ISO9001-2008Revisions SQA SedlakConsulting

ISO 9001:2008 Revisions from ISO 9001:2000
Introduction: ISO 9001 is now in its fourth edition. Starting with the 1987 initial edition, it changed in 1994 and again in 2000. The 2000 change was pretty extensive. It introduced the concept of process auditing and added a lot of emphasis to the importance of top management to the effectiveness of quality management systems. In November 2008, the fourth edition was released. Discussion: On November 13, 2008, the fourth edition of ISO 9001 became official. It is referred to as ISO 9001:2008. The good news is that it contains no substantive changes or new requirements. The changes that were made were done for two reasons: 1) clarifications to the requirements of ISO 9001:2000; 2) to improve alignment with ISO 14001:2004. The ANSI-ASQ National Accreditation Board (ANAB) has issued two Heads-up documents that deal with the changes and transition process for moving from ISO 9001:2000 to ISO 9001:2008. These can be accessed from the ANAB web page www.anab.org. Refer to Heads-up numbers 129 (migration) and 135 (where/how to buy the standard.) The transition/migration process has the following requirements: Twelve months after the release of ISO 9001:2008, all new and re-certification audits must be done to the ISO 9001:2008 standard. Twenty-four months after release of ISO 9001:2008, all ISO 9001:2000 certificates will be invalid. Upgrading from ISO 9001:2000 to ISO 9001:2008 requires a surveillance or recertification audit to be conducted.
If you are certified to ISO 9001:2000, you can continue with that revision level for a period of time depending where your organization is within its current three-year certificate cycle. Each certification/registration body (CRB) will have its own practices/rules regarding when and under what conditions an existing certification can be upgraded to ISO 9001:2008. However, in all cases, there must be either a surveillance or re-certification audit executed before an ISO 9001:2000 certificate can be upgraded to ISO 9001:2008. How can an organization demonstrate to its CRB that is has reviewed the changes to ISO 9001:2000, analyzed the new/changed wording of ISO 9001:2008 and, if required, made modifications to its quality management system (QMS)? One way is to use the following checklist. It has been developed based on the key clauses of ISO 9001:2008, clauses 4 thru 8.
Smithers Quality Assessments 2009: www.smithersregistrar.com Phone: 1-866-688-0134 J&S Sedlak, LLC 2009: www.sedlakconsulting.com Phone: 330-936-3436
How to Use the Checklist: First and foremost obtain at least one copy of ISO 9001:2008. (See ANAB Heads-up No. 135 for directions on how to obtain a copy.) Next, determine if the existing documented QMS and actual practices meet the requirements of ISO 9001:2008. The checklist has three categories: o Meets this requirement o Needs some modification o Clause not applicable. (If you check this box, remember that only sub-clauses in section 7 can be claimed to be not applicable, and your scope statement and related documentation must contain justification for such exclusions.) For each clause/sub-clause, use the Comments/Notation cells to annotate where the requirement is met. This may be a reference to a document, policy, procedure, work instruction, process document, etc. When completed, notify your CRB that you are ready to be audited in accordance with the requirements of ISO 9001:2008. The completed checklist will provide one form of objective evidence (at the minimum, it will be a solid audit-trail) that your organization has completed an analysis of ISO 9001:2008 and, if applicable, made required changes to its QMS.
About Smithers Quality Assessments Smithers Quality Assessments was established in 1993 as an accredited third-party registrar, providing manufacturers and service providers quality and environmental management system certification services to ISO 9001, ISO 14001 and other industry-specific standards. SQA is consistently ranked as a leader in customer satisfaction by independent surveys of registered companies. www.smithersregistrar.com
About J&S Sedlak, LLC (Sedlak Consulting) For over fifteen years, John Sedlak led Smithers Quality Assessments, a leading certification/registration body located in Akron, OH. Since retirement, he has established a training/consulting practice, J&S Sedlak, LLC, specializing in the ISO standards and their implementation. You can learn more by accessing the web page at www.sedlakconsulting.com. It is a quick-read. John welcomes your inquiries.
ISO 9001:2000 vs. ISO 9001:2008 Analysis Tool

