Quality Management System Preliminary Gap Analysis
Decide on a number from 0 to 5 for each item below. The scoring criteria are given in a table at the end. 1 to 5 Make notes to explain your score for future reference.
1. Have you established, documented, implemented and now maintain a Quality Management System (QMS) to any system including ISO 9001?
2. Have you identified the processes needed for your QMS and
a. the sequence of your production and service delivery processes,
b. the criteria and methods needed to ensure the processes are effective, and
c. have the resources and the information you need to support the processes?
3. Do you have
a. a Quality Manual including your Quality Policy and quality objectives, and
b. written procedures and work instructions?
4. Do your records provide evidence that your business processes are effective?
5. Is your Top Management committed to the development and implementation of a new QMS (i.e. based on the 2008 version of ISO 9001)?
6. Has your Top Management communicated the importance of meeting customer and other business requirements to all the employees?
7. Has your Top Management made a commitment to ensure your customers’ requirements are top priority?
8. Do your quality objectives include requirements for production and delivery?
9. Are your quality objectives measurable?
10. Have the responsibilities and authorities of managers and employees been defined and communicated to them?
11. Does your management have the drive and resources needed
a. to implement, and maintain a QMS and continually improve its effectiveness, and
b. to enhance customer satisfaction by meeting customer requirements?
12. Does your organization have procedures to select competent personnel for work activities?
13. Does your organization provide training or take other action to help develop your people?
14. Does your organization provide adequate:
a. buildings, workspace and utilities,
b. process equipment, and
c. supporting services such as transport or communication?
15. When you receive a customer order do you review it for
a. requirements specified by the customer, including the delivery and post-delivery activities,
b. requirements not stated by the customer but necessary for specified use or known and intended use, and
c. statutory and regulatory requirements related to the product?
16. Do you inform your customers concerning
a. product information,
b. enquiries, contracts or order handling, including changes, and
c. channels for customer feedback and complaints?
17. Does your organization plan and control product design and development activities?
18. Does your organization maintain records of design or development review, verification and validation activities and resulting action?
19. Does your organization inspect or otherwise confirm that purchased products, materials, components and services conform to your specified purchase requirements?
20. Does your organization select suppliers depending on how important the purchased product is for production?
21. Does your organization evaluate suppliers (subcontractors or vendors) based on their ability to satisfy your requirements?
22. Do you ensure production has
a. the information that describes the characteristics of the product,
b. the necessary work instructions,
c. suitable equipment, and
d. the monitoring and measuring devices needed?
23. Does your organization regularly confirm that your production and service processes are capable of consistently meeting your requirements?
24. Are parts, components, subassemblies and products identified throughout production or service delivery?
25. Are monitoring and measurement requirements clearly shown with the status of the product?
26. Where traceability is a requirement, does production keep records of unique product identification?
27. Do you care for and protect customers’ property under your control or being used by your people?
28. Do you look after your product (including the parts or components) during both production and delivery to the customer, by providing suitable identification, packaging, storage, preservation and handling?
29. Do you have instructions needed to identify inspection or monitoring activities to be done during production or service delivery and the devices to be used?
30. Is your measuring equipment:
a. Calibrated or verified at specified intervals, or prior to use?
b. Adjusted or re-adjusted as necessary?
c. Identified to enable the calibration status to be determined?
d. Safeguarded from adjustments that would invalidate the measurement result?
e. Protected from damage and deterioration during handling, maintenance and storage?
31. Does your organization monitor customer information that shows you have satisfied customer requirements?
32. Does your organization conduct internal quality audits at planned intervals?
33. Does your organization use suitable methods to monitor and, where practical, measure the performance of your processes?
34. Does your organization inspect or measure the characteristics of finished products and record the results?
35. Does your organization identify nonconforming products and review them for disposition?
36. Does your organization collect and analyze data to assess the suitability and effectiveness of the QMS?
37. Does your organization use data to evaluate or identify where continual improvement of the QMS can be made?
38. Does your organization continually improve the effectiveness of the QMS?
39. Does your organization take corrective action to eliminate the causes of problems and to prevent their recurrence?
40. Does your organization determine and eliminate potential nonconformities in order to prevent their occurrence?
To score this table:
0 – You do not understand what is required or believe it is necessary
1 – Your organization does not perform this activity
2.- You understand this activity is a good thing to do but do not do it
3 – You do this sometimes
4 – You do this but not very well
5 – You do this quite well.
