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
iso 9001 standard
Quality Management System
Review In ISO 9000 Standards
If you have your own business and now you are looking for ISO 9000 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9000 Standards developed many quality standards as per different -different business areas.
ISO 9000 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.
For implementing ISO 9000 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO 9000 standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards
An ISO consultant performs the various activities and explains the course objectives :
• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship
• describe the purpose of Quality Management Systems and 8 Quality Management Principles
• Interpret the ISO 9001: 2008 in the context of audit
•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems
• Develop understanding of Roles & Responsibilities of Lead Auditors
Hiring a Consultant is a better and easiest way to implement ISO 9000 in your organization.
ISO 9001 Standards Document Control
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 Standards Training DVD
The major reasons that company leadership or management decides to seek ISO 9001 certification are to gain continued or increased business and to maintain effective operations.
A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 9001 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
The Introduction to ISO 9001:2008 DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:
First, to describe some basic information on ISO 9001 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9001, version & certification in ISO 9000 Standards.
Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9001 vs. Quality, what is Quality Management System & etc.
Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.
What Is ISO 9001 Standard?
What Is ISO 9001 Standard?
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the companys products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Who Is ISO 9001 Consultant?
Who Is ISO 9001 Consultant?
ISO 9001 Consulting has been available ever since the ISO management system standards were initially published in the late 1970′s. As of now, nearly a million business companies internationally have been certified to one or more of several ISO business standards. These include ISO 9001, ISO 14001, AS9100, ISO/TS 16949, etc. The statistics that have been accumulated to date indicate that while many organizations deployed ISO standards using internal know-how, those that used outside ISO 9001 consulting services profited the most in terms of speed of implementation, effectiveness and return on investment.
ISO 9001 Consultancy firms provide a numberof services. Let’s take a look at some of these so that you can determine what collection of services would best suit your company:
How To Interpret The ISO 9001 Standard?
The ISO 9001 quality management system standard can be a hard document to understand. It is written in semi-legal language and specifies requirements in in a very general sense. This is deliberately so, as it is meant to consider just about any type of business activity. Many companies have problems relating it to their specific organizations. An experienced ISO 9001 consultant can show you exactly how to apply the standard to your specific business processes.
ISO 9001 Gap Evaluation
Prior to implementing the ISO standard within your organization, you need to know the gap between your existing business practices and controls relative to ISO 9001. Using ISO 9001 consulting services, you can have an evaluation done of your current management system practices, controls and documentation, to determine to what extent you comply to ISO 9001 requirements. The consultant will give you a detailed audit report listing the gaps in your company, along with their recommendations. This will assist in developing your ISO 9001 project implementation plan to accomplish full compliance.
ISO 9001 Project Planning and Organization
Depending size and complexity of your business, an ISO 9001 implementation project can take as few as 4 months to over 18 months to complete. Your ISO project needs to well-planned in terms of time and resources needed, specific activities to be carried out, who will be responsible for each activity, milestone reviews, authorizations, training, dealing with problems, etc. A good ISO 9001 consultant can be an invaluable resource in assisting a business address with this important activity.
ISO 9001 Business Process Identification and Documentation
ISO 9001 views business processes as the main point of control. These include internal as well as outsourced processes. Quite a few companies have issues differentiationg between processes, departments and functional activities. ISO 9001 consulting experts can assist you identify and effectively document all organizational processes pertaining to your quality management system. These include customer-oriented, management, product realization, resource planning, measurement, support and outsourced processes.
ISO 9001 System Development and Implementation
The main thrust of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the most time-consuming and difficult aspect of any ISO implementation project. Many questions may arise as to what processes must be be controlled, what should be an effective control, how best to communicate and implement it, the inter-process impact, how to set process goals and objectives and what records to keep. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide focus and speed up implementation.
ISO 9001 Management System Documentation
The latest ISO 9001:2008 standard minimizes the emphasis on documentation and maximizes its attention on effective planning and control. Adequate documentation is however needed for many business processes in order to establish consistent application of effective controls. Some business have either too much or too little documentation. An experienced consultant can help your organization determine where it is needed, how much and how it should be documented.
