From: ISO Standards Discussion
Date: Fri, 13 Oct 2000 16:16:22 -0500
Subject: Re: ISO 9000:1994 Vs. ISO 90002000 /../Whitcomb/Robinson/Paten
From: Mike Paten
In my opinion, Clause 4 of ISO 9001:2000 is auditable / audited for the same reasons Clause 4.2 of ISO 9001/2: 1994 was:
The General Requirements of clause 4.1 are met if the specific requirements of clauses 5-8 are met ( i.e. have you established a system that meets the requirements of ISO 9001:2000 ) - could be audited as follows:
Review quality manual to determine if a systematic approach is defined for:
1) identifying and managing QMS processes (or elements) in accordance with the "process approach" defined in clause 0.2 and Figure 1 of ISO 9001:2000 identifying and showing the relationship between the following QMS processes (or elements) and their related sub-processes: Clause:
* Management Responsibility
* Resource Management
* Product Realization
* Measurement, Analysis and
* Improvement
2) ensuring the criteria, methods, information and responsibilities for managing QMS processes are in place.
3) ensuring that data is collected, analyzed and used to assess QMS process effectiveness and to identify needed actions or improvements.
Likewise, The General Documentation Requirements of clause 4.2 could be audited as follows:
Review quality manual to ensure required procedures are included or referenced (per clause 5.5.5).
Review QMS documentation to determine if documented procedures are appropriate for the size and type of the organization, the complexity and interaction of processes, and competence of personnel.
Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation.
Note: there are only six "required" procedures:
* Document Control (clause 5.5.6)?
* Control of Quality Records (clause 5.5.7)?
* Internal Audit (clause 8.2.2)?
* Control of Nonconformity (clause 8.3)?
* Corrective Action (clause 8.5.2)?
* Preventive Action (clause 8.5.3)?
If/as appropriate, procedures may also be "needed" for:
* Planning (5.4, 7.1, 8.1, 8.5.1)
* Communications (5.5.4)
* Management Review (5.6)
* Resource Management (6)
* Training (6.2.2)
* Customer Processes (7.2)
* Design and Development (7.3)
* Purchasing(7.4)
* Operations Control (7.5.1)
* Product ID/Traceability ( 7.5.2)
* Customer Property (7.5.3)
* Preservation of Product (7.5.4)
* Validation of Processes (7.5.5)
* Process Measurement/Monitoring (8.2.3)
* Product Measurement/Monitoring (8.2.4)
* Analysis/ Improvement (8.4, 8.5)
Review applicable standards and statutory/regulatory documents to determine if the QMS identifies required documentation and records.
Review other external or internal documents to ensure QMS identifies documentation and records needed to effectively manage the organization's products, processes and activities.
Note: Clause 4.2 requires that documentation be defined here - QMS document and record controls must be per clauses 5.5.6 and 5.5.7).
This is how I read it anyway!
Mike Paten
Date: Fri, 13 Oct 2000 16:16:22 -0500
Subject: Re: ISO 9000:1994 Vs. ISO 90002000 /../Whitcomb/Robinson/Paten
From: Mike Paten
In my opinion, Clause 4 of ISO 9001:2000 is auditable / audited for the same reasons Clause 4.2 of ISO 9001/2: 1994 was:
The General Requirements of clause 4.1 are met if the specific requirements of clauses 5-8 are met ( i.e. have you established a system that meets the requirements of ISO 9001:2000 ) - could be audited as follows:
Review quality manual to determine if a systematic approach is defined for:
1) identifying and managing QMS processes (or elements) in accordance with the "process approach" defined in clause 0.2 and Figure 1 of ISO 9001:2000 identifying and showing the relationship between the following QMS processes (or elements) and their related sub-processes: Clause:
* Management Responsibility
* Resource Management
* Product Realization
* Measurement, Analysis and
* Improvement
2) ensuring the criteria, methods, information and responsibilities for managing QMS processes are in place.
3) ensuring that data is collected, analyzed and used to assess QMS process effectiveness and to identify needed actions or improvements.
Likewise, The General Documentation Requirements of clause 4.2 could be audited as follows:
Review quality manual to ensure required procedures are included or referenced (per clause 5.5.5).
Review QMS documentation to determine if documented procedures are appropriate for the size and type of the organization, the complexity and interaction of processes, and competence of personnel.
Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation.
Note: there are only six "required" procedures:
* Document Control (clause 5.5.6)?
* Control of Quality Records (clause 5.5.7)?
* Internal Audit (clause 8.2.2)?
* Control of Nonconformity (clause 8.3)?
* Corrective Action (clause 8.5.2)?
* Preventive Action (clause 8.5.3)?
If/as appropriate, procedures may also be "needed" for:
* Planning (5.4, 7.1, 8.1, 8.5.1)
* Communications (5.5.4)
* Management Review (5.6)
* Resource Management (6)
* Training (6.2.2)
* Customer Processes (7.2)
* Design and Development (7.3)
* Purchasing(7.4)
* Operations Control (7.5.1)
* Product ID/Traceability ( 7.5.2)
* Customer Property (7.5.3)
* Preservation of Product (7.5.4)
* Validation of Processes (7.5.5)
* Process Measurement/Monitoring (8.2.3)
* Product Measurement/Monitoring (8.2.4)
* Analysis/ Improvement (8.4, 8.5)
Review applicable standards and statutory/regulatory documents to determine if the QMS identifies required documentation and records.
Review other external or internal documents to ensure QMS identifies documentation and records needed to effectively manage the organization's products, processes and activities.
Note: Clause 4.2 requires that documentation be defined here - QMS document and record controls must be per clauses 5.5.6 and 5.5.7).
This is how I read it anyway!
Mike Paten