Add all the points together.
150 – 200
You are almost ready to complete your ISO 9001 QMS and apply for certification/
registration.
100 – 149
You are ready to implement the QMS. This will likely improve your business results.
0 – 99
You have a lot to do but should begin. You could consider seeking help from a
consultant or specialist.
Monday, September 21, 2009
Summaries of changes to ISO 14001
Summaries of changes to ISO 14001
ISO 14001 year 2004 changes are consider having some effect on EMS ISO 14001, the changes require reviewing the EMS and taking action for transition (information is under control of TC 207). Considering the most relevant changes in advancing / transition to ISO 14001 2004 standard includes (an overview for transition / implementation):
Clause 4.1, Scope – requires defining the scope of the EMS (environmental management system) linking to the organizations activities, products, and services (and processes). First consider defining the scope of the EMS within the “boundaries” of products, services, activities, and processes as these relate [for ISO 9001:2000 organizations consider requirement 4.1, and organizations implementing ISO 14001 may be helpful reading ISO 9001:2000 clause 4.1]. The previous indicates an overview on how the EMS fulfills ISO 14001 2004 [some thoughts are internal auditing, management system review providing that these link].
Clause 4.2, Policy – The scope of the EMS and its policy must be consistent. The requirements for the policy remains about the same, now explicitly indicating that must be developed by top management, and other explicit terms in tune with the 1996 version.
Clause 4.3.1, Environmental Aspects Identification – Changes involve in assisting to clarifying statements from 1996 version and the change of the “or” for “and” (within the scope of the EMS); “… products and services…” Control and influence are now mutually exclusive, whilst introducing planned and new developments… new and modified activities… Considering identifying significant aspects must occur from development, implementation, and maintaining the EMS (see 4.1). Information on environmental aspects needs be in documentation format.
To a more assertive statement, “… over which it can be expected to have…” changes to the following “…those which it can influence.”
Clause 4.3.2, Legal and Other Requirements – The wording changes to “legal” in better addressing context to different world regions. Consideration must be given with changes to clause 4.1, for development, implementation, and maintaining the EMS.
Clause 4.3.3 – No significant change.
Clause 4.3.4 – No significant change.
Clause 4.4.1 , Resources, Roles, Responsibility and Authority, please note that this is a new title. This title reflects the importance and relevancy of each term to the EMS. Some minor wording changes include from “…provide…” to “…ensure the availability…” Do not forget that this will require reviewing auditing, planning, and responding to emergencies.
Clause 4.4.2, Competence, Training and Awareness – Whilst using the same
terms in the title notice the change in sequence. This change reflects the expected order of importance of the terms-subjects. Also consider that introduces a new phrase that broadens the individuals within an EMS; “…persons working for, or on behalf of …” Combining these previous two sentences, provides for the organization to include not only relevancy to significant environmental aspects but as well extending to those working for or in behalf of the organization . (Note: also consider that training provider and supporting services are inclusive to 4.4.6).
Clause 4.4.3, Communication – In specifically addressing the European Requirements (EMAR / EMAS), if the organization decides communicating externally the environmental aspects (environmental performance), ISO 14001:2004 address this issue. This is strictly on a volunteer globally, realizing that within the European Union is require.
Clause 4.4.4, Environmental Management System Documentation – in pursuit
of continuing compatibility with ISO 9001:2000 the term applied is “Documentation.”
Thereof, consider this clause also in the light of ISO 9001:2000 when integrating
EMS and QMS. The EMS documentation and records must be those to ascertain
objective evidence on the effectiveness of implementing the policy, planning, and
execution (including improving), control of operations, verification, and control,
improving, and reviewing the EMS.
