ISO 9001:2000 and ISO 14001:1996
Requirement / Checks / Evidence – RecordsISO 9001:2000 Requirements
4.1 General requirements
Review of Mark use:.. Brochures, posters, advertisements, business cards.
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
Detailed work instructions defining criteria for workmanship, operational sequence, timeliness and responsibility.
Organizational charts, Process Flow Charts
Process job routers, Process monitoring instructions/records.
Internal Audit summaries with effective follow-up and trend analysis.
Process monitoring devices: i.e. C.P.K. analysis improvement matrix, Scrap monitoring improvement results, audits.
Internal waste elimination teams.
Systemic continuous improvement projects related to strategic company business indicators.
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
ISO 14001 – 4.1 General Requirements
Requirement / Checks / Document or EvidenceThe organization shall establish and maintain an environmental management system.
ISO 9001:2000 Requirements
4.2 General
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
4.2 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
e) records required by this International Standard (see 4.2.4). / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
Quality Policy
Quality Objectives
Internal Audit summaries with effective follow-up and trend analysis.
Process monitoring devices: i.e. C.P.K. analysis improvement matrix, scrap monitoring and improvement team results; audits.
Systemic continuous improvement projects related to strategic company business indicators.
Note 1: Where the tem “documented procedure” appears within this International Standard, this requires the procedure to be established, documented, implemented and maintained.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system. / Service/production scope and justifications for normal scope exclusions.
Responsibility Matrix
See 1.2
See 5.5.6
Note: The quality manual may be part of the overall documentation of the organization.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. / Drawing list with revision levels.
Procedure/compliance for control of internal, external pertinent issue of appropriate documents.
All appropriate documents show evidence of review and approval:
Control plans, work instructions…etc: living documents and are updated as improvements happen.
See 5.5.7
ISO 14001 - 4.4.4 Environmental Management System Documentation
Requirement / Document or EvidenceThe organization shall establish and maintain information, in paper or electronic form, to / Note: Also, see 4.4.6 Operational Control
a) describe the core elements of the management system and their interaction;
b) provide direction to related documentation.
ISO 14001 - 4.4.5 Document Control
Requirement / Document or EvidenceThe organization shall establish and maintain procedures for controlling all documents required by this International Standard to ensure that
a) they can be located;
b) they are periodically reviewed, revised as necessary and approved for adequacy by authorized personnel;
c) the current versions of relevant documents are available at all locations where operations essential to the effective functioning of the environmental management system are performed;
d) obsolete documents are promptly removed from all points of issue and points of use, or otherwise assured against unintended use;
e) any obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified.
Documentation shall be legible, dated (with dates or revision) and readily identifiable, maintained in an orderly manner and retained for a specified period.
Procedures and responsibilities shall be established and maintained concerning the creation and modification of the various types of document.
ISO 9001:2000 Con't
4.2.4 Control of quality recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. / Are quality inspection forms (i.e. audit forms, p-charts, spc, charts…etc..) dated and initialed and is the form controlled as per revision status.
Do quality records provide for documentation of non-standard procedures to sustain effective conformance to state objectives. (i.e. reaction plan notes, tracking of unstable processes…etc..)
Do quality records provide acceptance criteria and evidence of inspection status.
ISO 14001 - 4.5.3 Records
Requirement / Document or EvidenceThe organization shall establish and maintain procedures for the identification, maintenance and disposition of environmental records.
These records shall include training records and the results of audits and reviews.
Environmental records shall be legible, identifiable and traceable to the activity, product or service involved.
Environmental records shall be stored and maintained in such a way that they are readily retrievable and protected against damage, deterioration or loss.
Their retention times shall be established and recorded.
Records shall be maintained, as appropriate to the system and to the organization, to demonstrate conformance to the requirements of this International Standard.
ISO 9001:2000 Requirements
5.1 Management commitment
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources. / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
Evidence of company meetings describing importance to meet customer requirements and describing actual performance.
Ratings posted, departmental ownership
Clear customer focus throughout all levels of the organization.
Orientation of new employees
Posted objectives in relationship to actual performance
Management Review Records
Org. Charts filled?
ISO 14001 - 4.4.1 Structure and Responsibility
Requirement / Document or EvidenceRoles, responsibility and authorities shall be defined, documented and communicated in order to facilitate effective environmental management.
Management shall provide resources essential to the implementation and control of the environmental management system. Resources included human resources and specialized skills, technology and financial resources.
The organization’s top management shall appoint (a) specific management representative(s) who, irrespective of other responsibilities, shall have defined roles, responsibilities and authority for
a) ensuring that environmental management system requirements are established, implemented and maintained in accordance with this International Standard;
b) reporting on the performance of the environmental management system to top management for review and as a basis for improvement of the environmental management system.
ISO 9001:2000 Requirements
5.2 Customer focus
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
Customer goals communicated throughout organization via:
Company meetings describing importance to meet customer requirements, describing actual performance and appropriate corrective actions.
Ratings posted.
Departmental ownership of customer related indexes and associated actions.
(see 7.2.1) – Quality and Delivery Ratings from customer or methods to determine if not provided by customer.
(see 8.2.1) – Statutory and/or regulatory requirements
ISO 9001:2000 Requirements
5.3 Quality policy
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability. / OBJECTIVE EVIDENCE: Check( ) verified evidence and/or take notes
Policy to address customer performance requirements.
