Showing posts with label ISO 9001 consultants. Show all posts
Showing posts with label ISO 9001 consultants. Show all posts

Thursday, 22 September 2016

Role of HRM in effective implementation of QMS

When a business organization  lacks  in  the human resources with  correct  attitude and capability for  designing and operating the business processes that fulfill the customer expectations, the QMS may fail to deliver any tangible results.  This is the reason, why ISO 9001 :2015  has   the HRM principles embedded in the  basic structure.  People oriented philosophy is apparent in the following  quality management  principles: 

  • QMP2   principle of leadership,
  • QMP 3  principle  of people  engagement
  • QMP 7 principle of relationship management

The international  standard gives a lot of importance to the human aspect of an organization. Enthusiastic  teams  of  trained  and motivated employees can ensure that the company  achieves business purpose and  QMS objectives by supporting the system whole heartedly.
HRM functions include



  • defining the organization structure,  authority and  responsibilities of the employee roles,
  • clear communication of these roles  and job descriptions to employees,
  • determining skills and abilities(competence, experience , education ) needed for each role,
  • evaluating competence of employees and building competence through training,
  • evaluating the effectiveness of training
  • managing performance and compensation to motivate the workforce and
  • enhancing employee engagement .
Detailed  HRM requirements of  ISO 9001 certification

Planning for  ISO 9001 certification should be done with active  involvement of HR professionals as well as ISO 9001 consultants. Detailed clauses affecting  HRM are mentioned below. 
ISO 9001:2015, in clause 4.4 d requires resources (including human resources) needed  for the business  processes be determined. Clause 4.4e requires  that authorities and responsibilities be assigned for all processes in a very clear manner.

Clause 5.1.1 states that  the top management of the enterprise must  display leadership with commitment by
  1. accepting  accountability for  maintaining effectiveness of the QMS,
      b. making sure that  quality policy is established along with quality objectives, (quality policy must be fully aligned to strategic direction and  business environment( context)
c.  communicating quality policy to  ensure understanding  and application
d  integrating   QMS into enterprise  processes
e creating  employee awareness in favor of  process approach
f providing  resources for  QMS including human resources
g promoting  employee awareness of total quality management  and need for conformity to QMS requirements
h achieving business results through effectiveness of QMS
I motivating, directing, engaging  and supporting  all people to contribute to QMS effectiveness  
J  supporting and promoting  improvement throughout the enterprise
K   providing   support to different  management  roles for leadership  in areas of  their  responsibility towards QMS

Delegating authority and responsibility for QMS

Clause 5.3 stipulates that authorities as well as responsibilities for  roles relevant to QMS must be clearly assigned, with clear communication for understanding. This delegation is for
A.  ensuring conformity to requirements
B.  making enterprise QMS processes to deliver  intended outputs
C.  reporting to top management about QMS performance and  need for changes as well as improvements
D. making sure that customer focus is promoted
E. maintaining integrity  during managing  changes for the system.
6.2.2 c requires  determination of  who will achieve objectives.
6.3 c says that while planning changes,   management  should ensure availability of  resources( human as well as others) and (6.3d )consider  changes in responsibility authority to make changes fruitful.

Requirement of competence

7.2a. requires that the competence requirement of persons affecting quality performance of the organization must be determined

7.2b. requires that management make sure (by collecting information) that  people are competent ( through experience, training as well as  education)

Tuesday, 9 August 2016

ISO 9001 Consultants And Auditors: How To Select Them

In many organizations ISO 9001 consultants play a significant role in the implementation of ISO 9001 and the subsequent certification audit. Their role is crucial because they can do the hand holding during your journey towards attaining business excellence through successful Implementation of the ISO 9001 quality management system. They enable faster learning and help you establish and implement a system that suits you very well. They help you choose the auditing firm(certification body), which is best suited to your business processes.

ISO 9001 consultants


In order to attain successful ISO 9001 certification, it is essential to have a certification audit conducted in your premises. An independent auditing firm (registrar or the certification body) chosen by you will send qualified ISO 9001 auditors to visit your establishments for performing the external audit.  The firm will register your company for the audit and issue the certificate as soon as the audit process is completed successfully.

Sometimes there is confusion about the role of the external auditors and consultants. The consultants can’t audit and certify you, because they are meant to assist and coach you, whereas auditors must act as independent examiners. Consultants assist in planning and creating documentation so that a formal system is in place. If a QMS already exists; they will do the gap analysis to enable you to know what is missing, so that new procedures and other information can be added to ensure conformity. They train the internal auditors needed to conduct internal audit and provide awareness training to employees. They advise you on weaknesses in the system and preventive actions required. After the audit, they help you to resolve the NCs and other audit observations.