Clause 4.4.5, Document Control – Again, changing the title and wording reflects
compatibility with ISO 9001:2000. Other than compatibility between QMS ISO
9001:2000 and EMS ISO 14001:2004 there are no significant changes.
4.4.6, Operational Control – No significant change.
4.4.7, Emergency Preparedness and Response – The structure changes by
placing some of its already content in bullets to emphasize each as pointer for the organization to address.
4.5.1, Monitoring and Measurement – Best to see new clause 4.5.2.
4.5.2, Evaluation of Legal Compliance – This is a new clause
[Note: addressing the concern of many government entities / authorities on
their responsibility on environmental and social issues and EMS ISO 14001 1996].
This is construe as the most impacting change to ISO 14001 2004 – this “new” clause brings the last paragraph of 4.5.1 as a separate clause. This clause brings the importance of periodically reviewing legal requirements / compliance under which the organization ascribes. It implies provision of records to demonstrate that this review occurs. This requires that the EMS be review to address the requirements of this “new” clause.
4.5.3, Non Conformance, Corrective and Preventive Action – Includes clarifications ascertaining that prevention (measures or potential of non conformity)and corrective action are two occurring events (which may be mutually inclusive).
Thereof, “action to eliminate the causes of potential non conformities to prevent their occurrence” can lead to changes in your EMS procedures.
4.5.4, Records – States that organizations need records to demonstrate
implementation of procedures and achieving results. These must demonstrate complying with the EMS (procedures and results). Whilst record retention times are not specifically required, record retention needs being specified (consider legal requirements and contractual agreements such that provide a demonstrable sustainable EMS).
4.5.5, Environmental Management System Audit – Whilst there are no wording changes, auditing must be reviewed in the light and effect of other changes (such as 4.5.1, 4.4.2).
4.6, Management Review – The wording provides (more direct) compatibility with ISO 9001:2000, which includes inputs and outputs for reviewing the EMS. Addition includes reviewing for improving the EMS (from target and not merely objectives).
The advent of ISO 14001:2004 shall not require additional training, unless otherwise the organization decides for a short review presentation or an “IMS” (integrated management systems,” integration of management systems such as ILO-OSH, OSH.MS, OSHAS 18001, ISO 9001 and variants with ISO 14001.) It will require reviewing the EMS by management, (perhaps a gap analysis), acting on any changes, inclusive to auditing against ISO 14001:2004 before transition.
ISO 14001 year 2004 changes are consider having some effect on EMS ISO 14001, the changes require reviewing the EMS and taking action for transition (information is under control of TC 207). Considering the most relevant changes in advancing / transition to ISO 14001 2004 standard includes (an overview for transition / implementation):
Clause 4.1, Scope – requires defining the scope of the EMS (environmental management system) linking to the organizations activities, products, and services (and processes). First consider defining the scope of the EMS within the “boundaries” of products, services, activities, and processes as these relate [for ISO 9001:2000 organizations consider requirement 4.1, and organizations implementing ISO 14001 may be helpful reading ISO 9001:2000 clause 4.1]. The previous indicates an overview on how the EMS fulfills ISO 14001 2004 [some thoughts are internal auditing, management system review providing that these link].
Clause 4.2, Policy – The scope of the EMS and its policy must be consistent. The requirements for the policy remains about the same, now explicitly indicating that must be developed by top management, and other explicit terms in tune with the 1996 version.
Clause 4.3.1, Environmental Aspects Identification – Changes involve in assisting to clarifying statements from 1996 version and the change of the “or” for “and” (within the scope of the EMS); “… products and services…” Control and influence are now mutually exclusive, whilst introducing planned and new developments… new and modified activities… Considering identifying significant aspects must occur from development, implementation, and maintaining the EMS (see 4.1). Information on environmental aspects needs be in documentation format.
To a more assertive statement, “… over which it can be expected to have…” changes to the following “…those which it can influence.”
Clause 4.3.2, Legal and Other Requirements – The wording changes to “legal” in better addressing context to different world regions. Consideration must be given with changes to clause 4.1, for development, implementation, and maintaining the EMS.