Policy to address criteria for success and reaction plan to negative trends.
Cost, Quality, Service, Continuous improvement and Delivery…etc..
Orientation, new hires
Posted
See 5.5.6
How is it reviewed? Part of Management Review?
ISO 14001 - 4.2 Environmental Policy
Requirement / Document or EvidenceTop Management shall define the organization’s environmental policy and ensure that it:
a) is appropriate to the nature, scale and environmental impacts of its activities, products or services;
b) includes a commitment to continual improvement and prevention of pollution;
c) includes a commitment to comply with relevant environmental legislation and regulations, and with other requirements to which the organization subscribes;
d) provides the framework for setting and reviewing environmental objectives and targets;
e) is documented, implemented and maintained and communicated to all employees;
f) is available to the public.
ISO 9001:2000 Requirements
5.4 Planning
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
5.4.1 Quality Objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes:
Departmental goals and measurements consistent with organizational goals.
Records to show relevance of departmental goals and actions taken by
individual departments to internalize and improve on specific targets.
Evidence of continuous improvement of the measurables
See 7.1 a
ISO 14001 – 4.3.3 Objectives and Targets
Requirement / Document or EvidenceThe organization shall establish and maintain documented environmental objectives and targets, at each relevant function and level within the organization.
When establishing and reviewing its objectives, an organization shall consider the legal and other requirements, its significant environmental aspects, its technological options and its financial, operational and business requirements, and the views of interested parties.
The objectives and targets shall be consistent with the environmental policy, including the commitment to prevention of pollution.
ISO 9001:2000 Con’t
5.4.2 Quality management system planningTop management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. / Quality planning procedure defining link between goals and action (reference section 7.1).
Work instructions to detail interdepartmental actions in the planning process.
Organizational Chart, with appropriate number of positions filled.
Qualifications for management, production work orders, Quality control internal auditors, lab techs.
Have all the requirements in 4.1 been addressed?
ISO 14001 – 4.3.4 Environmental Management Program(s)
Requirement / Document or EvidenceThe organization shall establish and maintain (a) program (s) for achieving its objectives and targets. It shall include:
a) designation of responsibility for achieving objectives and targets at each relevant function and level of the organization;
b) the means and time-frame by which they are to be achieved.
If a project relates to new developments and new or modified activities, products or services, program(s) shall be amended where relevant to ensure that environmental management applies to such projects.
ISO 9001:2000 Requirement
5.5 Responsibility, authority and communication
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the
organization. / Company independent and dependant documentation to support and ensure effective operation and control of it’s processes.
Organizational Chart?
Addressed in Job Descriptions?
5.5.2 Management representative
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the organization. / Review organizational chart, procedure, job description.
Management Representative to be direct report to top management with authority for entire system.
Awareness training of customer expectations, performance and countermeasures.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. / Methods for communicating information relative to the effectiveness of the quality system.
ISO 14001 – 4.4.3 Communication
Requirement / Document or EvidenceWith regard to its environmental aspects and environmental management system, the organization shall establish and maintain procedures for:
a) internal communication between the various levels and functions of the organization;
b) receiving, documenting and responding to relevant communication from external interested parties.
The organization shall consider processes for external communication on its significant environmental aspects and record its decision.
ISO 9001:2000 Requirements
5.6 Management review
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
a)Management review must cover:
b)Evaluation of internal/external audit
c)Evaluation of customer satisfaction/dissatisfaction (complaints, reports)
d)C.P.K. analysis, scrap reporting, audit/containment results…etc.
e)Relevance and status of corrective/preventive actions in relationship to quality policy.
Review record of the last management review for the following:
a)Action plans for negative trends
b)Relationship between policy and objectives with results.
c)Quality cost considerations vs. containment/process control need
d)Organizational performance in regards to bottle necks and work performance.(personnel considerations)
5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
5.6.3 Review Output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs. / See 5.6.1 and 4.2.4
ISO 14001 - 4.6 Management Review
Requirement / Document or EvidenceThe organization’s top management shall, at intervals that it determines, review the environmental management system, to ensure its continuing suitability, adequacy and effectiveness.
The management review process shall ensure that the necessary information is collected to allow management to carry out this evaluation.
This review shall be documented.
The management review shall address the possible need for changes to policy, objectives and other elements of the environmental management system, in the light of environmental management system audit results, changing circumstances and the commitment to continual improvement.
ISO 9001:2000 Requirements
6. Resource Management
[ X ] NO NONCONFORMANCES FOUND[ ] NONCONFORMANCES FOUND
6.1 Provision of resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements. / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
Quality performance data vs. Quality Costs:
trends should be improving or effective corrective actions should be in place
Prioritize action plans tied to key internal objectives
6.2 Human resources
6.2.1 Competence, awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4). / OBJECTIVE EVIDENCE: Check ( )verified evidence and/or take notes
Key personnel education, experience and knowledge requirements (job description) in comparison to respective resumes.
Where qualifications are not met, review documented training prior to assignment.
6.2.2 Competence, awareness and training
The organization shall:
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4). / Training plans for all employees affecting quality and carried out to an appropriate degree relative to the industry, safety requirements and high risk production techniques?
Performance testing, job training effectiveness evaluations, review of internal audit summaries,
See 5.5.7
See 4.2.4
ISO 14001 - 4.4.2 Training, Awareness and Competence