TA的首页Control of Records 记录控制
Control of Records 记录控制
源自于jelly1921
Maintaining objective evidence of compliance 保持符合性的客观证据
by scott dawson
Record keeping is one of the most painstaking, and important requirements in the ISO9001 standard. Painstaking, because records must be identified, filed, protected and controlled throughout their lifecycle. Important, because they contain the history of how your quality management system (QMS) is functioning. The energy, effort and expense of keeping up your quality records are ongoing investments in building a reference-base for analysis, compliance and improvement.
记录保持是ISO9001标准里最令人头疼也是最重要的要求之一。说它头疼，是因为得在记录的全过程中去识别它，把它归档，保护它还得控制它。说它重要，是因为它包含了你们质量管理体系是如何发挥作用的历史。为分析，符合性和改进而一直在建立索引库，为此花费了精力、努力和费用，以保持质量记录。
WHY KEEP RECORDS? 为什么要保持记录呢？
The discipline of maintaining your QMS records ensures that you will have an objective means of assessing QMS effectiveness. With this historical evidence you can: 保持质量管理体系记录的规定保证你将拥有评价质量管理体系有效性方面的客观手段。拥有了这些历史证据，你就可以：
· Understand how well your QMS is performing 了解质量管理体系运行的有多好
· Trace back to the source of problems 追溯问题根源
· Demonstrate compliance to requirements 证明符合要求
· Evaluate trends in QMS performance 评估质量管理体系业绩趋势
· Monitor improvements 监控改进
With your quality records you can answer questions such as "why did this happen?", "when did this problem first appear?" and "is the problem gone?". With such valuable information at your fingertips, your records should be treated as invaluable.
有了质量记录，你就可以回答以下问题“这为什么发生？”“这样的问题第一次发生是在什么时候？”以及“问题消失了吗？”。手上握着这样有价值的信息，你的记录就该视为无价之宝。
Additionally, your quality records are a primary reference for your internal and external auditors to assess your compliance to requirements. As each record is filed, keep in mind that an auditor may want to retrieve it in order to evaluate the effectiveness of the QMS.
另外，质量记录是作为评价要求符合性的内外审的首要引证。但记录归档时，记住：文件编撰者也许要检索这个记录，以便评估质量管理体系的有效性。
WHAT RECORDS SHOULD BE KEPT? 应该保持什么记录？
The ISO9001 standard has a built-in reference to all required records wherever the phrase "see 4.2.4" is found (4.2.4 is the paragraph dealing with Control of Records). The 20 mandated ISO9001 records are:
ISO 9001标准对所需的记录有个内置索引，无论在何处见到“见4.2.4”即是。20个强制性记录是：
5.6.1
Records from management reviews shall be maintained
应保持管理评审的记录
6.2.2
e) maintain appropriate records of education, training, skills and experience
e) 保持教育、培训、技能和经验的适当记录
7.1
d) records needed to provide evidence that the realization processes and resulting product meet requirements
d) 为实现过程及其产品满足要求提供证据所需的记录
7.2.2
Records of the results of the review and actions arising from the review shall be maintained
评审结果及评审所引起的措施的记录应予保持
7.3.2
Inputs relating to product requirements shall be determined and records maintained
应确定与产品要求有关的输入，并保持记录
7.3.4
Records of the results of the reviews and any necessary actions shall be maintained
评审结果及任何必要措施的记录应予保持
7.3.5
Records of the results of validation and any necessary actions shall be maintained
验证结果及任何必要措施的记录应予保持
7.3.6
Records of the results of validation and any necessary actions shall be maintained
确认结果及任何必要措施的记录应予保持
7.3.7
Records of the results of the review of changes and any necessary actions shall be maintained
更改评审结果及任何必要措施的记录应予保持
7.4.1
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained
评价结果及评价所引起的任何必要措施的记录应予保持
7.5.2
d) requirements for records
d) 记录的要求
7.5.3
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records
在有可追溯性要求的场合，组织应控制产品的唯一性标识，并保持记录
7.5.4
If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records
组织应爱护在组织控制下或组织使用的顾客财产。组织应识别、验证、保护和维护供其使用或构成产品一部分的顾客财产。若顾客财产发生丢失、损坏或发现不适用的情况时，组织应报告顾客，并保持记录
7.6
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded
a) 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准和（或）验证。当不存在上述标准时，应记录校准或检定的依据；
record the validity of the previous measuring results when the equipment is found not to conform to requirements
当发现设备不符合要求时，组织应对以往测量结果的有效性进行评价和记录
Records of the results of calibration and verification shall be maintained
校准和验证结果的记录应予保持
8.2.2
Records of the audits and their results shall be maintained
应保持审核及其结果的记录
8.2.4
Records shall indicate the person(s) authorizing release of product for delivery to the customer
记录应指明有权放行产品以交付给顾客的人员
8.3
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained
应保持不合格的性质以及随后所采取的任何措施的记录，包括所批准的让步的记录
8.5.2
e) records of the results of action taken
e) 记录所采取措施的结果
8.5.3
d) records of results of action taken
e) 记录所采取措施的结果
共21个
In addition, you might give careful consideration to other records you might need to include in your QMS that would give you an important historical reference for critical areas. You may want to include records for maintenance (6.3) and customer satisfaction (8.2.1), for example.
