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.

Introduction to ISO Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:

Procedure by which a third party gives written assurance
that a product, process or service complies with the requirements
specified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).

ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:

ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminology
ISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must follow
ISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performance
ISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Introduction to ISO Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:

Procedure by which a third party gives written assurance
that a product, process or service complies with the requirements
specified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).

ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:

ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminology
ISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must follow
ISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performance
ISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.