Clause 4.3.3 – No significant change.
Clause 4.3.4 – No significant change.
Clause 4.4.1 , Resources, Roles, Responsibility and Authority, please note that this is a new title. This title reflects the importance and relevancy of each term to the EMS. Some minor wording changes include from “…provide…” to “…ensure the availability…” Do not forget that this will require reviewing auditing, planning, and responding to emergencies.
Clause 4.4.2, Competence, Training and Awareness – Whilst using the same
terms in the title notice the change in sequence. This change reflects the expected order of importance of the terms-subjects. Also consider that introduces a new phrase that broadens the individuals within an EMS; “…persons working for, or on behalf of …” Combining these previous two sentences, provides for the organization to include not only relevancy to significant environmental aspects but as well extending to those working for or in behalf of the organization . (Note: also consider that training provider and supporting services are inclusive to 4.4.6).
Clause 4.4.3, Communication – In specifically addressing the European Requirements (EMAR / EMAS), if the organization decides communicating externally the environmental aspects (environmental performance), ISO 14001:2004 address this issue. This is strictly on a volunteer globally, realizing that within the European Union is require.
Clause 4.4.4, Environmental Management System Documentation – in pursuit
of continuing compatibility with ISO 9001:2000 the term applied is “Documentation.”
Thereof, consider this clause also in the light of ISO 9001:2000 when integrating
EMS and QMS. The EMS documentation and records must be those to ascertain
objective evidence on the effectiveness of implementing the policy, planning, and
execution (including improving), control of operations, verification, and control,
improving, and reviewing the EMS.
Clause 4.4.5, Document Control – Again, changing the title and wording reflects
compatibility with ISO 9001:2000. Other than compatibility between QMS ISO
9001:2000 and EMS ISO 14001:2004 there are no significant changes.
4.4.6, Operational Control – No significant change.
4.4.7, Emergency Preparedness and Response – The structure changes by
placing some of its already content in bullets to emphasize each as pointer for the organization to address.
4.5.1, Monitoring and Measurement – Best to see new clause 4.5.2.
4.5.2, Evaluation of Legal Compliance – This is a new clause
[Note: addressing the concern of many government entities / authorities on
their responsibility on environmental and social issues and EMS ISO 14001 1996].
This is construe as the most impacting change to ISO 14001 2004 – this “new” clause brings the last paragraph of 4.5.1 as a separate clause. This clause brings the importance of periodically reviewing legal requirements / compliance under which the organization ascribes. It implies provision of records to demonstrate that this review occurs. This requires that the EMS be review to address the requirements of this “new” clause.
4.5.3, Non Conformance, Corrective and Preventive Action – Includes clarifications ascertaining that prevention (measures or potential of non conformity)and corrective action are two occurring events (which may be mutually inclusive).
Thereof, “action to eliminate the causes of potential non conformities to prevent their occurrence” can lead to changes in your EMS procedures.
4.5.4, Records – States that organizations need records to demonstrate
implementation of procedures and achieving results. These must demonstrate complying with the EMS (procedures and results). Whilst record retention times are not specifically required, record retention needs being specified (consider legal requirements and contractual agreements such that provide a demonstrable sustainable EMS).
4.5.5, Environmental Management System Audit – Whilst there are no wording changes, auditing must be reviewed in the light and effect of other changes (such as 4.5.1, 4.4.2).
4.6, Management Review – The wording provides (more direct) compatibility with ISO 9001:2000, which includes inputs and outputs for reviewing the EMS. Addition includes reviewing for improving the EMS (from target and not merely objectives).
The advent of ISO 14001:2004 shall not require additional training, unless otherwise the organization decides for a short review presentation or an “IMS” (integrated management systems,” integration of management systems such as ILO-OSH, OSH.MS, OSHAS 18001, ISO 9001 and variants with ISO 14001.) It will require reviewing the EMS by management, (perhaps a gap analysis), acting on any changes, inclusive to auditing against ISO 14001:2004 before transition.
