ISO 9000 Standards Document Control System

ISO 9000 Standards Document Control System
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.

Records Required by ISO 9001 Standard

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

Records Required by ISO 9001 Standard

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

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.

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.

ISO 9001 Standards – Quality Policy and Objectives

ISO 9001 Standards – Quality Policy and Objectives

A ISO 9001 Standards quality policy and its corresponding quality objectives are established to direct the organization towards two specific goals of a quality management system:

-Provision of products – goods and services – that meet customer and applicable legal requirements, and

- Enhancement of customer satisfaction

The quality policy and the objectives are also a means of controlling the quality management system’s processes. Simply, if you want to control a process, assign an objective to it (or more) and make sure it is aligned to the quality policy, then monitor and measure the process’ performance against the assigned objective. You need to provide adequate resources to the process to ensure that it is capable of achieving the objective. You continually improve the whole process by upgrading the objective, make corrective and preventive actions or introduce innovation to it. Corrective action addresses an undesirable situation’s cause in order to prevent its recurrence. Preventive action, by contrast, addresses the probable cause of a potentially undesirable situation. This is what the quality policy and objectives are supposed to do. They provide focus, direction and control.

The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties. When an organization has established a quality policy and a set of operational objectives, this means the only thing left to do is to design or plan the necessary processes or tasks that can realize those objectives. Therefore, the processes determine if the objectives will be met in full, partially or not at all. This is where the ISO 9001 standard play a critical role in specifying the required processes and the operating criteria. This is what ISO 9001 is all about. It even specifies criteria for the policy and the objectives.

A quality policy needs to satisfy the following requirements:

• It is appropriate to the purpose of the organization,
• It includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
• It provides a framework for establishing and reviewing quality objectives,
• It is communicated and understood within the organization, and
• It is reviewed for continuing suitability

Quality objectives must be established in order to enable the organization to comply with requirements and continually improve the effectiveness of the quality management system. Quality objectives must achieve four things:

• Enable the organization to meet customer requirements
• Enable the organization to enhance customer satisfaction
• Enable the organization to comply with all legal requirements applicable to the product
• Continually contribute to the effectiveness of the quality management system

Therefore, when you are in the meeting room with your management brainstorming on the appropriate objectives, have these four points in mind.

ISO 9001:2000 requires that management periodically review changes to both the policy and objectives. An organization’s objectives must be measurable and its processes designed to meet those objectives. An organization’s overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. To do this, it’s necessary to understand which processes are key to achieving business goals and align those processes with the quality objectives. It means aligning business goals, quality objectives and process measures to create real improvement. And it means using process mapping. Process mapping involves more than just flow charting. Among other things, it can manage and improve processes by illustrating process measures as well as process flows and interactions. One process-mapping method begins by involving the people who work in the process. Another entails mapping the process as is, taking action to improve it and then preparing a final map of the improved process.

Process owners are directly responsible for the attainment of the objectives. They must be given adequate resources, including competent human resources. They need to review the objectives periodically to ensure the key performance indicators are heading towards their objectives on schedule. If not, they need to initiate corrective actions and if the risks of non-achievement are visible, take preventive actions to control them and steer the KPI’s back on course.

Examples of quality objectives:

• Production rejects <>
• Machine breakdown <>
• Returned products = 0/mth
• Purchasing >95% on-time delivery
• Inventory damage = 0/mth

Conclusion: ISO 9001 requires that the quality management system achieves its objectives in order to realize the quality policy.

ISO 14001 Standards – Complying with Environmental Laws and Regulations

One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.

ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.

A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.