此外，你该仔细考虑其它记录是否需要包含在质量管理体系之中，这样的记录会为你关键区域提供重要的历史引证。你也许要包括例如维护和顾客满意方面的记录。
WHAT ARE THE ISO9001 REQUIREMENTS? 什么是ISO9001要求？
All 20 required quality records that are applicable to your organization's processes, and any additional records you decide are important to maintain, must be kept according to the "Control of Records" requirements in the ISO9001 standard:
保持所有20个【2008版本是21个，但不是所有的企业都需要这21个，比如把第7章“设计开发”进行了删减，设计开发部分的记录就不需要了——jelly】要求的质量记录和你定下的额外记录是非常重要的，必须按照“记录控制”要求进行保持：
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. (ref. 4.2.4)
为提供要求符合性和质量管理体系有效运作证据而建立的记录必须受控。组织应建立文件化程序为记录的识别，保管，保护，检索，保存和处置规定所需的控制。记录应保持可读性和易于识别和检索。
Let’s briefly clarify each requirement: 让我们一一澄清：
Legible – You must ensure handwritten records can be easily read and that you protect paper records from deterioration that might affect their readability. 可读性——你必须保证手写记录易读，保证纸记录免于影响可读性的损坏。
Readily Identifiable – Each record should be uniquely identified through a number, code, title, date, storage location or other appropriate method. Anyone looking at the records should be able to easily tell what they are looking at. 易识别——应该通过单独的号码，编号，标题，日期和保管区或其它适宜的方法识别每个记录。查看这些记录的人能够容易地说出他们在看什么。
Retrievable – Every record should be filed and stored in such as way as to be easy to find and access when needed. 检索——每个记录应以这样的方式归档和储存，即需要时容易发现和存取。
In addition, you must have a documented procedure for controlling records. In the procedure you must address how your organization handles the following: 另外，你必须拥有一个控制记录的文件化程序，其中你必须指出如何处置以下情形：
Identification – What minimum information must be added to every record for identification (see "Readily Identifiable" above). 标识——什么是加在每个记录用于标识的最少信息
Storage – How hardcopy and electronic records are stored to protect them. 保管——如何保存原件和电子记录
Protection – What methods must be used to preserve records from loss or deterioration. For hardcopy records, you may want to include where files are kept, in what types of storage containers and any environmental concerns (moisture, temperature, etc.). For electronic records, be sure to include how the data is backed-up regularly. 保护——采用什么办法保护记录免受丢失或损坏的危险？对于原件记录，你该要包括文件保存位置、储存箱以及环境因素（湿度，温度等等）。对于电子记录，保证包括如何进行日常备份。
Retrieval – Describe how records are indexed or otherwise organized to facilitate easy access (see "Retrievable" above). 检索——为了方便存取，描述如何索引或组织的
Retention Time – Specify minimum and/or maximum retention requirements for each type of record. Be sure to establish a schedule to review your records according to your requirements. 保存时间【2008版本不要求时间了——jelly】——规定每种记录保存最短和最长的要求。保证建立评审记录的时间表
Disposition – Determine how you will dispose of records when scheduled. For confidential records, be sure you are explicit about how you intend to destroy the records. 处置——确定如何按时间处置记录。对于保密记录，
HOW CAN WE KEEP IT SIMPLE? 如何让它简单一些呢？