ISO 9001 Pre-assessment
ISO 9001 Registrars (also referred to as Certification Bodies) conduct their certification audit in two stages. In stage 1, they determine your state of readiness (which includes your planning, documentation and internal review activities) and in stage 2 they evaluate your management system for effective implementation of planned controls, in both cases relative to the ISO 9001 standard. After spending several months of implementation, you feel your company ready for the certification audit, it might be useful to use external consulting to do an assessment to determine if you are truly ready, identify any issues and help you take appropriate corrective action, prior to the Registrar audit.
ISO 9001 Training
ISO 9001 Consultancy services generally provide a number of training alternatives. These include
- ISO 9001 awareness training to employees at all levels
- An executive summary of the ISO standard to senior management
- Process identification, mapping, analysis and improvement
- ISO project management
- ISO documentation and implementation
- Internal audit
- Use of problem-solving tools
Based on the amount of internal expertise inside your organization, you may want to have an external ISO 9001 consulting service provide some or all of this training.
Develop and Maintain your ISO 9001 Internal Audit Program
To be certified and maintain your certification, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, some comapnies are short on resources, internal audit expertise and personnel availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.
ISO 9001 Continual Improvement Process
The ISO 9001 standard requires your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Some ISO 9001 consulting firms have diversified skills and experience in continual improvement strategies and methods. These mayinclude problem-solving, six sigma, lean manufacturing, use of various business software and tools, etc. They can significantly accelerate your pace at gaining further operational efficiency, customer satisfaction and increased business profitability.
ISO 9000 Standards Document control procedures
ISO 9000 Standards Document control procedures
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.
This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.
Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.
Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.
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.)
ESTABLISHING THE INITIAL STATE OF THE QUALITY MANAGEMENT SYSTEM
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
- everise
- Posts: 113
- Joined: Tue Jun 09, 2009 9:02 am
ISO 9001 Standards Gap Analysis
ISO 9001 Standards Gap Analysis
One of the first steps in implementing ISO 9000 is to perform a gap analysis. This is the technical name for an initial comparison of the Quality Management System to the ISO 9001:2008 Standard. The goal in find the gap between the standard and the QMS. The Gap Analysis will establish the scope of the implementation project and will therefore be important information for determining the amount of resources that will be required to complete the project in the given timeline.
Typically the gap analysis is based on a Gap Analysis checklist. These can be purchased from several different sources on the web ( like theISOstore.com). A second option is to use the internal audit checklist from this web site as a gap analysis checklist. Either way, the key to have a list of questions based on the standard that will uncover any weaknesses in the QMS before the project begins.
Gap Analysis Auditors
Performing gap analysis is best done by someone who is familiar with the ISO 9001 standard. If the company has no one with this experience, then consider outside training for the person who will be the lead internal auditor. Without grasping the goals behind the standard, you and your company can waste a lot of time improperly documenting flaws and over engineering solutions.
Performing a Gap Analysis
I recommend performing a basic ISO 9000 awareness training before the gap analysis. The awareness training will help reduce fear or resistance to the change that sometimes comes with a large company wide project. Once everyone understands the goals of the ISO project and is ready to be audited, start the gap analysis in sections. Covering sections 4,5,6,7 and 8 all in one audit is a mind melting experience. Start with section 4 to see how fast you can properly document the a section. Then schedule the remaining section based on your experience.
As you go through each section, you will either find that a system is already in place that meets the requirements of the ISO9001 standard or you will write a finding for that section. If you find that the system is in place, simply log the document numbers on the gap analysis sheet and move on. If you find that a large portions of the quality systems are missing, then you can write the equivalent of a major finding with a larger scope and not waste too much time listing every detail of what is missing.
How to use the result of the gap analysis
Once you have completed the gap analysis, you will have a list of missing or under-developed documents, records and systems. If you use the checklist from this web site, the result of the gap analysis will be a list of individual item that must be corrected. If the check sheet said “what document is used to the describe record retention?” and you found no document, then the document should be created. Once you feel that everything is in place, then you will want to repeat the audit to confirm that you can answer every question on the internal audit checklist with a positive response.
If the gap analysis show that your systems are in relatively good shape with some area for improvement, then I would make the gap analysis the first record in your internal audit notebook. This will help build a history of audits. If the gap analysis shows major flaws, you may want to fix them and then perform an internal audit as the first record to meet your internal auditing requirements. External auditor will frequently look at your internal auditing records to see if there are any blatant problems with the QMS, so don’t make their job too easy.