Iso 9001 implementation

The three components to implementing an ISO 9001 quality management system are: 1)
documentation, 2) information management, and 3) operational changes.

Documentation

On the surface it may seem like developing the ISO 9001 documentation shouldn't be that
difficult. You must have a manual that includes a policy, objectives, scope, and the
interaction of the processes; and you must have written instructions for:

1. Managing the quality system documents

2. Managing the quality system records
3. Conducting internal audits
4. Controlling nonconforming product
5. Implementing corrective action
6. Implementing preventive action

The standard also hints at the need for additional instructions, e.g., referring to the work
instructions, section 7.1 states "shall determine the following, as appropriate," but
technically, aside from the manual and these six instructions, anything more is optional.

The reality, however, is that in order to get the most out of a quality management system
a significant amount of additional documentation is required. A primary function of the
system is to establish consistency and eliminate misunderstandings, which is best
facilitated with clear and unambiguous written instructions. Policies, which are a
pervasive part of any system, have absolutely no value if they're not in writing, and
enforcing accountability is extremely difficult if the responsibilities are not spelled out.

The ISO 9001 system documentation is normally organized into four sections, including:

1. The Manual, which provides background information and explains how the
system works;
2. The Administrative Procedures, which include the procedures and policies that
define how the company complies with the requirements of the standard and how
it manages the processes that are unique to its operation;
3. The Operating Instructions, which are the detailed instructions used to control
manufacturing and service activities; and
4. The Reference Documentation, which are documents like industry standards,
equipment maintenance manuals, corporate auditing guidelines, employee
policies, etc. that define practices, procedures, or performance criteria not covered
by the other documents. These can either be externally or internally generated.
No two organizations have the same goals and objectives or do things exactly the same
way, which means there are always some differences between the procedures and policies
of different organizations. It also means that completely documented "off-the-shelf"
systems don't exist and some document development is inevitable. The challenge is to
minimize the effort without sacrificing value.

The Manual - The administrative procedures are usually the more difficult and time-
consuming of the four sections to develop. The manual, on the other hand, is relatively
straightforward and probably the easiest part to develop. The standard suggests what
should be included, and an example of a "well written" manual can provide the format for
organizing the material. Most of the work is in converting the ideas of the example into
documents that describe your situation. Goals and objectives have to be established,
processes defined, responsibilities established, the interaction of the processes explained,
and the system parameters established.

Administrative Procedures - The secret to developing administrative procedures is 1)

using a format that creates readable documents, 2) finding examples of procedures that
offer solutions that apply to your needs, and 3) organizing the documentation based a
process list.

The "process approach" is the system structure recommended by the authors of the
standard and the process list is the starting point of the process approach.

Think of processes as objectives, i.e., maximizing employee output, making sure new
products comply with customer requirements, or making sure working conditions
adequately support the production objectives. A set of procedures that constitute a means
for meeting an objective is what the standard refers to as an "activity group". Employee
vetting, performance reviews, and training procedures is an examples of an activity group
that maximizes employee output. The objectives are the outputs of the "process
approach" and the procedures (the activity groups) the inputs. Example:

Input = Policies and procedures for making sure employees are motivated, informed, and
capable of performing the assigned responsibilities

Output = Maximum employee output

The process list is simply a list of those objectives that best represent the needs of your
organization. They can be different for every organization and are rarely in sync with the
outline of the standard.

The format used for developing the procedures, to a large extent, determines whether
employees will embrace the system. It can be the difference between documents that are
easy to read and ones that are not. The better formats include a clear propose, policies
that are relevant to the purpose, and an explanation why things are done the way they are
done. A good format also leaves no doubt as to who is accountable for the actions of the
procedures.

Examples of procedures from other systems provide ideas on how to develop new
procedures and how to improve existing procedures. The same examples can also provide
formatting ideas. Don't fall into the trap of thinking that there must be a procedure of
every requirement of the standard, or that the documentation has to follow the outline of
the standard. The authors of the standard have made it clear that this is not the case. You
are encouraged to use a process approach, which is inherently unique to your operation,
and to include processes that are important to you but may not included in the standard.

While individual examples can be helpful, continuous system templates that lock into the
outline of the standard tend to complicate the implementation process. They
depersonalize the system, limit the system to the scope of the standard, and make the
process of writing procedures more difficult. Also, don't go overboard on process
mapping and flowcharting. Procedures should be clear to everybody, not just the primary
users. A fundamental covenant of the system is continual improvement and some of best
improvement ideas come from employees with unrelated responsibilities.

Operating Procedures - The trick to developing operating procedures is in

understanding the balance between training and documentation requirements, and in
knowing how much information is needed. Too many companies develop too much
unnecessary detail.

The standard requires employers to provide employees with the information needed to
correctly perform their assigned responsibilities. Proof is either documentation showing
that they have been provided the necessary instructions, or training records, which also
verifies that they have been provided the necessary instructions. The value of written
operating instructions is that they make it easier to hold employees accountable for their
actions. From this standpoint, it is only necessary to document those aspects of an
operation that are subject to misinterpretation or misunderstanding, which normally
doesn't require a great deal of detail.