With at least 20 types of quality records to maintain according to the ISO9001 requirements, organizations are often seeking to simplify their approach to record keeping. Here are some suggestions: 根据ISO9001要求，至少有20个【2008标准是21个——jelly】质量记录要保持，组织经常寻找记录保持简化的方法。建议如下：
· Assign clear responsibility for filing, maintaining and disposing of each record. 为每个记录的归档、保持和处置指定清晰的工作内容
· Provide adequate storage capacity so filing can be maintained. 提供合适的储藏空间使归档可以坚持下去。
· Keep your records only as long as necessary, then dispose of them. 把记录保存必要长的时间，然后处置之。
· evelop a records retention matrix that shows who is responsible, storage locations, protections, security, retention requirements and disposal methods. 建立记录保存表，表明负责人，储藏位置，保护，安全，保存要求和处置办法。
· Move as many records as possible to a searchable, electronic format to keep storage costs down and make them easy to retrieve when needed. 尽可能多地建立可搜索的电子表格，降低保存成本，并在需要时使检索更容易。
By keeping your record keeping as simple as possible, you'll keep your costs down, prepare for seamless audits and keep your ISO-life somewhat manageable.
尽量简化记录，就会降低成本，准备天衣无缝的审核，并使你ISO的生涯略有章法。
源自于jelly1921
Maintaining objective evidence of compliance 保持符合性的客观证据
by scott dawson
Record keeping is one of the most painstaking, and important requirements in the ISO9001 standard. Painstaking, because records must be identified, filed, protected and controlled throughout their lifecycle. Important, because they contain the history of how your quality management system (QMS) is functioning. The energy, effort and expense of keeping up your quality records are ongoing investments in building a reference-base for analysis, compliance and improvement.
记录保持是ISO9001标准里最令人头疼也是最重要的要求之一。说它头疼，是因为得在记录的全过程中去识别它，把它归档，保护它还得控制它。说它重要，是因为它包含了你们质量管理体系是如何发挥作用的历史。为分析，符合性和改进而一直在建立索引库，为此花费了精力、努力和费用，以保持质量记录。
WHY KEEP RECORDS? 为什么要保持记录呢？
The discipline of maintaining your QMS records ensures that you will have an objective means of assessing QMS effectiveness. With this historical evidence you can: 保持质量管理体系记录的规定保证你将拥有评价质量管理体系有效性方面的客观手段。拥有了这些历史证据，你就可以：
· Understand how well your QMS is performing 了解质量管理体系运行的有多好
· Trace back to the source of problems 追溯问题根源
· Demonstrate compliance to requirements 证明符合要求
· Evaluate trends in QMS performance 评估质量管理体系业绩趋势
· Monitor improvements 监控改进
With your quality records you can answer questions such as "why did this happen?", "when did this problem first appear?" and "is the problem gone?". With such valuable information at your fingertips, your records should be treated as invaluable.
有了质量记录，你就可以回答以下问题“这为什么发生？”“这样的问题第一次发生是在什么时候？”以及“问题消失了吗？”。手上握着这样有价值的信息，你的记录就该视为无价之宝。
Additionally, your quality records are a primary reference for your internal and external auditors to assess your compliance to requirements. As each record is filed, keep in mind that an auditor may want to retrieve it in order to evaluate the effectiveness of the QMS.