Selection of the ISO 9001 consultant
Consultant is selected on the basis of his or her past performance as well as the background. Trade bodies such as chambers of commerce, as well as professional bodies sometimes keep a list of approved   QMS consultants. Minimum requirement is that the consultant or his staff must have attended lead assessor training courses and transition courses and qualified themselves as lead assessors for the latest revision of the QMS standard. Websites of the consultants may give some idea about the industries they are able to guide and advice. Prior experience and knowledge of the applicable business processes could be a plus point.

 References from previous clients, as well as the results of previous projects in terms of time and cost incurred are considered. Often a small part of the project such as gap analysis is awarded initially. Milestone based fee is also one of the options. Consultants often provide a written proposal for a fee based on the size of the clients operation.

Selection of  the ISO 9001 Auditors (Registrars or Certification body)
 The ISO 9001 Registrar (certification body) is the independent entity that sends the auditors to conduct your certification audit. One must look for officially accredited registrars. The reputation of registrars should also be ascertained with the help of trade bodies or the professional bodies. The criteria for the selection of registrar can be finalized with help of your consultant.

Critical factors to be considered in the selection process include:

  • accreditation and other credentials of certifying body or registrars (Every country has an accreditation body: ANSI-ASQ National accreditation Board in USA)
  • scope of the accreditation: determine if the scope of accreditation certificate applies to  your business processes,
  • references and global reputation/recognition
  • fee for certification audit as well as subsequent surveillance audits
  • their terms and conditions
  • comfort level, flexibility to suit your time frame
  • confidentiality and ethical issues
  • how to tackle issues of interpretation of clauses of the applicable standard
  • credentials and competence of  the auditors, who will be assigned to audit you.
Thus the selection of  a  competent consultant and  a reputed  certification body at a later stage, paves the way for successful certification of your company for ISO 90001.
  

Tuesday, 21 June 2016

“Interested parties”: their significance for quality management system

In early years, Quality management system (QMS) stipulated that companies must monitor customer need satisfaction as a mandatory requirement. However, in the 2008 version, ISO 9001 standard emphasized customer focus as well as the supplier relationship simultaneously. The standard focussed on supplier collaboration for knowledge sharing, expertise development and creating value for mutual benefit. Systems approach to integrating and aligning the processes, further provided opportunity for value creation for customers as well as suppliers. The Concept of treating the next process as customer, improved the collaboration, alignment and integration of processes, thus enabling a systems thinking approach.




The new version of Quality management system: integrated approach
2015 version of ISO 9001 combines the customers, suppliers as well as others as interested parties. Companies must identify and understand the needs and expectations of relevant interested parties. List of interested parties should include:
  • direct customers,
  • regulators and government agencies,
  • distributors,  contractors,
  • wholesalers and retailers,  stockists,
  • shareholders and lenders,
  • suppliers, transporters and partners in supply chain,
  • end users,
  • Employees.
Relevance of needs and expectations of interested parties must be understood and process integration should be built in such a way as to benefit them as well as the company.  

Section 4.2 of ISO 9001:2015 standard speaks about understanding the needs and expectations of interested parties.

Section 4.1 talks about organizations ability to attain intended outcomes and internal/external issues affecting the capacity of the company, as a result of needs of interested parties.

Section 6.1 mentions the issues and risks and opportunities arising out of needs of interested parties to be addressed in QMS, through plans and processes for prevention of undesirable effects on the intended output of goods and services.

Section 4.3: The scope of your QMS should enable you to address the relevant needs of the interested parties.

Other clauses and areas due to which QMS must address the needs of interested parties:
Section 5.2.2 your Quality Policy
Section 9.3 management review
Section 8.3 design inputs for development of new goods and services

In determining as well as fulfilling  the relevant expectations of   interested parties their relationship with the company must be analysed, as discussed below.

End users and Customers
End users are not buying the goods and services directly, but are affected by the way the processes are carried out and controlled. In many cases end users may be more important than the direct customers, because, they may  not be easily identified and their needs and expectations could be difficult to determine. Monitoring changes in their needs and expectations may be a difficult task and QMS should address these issues. Their requirements may affect the firm’s ability to fulfil them. Their needs and expectations should be utilized in new product development and customer service design and improving the processes.

Customers are the people who buy the company’s goods and services directly. They are more vocal in voicing their expectations.  The company must monitor and   understand the changes in their expectations and needs. They are directly impacted by the quality of goods and services offered as well as the pricing.

Regulators and Governmental agencies
Expectations of regulators and govt. agencies are based on the legal requirements and regulatory controls, such as industry specific environmental regulations, safety regulations and occupational health requirements. Expectations may relate to processes as well as goods and services. These requirements must be addressed in the QMS and any changes in regulatory requirements too need to be identified and addressed promptly.