Information Management

Managing information is a big part of the standard. The standard states that records shall
be maintained in the case of management review meeting minutes (5.6.1); education,
training, skills and experience (6.2.2); product validation and verification (7.1.d); inputs
for product design and development (7.3.2); and calibration records (7.6). In addition, the
standard also requires "evidence of conformity", which is either physical evidence or
documented records, and in many cases records are preferable and sometimes the only
alternative.

Records provide a means of confirming that the quality system is controlled, customer
requirements are understood, audits are conducted, customers are heard, problems are
found and corrected, non-conforming goods are managed, purchasing information is
correct, products are traceable, and incoming goods are inspected.

The method of managing information is generally some combination of 1) a file

management program, 2) database files such as Microsoft Access, or 3) hard copy files,
i.e., binders, file cabinets and manila folders, all of which have advantages and
disadvantages.

File Management Programs - File management programs are typically tamper-proof

and capable of handling a large volume of information. They're designed to be paperless
systems. Assignments, authorization levels, and additions and revisions to records are
keyed into the program, which, under certain conditions, trigger action commands that
are communicated via email. There are a few programs tailored to manage primarily ISO
9000 records, but most are universal in nature and designed to manage all types of
records. The user is normally responsible for developing the forms and reports needed to
manage specific types of records.

The programs are expensive; they come with annual and sometimes monthly
maintenance fees; and there are usually costs associated with installation, the number of
users, data migration, and training. Many have their own programming language, which
makes the user dependent on people with that language skill. And some are web based,
which means the program is running on someone else's server. Generally, they are best
suited for companies with a lot of people dealing with a large volume of information.

Database Files - Database files are less expensive, more flexible, and easier to manage.
You can either develop your own files or purchase files that have been programmed to
deal with specific types of records.

The majority use Microsoft Access and run on a Microsoft Windows operating system.
The cost is the cost of the files plus the cost of the Microsoft programs. (The 9000
Advisers offer individual Access files for all the ISO 9001 record keeping requirements.)
The files are placed on a server and secured by whatever means is used to secure the
server files. Changes and enhancements can be made by anyone who understands
Microsoft Access. In most cases there are no user fees or reoccurring maintenance fees,
and existing database files can be transferred into the files with the migration functions of
the Access program.

Hard Copy Records - Almost everyone ends up with some hard copy records:
documents that can't be scanned, documents with signatures, and documents that are
available to all employees. However, building a record keeping policy completely around
this approach is risky, even for small companies. It is too easy to misplace documents
that move from one person to the next; and it is difficult to manage information that is
located in various files, in different offices, and assigned to different people.
Responsibilities change and individuals tend to change the way information is gathered
and filed. Manual record keeping frequently results in unnecessary duplication, e.g., sales
using a different customer list than the person keeping track of the customer complaints.
It is also difficult to gather, analyze, and disseminate information. File cabinets are not as
accessible as computers and don't have the sorting, reporting, linking and analytical
capabilities of database files.

Operational Changes

The final component of the implementation process is the operational changes, which are
the changes needed in order to meet the procedural requirements of a system. They
include both the things that are done in order to ensure that the products and services
comply with the requirements specified by the customer, as well as the measure taken to
in order to improve products and services and the processes used to produce the products
and services.

Some of the more common ones include:

Administration - 1) Conduct at least one management review meeting. 2) Communicate

system developments to all employees. 3) Demonstrate that the key performance
indicators are measured, evaluated, and communicated.

ISO Representative - 1) Make sure that the auditors are adequately trained. 2) Develop
an audit schedule and conduct audits on all of the system procedures. 3) Demonstrate that
the corrective and preventive action processes are working. 4) Make system procedures
and forms available to employees.

Human Resources -1) Verify that all employees have a basic understanding of the ISO
9000 system. 2) Prove that all employees are capable of performing their respective work
assignments, including the top-level executives. 2) Establish a training program for
developing employee skills.

Purchasing - 1) Demonstrate that all of the primary vendors are qualified and that their
performance is routinely evaluated. 2) Prove that material specifications are verified
before they are released to vendors.

Sales/Customer Service - 1) Demonstrate that customer feedback is gathered and

analyzed, including records of complaints. 2) Prove that processing capabilities are
reviewed before orders for new products are confirmed.

Engineering - 1) Demonstrate that the information released to production is current,

accurate, and complies with customer requirements. 2) Demonstrate that product changes
affecting form, fit, or function are not implemented without customer approval.

Production - 1) Establish a calibration program that complies with the requirements of

the standard. 2) Demonstrate that machinery capabilities have been validated. 3) Prove
that nonconforming materials are not mixed in with satisfactory materials. 4) Prove that
that shipments comply with the customer requirements. 5) Prove that incoming materials
comply with purchase specifications. 6) Prove that operators are provided with the
information required to produce products that conform to customer requirements. 7)
Demonstrate how materials with shelf life are managed.

System documentation and information management are the paperwork part of the
system. The operational changes are the action part and represent the part of the
implementation process that makes the system work.

If you want to download over free 50 ebook for iso 9001 standard, you can visit:

http://iso9001ebooks.info

Best regards