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ISO 9001:2015
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 1 OF 21
8.5.5 Post-delivery activities ..................................................................................................................................... 12
8.5.6 Control of Changes........................................................................................................................................... 12
8.6 Release of products and services ........................................................................................................................13
8.7 Control of nonconforming outputs ....................................................................................................................13
8.7.1 ...............................................................................................................................................................................13
8.7.2 ..............................................................................................................................................................................13
9 Performance evaluation ......................................................................................................................................... 14
9.1 Monitoring, measurement, analysis and evaluation ........................................................................................ 14
9.1.1 General ................................................................................................................................................................ 14
9.1.2 Customer satisfaction ....................................................................................................................................... 14
9.1.3 Analysis and evaluation .................................................................................................................................... 14
9.2 Internal audits...................................................................................................................................................... 14
9.3 Management review ............................................................................................................................................ 15
9.3.1 General ............................................................................................................................................................... 15
9.3.2 Management review inputs ............................................................................................................................. 15
9.3.3 Management review outputs ........................................................................................................................... 15
10 Improvement ......................................................................................................................................................... 15
10.1 General ................................................................................................................................................................. 15
10.2 Nonconformity and corrective action .............................................................................................................. 16
10.2.1 ............................................................................................................................................................................ 16
10.2.2 ............................................................................................................................................................................ 16
10.3 Continual improvement .................................................................................................................................... 16
Addendum A Customer RFQ – Order Entry Process............................................................................................. 17
Addendum B Purchasing – Vendor Approval Process ........................................................................................... 18
Addendum C Process Realization ............................................................................................................................ 21
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 2 OF 21
4 Context of the Organization
4.1 Understanding the organization and its context
Company
Metallurgical Solutions Incorporated (MSI) is a leading heat treater of high-speed, low alloy, and tool steels in bulk or
machined form. We have been working in Rhode Island since 1989 under the guidance of two families. It is the last
commercial molten-salt heat treater in New England. We also have performed Ferritic Nitro-carburizing (FNC) surface
finishing since 2009.
Industry
The heat treating industry has been with us as long as metal working has. MSI came about in response to a decline in the
practice of salt-bath heat treatment of tool steel. Salt-bath heat treatment is significantly more forgiving (consistent
temperature and rapid heat transfer yield a finer grain size) a process and the preferred method for consistent quality results.
Customers
MSI has a variety of customers, both large and small, that use our services for cutting and tool manufacturers. The business is
broken up with approximately 38% military/defense, 20% OEM Manufacturers, 28% Tool & Die, 10% Food Processing, and 2%
Mining & Processing, and 2% Paper Products.
Competition
There are no competitors of MSI for salt-bath heat treatment within New England. Outside of that area there are some
competitors but proximity to customers prevents them from actively working in the New England area.
Context
MSI has identified its issues (internal - strengths & weaknesses and external - opportunities & threats) that may affect its
business. They are listed in the ‘Risk Management Plan’.
Top management reviews any potential or actual changes in the issues during the ‘Management Review’.
4.2 Understanding the needs and expectations of interested parties
MSI has identified the parties interested in the business and determined their requirements which are relevant to the MSI
Quality Management System (QMS).
Top management reviews any potential or actual changes in interested parties and/or their requirements during the
‘Management Review’.
INTERESTED PARTY REQUIREMENTS
• Consistent quality based on their requirements
• 100% on-time Deliveries
Customers
• Costs per the Quote/Purchase Order
• Good lines of communication on status of the job
• Company continues to grow in value and size
• Growth in market share and markets
Owners
• Everyone promote a good work environment
• Employees pursue competency in their jobs
• Knowledge of what is expected of them
• Clear quality requirements on a job-to-job basis
Employees
• Steady employment
• Safe and comfortable work environment
• Clearly stated requirements
• Sufficient lead times
Vendors
• Competitive pricing vs other similar vendors or industry standard
• Clearly stated feedback in the event of a nonconformance
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 3 OF 21
4.3 Determining the scope of the QMS
The scope of the QMS of Metallurgical Solutions, Inc., located at 85 Aldrich St., Providence, Rhode Island, 02905, is associated
with commercial heat treating and surface conditioning ferrous and non-ferrous metals.