Supply chain partners and stake holders
Partners in the supply chain such as suppliers, contractors, transporters, stockists, wholesalers and retailers have an important role to play in ensuring effectiveness of your QMS. Their expectations must be addressed by integrating them in the critical processes of the QMS. Similarly employees, shareholders and lenders are also affected by the effectiveness of QMS and their concerns and expectations need to be identified and addressed.

Conclusion
The purpose of your business is to satisfy the needs of the customers and other interested parties. ISO 9001 requires that you understand the needs and the expectations of customers and end users, regulators as well as other interested parties, and address those needs through  integrated processes, which maximize the benefit to the interested parties while also attaining the goals of the company.
 When your QMS ensures integration of the processes in order to fulfil the expectations of the interested parties you are closer to the planned compliance and certification to the requirements of ISO 9001:2015.

ISO 9001 certification
Organisation are looking to achieve ISO 9001 Certification for several reasons eg: getting pre qualified for tenders, Customer request, etc,. To develop and Implement systems quickly and have a systems that adds value to your organisation you may need the services of specialist ISO 9001Consultants who can guide you through the requirements of the ISO 9001 Quality management system including the identification of relevenat interested parties to the organisation.

Wednesday, 24 February 2016

ISO 9001 Do You Even Need To Become Certified

A number of establishments throughout the world have the feeling, whether they even have a need to become ISO 9001 compliant. They could have different reasons for this feeling. Most of the establishments we are talking about are working in an industry that is highly regulated and have regular audits carried out for every step the industry is involved in. When looking forward to getting certified for ISO 9001 establishments will have to comply with certain regulations that will look difficult, but they are in no way compelled to implement the guidelines required unless they are prepared to do so. Industries that are highly regulated for any reason can easily begin to feel they can give up on the certificate for ISO 9001 because they are required to comply with other regulations that are specific to the business they are involved in. It is these reasons which give some establishments the feeling they no longer have to be involved in matters like getting certified or maintaining the standards of ISO.





Industries which now believe they no longer require certification from ISO 9001 or decide to give up on the certification they earned after becoming compliant with the regulations will have a decision to make because while the certification would have given their businesses, several advantages also have been an optional requirement. They would not have been compelled to become certified just because they had been involved in industry offering goods and services that were sensitive and required quality measures of the highest kind. They would be required to pay for the annual audits, which are carried out by the third-party body and therefore, could get the feeling; they should no longer be spending their resources on such matters. It is also possible they may not have hired the services of ISO 9001 certification consultants to understand how they could continue reaping the benefits of their efforts. Things would certainly be different if they had ISO consultants of repute to make them understand why they should not be looking forward to giving up after getting the certificate they wanted. While there are costs involved with remaining compliant with ISO 9001 guidelines industries have no obligation to continue remaining compliant and can easily give up on their certification without the inclusion of any further costs. The fact that other bodies constantly regulate them could perhaps give them the feeling that they no longer need to indulge in extra expenditure and therefore, conclude they should not be getting involved in such matters.

Most ISO certification consultants will hesitate to offer the complete information about how or why establishments will benefit after they are certified for ISO 9001. They will generally be concerned about holding on to their client's keeping in mind the revenue they can generate from the establishment. However, this will not be the case with consultants of repute because they will not hesitate to give appropriate information to the establishments making it clear why they should be looking forward to staying compliant with the regulations for ISO 9001 forwarding them on details about the benefits they can look forward to.

Companies and establishments generally do not understand the reasons why they should continue maintaining the approval from ISO and the onus of forwarding the correct information to them will rest upon ISO certification consultants who they hire for getting them certified. Moreover, this is one regulatory body that is constantly looking forward to making improvements for the benefit of businesses in the industry of goods and services. Therefore, the ISO consultant will be required to keep his or her client regularly updated about the changes to make them compliant with the regulations regardless of what type of industry they may be working in. ISO consultants must be in a position to convince their clients about the need to maintain the certificate of approval the regulatory body gave them. They must emphasize the importance of the certificate making it clear to the clients concerned why it has better benefits for them than any other regulations they are required to comply with.

Coming to the matter about whether a company or an establishment even needs to become ISO compliant will certainly depend upon the kind of industry they are involved in. There are no compulsions on an industry to follow the terms and conditions laid down by ISO. However, information is also available to show why getting certified and deciding to continue remaining compliant will make it easier for the industries concerned to continue with their business unobstructed within their country and in international markets is a matter which will have to be discussed with them by ISO certification consultants that are assisting them.
Establishments that have decided to retain the services of Anitech Consulting will not come across these problems because this is an agency of repute and will make an effort to provide all information about why the establishment should continue remaining compliant with the regulations set forth by ISO. Establishments can contact this agency by sending an email to get all the information they need about how they can remain in line with the requirements of ISO. Establishments can contact the agency on http://www.anitechconsulting.com.au with the knowledge that they will soon receive a response that will make it easier for them to decide about how they should be looking ahead.