Requirements of Quality Management System

What are Requirements of ISO 9001 Quality Management Systems?

audited image1The ISO offers one among the known management systems within the world. Overall, the systems are enforced by quite one million organizations in many countries. The ISO 9001 certified company follows tips set by the organization. The standards represent the foremost comprehensive existing nowadays, and are a tried and tested framework for firms to higher make sure that they’re meeting the wants of their several purchasers.

Requirements – Documentation

In order to be ISO 9001 compliant, an authorized company giving services or product should be in possession of documented statements of a top quality policy that delineates the standard objectives.

Quality Manual

A company seeking ISO 9001 certification should possess a top ISO 9001 quality manual that sets forth the scope of the standard management system and documented procedures for addressing quality problems.

Control of Documentation

Documentation should be controlled therefore on make sure the documents are approved before being issued. Additionally, all documentation should be unbroken up-to-date. Revisions should be resubmitted for approval once an amendment is formed.

Management Responsibility

Although the ISO 9001 produces the management standards, it’s the responsibility of the corporate to self-audit. Additionally, the corporate might permit customers to perform an audit likewise. To be certified as compliant, businesses management practices should be reviewed by a freelance ISO 9001 quality system certification company.

Measurement and Analysis

Per Section eight of the ISO standards, an organization should set up and implement “the watching, measure, analysis and improvement processes” that are required to demonstrate conformity to product necessities, guarantee conformity of the standard management system, and to supply continual improvement of the standard management necessities.

Continual Improvement

In order to stay compliant with the ISO standards, an organization should frequently develop and improve its own tips to make sure corrective and preventative measures are in situ to contend with any nonconformity that will arise.



ISO 9001:2008 to ISO/DIS 9001 Correlation Matrix

What to expect in new revision of ISO 9001? ISO 9001

ISO 9001:2008 to ISO/DIS 9001 (rev.2015) Correlation Matrix

ISO 9001:2008 ISO/DIS 9001
4        Quality management system 4         Quality management system
4.1     General requirements 4.4     Quality management system and its processes
4.2     Documentation requirements 7.5     Documented information
4.2.1  General 7.5.1  General
4.2.2  Quality manual 4.3     Determining the scope of the quality management system

7.5.1  General

4.4     Quality management system and its Processes

4.2.3  Control of documents 7.5.2  Creating and updating

7.5.3  Control of documented Information

4.2.4  Control of records 7.5.2  Creating and updating

7.5.3  Control of documented Information

5         Management responsibility 5        Leadership
5.1      Management commitment 5.1     Leadership and commitment

5.1.1  Leadership and commitment for the    quality management system

5.2      Customer focus 5.1.2  Customer focus
5.3      Quality policy 5.2     Quality policy
5.4      Planning 6        Planning for the quality management system
5.4.1  Quality objectives 6.2     Quality objectives and planning to achieve them
5.4.2  Quality management system planning 6        Planning for the quality management system

6.1     Actions to address risks and opportunities

6.3     Planning of changes

5.5      Responsibility, authority and communication 5        Leadership
5.5.1   Responsibility and authority 5.3     Organizational roles, responsibilities and  authorities
5.5.2   Management representative           Title removed

5.3     Organizational roles, responsibilities and  authorities

5.5.3   Internal communication 7.4     Communication
5.6      Management review 9.3     Management review
5.6.1   General 9.3.1  Management review
5.6.2   Review input 9.3.1  Management review
5.6.3   Review output 9.3.2  Management review
6         Resource management 7.1     Resources
6.1      Provision of resources 7.1.1  General

7.1.2  People

6.2      Human resources           Title removed

7.2     Competence

6.2.1   General 7.2     Competence
6.2.2  Competence, training and awareness 7.2      Competence

7.3      Awareness

6.3      Infrastructure 7.1.3  Infrastructure
6.4      Work environment 7.1.4  Environment for the operation of processes
7         Product realization 8         Operation
7.1      Planning of product realization 8.1      Operational planning and control
7.2      Customer-related processes 8.2      Determination of requirements for products and services
7.2.1  Determination of requirements related to the product 8.2.2  Determination of requirements related to products and services
7.2.2  Review of requirements related to the product 8.2.3  Review of requirements related to the products and services
7.2.3  Customer communication 8.2.1  Customer communication
7.3      Design and development 8.5      Production and service provision
7.3.1  Design and development planning 8.3      Design and development of products and services