Monday, September 14, 2009
Five Steps to Implementing ISO 14001:2004
ISO 14001 provides a logical, common-sense approach for
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.
ISO 9001:2008 Requirements – Documentation Requirements
ISO 9001:2008 Requirements – Documentation Requirements
Include in the quality management system documentation:? Documented statements of a quality policy and quality objectives? A quality manual? Documented procedures and records required by ISO 9001? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processesNOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:? Size of the organization and type of activities? Complexity of processes and their interactions? Competence of personnelNOTE 3: The documentation can be in any form or type of medium.4.2.2 Quality ManualEstablish and maintain a quality manual with:? Scope of the quality management system? Details and justification for any exclusions? Procedures or references to the procedures? Description of interaction between processes4.2.3 Control of DocumentsControl the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:? Approve documents for adequacy prior to issue? Review, update as necessary, and re-approve documents? Identify the changes and current document revision status? Make relevant documents available at points of use? Ensure the documents remain legible and readily identifiable? Identify external documents and control their distribution? Prevent obsolete documents from unintended use? Apply suitable identification if obsolete documents are retained4.2.4 Control of RecordsEstablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for record:? Identification? Storage? Protection? Retrieval? Retention? DispositionKeep records legible, readily identifiable, and retrievable.
Include in the quality management system documentation:? Documented statements of a quality policy and quality objectives? A quality manual? Documented procedures and records required by ISO 9001? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processesNOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:? Size of the organization and type of activities? Complexity of processes and their interactions? Competence of personnelNOTE 3: The documentation can be in any form or type of medium.4.2.2 Quality ManualEstablish and maintain a quality manual with:? Scope of the quality management system? Details and justification for any exclusions? Procedures or references to the procedures? Description of interaction between processes4.2.3 Control of DocumentsControl the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:? Approve documents for adequacy prior to issue? Review, update as necessary, and re-approve documents? Identify the changes and current document revision status? Make relevant documents available at points of use? Ensure the documents remain legible and readily identifiable? Identify external documents and control their distribution? Prevent obsolete documents from unintended use? Apply suitable identification if obsolete documents are retained4.2.4 Control of RecordsEstablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for record:? Identification? Storage? Protection? Retrieval? Retention? DispositionKeep records legible, readily identifiable, and retrievable.
ISO 9001:2008 Requirements – Resource Management
ISO 9001:2008 Requirements – Resource Management
6.1 Provision of ResourcesDetermine and provide the resources necessary to:? Implement and maintain the quality management system? Continually improve the effectiveness of the system? Enhance customer satisfaction by meeting customer requirements6.2 Human Resources6.2.1 GeneralEnsure people performing work affecting conformity to product requirements are competent based on the appropriate education, training, skills, and experience.NOTE: Conformity to product requirements can be affected directly, or indirectly, by personnel performing any task within the quality management system.6.2.2 Competence, Training, and AwarenessThe organization must:? Determine the competency needs for personnel? Provide training (or take other actions) to achieve the necessary competence? Evaluate the effectiveness of the actions taken? Inform employees of the relevance and importance of their activities? Ensure they know their contribution to achieving quality objectives? Maintain education, training, skill, and experience records
6.3 InfrastructureDetermine, provide, and maintain the necessary infrastructure to achieve product conformity. Infrastructure includes, as applicable:? Buildings, workspace, and associated utilities? Process equipment (both hardware and software)? Supporting services (such as transport, communication, or information systems)6.4 Work EnvironmentDetermine and manage the work environment needed to achieve product conformity.NOTE: The term “work environment” relates to those conditions under which work is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather.