* ISO 9001:2008 was released on November 13, 2008 * On or after November 13, 2009, all new certifications and re-certifications must be to ISO 9001:2008. * On or after November 13, 2010, any existing certification to ISO 9001:2000 will no longer be valid. Current QMS Documentation & Practice ---Meets this Needs some Clause is not Requirement Modification Applicable
Clause 4.1 a 4.1 e
Summary of change(s)
Comment on Change(s)
Very slight change in wording. Provides some leeway to organization - not all process need to be "measured." More emphasis on the need for the organization to retain control for outsourced processes, and not rely solely on the controls of the organization to which the process was outsourced; "processes" not limited to product realization processes.
Comments / Notations
"where applicable" added to "measure" these processes.
4.1 plus Notes 1, 2&3
If process(es) that affect quality of product are outsourced, organization must define controls.
Clause
Slight shift in emphasis to indicate "procedures" and "records" are related. Can be: a stand alone procedure; one document containing more than one procedure; one procedure may be expressed in more than one document. Reduces the need to control all external documents. However, places extra responsibility on the organization to define those external documents that are important. Added emphasis from previous "maintained."
Current QMS Documentation & Practice ---Meets this Needs some Clause is not Requirement Modification Applicable
4.2.1 "Records" now c&d included in these sub-clauses.
4.2.1, Slight elaboration on Note 1 meaning of "Documented procedure"
4.2.3 f External documents determined to be important must be controlled
4.2.4 Records are to be controlled.
Clause
Emphasis on the fact that the management representative needs to be employed by the organization and be a member of the organization's management team. "Affecting product quality requirements" applies to any task within the QMS, not just direct manufacturing or service provision Removed the word "quality" to indicate that all requirements are important, not just "quality requirements." Emphasis on need to "achieve" and not just "satisfy" competency requirements.
5.5.2 Management representative to be a member of organization's management.
6.2.1 Persons that affect product conformity requirements to be competent
6.2.2 Determine a ,b competency of personnel affecting product requirements; provide training to achieve needed competence.
Clause
Recognized the importance of IS in today's environment. Physical factors and others, e.g., noise, temperature, humidity, lighting, weather. Grammar only. "Measurement" added to be sure that this action is included when considering elements of the QMS needed to achieve conformity with requirements. Added to clarify the "statutory" as used applies only to product requirements. Slight shift in emphasis from simply taking action to taking responsibility.
6.3 Added "information systems" (IS) to support services. 6.4 Added a note to explain "work environment."
7.1 b Restructure of grammar. 7.1 c Added "measurement" as an action to be considered.
7.2.1 c Added word "applicable."
7.2.1 d "Determined" changed to "considered necessary."
Clause
Explains what is meant by "post delivery activities." Elaborates on the differences and similarities between design "review," "verification" and "validation;" may be separate or combined depending upon needs of product or organization. Grammar only.
7.2.1 New Note.
7.3.1 New Note.
7.3.2 2nd para 7.3.3 1st para
"These" changed to "The." Changed "in a form that enables " to "in a form suitable for" verification.
7.3.3 b Eliminated "for."
Emphasis placed on suitability of design being verified not simply an arbitrary acknowledgement that it can be verified. Grammar only.
Clause
Information can include details on preservation of product. Grammar only.
7.3.3 New Note
7.3.7 No text changes 1st & paragraphs merged. 2nd para 7.5.1 d "Devices" changed to "equipment."
Recognition that measurements can be taken with a wide variety of options. Clarified that the subject was release of product. The word "consequences" adds emphasis to the responsibility of the organization to establish process controls for "special processes."
7.5.1 f Added "product" before "release."
7.5.2 Slight change in wording to emphasize the need for process controls for "special processes."
Clause
Clarified that it is important for product to be identified relative to its conformance status throughout the product realization process. Emphasis shift from simple recording to maintenance of such records. No substantive change.
7.5.3 Expanded 2nd requirement for para inspection (monitoring and measuring) status throughout the product realization process. 7.5.3 Regarding 3rd para "traceability:" changed "record" to "maintain records." 7.5.4 Regarding damaged 1st para or unsuitable customer supplied product, minor rewording. 7.5.4 Added "and personal Note data."
Slight addition to indicate that there may be times when organizations come into possession of personal data from folks that are not their employees.
Clause
Expanded to convey intent of requirement.
7.5.5 Regarding 1st para preservation of product, added words to convey that this applies to "conformity to requirements." 7.6 "Devices" changed to "equipment."
Recognition that measurements can be taken with a wide variety of options. Clarified that organization must decide all actions, not just one or the other. Grammar only.
7.6 a Added "or both" to "verified or calibrated."
7.6 c Regarding evidence of "calibration status' only a slight rewording. 7.6 Made a separate 4th para paragraph of one sentence.
Grammar only.
Clause
Expanded explanation of confirmation and validation of computer software; included in actions associated with configuration management. Change made to clarify that there may be other product requirements that go beyond those that simply define the product. Offers hints at sources for monitoring customer satisfaction. Grammar only.
7.6 Completely Note rewritten.
8.1 Conformity "of the product" changed to "to product requirements."
8.2.1 Customer new satisfaction. Note
8.2.2 Added the word 2nd "The" at the para beginning of 3rd sentence.
Clause
Grammar only.
8.2.2 Actually, just a total new rewording dealing para with the need for a documented procedure. 8.2.2 Simply a move of 4th para part of "old" 3rd paragraph to a separate paragraph dealing with need to maintain records. 8.2.2 Move of some words, 5th para and added "any necessary corrections and corrective."
Grammar only.
8.2.2 Deleted references Note to obsolete documents (ISO 10011-1, -3) and added reference to ISO 19011. 8.2.3 Deleted "to ensure 1st para conformity of the product."
Clarification of required actions on the part of persons responsible for area audited to take action. Organizations should obtain a copy of ISO 19011, review and assess impact on internal audit process. This should be selfevident; also actions may be taken to correct the system.
Clause
Provides latitude to management, but also places onus of proof that the defined monitoring and measuring are the results of a well executed thought process.
8.2.3 Deals with selection new of monitoring and Note measurement techniques for processes.
8.2.4 Added need to 1st para provide evidence of product conformity.
Just good record keeping; allows organization to use data for improvement actions.
8.2.4 Emphasis on 2nd identification of para person authorizing release of product to the customer.
Someone needs to say "okay to ship."
Clause
No substantive change.
8.2.4 Slight change in 3rd para word-order dealing with release of product to the customer and such action not being taken until all required actions are taken. 8.3 Slight change in 1st para wording of second sentence dealing with need for a procedure for control of nonconforming product. 8.3 "Where applicable" 2nd added to start of para second applicable.
No substantive change.
Recognizes that there are a myriad of circumstances that affect disposition of nonconforming product.
Clause
Actually, not a new requirement - simply a move of the requirement from paragraph status to bullet point "d." No substantive change.
8.3 d Addresses those new situations where nonconforming product may be in the hands of the customer. 8.3 Some paragraph 3rd & positions changed. 4th paras 8.4 b Deleted reference to 7.2.1; added reference to 8.2.4. 8.4 c Added references to 8.2.3 and 8.2.4 8.4 d Added reference to 7.4. 8.5.2 Changed "cause" 1st para (singular) to "causes" (plural). 8.5.2 f Added "the effectiveness"
No substantive change. No substantive change. No substantive change. Recognized that there may be one or more causes for problems. Emphasis on the need for corrective actions to be effective - e.g., not repeat or cause other issues/problems.
Clause
Emphasis on the need for preventive actions to be effective - e.g., truly prevent the identified potential problem and cause other issues/problems.
8.5.3 e Added "the effectiveness"