另外，质量记录是作为评价要求符合性的内外审的首要引证。但记录归档时，记住：文件编撰者也许要检索这个记录，以便评估质量管理体系的有效性。
WHAT RECORDS SHOULD BE KEPT? 应该保持什么记录？
The ISO9001 standard has a built-in reference to all required records wherever the phrase "see 4.2.4" is found (4.2.4 is the paragraph dealing with Control of Records). The 20 mandated ISO9001 records are:
ISO 9001标准对所需的记录有个内置索引，无论在何处见到“见4.2.4”即是。20个强制性记录是：
- Document Control (4.2.3) 文件控制
- Management Review (5.6.1) 管理评审
- Education, Training, Skills and Experience (6.2.2) 教育，培训，技能和经验
- Product Realization (7.1) 产品实现
- Customer Requirements Review (7.2.2) 顾客要求评审
- Design and Development Inputs (7.3.2) 设计开发输入
- Design and Development Review (7.3.4) 设计开发评审
- Design and Development Verification (7.3.5) 设计开发验证
- Design and Development Validation (7.3.6) 设计开发确认
- Design and Development Changes (7.3.7) 设计开发变更
- Supplier Evaluations (7.4.1) 供应商评价
- Production/Service Processes (7.5.2) 生产/服务过程
- Identification and Traceability (7.5.3) 标识和可追溯性
- Damaged/Lost Customer Property (7.5.4) 顾客财产损害/遗失
- Calibration (7.6) 校准
- Internal Audit (8.2.2) 内审
- Product Conformity (8.2.4) 产品符合性
- Nonconforming Product (8.3) 不符合品
- Corrective Action (8.5.2) 纠正措施
- Preventive Action (8.5.3) 预防措施
5.6.1
Records from management reviews shall be maintained
应保持管理评审的记录
6.2.2
e) maintain appropriate records of education, training, skills and experience
e) 保持教育、培训、技能和经验的适当记录
7.1
d) records needed to provide evidence that the realization processes and resulting product meet requirements
d) 为实现过程及其产品满足要求提供证据所需的记录
7.2.2
Records of the results of the review and actions arising from the review shall be maintained
评审结果及评审所引起的措施的记录应予保持
7.3.2
Inputs relating to product requirements shall be determined and records maintained
应确定与产品要求有关的输入，并保持记录
7.3.4
Records of the results of the reviews and any necessary actions shall be maintained
评审结果及任何必要措施的记录应予保持
7.3.5
Records of the results of validation and any necessary actions shall be maintained
验证结果及任何必要措施的记录应予保持
7.3.6
Records of the results of validation and any necessary actions shall be maintained
确认结果及任何必要措施的记录应予保持
7.3.7
Records of the results of the review of changes and any necessary actions shall be maintained
更改评审结果及任何必要措施的记录应予保持
7.4.1
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained
评价结果及评价所引起的任何必要措施的记录应予保持
7.5.2
d) requirements for records
d) 记录的要求
7.5.3
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records
在有可追溯性要求的场合，组织应控制产品的唯一性标识，并保持记录
7.5.4
If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records
组织应爱护在组织控制下或组织使用的顾客财产。组织应识别、验证、保护和维护供其使用或构成产品一部分的顾客财产。若顾客财产发生丢失、损坏或发现不适用的情况时，组织应报告顾客，并保持记录
7.6
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded
a) 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准和（或）验证。当不存在上述标准时，应记录校准或检定的依据；
record the validity of the previous measuring results when the equipment is found not to conform to requirements
当发现设备不符合要求时，组织应对以往测量结果的有效性进行评价和记录
Records of the results of calibration and verification shall be maintained
校准和验证结果的记录应予保持
8.2.2
Records of the audits and their results shall be maintained
应保持审核及其结果的记录
8.2.4
Records shall indicate the person(s) authorizing release of product for delivery to the customer
记录应指明有权放行产品以交付给顾客的人员
8.3
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained
应保持不合格的性质以及随后所采取的任何措施的记录，包括所批准的让步的记录
8.5.2
e) records of the results of action taken
e) 记录所采取措施的结果
8.5.3
d) records of results of action taken
e) 记录所采取措施的结果
共21个
In addition, you might give careful consideration to other records you might need to include in your QMS that would give you an important historical reference for critical areas. You may want to include records for maintenance (6.3) and customer satisfaction (8.2.1), for example.