6.1 Provision of ResourcesDetermine and provide the resources necessary to:? Implement and maintain the quality management system? Continually improve the effectiveness of the system? Enhance customer satisfaction by meeting customer requirements6.2 Human Resources6.2.1 GeneralEnsure people performing work affecting conformity to product requirements are competent based on the appropriate education, training, skills, and experience.NOTE: Conformity to product requirements can be affected directly, or indirectly, by personnel performing any task within the quality management system.6.2.2 Competence, Training, and AwarenessThe organization must:? Determine the competency needs for personnel? Provide training (or take other actions) to achieve the necessary competence? Evaluate the effectiveness of the actions taken? Inform employees of the relevance and importance of their activities? Ensure they know their contribution to achieving quality objectives? Maintain education, training, skill, and experience records
6.3 InfrastructureDetermine, provide, and maintain the necessary infrastructure to achieve product conformity. Infrastructure includes, as applicable:? Buildings, workspace, and associated utilities? Process equipment (both hardware and software)? Supporting services (such as transport, communication, or information systems)6.4 Work EnvironmentDetermine and manage the work environment needed to achieve product conformity.NOTE: The term “work environment” relates to those conditions under which work is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather.
Wednesday, September 9, 2009
Summaries of changes to ISO 14001
Summaries of changes to ISO 14001
ISO 14001 year 2004 changes are consider having some effect on EMS ISO 14001, the changes require reviewing the EMS and taking action for transition (information is under control of TC 207). Considering the most relevant changes in advancing / transition to ISO 14001 2004 standard includes (an overview for transition / implementation):
Clause 4.1, Scope – requires defining the scope of the EMS (environmental management system) linking to the organizations activities, products, and services (and processes). First consider defining the scope of the EMS within the “boundaries” of products, services, activities, and processes as these relate [for ISO 9001:2000 organizations consider requirement 4.1, and organizations implementing ISO 14001 may be helpful reading ISO 9001:2000 clause 4.1]. The previous indicates an overview on how the EMS fulfills ISO 14001 2004 [some thoughts are internal auditing, management system review providing that these link].
Clause 4.2, Policy – The scope of the EMS and its policy must be consistent. The requirements for the policy remains about the same, now explicitly indicating that must be developed by top management, and other explicit terms in tune with the 1996 version.
Clause 4.3.1, Environmental Aspects Identification – Changes involve in assisting to clarifying statements from 1996 version and the change of the “or” for “and” (within the scope of the EMS); “… products and services…” Control and influence are now mutually exclusive, whilst introducing planned and new developments… new and modified activities… Considering identifying significant aspects must occur from development, implementation, and maintaining the EMS (see 4.1). Information on environmental aspects needs be in documentation format.
To a more assertive statement, “… over which it can be expected to have…” changes to the following “…those which it can influence.”
Clause 4.3.2, Legal and Other Requirements – The wording changes to “legal” in better addressing context to different world regions. Consideration must be given with changes to clause 4.1, for development, implementation, and maintaining the EMS.
Clause 4.3.3 – No significant change.
Clause 4.3.4 – No significant change.
Clause 4.4.1 , Resources, Roles, Responsibility and Authority, please note that this is a new title. This title reflects the importance and relevancy of each term to the EMS. Some minor wording changes include from “…provide…” to “…ensure the availability…” Do not forget that this will require reviewing auditing, planning, and responding to emergencies.
Clause 4.4.2, Competence, Training and Awareness – Whilst using the same
terms in the title notice the change in sequence. This change reflects the expected order of importance of the terms-subjects. Also consider that introduces a new phrase that broadens the individuals within an EMS; “…persons working for, or on behalf of …” Combining these previous two sentences, provides for the organization to include not only relevancy to significant environmental aspects but as well extending to those working for or in behalf of the organization . (Note: also consider that training provider and supporting services are inclusive to 4.4.6).
Clause 4.4.3, Communication – In specifically addressing the European Requirements (EMAR / EMAS), if the organization decides communicating externally the environmental aspects (environmental performance), ISO 14001:2004 address this issue. This is strictly on a volunteer globally, realizing that within the European Union is require.
Clause 4.4.4, Environmental Management System Documentation – in pursuit
of continuing compatibility with ISO 9001:2000 the term applied is “Documentation.”
Thereof, consider this clause also in the light of ISO 9001:2000 when integrating
EMS and QMS. The EMS documentation and records must be those to ascertain
objective evidence on the effectiveness of implementing the policy, planning, and
execution (including improving), control of operations, verification, and control,
improving, and reviewing the EMS.
