processes
b. Identifying improvements
c. Reviewing documents and processes for opportunities for improvement
7. Factual approach to decision making
This principle is expressed as follows:
Effective decisions are based on the analysis of data and information.
The factual approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Reviews, measurements and monitoring to obtain facts
b. Control of measuring devices
c. Analysis to obtain facts from information
d. Records for documenting the facts
e. Approvals based on facts
8. Mutually beneficial supplier relationships
This principle is expressed as follows:
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
The mutually beneficial supplier relationships principle is reflected in ISO 9000 Standardsthrough the requirements addressing:
a. Control of suppliers
b. Evaluation of suppliers
c. Analysis and review of supplier data
ISO 9000 Standards – Document Approval
The ISO 9000 Standards requires that documents be approved for adequacy prior to issue.
Approval prior to issue means that designated authorities have agreed the document before being made available for use. Whilst the term ade-
quacy is a little vague it should be taken as meaning that the document is judged as fit for the intended purpose. In a paper based system, this means approval before the document is distributed. With an electronic system, it means that the documents should be approved before they are published or made available to the user community.
The ISO 9000 Standards document control process needs to define the process by which documents are approved. In some cases it may not be necessary for anyone other than the approval authority to examine the documents. In others it may be necessary to set up a panel of reviewers to solicit their comments before approval is given.
It all depends on whether the approval authority has all the information
needed to make the decision and is therefore ‘competent’. One might think that the CEO could approve any document in the organization but just because a person is the most senior executive does not mean he or she is competent to perform any role in the organization.
Users should be the prime participants in the approval process so that the
resultant documents reflect their needs and are fit for the intended purpose. If the objective is stated in the document, does it fulfil that objective? If it is stated that the document applies to certain equipment, area or activity, does it cover that equipment, area or activity to the depth expected of such a document? One of the difficulties in soliciting comments to documents is that you will gather comment on what you have written but not on what you have omitted. A useful method is to ensure that the procedures requiring the document specify the acceptance criteria so that the reviewers and approvers can check the document against an agreed standard.
To demonstrate documents have been deemed as adequate prior to issue,
you will need to show that the document has been processed through the
prescribed document approval process. Where there is a review panel, a simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the drafting process you may undertake several revisions. You may feel it
necessary to retain these in case of dispute later, but you are not required to do so. You also need to show that the current issue has been reviewed so your comment sheets need to indicate document issue status.
Preparing The ISO 9000 Standards Quality Manual
Preparing The ISO 9000 Standards Quality Manual
| The standard requires a quality manual to be established and maintained that includes the scope of the quality management system, the documented procedures or reference to them and a description of the sequence and interaction of processes included in the quality management system. ISO 9000 defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the manual be a response to the requirements of ISO 9001. As the top-level document describing the management system it is a system description describing how the organization is managed. Countless quality manuals produced to satisfy ISO 9000 :2008, were no more than 20 sections that paraphrased the requirements of the standard. Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate. This requirement responds to the System Approach Principle. A description of the management system is necessary as a means of showing how all the processes are interconnected and how they collectively deliver the business outputs. It has several uses as : a means to communicate the vision, values, mission, policies and objectives of the organization a means of showing how the system has been designed a means of showing linkages between processes a means of showing who does what an aid to training new people a tool in the analysis of potential improvements a means of demonstrating compliance with external standards and regulations When formulating the policies, objectives and identifying the processes to achieve them, the manual provides a convenient vehicle for containing such information. If left as separate pieces of information, it may be more difficult to see the linkages. The requirement provides the framework for the manual. Its content may therefore include the following: 1 Introduction (a) Purpose (of the manual) (b) Scope (of the manual) (c) Applicability (of the manual) (d) Definitions (of terms used in the manual) 2 Business overview (a) Nature of the business/organization – its scope of activity, its products and services (b) The organization’s interested parties (customers, employees, regulators, shareholders, suppliers, owners etc.) (c) The context diagram showing the organization relative to its external environment (d) Vision, values (e) Mission 3 Organization (a) Function descriptions (b) Organization chart (c) Locations with scope of activity 4 Business processes (a) The system model showing the key business processes and how they are interconnected (b) System performance indicators and method of measurement (c) Business planning process description (d) Resource management process description (e) Marketing process description (f) Product/service generation processes description (g) Sales process description (h) Order fulfilment process description 5 Function matrix (Relationship of functions to processes) 6 Location matrix (Relationship of locations to processes) 7 Requirement deployment matrices (a) ISO 9001 compliance matrix (b) ISO 14001 compliance matrix (c) Regulation compliance matrices (FDA, Environment, Health, Safety, CAA etc.) 8 Approvals (List of current product, process and system approvals) |
Develop Quality Management System Documentation In ISO 9000 Standards
Develop Quality Management System Documentation In ISO 9000 Standards
Documentation is the most common area of non-conformance among organizations
wishing to implement ISO 9000 quality management systems. As one company
pointed out: “When we started our implementation, we found that documentation
was inadequate. Even absent, in some areas. Take calibration. Obviously it’s
necessary, and obviously we do it, but it wasn’t being documented. Another area
was inspection and testing. We inspect and test practically every item that leaves
here, but our documentation was inadequate”.
Documentation of the quality management system should include:
1. Documented statements of a quality policy and quality objectives,
2. A quality manual,
3. Documented procedures and records required by the standard ISO 9001:2008, and
4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.
Quality documentation is generally prepared in the three levels indicated below that follows. Use ISO 10013:1995 for guidance in quality documentation.
Level A: Quality manual
States the scope of the quality management system, including exclusions and
details of their justification; and describes the processes of the quality
management system and their interaction. Generally gives an organization
profile; presents the organizational relationships and responsibilities of persons
whose work affects quality and outlines the main procedures. It may also
describe organization’s quality policy and quality objectives.
Level B: Quality management system procedures
Describes the activities of individual departments, how quality is controlled in
each department and the checks that are carried out.
Level C: Quality documents (forms, reports, work instructions, etc.)
1. Work instructions describe in detail how specific tasks are performed; include
drawing standards, methods of tests, customer’s specifications, etc.
2. Presents forms to be used for recording observations, etc.