8.3.1  General

8.3.2  Design and development planning

7.3.2  Design and development inputs 8.3.3  Design and development Inputs
7.3.3  Design and development outputs 8.3.5  Design and development outputs
7.3.4  Design and development review 8.3.4  Design and development controls
7.3.5  Design and development verification 8.3.4  Design and development controls
7.3.6  Design and development validation 8.3.4  Design and development controls
7.3.7  Control of design and development changes 8.3.6  Design and development changes
7.4      Purchasing 8.4      Control of externally provided products and services
7.4.1  Purchasing process 8.4.1  General

8.4.2  Type and extent of control of external provision

7.4.2  Purchasing information 8.4.3  Information for external providers
7.4.3  Verification of purchased product 8.6      Release of products and services
7.5      Production and service provision 8.5      Production and service provision
7.5.1  Control of production and service provision 8.5.1  Control of production and service provision

8.5.5  Post-delivery activities

7.5.2  Validation of processes for production and service provision 8.5.1  Control of production and service provision
7.5.3  Identification and traceability 8.5.2  Identification and traceability
7.5.4  Customer property 8.5.3  Property belonging to customers or external providers
7.5.5  Preservation of product 8.5.4  Preservation
7.6      Control of monitoring and measuring equipment 7.1.5  Monitoring and measuring resources
8.0      Measurement, analysis and improvement 9.1      Monitoring, measurement, analysis and evaluation
8.1      General 9.1.1  General
8.2      Monitoring and measurement 9.1      Monitoring, measurement, analysis and evaluation
8.2.1  Customer satisfaction 9.1.2  Customer satisfaction
8.2.2  Internal audit 9.2      Internal audit
8.2.3  Monitoring and measurement of processes 9.1.1  General
8.2.4  Monitoring and measurement of product 8.6      Release of products and services
8.3      Control of nonconforming product 8.7      Control of nonconforming process outputs, products and services
8.4      Analysis of data 9.1.3  Analysis and evaluation
8.5      Improvement 10       Improvement
8.5.1  Continual improvement 10.1   General

10.3   Continual Improvement

8.5.2  Corrective action 10.2   Nonconformity and corrective action
8.5.3  Preventive action            Clause removed

6.1       Actions to address risks and opportunities (see 6.1.1, 6.1.2)

ISO 9001 Revision 2015 Is Coming

The ISO 9001 Revision 2015 timetable for development is as follows:

July 2015 – Final Draft International Standard ballot opens
August 2015 –  Final Draft International Standard ballot closes
9 September 2015 – ISO 9001:2015 International Standard is published
 According to the draft design specification, the revised ISO 9001:2015 standard should:
  • Provide a stable core set of requirements for the next 10 years or moreISO
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

Seven Significant Changes in ISO 9001 Revision 2015 Committee Draft

  1. The term „product” has been replaced by „goods and services”.
  2. Two new clauses related to the context of the organization:
    4.1 Understanding the organization and its context
    4.2 Understanding the needs and expectations of interested parties.
  3. The requirement to use the „process approach” has been more explicit by adding a new clause.
    4.4.2 Process approach
  4. The standard does not include a specific clause for „Preventive Actions”.
  5. The terms „document” and „records” have been replaced with the term „documented information”.
  6. of external provision of goods and services address all forms of external provisions.
  7. The term „continual improvement” has been replaced with „improvement”.


Understanding Change in a Quality Culture

Clock with time for change written on itIn any improvement process, managing the influence of change and the anti-change culture that will continually try to raise its head will be one of the most ardent tasks. Learn to deal with this as effectively as you do the project management itself. There are many well-written books on the subject of change in every category of change that you could imagine. Below is a compiled list of items about change that are relevant to implementing process change.

When examining change it is necessary to understand the stages of change that have been identified. It is interesting to note that these stages take place in varying degrees in different people, but are exactly the same whether the change is a different process in the workplace or the death of someone close. You should be able to identify and deal with the levels of acceptance encountered. Here are the stages and some tips on how to deal with them.


A wonderful self-preservation response. It is characterised by minimising the situation, and saying (or thinking) things like „This isn’t happening”, „It won’t help”, and „There’s no problem.” You may find the person will avoid talking about the situation, or even make up excuses for not attending meetings.

  • Explain the denial to commitment process that you went through to get where you are.
  • Present the situation openly and allow a lot of time for questions and answers.
  • Have a training session on change management.
  • Present a caring and understanding front. Though this may not be your normal attitude, during this process it will be invaluable.
  • Be a broken record with memos, thank you emails, posters, or anything else that presents your platform in a positive light.