Clause 4.4.5, Document Control – Again, changing the title and wording reflects
compatibility with ISO 9001:2000. Other than compatibility between QMS ISO
9001:2000 and EMS ISO 14001:2004 there are no significant changes.
4.4.6, Operational Control – No significant change.
4.4.7, Emergency Preparedness and Response – The structure changes by
placing some of its already content in bullets to emphasize each as pointer for the organization to address.
4.5.1, Monitoring and Measurement – Best to see new clause 4.5.2.
4.5.2, Evaluation of Legal Compliance – This is a new clause
[Note: addressing the concern of many government entities / authorities on
their responsibility on environmental and social issues and EMS ISO 14001 1996].
This is construe as the most impacting change to ISO 14001 2004 – this “new” clause brings the last paragraph of 4.5.1 as a separate clause. This clause brings the importance of periodically reviewing legal requirements / compliance under which the organization ascribes. It implies provision of records to demonstrate that this review occurs. This requires that the EMS be review to address the requirements of this “new” clause.
4.5.3, Non Conformance, Corrective and Preventive Action – Includes clarifications ascertaining that prevention (measures or potential of non conformity)and corrective action are two occurring events (which may be mutually inclusive).
Thereof, “action to eliminate the causes of potential non conformities to prevent their occurrence” can lead to changes in your EMS procedures.
4.5.4, Records – States that organizations need records to demonstrate
implementation of procedures and achieving results. These must demonstrate complying with the EMS (procedures and results). Whilst record retention times are not specifically required, record retention needs being specified (consider legal requirements and contractual agreements such that provide a demonstrable sustainable EMS).
4.5.5, Environmental Management System Audit – Whilst there are no wording changes, auditing must be reviewed in the light and effect of other changes (such as 4.5.1, 4.4.2).
4.6, Management Review – The wording provides (more direct) compatibility with ISO 9001:2000, which includes inputs and outputs for reviewing the EMS. Addition includes reviewing for improving the EMS (from target and not merely objectives).
The advent of ISO 14001:2004 shall not require additional training, unless otherwise the organization decides for a short review presentation or an “IMS” (integrated management systems,” integration of management systems such as ILO-OSH, OSH.MS, OSHAS 18001, ISO 9001 and variants with ISO 14001.) It will require reviewing the EMS by management, (perhaps a gap analysis), acting on any changes, inclusive to auditing against ISO 14001:2004 before transition.
ISO 14001 year 2004 changes are consider having some effect on EMS ISO 14001, the changes require reviewing the EMS and taking action for transition (information is under control of TC 207). Considering the most relevant changes in advancing / transition to ISO 14001 2004 standard includes (an overview for transition / implementation):
Clause 4.1, Scope – requires defining the scope of the EMS (environmental management system) linking to the organizations activities, products, and services (and processes). First consider defining the scope of the EMS within the “boundaries” of products, services, activities, and processes as these relate [for ISO 9001:2000 organizations consider requirement 4.1, and organizations implementing ISO 14001 may be helpful reading ISO 9001:2000 clause 4.1]. The previous indicates an overview on how the EMS fulfills ISO 14001 2004 [some thoughts are internal auditing, management system review providing that these link].
Clause 4.2, Policy – The scope of the EMS and its policy must be consistent. The requirements for the policy remains about the same, now explicitly indicating that must be developed by top management, and other explicit terms in tune with the 1996 version.
Clause 4.3.1, Environmental Aspects Identification – Changes involve in assisting to clarifying statements from 1996 version and the change of the “or” for “and” (within the scope of the EMS); “… products and services…” Control and influence are now mutually exclusive, whilst introducing planned and new developments… new and modified activities… Considering identifying significant aspects must occur from development, implementation, and maintaining the EMS (see 4.1). Information on environmental aspects needs be in documentation format.
To a more assertive statement, “… over which it can be expected to have…” changes to the following “…those which it can influence.”
Clause 4.3.2, Legal and Other Requirements – The wording changes to “legal” in better addressing context to different world regions. Consideration must be given with changes to clause 4.1, for development, implementation, and maintaining the EMS.