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ISO 9001:2008 Revisions from ISO 9001:2000

ISO 9001:2000 vs. ISO 9001:2008 Analysis Tool

Clause 4.1 a 4.1 e

"where applicable" added to "measure" these processes.

4.1 plus Notes 1, 2&3

4.2.1 "Records" now c&d included in these sub-clauses.

4.2.1, Slight elaboration on Note 1 meaning of "Documented procedure"

4.2.3 f External documents determined to be important must be controlled

4.2.4 Records are to be controlled.

5.5.2 Management representative to be a member of organization's management.

6.2.1 Persons that affect product conformity requirements to be competent

7.1 b Restructure of grammar. 7.1 c Added "measurement" as an action to be considered.

7.2.1 c Added word "applicable."

7.2.1 d "Determined" changed to "considered necessary."

7.2.1 New Note.

7.3.1 New Note.

7.3.2 2nd para 7.3.3 1st para

7.3.3 b Eliminated "for."

7.3.3 New Note

7.5.1 f Added "product" before "release."

7.6 a Added "or both" to "verified or calibrated."

7.6 Completely Note rewritten.

8.1 Conformity "of the product" changed to "to product requirements."

8.2.1 Customer new satisfaction. Note

8.2.4 Added need to 1st para provide evidence of product conformity.

Someone needs to say "okay to ship."

8.5.3 e Added "the effectiveness"

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