The QMS ‘Quality Manual’ addresses all the required clauses of the ISO 9001:2015 International QMS Standard except 8.3 –
‘Design and Development of Products and Services’ (because MSI only provides services for products that Customers have
designed & developed) and 8.5.5 ‘Post-Delivery Activities’ (because MSI provides no post-delivery warrantees, training, etc.).
Documented procedures and records are identified on the ‘Master Document Matrix’.
The ‘Metallurgical Solutions Organization & Quality Management System’ flow chart provides the description of the
interaction between QMS processes.
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 4 OF 21
4.4.2
MSI maintains information to support the operation of its processes and retain documented information to have confidence
that the processes are being carried out as planned.
5 Leadership
5.1 Leadership and commitment
5.1.1 General
Top management demonstrates leadership and commitment by accepting accountability for the effectiveness of the MSI QMS.
They have established the ‘Quality Policy’ and ‘Quality Objectives’ for the QMS that are compatible with the context and
strategic direction of MSI.
Top management has integrated QMS requirements into the business processes and promotes the use of the process approach
and risk-based thinking.
One function of the ‘Management Review’ is to ensure that the resources needed for the QMS are available.
The ‘Quality Policy’ and ‘Quality Objectives’ are compatible with the context and strategic direction of MSI and its QMS
requirements are integrated into their business processes.
MSI provides ‘Introduction to ISO 9001:2015’ training that promotes the use of the process approach and risk-based thinking.
It also communicates the importance of effective quality management, conformance to the QMS requirements, and continual
improvement.
Top management ensures that the QMS achieves its intended results by engaging, directing and supporting persons to
contribute to the effectiveness of the QMS. They call for support by other relevant management roles to demonstrate their
leadership as it applies to their area of responsibility in the ‘Roles, Responsibilities, and Authorities Matrix’.
5.2 Policy
5.2.1 Establishing the quality policy
“The policy of Metallurgical Solutions Incorporated, is to provide a service consistent with customer requirements. MSI
recognizes that in order to meet customer requirements, implementation and maintenance of a Quality Assurance System is
crucial. It is the policy of MSI to demonstrate total dedication to the attainment of 100% quality in the services provided to its
Customers and continual improvement of its Quality Management System.”
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 5 OF 21
5.3 Organizational roles, responsibilities and authorities
Top management, consisting of the President, Vice President, General Manager, Facilities Engineer, and Office Manager has
defined and communicated responsibilities and authorities within MSI.
Key positions within MSI, that are responsible for ensuring the QMS is consistently applied to all service realization activities
are included, along with their responsibilities and authorities, in the ‘Roles, Responsibilities and Authorities Matrix’, ‘Quality
Policy’, ‘Job Descriptions’, and other Work Instructions.
These responsibilities include ensuring the MSI QMS conforms to requirements of the ISO 9001:2015 International QMS
Standard, ensuring processes are delivering their intended outputs, reporting on the performance of the QMS and on
opportunities for improvement to top management, ensuring the promotion of customer focus throughout MSI, and
maintaining the integrity of the QMS when planning and implementing changes to it.
6. Planning
6.1 Actions to address risks and opportunities
6.1.1
When top management plans for the QMS, they consider the issues referred to in 4.1 and the requirements referred to in 4.2 as
well as determine the risks and opportunities that need to be addressed by using any one of a variety of Risk Management
tools, including but not limited to: SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis or Force Field analysis
as appropriate to the level of application. The use of these tools by top management and the employees at MSI ensures that
the QMS can achieve its intended results, enhance desirable effects, prevent or reduce undesired effects, and achieve
improvement of the QMS.
6.1.2
Top management plans actions to address these risks and opportunities. The plans are identified in the ‘Risk Management
Plan’ and include how to integrate and implement the actions into the QMS processes.
Effectiveness of the actions taken are evaluated after completion and at the ‘Management Review’ (in relationship to
nonconformance’s, complaints, and other failures).