It is at this stage that you may see the active signs of sabotage. They may be passive, as in „I’ll just do it my way anyway”, along with a lot of whining-crabbing about the new systems. Or they may manifest in physical methods of sabotage depending on the character of the person. Be aware that these are real threats to the success of any project. But for the most part, those who fall into this category will show a lack of interest and a lot of time spent on finding reasons it won’t work.

  • Listen! And I mean listen. You can hear more in the tone and inflection of what is being said as well as the body language than you can imagine.
  • Solicit Response. People love to know that they are being heard and even more that their suggestions are valid. Many of them are. These are the people who will make or break the installation, let them know they have input to the outcome.
  • Acknowledge Feelings. Let them know you went through a similar process in getting where you are. Validate that they are not alone.


People will begin to see some of the good that may occur in the situation, and will generally vacillate between thinking that it might be ok and that it is still a bad idea. But, the up side is that you are beginning to get them on your side and they will begin to make effort to get the changes in place.

  • Facilitate. People are more open at this point. Take advantage of it. Be your own commercial! Challenge people to find a better way within the new system. It gets them thinking about the next round of change and off the current.
  • Reward forward thinking with mounds of compliments. Praise the desired behaviour.
  • Seek out new possibilities. Have brainstorming sessions. It does wonders for everyone’s moral.


You’ve got buy-in and will see productivity through the changes. People can see the bigger picture and the opportunity that the change affords.

When dealing with this from a management point of view, it is important to remember several things. These feelings are very real and they happen at different times for different areas of the organisation. Do not expect to spend several months agonising over the commitment to purchase expensive software only to turn around and expect everyone else to do a Tarzan swing from denial to commitment in a week. Remember the process you had to get through in order to accept the change. Others will require the same; allow the process to manifest itself in others. You can facilitate the process by understanding it and helping others to get through.

  • Recognise and acknowledge those who get there. Give them more opportunity to improve the process and celebrate their victories.
  • Inspire people to get others on board. Teach them about the process and how to recognise the people in various stages and how to move them along.
  • CELEBRATE!!!!! Most important. When you have achieved goals, let everyone know and celebrate, celebrate, celebrate. When people know their efforts will be recognised and appreciated, you will have fewer problems in future change.

Remember that we have a tremendous amount of information to process every day. There is more information in a single daily paper today than a person in the 15th century processed in a lifetime. Change takes form in one of three types; that which we cannot control, that which we can, and that which we can influence. Being positive and trying to move things from cannot control to can influence helps in the ability to manage the changes that occur. But, there will always be those things you cannot control and acceptance of that fact is the only road to remaining sane.

Source: ,  John W. Wright III

Why You Should Experiment

The human mind is often perplexed and confused by all of the cause-and-effect events happening around us. While the cause of some things is self-evident, others are not. For those that are not, we attempt to manipulate certain causes in an effort to discover what happens to something of interest. If such testing is arbitrary, sporadic and without structure, our conclusions are at risk of being declared true when, in reality, they were false — and vice versa.

However, if we bring scientific order to the ways and means we manipulate and test the speculative causes, we can greatly reduce the risk of drawing false conclusions. The ways and means of scientifically doing this is called „Design of Experiments,” or DOE as it is often referred to. Through the scientific process of DOE we are able to more confidently link potential causes to certain effects.

Thus, we are able to exert better control over the world around us; thereby, giving us the choice to improve the quality of our lives in a more purposeful, deliberate and confident way. Only in this way can we strip our fate from the jaws of perplexity, uncertainty and chaos. When we achieve victory over nature, we can set a course that is of our own choosing.

source: Mikel Harry, Ph.D. Co-Creator of Six Sigma, National Best Selling Author and Consultant to World’s Top Executives

By Source Management Systems Consulting

Key: Quality Management Plan

The Quality Management Plan defines the acceptable level of quality, which is typically defined by the customer, and describes how the project will ensure this level of quality in its deliverables and work processes. Quality management activities ensure that:

  • Products are built to meet agreed- upon standards and requirements
  • Work processes are performed efficiently and as documented
  • Non-conformances found are identified and appropriate corrective action is taken


Quality Management plans apply to project deliverables and project work processes. Quality control activities monitor and verify that project deliverables meet defined quality standards. Quality assurance activities monitor and verify that the processes used to manage and create the deliverables are followed and are effective.