此外，你该仔细考虑其它记录是否需要包含在质量管理体系之中，这样的记录会为你关键区域提供重要的历史引证。你也许要包括例如维护和顾客满意方面的记录。
WHAT ARE THE ISO9001 REQUIREMENTS? 什么是ISO9001要求？
All 20 required quality records that are applicable to your organization's processes, and any additional records you decide are important to maintain, must be kept according to the "Control of Records" requirements in the ISO9001 standard:
保持所有20个【2008版本是21个，但不是所有的企业都需要这21个，比如把第7章“设计开发”进行了删减，设计开发部分的记录就不需要了——jelly】要求的质量记录和你定下的额外记录是非常重要的，必须按照“记录控制”要求进行保持：
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. (ref. 4.2.4)
为提供要求符合性和质量管理体系有效运作证据而建立的记录必须受控。组织应建立文件化程序为记录的识别，保管，保护，检索，保存和处置规定所需的控制。记录应保持可读性和易于识别和检索。
Let’s briefly clarify each requirement: 让我们一一澄清：
Legible – You must ensure handwritten records can be easily read and that you protect paper records from deterioration that might affect their readability. 可读性——你必须保证手写记录易读，保证纸记录免于影响可读性的损坏。
Readily Identifiable – Each record should be uniquely identified through a number, code, title, date, storage location or other appropriate method. Anyone looking at the records should be able to easily tell what they are looking at. 易识别——应该通过单独的号码，编号，标题，日期和保管区或其它适宜的方法识别每个记录。查看这些记录的人能够容易地说出他们在看什么。
Retrievable – Every record should be filed and stored in such as way as to be easy to find and access when needed. 检索——每个记录应以这样的方式归档和储存，即需要时容易发现和存取。
In addition, you must have a documented procedure for controlling records. In the procedure you must address how your organization handles the following: 另外，你必须拥有一个控制记录的文件化程序，其中你必须指出如何处置以下情形：
Identification – What minimum information must be added to every record for identification (see "Readily Identifiable" above). 标识——什么是加在每个记录用于标识的最少信息
Storage – How hardcopy and electronic records are stored to protect them. 保管——如何保存原件和电子记录
Protection – What methods must be used to preserve records from loss or deterioration. For hardcopy records, you may want to include where files are kept, in what types of storage containers and any environmental concerns (moisture, temperature, etc.). For electronic records, be sure to include how the data is backed-up regularly. 保护——采用什么办法保护记录免受丢失或损坏的危险？对于原件记录，你该要包括文件保存位置、储存箱以及环境因素（湿度，温度等等）。对于电子记录，保证包括如何进行日常备份。
Retrieval – Describe how records are indexed or otherwise organized to facilitate easy access (see "Retrievable" above). 检索——为了方便存取，描述如何索引或组织的
Retention Time – Specify minimum and/or maximum retention requirements for each type of record. Be sure to establish a schedule to review your records according to your requirements. 保存时间【2008版本不要求时间了——jelly】——规定每种记录保存最短和最长的要求。保证建立评审记录的时间表
Disposition – Determine how you will dispose of records when scheduled. For confidential records, be sure you are explicit about how you intend to destroy the records. 处置——确定如何按时间处置记录。对于保密记录，
HOW CAN WE KEEP IT SIMPLE? 如何让它简单一些呢？
With at least 20 types of quality records to maintain according to the ISO9001 requirements, organizations are often seeking to simplify their approach to record keeping. Here are some suggestions: 根据ISO9001要求，至少有20个【2008标准是21个——jelly】质量记录要保持，组织经常寻找记录保持简化的方法。建议如下：
· Assign clear responsibility for filing, maintaining and disposing of each record. 为每个记录的归档、保持和处置指定清晰的工作内容
· Provide adequate storage capacity so filing can be maintained. 提供合适的储藏空间使归档可以坚持下去。
· Keep your records only as long as necessary, then dispose of them. 把记录保存必要长的时间，然后处置之。
· evelop a records retention matrix that shows who is responsible, storage locations, protections, security, retention requirements and disposal methods. 建立记录保存表，表明负责人，储藏位置，保护，安全，保存要求和处置办法。
· Move as many records as possible to a searchable, electronic format to keep storage costs down and make them easy to retrieve when needed. 尽可能多地建立可搜索的电子表格，降低保存成本，并在需要时使检索更容易。
By keeping your record keeping as simple as possible, you'll keep your costs down, prepare for seamless audits and keep your ISO-life somewhat manageable.
尽量简化记录，就会降低成本，准备天衣无缝的审核，并使你ISO的生涯略有章法。
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