Actions taken to address risk and opportunities are proportionate to the potential impact on the conformity of services.
6.2.2
When planning to achieve the ‘Quality Objectives’, top management maintains a ‘Quality Objective Support Matrix’ to
document what actions are being done, what resources are required to do them, who is responsible for their accomplishment,
the actions’ due dates, and how to evaluate the results.
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 6 OF 21
6.3 Planning of changes
The MSI QMS ‘Quality Manual’ serves as the ‘Quality Plan’.
Changes to the QMS are planned and the implementation reviewed during the ‘Management Review’. Appropriate elements
of the ‘Quality Manual’ are reviewed and revised if major changes are made to the ‘Quality Plan’.
During the ‘Management Review’, top management considers the purpose of the changes and their potential consequences,
the integrity of the QMS, the availability of resources, and the allocation or reallocation of responsibilities and authorities.
7 Support
7.1 Resources
7.1.1 General
Top management determines and provides the resources (people, equipment, facilities, etc.) needed for the establishment,
implementation, maintenance, and continual improvement of the QMS during the ‘Management Review’.
They consider the capabilities of and constraints on existing internal resources and identify what needs to be obtained from
external providers (consumables, utilities, calibration) when performing customer requirement reviews.
7.1.2 People
Top management determines and provides the personnel needed for the effective implementation of its QMS during strategic
business planning sessions and the ‘Management Review’.
Personnel needed for the operation and control of its processes are also identified during ‘Customer Requirement Reviews’.
Effective use of recruiting and training services provide those resources.
7.1.3 Infrastructure
MSI leadership determines, provides and maintains the infrastructure necessary for the operation of its processes and to
achieve conformity of its services.
They maintain a 14,000 square foot facility located at 85 Aldrich St., Providence, Rhode Island, 02905 for the receipt, heat
treatment, inspection, storage, and shipment of customers’ ferrous and non-ferrous metal. There is a 2,700 sq. ft. office located
at 94 Aldrich St.
Equipment used for these services include fluidized beds, carburizing, vacuum, and atmospheric furnaces, salt-baths,
induction heating equipment, test equipment (hardness, salt titration, etc.), surface finishing and cleaning stations.
Documents are managed on a computer using Word and Excel. Cooltreat software is used for process documents such
(Process Sheets, Shipping Labels, etc.) and Quickbooks is used for order and billing management.
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 7 OF 21
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by MSI to be an essential part of providing confidence in
the validity of measurement results, measuring equipment is calibrated at specified intervals against measurement standards
traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration
or verification is recorded.
MSI measuring equipment is logged in the ‘Measuring and Monitoring Equipment Matrix’ and a sticker is affixed to a piece of
measurement equipment shows its calibration status.
All equipment is safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and
subsequent measurement results.
Part of the MSI calibration and nonconformance system calls for validation of previous measurement results that may have
been adversely affected when measuring equipment is found to be unfit for its intended purpose, and take appropriate action
as necessary.
7.2 Competence
MSI has determined the necessary competence of employees and sub-contractors working under its control that affects the
performance and effectiveness of the QMS. MSI ensures that they are all competent because of their appropriate education,
training, or experience. These contributing elements of competency are initially documented in the ‘Qualifications Required
for Employment by Roles Matrix’.
If new competencies are required, MSI, where applicable, takes actions to acquire the necessary competence, and evaluates the
effectiveness of the actions taken.
MSI retains an ‘Employee Training Matrix’ to be updated when competency requirements change and/or training, education,
or experience is acquired.
7.3 Awareness
MSI provides training and periodic reviews to ensure employees are aware of the ‘Quality Policy’, relevant ‘Quality Objectives’,
and their contribution to the effectiveness of the QMS, including the benefits of improved performance and the implications
of not conforming to the QMS requirements.
This information is retained in the ‘Master Communication Plan’.
MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 8 OF 21
7.4 Communication
MSI has determined the internal and external communications relevant to the QMS, including on what it communicates,
when to communicate, with whom to communicate, how to communicate, and who communicates.