Quality Plan Components
The Quality Management Plan describes the following quality management components:

  • Quality objectives
  • Key project deliverables and processes to be reviewed for satisfactory quality level
  • Quality standards
  • Quality control and assurance activities
  • Quality roles and responsibilities
  • Quality tools
  • Plan for reporting q uality control and assurance problems

The purpose of developing a quality plan at the Stage 3 level is to elicit the customer’s expectations in terms of quality and prepare a proactive quality management plan to meet those expectations.

The Quality Management Plan helps the project manager determine if deliverables are being produced to an acceptable quality level and if the project processes used to manage and create the deliverables are effective and properly applied.

Who is involved
Project Manager
Project Team
Project Sponsor

Quality Management Plan segment of the Project Plan

Management Strategy

Managers and employees alike need to earn the respect of team members, colleagues and company leaders. As we all know, respect is not something that comes automatically with a job title – it must be earned. And it’s not only for the management team; every employee will achieve more success and have more confidence at work when they know they have earned the respect of their colleagues.


Here are a few guiding principles to earn respect, and build success, at work.

Listen to Your Inner Voice – Each of us makes decisions based on our personal compass of what is good or bad, right or wrong, fair or unfair. Particularly while practicing Human Resources, it seems like there are so many rules, there must be one for every situation! But more often than not, we are interpreting the law and also doing the right thing. This is where a strong moral compass is one of the best tools in your management belt.

Wait 24 Hours… Sometimes – Today we are so connected through technology and our work demands quick responses. When considering options or weighty decisions, remember you (and others impacted) will have to live with the decision much longer than it takes to make it. Although we all have to be ready to turn on a dime sometimes, do not underestimate the power of thoughtfulness.

Pick Your Battles – When working in a team environment, the decision does not always need to go your way. Respectfully agreeing with a leader or the group shows that you can successfully manage change while demonstrating adaptability.

Bring Something To The Table –Be the best you can at what you do, and don’t be afraid to speak up when you have a good idea. Make sure that you are delivering expertise the company will always value. Think constantly about your contribution to the organization and your team.

Keep Your Word – If you commit to a deliverable or a deadline, stick to it. A key element of keeping your word is proactively renegotiating a deadline in advance if you realize you will not be able to reach it. You will gain the respect of all your colleagues due to your reliability. If you come through for others, they will usually come through for you.

Be a Supportive Teammate – Managers should be develop and support their teams. Colleagues should also champion and congratulate one another on accomplishments. You will foster trust and loyalty through your own generosity.

Give Second Chances (Including to Yourself!) – Every employee – including the boss – is going to have a few missteps. When a member of the team is asked to put themselves out on a limb or try something new, they also need to feel there will be a safety net of forgiveness backing them up. Just be candid and admit when one of your teammates, or you, made a mistake, move on, and don’t let it happen too frequently.


Objectives of Quality Management System Certification

Objectives of Quality Management System Certification

ISO 9001(1)1QMS standard may be a set of quality management tips that are adopted by thousands of organizations round the world. It provides processes and procedures to assist corporations improve the standard of the merchandise or service they supply. So as to attain ISO accreditation, businesses have to be compelled to demonstrate to meet variety of objectives for effective QMS implementation.

Senior Management Commitment

Effective Quality Management System requires that the complete commitment and backing of senior management may be a very important component of achieving ISO accreditation. While not the complete support of the senior management team, the creation and implementation of quality management systems and processes can lack the impetus needed to form them winning. This will increase the chance that any enforced procedures will quickly fail, so compromising quality.

Design Process

ISO 9001 states that everyone comes should be planned completely and with quality as a priority in any respect stages within the life cycle of the merchandise, from style to manufacture to maintenance. Any changes or alterations within the style of the merchandise have to be compelled to be QMS 9001 documentation and recorded, and therefore the data of the amendment communicated to any or all relevant parties.

Supplier Vetting

It may be requirements of QMS 9001 that every one new supplier is completely vetted before any contracts are awarded. This is to determine the standard of service and products that the provider can give; similarly as guaranteeing that they need the resources necessary to satisfy your demand. This can lead to long and productive operating relationships with suppliers.

Inspection and Testing

All materials and product utilized in the creation and producing of an item should be completely inspected before use. This is often to confirm that they’re fit purpose, and every one testing records should be maintained and filed. Before a product is free to the general public, it should endure final testing and attain the sign-off of senior management.

Internal Audits

All businesses seeking QMS certification should do regular and thorough internal audits to check that the processes and procedures that are enforced among the corporate are operating and being well maintained. Any shortcomings, discrepancies or areas of improvement should be communicated to senior management and a point in time given for any issues to be corrected.