Clause 4.3.3 – No significant change.
Clause 4.3.4 – No significant change.
Clause 4.4.1 , Resources, Roles, Responsibility and Authority, please note that this is a new title. This title reflects the importance and relevancy of each term to the EMS. Some minor wording changes include from “…provide…” to “…ensure the availability…” Do not forget that this will require reviewing auditing, planning, and responding to emergencies.
Clause 4.4.2, Competence, Training and Awareness – Whilst using the same
terms in the title notice the change in sequence. This change reflects the expected order of importance of the terms-subjects. Also consider that introduces a new phrase that broadens the individuals within an EMS; “…persons working for, or on behalf of …” Combining these previous two sentences, provides for the organization to include not only relevancy to significant environmental aspects but as well extending to those working for or in behalf of the organization . (Note: also consider that training provider and supporting services are inclusive to 4.4.6).
Clause 4.4.3, Communication – In specifically addressing the European Requirements (EMAR / EMAS), if the organization decides communicating externally the environmental aspects (environmental performance), ISO 14001:2004 address this issue. This is strictly on a volunteer globally, realizing that within the European Union is require.
Clause 4.4.4, Environmental Management System Documentation – in pursuit
of continuing compatibility with ISO 9001:2000 the term applied is “Documentation.”
Thereof, consider this clause also in the light of ISO 9001:2000 when integrating
EMS and QMS. The EMS documentation and records must be those to ascertain
objective evidence on the effectiveness of implementing the policy, planning, and
execution (including improving), control of operations, verification, and control,
improving, and reviewing the EMS.
Clause 4.4.5, Document Control – Again, changing the title and wording reflects
compatibility with ISO 9001:2000. Other than compatibility between QMS ISO
9001:2000 and EMS ISO 14001:2004 there are no significant changes.
4.4.6, Operational Control – No significant change.
4.4.7, Emergency Preparedness and Response – The structure changes by
placing some of its already content in bullets to emphasize each as pointer for the organization to address.
4.5.1, Monitoring and Measurement – Best to see new clause 4.5.2.
4.5.2, Evaluation of Legal Compliance – This is a new clause
[Note: addressing the concern of many government entities / authorities on
their responsibility on environmental and social issues and EMS ISO 14001 1996].
This is construe as the most impacting change to ISO 14001 2004 – this “new” clause brings the last paragraph of 4.5.1 as a separate clause. This clause brings the importance of periodically reviewing legal requirements / compliance under which the organization ascribes. It implies provision of records to demonstrate that this review occurs. This requires that the EMS be review to address the requirements of this “new” clause.
4.5.3, Non Conformance, Corrective and Preventive Action – Includes clarifications ascertaining that prevention (measures or potential of non conformity)and corrective action are two occurring events (which may be mutually inclusive).
Thereof, “action to eliminate the causes of potential non conformities to prevent their occurrence” can lead to changes in your EMS procedures.
4.5.4, Records – States that organizations need records to demonstrate
implementation of procedures and achieving results. These must demonstrate complying with the EMS (procedures and results). Whilst record retention times are not specifically required, record retention needs being specified (consider legal requirements and contractual agreements such that provide a demonstrable sustainable EMS).
4.5.5, Environmental Management System Audit – Whilst there are no wording changes, auditing must be reviewed in the light and effect of other changes (such as 4.5.1, 4.4.2).
4.6, Management Review – The wording provides (more direct) compatibility with ISO 9001:2000, which includes inputs and outputs for reviewing the EMS. Addition includes reviewing for improving the EMS (from target and not merely objectives).
The advent of ISO 14001:2004 shall not require additional training, unless otherwise the organization decides for a short review presentation or an “IMS” (integrated management systems,” integration of management systems such as ILO-OSH, OSH.MS, OSHAS 18001, ISO 9001 and variants with ISO 14001.) It will require reviewing the EMS by management, (perhaps a gap analysis), acting on any changes, inclusive to auditing against ISO 14001:2004 before transition.
Wednesday, September 2, 2009
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