This information is maintained in the ‘Master Communication Plan’.
7.5.3.2
MSI maintains a ‘Master Document Matrix’ for the control of documented information for the management of change control
(version control) through the ‘date-of-revision’ of the documents maintained on the list.
Documented information of external origin determined by MSI to be necessary for the planning and operation of the QMS is
identified on the ‘Master Document Matrix’ and controlled, as appropriate.
The ‘Master Document Matrix’ addresses the storage and preservation, retention and disposition of records maintained as
required by the QMS.
All documents retained as evidence of conformity to the QMS are protected in the Main Office or on the ISO Drive to allow
review but prevent unintended alterations.
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8 Operation
8.1 Operational planning and control
MSI plans, implements and controls the processes (see 4.4, Figure 1) needed to meet the requirements for the provision of
services and to implement the actions determined in Clause 6 (Actions to address risks and opportunities).
In determining the requirements for its services, MSI creates a ‘Process Sheet’ for each new job which includes customer
requirements and drawings, if necessary.
Criteria for processes and the acceptance of services are defined in the drawings, specifications or ‘Process Sheet’.
The quote documents and the supporting documentation are maintained and retained in the ‘Customer File’ to provide
evidence that processes have been carried out as planned and to demonstrate the conformity of services to their requirements.
MSI performs a customer requirement review to outline and describe the process and to control planned changes and review
the consequences of unintended changes, and taking action to mitigate any adverse effects, as necessary.
Outsourced processes are controlled, as necessary (see ‘MSI - Purchasing - Vendor Approval Process’ flow chart).
8.2.3.2
MSI retains documented information or records in the ‘Quote File’ on the results of the reviews and on any new requirements
identified or requested by the customer for services to be provided.
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8.4 Control of externally provided processes, products, and services
8.4.1 General
MSI ensures externally provided services conform to requirements (see ‘MSI - Purchasing – Vendor Approval Process’ flow
chart).
MSI has determined the controls to be applied to Vendors providing consumable material and additional services.
Top management has determined and applies the criteria of 1. Availability, 2. Price, 3. Quality, 4. Service for the evaluation,
selection, monitoring of performance, and re-evaluation of vendors.
MSI purchases consumable material and additional services only from ‘Approved Vendors’ in Quickbooks. Products and
vendors are reviewed for quality, price, availability and performance. Vendors and the consumables or services approved are
entered into Quickbooks.
MSI retains documented information of these activities and any necessary actions arising from the evaluations in the PO’s for
purchases from new vendors, in the ‘Approved Vendor List’, and in the ‘Management Review Minutes’.
Vendors that do not meet specifications delineated within their purchasing requirements may be considered for removal from
the ‘Approved Vendor List’ depending on the frequency or impact of the defect. Purchasing may take that action and review it
at the ‘Management Review’.
The Grandfathered Vendor Clause (good historical performance) is in effect as of 10/25/16.
8.5.4 Preservation
MSI uses adequate methods of handling, storage, and packaging of materials and product to insure conformance to
specifications.
All components and product are protected from loss, deterioration, or contamination throughout the heat treatment process.
All components and product are protected from loss or damage while in storage at MSI.
All material is positively identified while in storage with a ‘Product Tag’ or ‘Hardness Tag’, and ‘Process Sheet’. All finished
product is packaged using materials meeting commercial or customer requirements (as necessary) while providing adequate
protection against cosmetic and environmental damage.
Delivery of material and finished product is done using the MSI truck or standard common carriers except where specified by
customer requirements.
Any material or finished product requiring special handling, storage, packaging, or delivery, is performed in accordance with
specified contractual agreements.
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8.6 Release of products and services
MSI implements planned arrangements, at appropriate stages to verify that the service requirements have been met.
When consumable materials or customers’ parts are received in, the Receiver checks materials as received for identity/count
against the Bill of Lading and for damage. If damaged material is received it is documented with a ‘Nonconformance Report’
and the customer is notified.
The General Manager verifies damaged materials. The ‘Nonconformance Report’ is used to track vendor deficiencies.
Operators perform in-process checks during applicable process steps and results are recorded in the ‘Process Sheet’.
A Final inspection is performed before final release and documented in the ‘Process Sheet’.
The release to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless
otherwise approved by the Vice President and, as applicable, by the customer.
MSI retains documented information on the release in the Main Office files, including evidence of conformity with acceptance
criteria and traceability to the person(s) authorizing the release.
8.7.2
Records of the nature of nonconformities identified during the manufacturing process are maintained in the ‘Nonconformance
Folder’.
Records of the nature of nonconformities identified after delivery, and any subsequent actions taken, including concessions
obtained, are maintained in the ‘Nonconformance Folder’.
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9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
MSI has determined what needs to be monitored and measured, the methods for monitoring and measurement, analysis and
evaluation needed to ensure valid results, and when the monitoring and measuring is performed.
The ‘Monitoring and Measurement Matrix’ serves as the plan for the implementation of the monitoring, measurement,
analysis, and improvement processes needed to demonstrate conformity of the service.
Internal audits are performed to ensure conformity of the QMS.
The results from monitoring and measurement of incoming materials or components and in-process or final service are
analyzed and evaluated before appropriate action (acceptance, rejection, ‘Nonconformance Report’ or ‘Corrective Action
Request’) is taken.
Top management evaluates the performance and the effectiveness of the QMS during ‘Management Reviews’ and the results
are noted in the ‘Management Review Checklist and Minutes’.
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9.2.2
The internal quality audit is used as a tool in determining the effectiveness of the QMS and adherence to work procedures.
Audits are conducted against the requirements of the ISO 9001:2015 International Standard and company procedures and
work instructions.
Internal Quality Audits are conducted by the Internal Quality Auditors or Authorized Contract Personnel to ensure objectivity
and the impartiality of the audit process. Internal Auditors cannot audit their own work.
The ‘ISO 9001:2015 Audit Checklist’ is used to conduct and document the Internal Quality Audit. If nonconformities or
opportunities for improvement are identified, they are documented on an ‘Internal Audit Report’. Corrective actions are taken
without undue delay and verification of the actions taken are reported.
Results of the audit and corrective action verification are communicated to top management. Records of the Internal Quality
Audits, captured with the ‘ISO 9001:2015 Audit Checklist’ and ‘Internal Audit Report’, are maintained as required.
10 Improvement
10.1 General
MSI strives to continually improve the effectiveness of the QMS through the use of the ‘Quality Policy’, ‘Quality Objectives’,
audit results, analysis of data, corrective actions, risk and opportunities identified and ‘Management Review’.
Top management works to improve services and to meet requirements as well as to address future needs and expectations.
Potential opportunities to correct, prevent, or reduce undesired effects of services are identified during customer requirement
reviews.
Internal Audits are conducted and the results are used for improving the performance and effectiveness of the QMS.
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10.2 Nonconformity and corrective action
10.2.1
When a nonconformity occurs, including any arising from complaints, MSI reacts to the nonconformity and, as applicable,
takes action to control and correct it and deals with the consequences.
The ‘Corrective Action Request’ has sections in it that call for a: Description of the nonconformity, determination of the extent
of the nonconformity in terms of the service, process, area, or organizations involved that may need to be part of the
corrective action, determination of the root cause(s) of the nonconformity, the corrective action(s) to take and the
effectiveness of those actions, the impact on risk management, any needed changes to the QMS, and any other any other
required follow-up.
The area responsible for the nonconformity will determine and implement the corrective actions.
Corrective actions taken are appropriate to the intensity or frequency of the nonconformities found.
10.2.2
Completed ‘Corrective Action Requests’ are retained as evidence of the nature of nonconformities and subsequent actions to
address them as well as the results of the corrective actions.
A summary of corrective actions is one of the ‘Management Review’ inputs.
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Addendum A - Customer RFQ – Order Entry Process
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Addendum B Purchasing – Vendor Approval Process
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Addendum C Process Realization
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